Version July 2023
The FDA has approved an extension of the expiration date of ADMA Biologics' Asceniv (immune globulin) 10% liquid from 24 to 36 months when stored at 2 to 8°C (36 to 46°F). The new expiration date is valid for 6 Asceniv lots that were manufactured and distributed in 2019 and 2020. Future lots will be labeled according to the new dating period.
Further information, including the impacted lots, may be found at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/expiration-date-extension-6-asceniv-immune-globulin-intravenous-human-slra-10-liquid-lots.
The FDA has approved an extension of the expiration date of ADMA Biologics’ Bivigam (immune globulin) intravenous liquid 10% from 24 to 36 months when stored at 2 to 8°C (36 to 46°F). The new expiration date is valid for 120 Bivigam lots that were manufactured and distributed in 2020 to 2022. Future lots will be labeled according to the new dating period.
Further information, including the impacted lots, may be found at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/expiration-date-extension-120-bivigam-immune-globulin-intravenous-human-10-liquid-lots-manufactured.
The FDA along with manufacturers of affected products have voluntarily withdrawn certain lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) due to a higher rate of allergic/hypersensitivity-type reactions, some clinically significant.
Further information on affected products and lot numbers is available at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/voluntary-lot-withdrawals-immune-globulin-intravenous-igiv-and-immune-globulin-subcutaneous-igsc
The FDA has approved an extension of the expiration date of Octapharma’s Cutaquig (immune globulin) subcutaneous injection from 24 to 36 months when stored at 2 to 8°C (36 to 46°F). The new expiration date is valid for 42 Cutaquig lots that were manufactured and distributed in 2019 to 2020. The 6-month shelf life for Cutaquig stored at room temperature up to 25°C (77°F) is unchanged, and the expiration date extension does not apply to lots of Cutaquig that have already been stored at 25°C.
For additional information and the list of lots, please refer to https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/expiration-date-extension-42-cutaquig-immune-globulin-subcutaneous-human-hipp-165-solution-lots.
Thrombosis may occur with immune globulin products. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. (Note: The following IV products do not contain sucrose: Asceniv, Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam 5%, Octagam 10%, Panzyga, and Privigen.) For patients at risk of renal dysfunction or acute renal failure, administer IGIV products at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration.
Note: Not all products are interchangeable with regards to route of administration; consult manufacturers' labeling for additional information. Consider osmolarity and concentration during product selection; infuse as slowly as indication and stability allow (see "Immune Globulin Product Comparison" section in Appendix for details). Dosage expressed as mg/kg or mL/kg dependent upon route of administration; use extra caution to ensure accuracy.
Immune thrombocytopenia (ITP):
Acute: Carimune NF 6%, Gammaked, Gamunex C: IV: 400 mg/kg/day for 2 to 5 consecutive days or 1,000 mg/kg/day for 1 to 2 days.
Isoimmune hemolytic disease (Rh-incompatibility): IV: GA ≥35 weeks: 500 to 1,000 mg/kg/dose once over 2 hours; if needed, dose may be repeated in 12 hours; most effective when administered as soon as possible after diagnosis (Ref).
Measles, prophylaxis (Ref):
Preexposure prophylaxis (eg, during an outbreak, travel to endemic area): Immunocompromised patients: IV: ≥400 mg/kg/dose within 3 weeks before anticipated exposure.
Postexposure prophylaxis: Any neonate without evidence of measles immunity:
IM: 0.5 mL/kg/dose within 6 days of exposure. Note: Not all immune globulin preparations may be administered by the IM route; of the products currently available on the market, GamaSTAN may be given IM; consult product labeling for additional information as market availability may change. Note: GamaSTAN manufacturer labeling suggests a lower IM dose; however, this dosing was based on previous immune globulin donor potency concentrations; recent data indicates that potency from current donor populations has decreased (ie, measles immunity now from vaccinations instead of immunity from disease) requiring a higher IM immune globulin dose (0.5 mL/kg) in all patients without evidence of measles immunity to ensure adequate serum titers.
IV: 400 mg/kg/dose within 6 days of exposure.
Myasthenia gravis (severe exacerbation): IV: 400 to 1,000 mg/kg/dose once daily over 2 to 5 days for a total dose of 2,000 mg/kg; if additional therapy required, dose should be based on clinical response and titrated to minimum effective dose (Ref).
Myocarditis, acute: IV: 2,000 mg/kg as a single dose. A cohort study of 21 young patients, including neonates, showed improvement in LVF recovery and survival at 1 year as compared to untreated historical cohort (Ref); efficacy results are variable (Ref); the largest data analysis did not show clear clinical benefit nor positive impact on survival (Ref).
Sepsis, adjunctive treatment: IV: Limited data available; efficacy results variable: Usual dose: 500 to 1,000 mg/kg/dose once daily for 1 to 3 days (Ref). The largest trial, INIS (n=3,493), reported no difference in outcomes (including incidence of subsequent sepsis, death, or major disability at 2 years) between treatment and control groups using 500 mg/kg/day for 2 days (Ref).
Note: Not all products are interchangeable with regards to route of administration; consult manufacturers' labeling for additional information. Product-specific dosing is provided where applicable; approval ages vary by product; see manufacturers' labeling. Some clinicians use ideal body weight or an adjusted ideal body weight in morbidly obese patients to calculate an IVIG dose (Ref). Dosage expressed as mg/kg or mL/kg and is dependent upon route of administration; use extra caution to ensure accuracy.
Acute disseminated encephalomyelitis (ADEM): Limited data available: Children and Adolescents: IV: 1,000 mg/kg/dose once daily for 2 days (Ref).
Colitis due to Clostridioides difficile, chronic: Limited data available: Infants and Children: IV: 400 mg/kg/dose every 3 weeks resulted in resolution of colitis symptoms during treatment; duration of therapy was unclear (n=5; age range: 6 to 37 months) (Ref).
Dermatomyositis, refractory: Limited data available: Children: IV: 1,000 mg/kg/dose once daily for 2 days; Note: If maintenance therapy is required, the dose and frequency should be based on clinical response and doses should not exceed 2,000 mg/kg per treatment course (Ref).
Hematopoietic cell transplantation (HCT) with hypogammaglobulinemia (IgG <400 mg/dL), prevention of bacterial infection: Limited data available (Ref): Note: Increase dose or frequency to maintain IgG concentration >400 mg/dL.
Within first 100 days after HCT:
Infants and Children (Allogeneic HCT recipients): IV: 400 mg/kg/dose once monthly.
Adolescents: IV: 500 mg/kg/dose once weekly.
>100 days after HCT: Infants, Children, and Adolescents: IV: 500 mg/kg/dose every 3 to 4 weeks.
Hepatitis A, prophylaxis: Limited data available:
Preexposure prophylaxis upon travel into endemic areas (Ref): Note: Hepatitis A vaccine preferred for pediatric patients ≥6 months (Ref):
Infants, Children, and Adolescents: GamaSTAN:
Anticipated duration of risk ≤1 month: IM: 0.1 mL/kg/dose as a single dose.
Anticipated duration of risk 1 to 2 months: IM: 0.2 mL/kg/dose as a single dose.
Anticipated duration of risk ≥2 months: IM: 0.2 mL/kg/dose every 2 months.
Postexposure prophylaxis (Ref): Note: Hepatitis A vaccine preferred for pediatric patients ≥12 months (Ref):
Infants: GamaSTAN: IM: 0.1 mL/kg/dose as a single dose given within 14 days of exposure and prior to manifestation of disease.
Children and Adolescents: GamaSTAN: IM: 0.1 mL/kg/dose as a single dose given within 14 days of exposure and prior to manifestation of disease; not needed if at least 1 dose of hepatitis A vaccine was given previously or as part of postexposure prophylaxis unless patient has chronic liver disease or is immunocompromised.
Bacterial infection prophylaxis in patients with HIV and hypogammaglobulinemia: Limited data available (Ref):
Infants and Children:
Primary prophylaxis for serious bacterial infection in patients with hypogammaglobulinemia (IgG <400 mg/dL): IV: 400 mg/kg/dose every 2 to 4 weeks.
Secondary prophylaxis for invasive bacterial infections: Should only be used if subsequent infections are frequent severe infections (>2 infections during a 1-year period): IV: 400 mg/kg/dose every 2 to 4 weeks.
Immune thrombocytopenia (ITP):
Carimune NF 6%: Infants, Children, and Adolescents:
Acute therapy: IV: 400 mg/kg/dose once daily for 2 to 5 days to maintain platelet count ≥30,000/mm3 and/or to control significant bleeding. If platelet response is adequate (30,000 to 50,000/mm3) after the first 2 doses, then may discontinue therapy.
Chronic therapy: IV: 400 mg/kg/dose as a single infusion to maintain platelet count ≥30,000/mm3 and/or to control significant bleeding; may increase to 800 to 1,000 mg/kg/dose if response inadequate.
Flebogamma DIF 10%: Children ≥2 years and Adolescents: Chronic therapy: IV: 1,000 mg/kg/dose once daily for 2 consecutive days.
Gammaked, Gamunex-C: Infants, Children, and Adolescents: Acute or chronic therapy: IV: 400 mg/kg/dose once daily for 5 consecutive days or 1,000 mg/kg/dose once daily for 2 consecutive days; if an adequate platelet response is observed after the initial 1,000 mg/kg/dose, then the subsequent dose may be held.
Privigen: Adolescents ≥15 years: Chronic therapy: IV: 1,000 mg/kg/dose once daily for 2 days.
Kawasaki disease, treatment: Limited data available: Note: Use in combination with aspirin; may consider the addition of corticosteroids in patients at high risk for IVIG resistance or developing coronary artery aneurysms (Ref).
Infants and Children: IV: 2,000 mg/kg as a single dose infused over 8 to 12 hours; usually administered within 10 days of disease onset; however, may be administered >10 days from onset in patients with delayed diagnosis or with persistent symptoms of systemic inflammation with persistent fever and/or coronary artery aneurysms. If signs and symptoms persist ≥36 hours after completion of the infusion, retreatment with a second dose of 1,000 or 2,000 mg/kg infusion may be considered with or without corticosteroids; a lower second dose has been suggested to minimize risk for adverse drug reactions (eg, hemolytic anemia) (Ref). Note: A maximum dose has not been defined; a reasonable maximum dose of 100 to 140 g/dose has been suggested during times of drug shortages or when cost is a consideration (Ref).
Measles, prophylaxis: Note: Route of administration varies with product; verify route prior to administration.
ACIP recommendations (Ref): Infants, Children, and Adolescents:
Preexposure prophylaxis (eg, during an outbreak, travel to endemic area): Note: Indicated for patients already receiving immune globulin therapy.
IV: ≥400 mg/kg/dose within 3 weeks before anticipated exposure.
SUBQ: 200 mg/kg/dose once weekly for 2 consecutive weeks prior to anticipated exposure. Note: Not all immune globulin preparations may be administered by the SUBQ route; consult product labeling for additional information as market availability may change.
Postexposure prophylaxis (in any person without evidence of measles immunity):
Infants, Children, and Adolescents:
IM: 0.5 mL/kg/dose (maximum dose: 15 mL/dose) within 6 days of exposure; in adults, doses >10 mL should be split into multiple injections and administered at different sites; in pediatric patients, may also split doses <10 mL based on patient size. Note: Not all immune globulin preparations may be administered by the IM route; of the products currently available on the market, GamaSTAN may be given IM; consult product labeling for additional information as market availability may change. GamaSTAN manufacturer labeling suggests a lower IM dose; however, this dosing was based on previous immune globulin donor potency concentrations; recent data indicates that potency from current donor populations has decreased (ie, measles immunity now from vaccinations instead of immunity from disease) requiring a higher IM immune globulin dose (0.5 mL/kg) in all patients without evidence of measles immunity to ensure adequate serum titers.
IV: 400 mg/kg/dose within 6 days of exposure.
Product-specific dosing:
Cutaquig: SUBQ infusion: Patients with primary humoral immunodeficiency: Children ≥2 years and Adolescents:
Preexposure prophylaxis: SUBQ: Increase dose to ≥245 mg/kg/dose once weekly or equivalent if dosing is not on a weekly schedule (if current dose is less).
Cuvitru: SUBQ infusion: Patients with primary humoral immunodeficiency: Children ≥2 years and Adolescents:
Preexposure prophylaxis: SUBQ: Increase dose to ≥230 mg/kg/dose once weekly or equivalent if dosing is not on a weekly schedule (if current dose is less).
Flebogamma DIF 5%, Gammagard Liquid, Gammagard S/D, Gammaplex 5% and 10%: IV: Patients with primary humoral immunodeficiency: Children ≥2 years and Adolescents:
Preexposure prophylaxis: IV: Increase dose to ≥530 mg/kg every 3 to 4 weeks (if current dose is less).
Postexposure prophylaxis: IV: 400 mg/kg once as soon as possible and within 6 days of exposure.
GamaSTAN: IM: Infants, Children, and Adolescents
Immunocompromised:
Postexposure prophylaxis: IM: 0.5 mL/kg immediately; maximum dose: 15 mL/dose.
Immunocompetent:
Postexposure prophylaxis: IM: 0.25 mL/kg within 6 days of exposure. Note: CDC/ACIP recommend 0.5 mL/kg/dose for all patients (Ref).
Gammaked, Gamunex-C: IV: Children ≥2 years and Adolescents:
Preexposure prophylaxis: IV: Increase dose to ≥400 mg/kg every 3 to 4 weeks just prior to expected exposure (if current dose is less).
Postexposure prophylaxis: IV: 400 mg/kg once as soon as possible after exposure.
Hizentra: SUBQ infusion: Patients with primary humoral immunodeficiency: Children ≥2 years and Adolescents:
Preexposure prophylaxis: SUBQ:
Patients receiving weekly or more frequent dosing receiving <200 mg/kg weekly: Increase dose to ≥200 mg/kg/dose weekly for 2 consecutive weeks.
Patients receiving biweekly dosing: Increase dose to ≥400 mg/kg once (if current dose is less).
Postexposure prophylaxis (regardless of prior dosing schedule): SUBQ: 400 mg/kg administered as soon as possible after exposure.
Octagam 5%: IV: Patients with primary humoral immunodeficiency: Children ≥6 years and Adolescents:
Preexposure prophylaxis: IV: Increase dose to ≥530 mg/kg every 3 to 4 weeks (if current dose is less).
Postexposure prophylaxis: IV: 400 mg/kg once as soon as possible and within 6 days of exposure.
Privigen: IV: Patients with primary humoral immunodeficiency: Children ≥3 years and Adolescents:
Preexposure prophylaxis: IV: Increase dose to ≥530 mg/kg every 3 to 4 weeks (if current dose is less).
Postexposure prophylaxis: IV: 400 mg/kg once as soon as possible and within 6 days of exposure.
Multiple sclerosis (relapsing-remitting, when other therapies cannot be used): Limited data available:
Children and Adolescents: Dosage regimen variable; optimal dose not established: IV: 1,000 mg/kg/dose once monthly, with or without an induction of 400 mg/kg/day for 5 days (Ref).
Multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2: Limited data available:
Note: Recommended for initial therapy in combination with glucocorticoids (ie, methylprednisolone) (Ref).
Infants, Children, and Adolescents: IV: 2,000 mg/kg once, infused over ~12 hours; maximum dose: 100 g (Ref). Note: If cardiac function is impaired or patient is fluid overloaded, consider slowing administration rate (eg, ≥16 hours) or splitting into 2 infusions (1,000 mg/kg/dose daily for 2 days); monitor fluid status closely (Ref).
Myasthenia gravis, severe exacerbation: Limited data available: Children: IV: 400 to 1,000 mg/kg/dose once daily over 2 to 5 days for a total dose of 2,000 mg/kg; if additional therapy required, dose should be based on clinical response and titrated to minimum effective dose (Ref).
Myocarditis, acute: Limited data available: Infants, Children, and Adolescents: IV: 2,000 mg/kg as a single dose. A cohort study of 21 children showed improvement in LVF recovery and survival at 1 year as compared to untreated historical cohort (Ref); efficacy results are variable (Ref); the largest data analysis did not show clear clinical benefit nor positive impact on survival (Ref).
Primary immunodeficiency disorders: Adjust dose/frequency based on desired IgG concentration and clinical response; a trough IgG concentration of ≥500 mg/dL has been recommended by some experts (Ref); consult product specific labeling for appropriate age groups.
IV infusion:
Asceniv: Children ≥12 years and Adolescents: IV: 300 to 800 mg/kg every 3 to 4 weeks.
Bivigam: Children ≥6 years and Adolescents: IV: 300 to 800 mg/kg every 3 to 4 weeks.
Carimune NF: Infants, Children, and Adolescents: IV: 400 to 800 mg/kg/dose every 3 to 4 weeks.
Flebogamma 5% DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gamunex-C, Panzyga: Children ≥2 years and Adolescents: IV: 300 to 600 mg/kg/dose every 3 to 4 weeks.
Gammaplex 5% and 10%: Children ≥2 years and Adolescents: IV: 300 to 800 mg/kg every 3 to 4 weeks.
Octagam 5%: Children ≥6 years and Adolescents: IV: 300 to 600 mg/kg/dose every 3 to 4 weeks.
Privigen: Children ≥3 years and Adolescents: IV: 200 to 800 mg/kg/dose every 3 to 4 weeks.
SUBQ infusion:
Cutaquig, Cuvitru: Children ≥2 years and Adolescents:
Patients switching from IGIV therapy: SUBQ infusion: Begin 1 week after last immune globulin IV dose. Use the following equations to calculate initial dose:
Initial weekly dosing: Dose (grams) = (IV dose [grams] divided by IV dose interval [weeks]), then multiply this dose by 1.3 (dose adjustment factor). Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5 (for Cuvitru) or by 6 (for Cutaquig).
Biweekly dosing (grams): Multiply the calculated weekly dose by 2.
Frequent dosing (2 to 7 times per week) (grams): Divide the calculated weekly dose by the desired number of times per week.
Note: For subsequent dose adjustments, refer to product labeling.
Patients switching from another IG SubQ product: SUBQ infusion:
Weekly dosing (grams): Weekly dose is the same as the prior immune globulin subcutaneous weekly dose.
Biweekly dosing (grams): Multiply the calculated weekly dose by 2.
Frequent dosing (2 to 7 times per week) (grams): Divide the calculated weekly dose by the desired number of administration times per week.
Note: For subsequent dose adjustments, refer to product labeling.
Gammagard Liquid, Gammaked, Gamunex-C: Children ≥2 years and Adolescents: SUBQ infusion: Begin 1 week after last IV dose. Use the following equation to calculate initial dose:
Initial weekly dose: Dose (grams) = (1.37 x IV dose [grams]) divided by (IV dose interval [weeks]); Note: For subsequent doses, refer to product labeling. Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 10.
Hizentra: Children ≥2 years and Adolescents: SUBQ infusion: For weekly dosing or frequent (up to daily), begin 1 week after last IV or SUBQ infusion. For biweekly dosing, begin 1 or 2 weeks after last IV infusion or 1 week after the last SUBQ weekly infusion. Note: Patient should have received an IV immune globulin routinely for at least 3 months before switching to SUBQ. Use the following equation to calculate initial dose:
Initial weekly dose: Dose (grams) = (Previous IV dose [grams]) divided by (IV dose interval [weeks]) then multiply by 1.37; if switching from a different SUBQ formulation to Hizentra, maintain previous weekly SUBQ dose initially. Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5.
Note: Provided the total weekly dose is maintained, any dosing interval from daily up to biweekly (every 2 weeks) may be used. Use the following calculations to calculate frequent or biweekly dosing:
Biweekly dose (grams): Dose = Calculated or previous weekly SUBQ dose (grams) multiplied by 2.
Frequent (2 to 7 times per week) dosing: Dose (grams) = Calculated or previous weekly dose (grams) divided by the desired number of times per week (eg, for 3 times per week dosing, divide weekly dose by 3).
Note: For subsequent doses refer to product labeling.
Xembify: Children ≥2 years and Adolescents:
Patients switching from another IG SUBQ product: SUBQ infusion: Weekly dose is the same as the prior immune globulin subcutaneous weekly dose (grams).
Note: For subsequent dose adjustments, refer to product labeling.
Patients switching from IGIV therapy: SUBQ infusion: Begin treatment 1 week after patient's last immune globulin IV.
Initial weekly dosing (grams): Previous IV dose (grams) divided by IV dose interval (weeks) then multiply by 1.37. Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5.
Note: For subsequent dose adjustments, refer to product labeling.
Frequent (2 to 7 times per week) dosing (grams): Divide the calculated weekly dose by the desired number of times per week.
Rubella, prophylaxis during pregnancy (postexposure): GamaSTAN: Adolescents: IM: 0.55 mL/kg/dose as a single dose within 72 hours of exposure (Ref); Note: Not recommended for routine use; may reduce, but not eliminate, risk for rubella. In adults, total dose volumes >10 mL should be split into multiple injections given at different sites.
Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN): Limited data available:
Infants, Children, and Adolescents: IV: Usual dose: 1,500 to 2,000 mg/kg total dose as a single dose or divided over 2 to 4 days; dosing based on retrospective reviews and case reports; efficacy results are variable (Ref).
Varicella-zoster, postexposure prophylaxis (independent of HIV-status):
Infants, Children, and Adolescents: Note: Use only if varicella-zoster immune globulin is unavailable.
IV: 400 mg/kg as a single infusion as soon as possible and within 10 days of exposure; ideally within 96 hours of exposure (Ref).
IM: GamaSTAN: 0.6 to 1.2 mL/kg/dose as a single dose within 72 hours of exposure (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
IV: Use with caution due to risk of immune globulin-induced renal dysfunction; the rate of infusion and concentration of solution should be minimized. Discontinue if renal function deteriorates during treatment.
IM: There are no dosage adjustments provided in the manufacturer's labeling.
SubQ infusion: There are no dosage adjustments provided in the manufacturer's labeling; consider lower, more frequent dosing.
IM, IV, SubQ infusion: There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Immune globulin (Intravenous, subcutaneous, and intramuscular): Drug information")
Note: Always administer each initial IV dose under medical supervision. Route of administration: Not all products are interchangeable with regard to route of administration; consult manufacturer labeling. Several intravenous immune globulin (IVIG) 10% formulations FDA-approved for IV administration only may be administered as a SUBQ infusion based on clinical judgment and patient tolerability. In contrast, do not give higher concentration SUBQ products (eg, 20% [Cuvitru, Hizentra, Xembify]) or IM products (eg, 16% [GamaSTAN {Canadian product}]) intravenously. Dosing: Dosage is expressed as mg/kg or mL/kg and is dependent upon route of administration; use extra caution to ensure accuracy. Product-specific dosing is provided where applicable. Pretreatment: Ensure adequate hydration when using formulations containing certain stabilizers (eg, sucrose) and for patients with risk factors for thrombosis and/or renal complications (eg, preexisting renal insufficiency, diabetes, >65 years of age, heart disease, paraproteinemia, concomitant nephrotoxic agents) (Ref). Many patients do not require premedication prior to receiving IVIG; however, some clinicians may consider administering premedication (eg, acetaminophen, a nonsteroidal anti-inflammatory drug, a glucocorticoid, and/or diphenhydramine), especially if there have been prior reactions or other reasons for special concern (Ref).
Antibody-mediated rejection, treatment (off-label use):
Note: Optimal dose, frequency, and duration are unknown and vary based on institutional protocols. Dose may require large volume of fluid. These are only example regimens; dosing is center dependent.
Heart transplantation: IV: 2 g/kg divided into 2 or 4 doses and given on consecutive days as part of an appropriate combination regimen; if plasmapheresis is utilized, administer 100 mg/kg after each session. Regimen may be re-dosed monthly, if necessary, based on response (Ref).
Kidney transplantation:
Antibody-mediated rejection <1 year after transplant: IV: 1 to 2.4 g/kg in divided doses over 1 to 3 consecutive days as part of an appropriate combination regimen (maximum total daily dose: 1 g/kg); with plasmapheresis, give 100 mg/kg after each session and remaining total dose after final session over 1 to 2 days (Ref).
Antibody-mediated rejection >1 year after transplant: IV: 200 mg/kg every 2 weeks for 3 doses as part of an appropriate combination regimen (Ref).
Lung transplantation: IV: 500 mg/kg to 2 g/kg as part of an appropriate combination regimen (doses >1 g/kg are typically divided into 2 doses and given over 2 days). This regimen may be re-dosed monthly, if necessary, based on response (Ref).
Antiviral prophylaxis:
Hepatitis A, prophylaxis (adjunctive agent):
Note: Hepatitis A vaccine alone is preferred for most individuals; IVIG may be administered in combination with hepatitis A vaccine (at a different anatomical site) in high-risk settings, or alone in individuals who are allergic to hepatitis A vaccine (Ref).
Preexposure prophylaxis upon travel into endemic areas (alternative agent) (GamaSTAN, GamaSTAN S/D [Canadian product]):
Anticipated risk of exposure <1 month: IM: 0.1 mL/kg (Ref).
Anticipated risk of exposure 1 to 2 months: IM: 0.2 mL/kg (Ref).
Anticipated risk of exposure ≥2 months: IM: 0.2 mL/kg every 2 months (Ref).
Postexposure prophylaxis (alternative agent) (GamaSTAN, GamaSTAN S/D [Canadian product]):
IM: 0.1 mL/kg given as soon as possible within 14 days of exposure and/or prior to manifestation of disease; not needed if at least 1 dose of hepatitis A vaccine was given at ≥1 month before exposure, unless patient has HIV infection (Ref).
Measles, prophylaxis:
Measles, preexposure prophylaxis in patients with primary humoral immunodeficiency at risk of measles exposure (eg, during an outbreak, travel to endemic area) who are currently receiving immune globulin therapy:
IV:
Patients receiving Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex 5%, Gammaplex 10%, Gamunex-C, Flebogamma DIF 5%, Flebogamma DIF 10%, Octagam 5%, or Privigen:
If prior routine dose is <400 mg/kg (Gammaked only) or <530 mg/kg (other products): Give at least 400 mg/kg (Gammaked only) or at least 530 mg/kg (other products) as soon as possible before expected exposure followed by resumption of prior dosing in 3 to 4 weeks.
Patients receiving Panzyga:
If prior dose <530 mg/kg: Increase dose to at least 530 mg/kg immediately before expected exposure; increased dose provides adequate serum level for at least 22 days.
If prior dose ≥530 mg/kg: Maintain current dose.
SUBQ:
Patients receiving Cutaquig:
If prior weekly dose <245 mg/kg: Increase dose to 245 mg/kg weekly.
If prior weekly dose ≥245 mg/kg: Maintain current dose.
Patients receiving Cuvitru:
If prior weekly (or weekly equivalent) dose <230 mg/kg: Increase dose to at least 230 mg/kg weekly or the weekly equivalent of 230 mg/kg for dosing intervals other than weekly.
Patients receiving Hizentra:
If prior dosing is weekly or more frequent: Ensure total weekly dose of ≥200 mg/kg for 2 consecutive weeks followed by resumption of prior dosing schedule.
If prior dosing is biweekly: Administer at least 400 mg/kg once followed by resumption of prior dosing schedule.
Measles, postexposure prophylaxis in patients with primary humoral immunodeficiency currently receiving SUBQ or IV immune globulin therapy; patients who are immunocompromised without evidence of immunity; and pregnant or severely immunocompromised patients without evidence of measles immunity (Ref):
IV: 400 mg/kg as a single dose as soon as possible and within 6 days of exposure (Ref). For patients with primary humoral immunodeficiency currently receiving SUBQ or IV immune globulin therapy, resume prior dosing schedule.
SUBQ (Hizentra only): 400 mg/kg as a SUBQ infusion as soon as possible and within 6 days of exposure followed by resumption of prior dosing schedule (Ref). Note: This regimen is generally used for patients with primary humoral immunodeficiency currently receiving Hizentra.
Varicella, postexposure prophylaxis (alternative agent):
Note: Varicella zoster immune globulin is preferred; IVIG may be used if varicella zoster immune globulin is unavailable (Ref).
IV: 400 mg/kg administered as a single dose within 10 days but, ideally, within 96 hours of exposure (Ref).
IM ( GamaSTAN, GamaSTAN S/D [Canadian product]) : 0.6 to 1.2 mL/kg once within 72 hours of exposure. Note: For patients at risk of thrombosis, administer at the lower end of the recommended dosage range (Ref).
Chronic inflammatory demyelinating polyneuropathy:
IV:
Initial: 2 g/kg administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days) followed by maintenance dosing (maximum total daily dose: 1 g/kg) (Ref).
Maintenance: 1 g/kg administered as a single infusion over 1 day or divided into 2 doses over 2 consecutive days, every 3 weeks (Ref). Continue maintenance therapy for 2 to 3 months before determining response to therapy. Further tapering of dose or frequency and the duration of maintenance therapy are individualized depending upon clinical response (Ref).
SUBQ (alternative route): Note: May be used as maintenance therapy for patients who respond to initial IVIG therapy (Ref). Begin maintenance therapy 1 week after last IVIG infusion.
Maintenance: 200 to 400 mg/kg/week administered in 1 or 2 sessions over 1 or 2 consecutive days (Ref). For worsening symptoms, consider restarting IVIG using dosing above.
Dermatomyositis/Polymyositis , severe, life-threatening or refractory:
Note: For dermatomyositis, use in combination with other agents (Ref).
IV: 1 g/kg per day on 2 consecutive days every 4 weeks or 2 g/kg as a single dose every 4 weeks (total monthly dose: 2 g/kg) (Ref). For patients who develop intolerable adverse effects, some experts give 1 g/kg per day once every 2 weeks. Dosing interval may be lengthened once complete clinical response is achieved (Ref).
SUBQ (alternative route): 500 mg/kg once weekly (total monthly dose: 2 g/kg) (Ref).
Duration: Full clinical effect may take up to 6 months. Relapse may occur upon treatment discontinuation; continued treatment may be necessary to maintain control (Ref).
Hypogammaglobulinemia, prophylaxis against bacterial infection:
Acquired secondary to malignancy:
Note: Reserve for patients who have had recurrent infections and have a low serum IgG (eg, <300 to 500 mg/dL); routine prophylaxis not recommended and thresholds for treatment vary (Ref).
IV: Initial: 200 to 400 mg/kg given as a single dose once every 3 to 4 weeks. Adjust dose or frequency to maintain IgG concentration >500 to 700 mg/dL and/or based on response to therapy (Ref).
Hematopoietic cell transplantation (off-label use):
Note: Reserve for patients who have had recurrent infections and have a low serum IgG (eg, <300 to 500 mg/dL); routine prophylaxis not recommended and thresholds for treatment vary (Ref).
≤100 days post–hematopoietic cell transplantation: IV: 500 mg/kg administered as a single dose once weekly (Ref).
>100 days post–hematopoietic cell transplantation: IV: 500 mg/kg administered as a single dose every 3 to 4 weeks (Ref).
Note: Adjust dose or frequency to maintain IgG concentration >500 to 700 mg/dL and/or based on patient's response to therapy (Ref).
Primary humoral immunodeficiency disorders:
IV: 400 to 600 mg/kg as a single dose once every 3 to 4 weeks; adjust dose based on clinical condition and response (see "Note" below). Dosage range: 200 to 800 mg/kg (Ref). Consider using lower concentrations (eg, Carimune NF 3%) in previously untreated patients; may use higher concentrations if tolerated.
SUBQ: 100 to 200 mg/kg once weekly; adjust dose based on clinical condition and response (see "Note" below). Dosage range: 200 to 800 mg/kg (Ref). May facilitate absorption by administering along with hyaluronidase (Ref).
HyQvia: See manufacturer's labeling for initial ramp-up schedule (initiating treatment with a full monthly dose has not been evaluated).
Note: Consistent IgG trough concentrations are typically achieved after 3 to 6 months of regular therapy. Adjust dose to maintain goal IgG trough 500 to 800 mg/dL; occasionally, a goal of >1 g/dL is required (Ref). Refer to "Switching from IV to SUBQ infusion dosing or switching between SUBQ products" below for dosing and administration recommendations when switching between products.
Immune thrombocytopenia:
Immune thrombocytopenia (adjunctive or alternative agent):
Note: For patients who require a rapid increase in platelet count, those who do not respond to glucocorticoids, and those who cannot tolerate glucocorticoids. IVIG may also be used for patients with critical bleeding or a need for urgent surgery or procedures (eg, pregnancy) (Ref).
IV: 1 g/kg once daily for 1 or 2 days; second dose may be withheld if adequate platelet response (eg, platelets >50,000/mm3) in 24 hours (Ref). Alternative dosing: 400 mg/kg once daily for 5 days (Ref).
Fetal and neonatal alloimmune thrombocytopenia (maternal administration): IV: 1 to 2 g/kg per week, with or without glucocorticoids (doses >1 g/kg are typically divided into 2 doses and given over 2 days). Dose is dependent upon gestational age and risk (Ref).
Lambert-Eaton myasthenic syndrome (off-label use): IV: 2 g/kg administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days) (maximum total daily dose: 1 g/kg) (Ref). For patients who respond to initial therapy, IVIG may be repeated every 4 to 12 weeks for symptom recurrence (Ref).
Multifocal motor neuropathy:
Initial: IV: 2 g/kg administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days) (maximum total daily dose: 1 g/kg) (Ref).
Maintenance: Note: Dosing is individualized and based on clinical response.
IV: 1 to 2 g/kg every 2 to 6 weeks. If initial dose was administered over 5 days and was well tolerated, maintenance dose may be administered over a shorter duration (eg, total dose of 2 g/kg administered as 1 g/kg daily for 2 consecutive days) (Ref).
Myasthenia gravis, acute exacerbation (off-label use): IV: 2 g/kg per treatment course, administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days or 1 g/kg once daily for 2 days) (maximum total daily dose: 1 g/kg) (Ref). Note: A single dose of 1 g/kg may have similar efficacy to 1 g/kg given on 2 consecutive days (Ref).
Parvovirus B19 infection, treatment, immunocompromised host (off-label use):
Solid organ transplant: IV: 400 mg/kg once daily for 5 days in combination with a reduction of immunosuppression, if possible (Ref).
Patients with HIV:
Note: Optimal dose not well-defined.
Initial: IV: 400 mg/kg once daily for 5 to 10 days or 1 g/kg once daily for 2 days (Ref).
Maintenance: Note: For patients with a CD4 count <100 cells/mm3 to prevent relapse (Ref).
IV: 400 mg/kg once every 4 weeks (Ref).
Pemphigus foliaceus and vulgaris, refractory (off-label use): IV: 2 g/kg administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days); may repeat every 4 to 6 weeks based on clinical response (Ref).
Toxic shock syndrome, streptococcal (adjunctive agent) (off-label use): IV: 1 g/kg on day 1, followed by 500 mg/kg once daily on days 2 and 3 (Ref).
Switching from IV to SUBQ infusion dosing or switching between SUBQ products:
S witching from IV to SUBQ infusion dosing:
Cutaquig, Cuvitru:
SUBQ infusion: Begin treatment 1 week after patient's last IVIG dose.
Initial weekly dose (grams): Divide the previous IVIG dose (grams) by the number of weeks between IV doses, then multiply this dose by 1.3 (dose adjustment factor).
Every-2-week dosing (grams): Multiply the calculated weekly dose by 2.
Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated weekly dose by the desired number of injections per week.
Note: For subsequent dose adjustments, refer to product labeling.
Gammagard Liquid, Gammaked, Gamunex-C:
SUBQ infusion: Begin 1 week after last IV dose. Use the following equation to calculate initial dose:
Initial weekly dose (grams) = [1.37 × previous IVIG dose (grams)] divided by [number of weeks between IV doses].
Note: For subsequent dose adjustments, refer to product labeling.
Hizentra:
SUBQ infusion: For weekly or frequent (up to daily) dosing, begin 1 week after last IVIG dose. For every-2-week dosing, begin 1 or 2 weeks after last IVIG dose. Note: Patient should have received IVIG routinely for at least 3 months before switching to SUBQ. Use the following equation to calculate initial weekly dose:
Initial weekly dose (grams) = [1.37 × previous IVIG dose (grams)] divided by [number of weeks between IV doses]. To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5.
Note: Provided the total weekly dose is maintained, any dosing interval from daily up to every 2 weeks may be used. Use the following calculations to calculate frequent or every-2-week dosing:
Every-2-week dosing (grams): Multiply the calculated or previous weekly dose by 2.
Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated or previous weekly dose by the desired number of injections per week.
Note: For subsequent dose adjustments, refer to product labeling.
HyQvia:
SUBQ infusion: For patients previously on another IVIG treatment, administer the first dose ~1 week after the last infusion of previous treatment.
Administer the same dose and frequency as the previous IVIG treatment after the initial dose ramp-up. For subsequent dose adjustments, refer to product labeling.
Xembify:
SUBQ infusion: Begin treatment 1 week after patient's last IVIG dose.
Initial weekly dose (grams): [1.37 × previous IVIG dose (grams)] divided by [number of weeks between IV doses].
Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated weekly dose by the desired number of injections per week.
Note: For subsequent dose adjustments, refer to product labeling.
Switching between SUBQ products:
Cutaquig:
SUBQ infusion: Begin treatment 1 week after patient's last SUBQ immune globulin dose regardless of prior treatment regimen/frequency.
Initial weekly dose (grams): Use the same dose as the prior SUBQ immune globulin treatment (grams).
Every-2-week dosing (grams): Multiply the calculated weekly dose by 2.
Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated weekly dose by the desired number of administration injections per week.
Note: For subsequent dose adjustments, refer to product labeling.
Cuvitru:
SUBQ infusion: Begin treatment 1 week after patient's last SUBQ immune globulin dose regardless of prior treatment regimen/frequency.
Weekly dosing (grams): Weekly dose is the same as the prior immune globulin SUBQ weekly dose. If switching from HyQvia, divide the previous HyQvia dose (grams) by the number of weeks between HyQvia doses, then multiply this dose by 1.3 (dose adjustment factor).
Every-2-week dosing (grams): Multiply the calculated weekly dose by 2.
Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated weekly dose by the desired number of administration injections per week.
Note: For subsequent dose adjustments, refer to product labeling.
Hizentra:
SUBQ infusion: For weekly or frequent (up to daily) dosing, begin 1 week after last SUBQ infusion. For every-2-week dosing, begin 1 week after the last SUBQ weekly infusion. Note: Use the following equation to calculate initial weekly dose:
Initial weekly dose: Use previous weekly SUBQ dose initially.
Note: Provided the total weekly dose is maintained, any dosing interval from daily up to every 2 weeks may be used. Use the following conversions to calculate dosing:
Every-2-week dosing (grams): Multiply the calculated or previous weekly dose by 2.
Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated or previous weekly dose by the desired number of injections per week.
Note: For subsequent dose adjustments, refer to product labeling.
HyQvia:
SUBQ infusion: Begin treatment 1 week after patient's last infusion of their previous treatment regardless of prior treatment regimen/frequency.
See manufacturer's labeling for initial ramp-up schedule (initiating treatment with a full monthly dose has not been evaluated).
Xembify:
SUBQ infusion: Weekly dose is the same as the prior immune globulin SUBQ weekly dose (grams).
Note: For subsequent dose adjustments, refer to product labeling.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
IV: Use with caution due to risk of immune globulin-induced renal dysfunction; the rate of infusion and concentration of solution should be minimized. Discontinue if renal function deteriorates during treatment.
IM: There are no dosage adjustments provided in the manufacturer's labeling.
SUBQ infusion: There are no dosage adjustments provided in the manufacturer's labeling; consider lower, more frequent dosing.
IM, IV, SUBQ infusion: There are no dosage adjustments provided in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injectable, Intramuscular [preservative free]:
GamaSTAN: 15% to 18% [150 to 180 mg/mL] (2 mL, 10 mL)
Kit, Subcutaneous:
Hyqvia: 10 g immune globulin (human)/100 mL with an 800 unit hyaluronidase vial, 5 g immune globulin (human)/50 mL with a 400 unit hyaluronidase vial, 2.5 g immune globulin (human)/25 mL with a 200 unit hyaluronidase vial, 20 g immune globulin (human)/200 mL with a 1,600 unit hyaluronidase vial, 30 g immune globulin (human)/300 mL with a 2,400 unit hyaluronidase vial [contains albumin human, edetate (edta) disodium dihydrate]
Solution, Injection [preservative free]:
Gammagard: 1 g/10 mL (10 mL); 2.5 g/25 mL (25 mL); 5 g/50 mL (50 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 30 g/300 mL (300 mL) [latex free]
Gammaked: 1 g/10 mL (10 mL); 5 g/50 mL (50 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL) [latex free]
Gamunex-C: 1 g/10 mL (10 mL); 2.5 g/25 mL (25 mL); 5 g/50 mL (50 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 40 g/400 mL (400 mL) [latex free]
Solution, Intravenous [preservative free]:
Asceniv: 5 g/50 mL (50 mL) [contains polysorbate 80]
Bivigam: 10 g/100 mL (100 mL) [latex free, sugar free; contains polysorbate 80]
Bivigam: 5 g/50 mL (50 mL) [contains polysorbate 80]
Bivigam: 5 g/50 mL (50 mL [DSC]) [sugar free; contains polysorbate 80]
Flebogamma DIF: 0.5 g/10 mL (10 mL); 5 g/50 mL (50 mL); 5 g/100 mL (100 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 20 g/400 mL (400 mL); 10 g/200 mL (200 mL); 2.5 g/50 mL (50 mL) [contains polyethylene glycol (macrogol)]
Gammaplex: 5 g/50 mL (50 mL); 5 g/100 mL (100 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 20 g/400 mL (400 mL); 10 g/200 mL (200 mL) [contains polysorbate 80]
Octagam: 1 g/20 mL (20 mL); 2 g/20 mL (20 mL); 5 g/50 mL (50 mL); 5 g/100 mL (100 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 25 g/500 mL (500 mL [DSC]); 30 g/300 mL (300 mL); 10 g/200 mL (200 mL); 2.5 g/50 mL (50 mL) [sucrose free]
Panzyga: Immune globulin (human)-ifas 1 g/10mL (10 mL); Immune globulin (human)-ifas 30 g/300 mL (300 mL); Immune globulin (human)-ifas 20 g/200 mL (200 mL); Immune globulin (human)-ifas 2.5 g/25 mL (25 mL); Immune globulin (human)-ifas 10 g/100 mL (100 mL); Immune globulin (human)-ifas 5 g/50 mL (50 mL) [latex free]
Panzyga: Immune globulin (human)-ifas 1 g/10mL (10 mL); Immune globulin (human)-ifas 5 g/50 mL (50 mL); Immune globulin (human)-ifas 10 g/100 mL (100 mL); Immune globulin (human)-ifas 2.5 g/25 mL (25 mL); Immune globulin (human)-ifas 20 g/200 mL (200 mL); Immune globulin (human)-ifas 30 g/300 mL (300 mL)
Privigen: 5 g/50 mL (50 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 40 g/400 mL (400 mL)
Solution, Subcutaneous [preservative free]:
Cutaquig: 1 g/6 mL (6 mL); 1.65 g/10 mL (10 mL); 2 g/12 mL (12 mL); 3.3 g/20 mL (20 mL); 4 g/24 mL (24 mL); 8 g/48 mL (48 mL) [latex free; contains polysorbate 80]
Cuvitru: 1 g/5 mL (5 mL); 2 g/10 mL (10 mL); 4 g/20 mL (20 mL); 8 g/40 mL (40 mL); 10 g/50 mL (50 mL)
Hizentra: 1 g/5 mL (5 mL); 2 g/10 mL (10 mL); 4 g/20 mL (20 mL); 10 g/50 mL (50 mL) [contains polysorbate 80]
Xembify: Immune globulin (human)-klhw 1 g/5 mL (5 mL); Immune globulin (human)-klhw 2 g/10 mL (10 mL); Immune globulin (human)-klhw 4 g/20 mL (20 mL); Immune globulin (human)-klhw 10 g/50 mL (50 mL) [latex free; contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Hizentra: 1 g/5 mL (5 mL); 2 g/10 mL (10 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Hizentra: 4 g/20 mL (20 mL) [contains polysorbate 80]
Solution Reconstituted, Intravenous [preservative free]:
Carimune NF: 6 g (1 ea [DSC]); 12 g (1 ea [DSC])
Gammagard S/D Less IgA: 5 g (1 ea); 10 g (1 ea) [contains albumin human, polyethylene glycol (macrogol), polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injectable, Intramuscular:
Gamastan S/D: 15% to 18% [150 to 180 mg/mL] ([DSC])
Solution, Intravenous:
Gammagard: 10% (10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 300 mL)
Gamunex: 10% (25 mL, 50 mL, 100 mL, 200 mL, 400 mL)
Octagam: 5% (50 mL, 100 mL, 200 mL); 10% (20 mL, 50 mL, 100 mL, 200 mL)
Panzyga: 100 mg/mL (10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 300 mL)
Privigen: 10% (25 mL, 50 mL, 100 mL, 200 mL, 400 mL)
Solution, Subcutaneous:
Cutaquig: 165 mg/mL (6 mL, 12 mL, 24 mL, 48 mL) [contains polysorbate 80]
Hizentra: 200 mg/mL (5 mL, 10 mL, 15 mL, 20 mL) [contains polysorbate 80]
Generic: 200 mg/mL (5 mL, 10 mL, 20 mL, 40 mL, 50 mL)
Solution Prefilled Syringe, Subcutaneous:
Hizentra: 4 g/20 mL (20 mL) [contains polysorbate 80]
Solution Reconstituted, Intravenous:
Gammagard S/D: 5 g (1 ea); 10 g (1 ea) [contains albumin human, polyethylene glycol (macrogol), polysorbate 80]
IGIVnex: 10 g (10 mL, 25 mL, 50 mL, 100 mL, 200 mL)
Iveegam Immuno: 1 g (1 ea); 7.5 g (1 ea); 10 g (1 ea)
Carimune NF may contain a significant amount of sodium and also contains sucrose.
Cutaquig contains maltose.
Gammagard S/D may contain a significant amount of sodium and also contains glucose.
Octagam contains maltose.
Hyqvia Kit is supplied with a Hyaluronidase (Human Recombinant) component intended for injection prior to Immune Globulin administration to improve dispersion and absorption of the Immune Globulin.
Parenteral: Note: If plasmapheresis employed for treatment of condition, administer immune globulin after completion of plasmapheresis session.
IV: Infuse over 2 to 24 hours with initial infusion administered slowly and titrated as tolerated; administer in separate infusion line from other medications; if using primary line, flush with NS or D5W (product specific; consult product prescribing information) prior to administration. Decrease dose, rate, and/or concentration of infusion in patients who may be at risk of renal failure. Decreasing the rate or stopping the infusion may help relieve some adverse effects (flushing, changes in pulse rate, changes in blood pressure). Epinephrine should be available during administration.
For initial treatment, a lower concentration and/or a slower rate of infusion should be used. Initial rate of administration and titration is specific to each IVIG product. Refrigerated products should be warmed to room temperature prior to infusion. Some products require filtration; refer to individual product labeling. Antecubital veins should be used, especially with concentrations ≥10% to prevent injection site discomfort.
Asceniv 10%: Primary humoral immunodeficiency: Initial (first 15 minutes): 0.5 mg/kg/minute (0.3 mL/kg/hour); if tolerated, increase every 15 minutes up to 8 mg/kg/minute (4.8 mL/kg/hour).
Bivigam 10%: Primary humoral immunodeficiency: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour) for 10 minutes; if tolerated, increase every 20 minutes by 0.8 mg/kg/minute (0.48 mL/kg/hour) up to 6 mg/kg/minute (3.6 mL/kg/hour).
Carimune NF: Primary humoral immunodeficiency or immune thrombocytopenia: Initial rate: 0.5 mg/kg/minute for 30 minutes; if tolerated, increase to 1 mg/kg/minute, if tolerated after 30 minutes, may increase gradually up to 3 mg/kg/minute; rate in mL/kg/hour varies based on concentration; refer to product labeling.
Flebogamma DIF 5%: Primary humoral immunodeficiency: Initial rate: 0.5 mg/kg/minute (0.6 mL/kg/hour) for the first 30 minutes; if tolerated, increase slowly up to 5 mg/kg/minute (6 mL/kg/hour).
Flebogamma DIF 10%: Primary humoral immunodeficiency or immune thrombocytopenia: Initial rate: 1 mg/kg/minute (0.6 mL/kg/hour) for first 30 minutes; if tolerated, increase slowly up to 8 mg/kg/minute (4.8 mL/kg/hour).
Gammagard Liquid 10%: Primary humoral immunodeficiency: Initial rate: 0.8 mg/kg/minute (0.5 mL/kg/hour) for 30 minutes; if tolerated, increase every 30 minutes up to 8 mg/kg/minute (5 mL/kg/hour).
Gammagard S/D: 5% solution: Initial rate: 0.5 mL/kg/hour; if tolerated, may increase to a maximum rate of 4 mL/kg/hour. If 5% solution is tolerated at maximum rate, may administer 10% solution with an initial rate of 0.5 mL/kg/hour; if tolerated, may increase to a maximum rate of 8 mL/kg/hour.
Gammaked 10%:
CIDP: Initial rate: 2 mg/kg/minute (1.2 mL/kg/hour) for 30 minutes; if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).
Primary humoral immunodeficiency or ITP: Initial rate: 1 mg/kg/minute (0.6 mL/kg/hour) for 30 minutes; if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).
Gammaplex 5%: Primary humoral immunodeficiency or ITP: Initial rate: 0.5 mg/kg/minute (0.6 mL/kg/hour) for 15 minutes; if tolerated, increase every 15 minutes up to 4 mg/kg/minute (4.8 mL/kg/hour).
Gammaplex 10%: Primary humoral immunodeficiency or ITP: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour) for 15 minutes; if tolerated, increase every 15 minutes up to 8 mg/kg/minute (4.8 mL/kg/hour).
Gamunex-C 10%:
CIDP: Initial rate: 2 mg/kg/minute (1.2 mL/kg/hour) for 30 minutes; if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).
Primary humoral immunodeficiency or ITP: Initial rate: 1 mg/kg/minute (0.6 mL/kg/hour) for 30 minutes; if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).
Octagam 5%: Primary humoral immunodeficiency: Initial rate: 0.5 mg/kg/minute (0.6 mL/kg/hour) for 30 minutes; if tolerated, double the infusion rate every 30 minutes up to a maximum rate of <3.33 mg/kg/minute (4.2 mL/kg/hour).
Panzyga 10%: Primary humoral immunodeficiency: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); if tolerated, increase gradually every 15 to 30 minutes up to 8 mg/kg/minute (4.8 mL/kg/hour) in treatment-naive patients or if it has been >8 weeks since last infusion or up to 12 to 14 mg/kg/minute (7.2 to 8.4 mL/kg/hour) in treatment-experienced patients.
Privigen 10%:
ITP: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour); if tolerated, increase gradually up to 4 mg/kg/minute (2.4 mL/kg/hour).
Primary humoral immunodeficiency: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour); if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).
CIDP: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour); if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).
IM: Administer IM in the anterolateral aspects of the upper thigh or deltoid muscle of the upper arm. Avoid gluteal region due to risk of injury to sciatic nerve. Divide doses >10 mL (adult) and inject in multiple sites; in pediatric patients, consider splitting doses <10 mL based on patient size.
SUBQ infusion: Initial dose should be administered in a health care setting capable of providing monitoring and treatment in the event of hypersensitivity. Using aseptic technique, follow the infusion device manufacturer's instructions for filling the reservoir and preparing the pump. Remove air from administration set and needle by priming. Dose may be infused into multiple sites simultaneously. After administration sites are clean and dry, insert subcutaneous needle and prime administration set. Attach sterile needle to administration set, gently pull back on the syringe to assure a blood vessel has not been inadvertently accessed; if blood is present, remove and discard needle and tubing; repeat process using a new needle and tubing and different injection site. Repeat for each injection site; deliver the dose following instructions for the infusion device. Rotate the site(s) between successive infusions. Treatment may be transitioned to the home/home care setting in the absence of adverse reactions.
Cutaquig:
Injection sites: Abdomen, thigh, upper arm, and/or upper leg/hip area (avoid areas that are scarred, tattooed, injured, or inflamed); ≤6 simultaneous injection sites (spaced ≥2 inches apart).
Recommended infusion rate:
Children ≥2 years and Adolescents <18 years: First 2 infusions: ≤15 mL/hour per injection site; subsequent infusions: Gradually increase as tolerated by ~5 to 10 mL/hour per injection site every 2 to 4 weeks to maximum rate of 25 mL/hour per injection site.
Adolescents ≥18 years: First 2 infusions: ≤20 mL/hour per injection site; subsequent infusions: Gradually increase as tolerated by ~10 mL/hour per injection site every 2 to 4 weeks to a maximum rate of 52 mL/hour per injection site.
Recommended infusion volume:
Children ≥2 to 6 years: First 2 infusions: ≤10 mL per injection site; subsequent infusions: Gradually increase as tolerated by ~5 to 10 mL per infusion site every 2 to 4 weeks up to a maximum of 15.5 mL per injection site.
Children >6 years and Adolescents <17 years: First 2 infusions: ≤15 mL per injection site; subsequent infusions: Gradually increase as tolerated by ~5 to 10 mL per infusion site every 2 to 4 weeks up to a maximum of 29 mL per injection site.
Adolescents ≥17 years: First 2 infusions: ≤25 mL per injection site; subsequent infusions: Gradually increase as tolerated by ~10 mL per infusion site every 2 to 4 weeks up to a maximum of 40 mL per site.
Cuvitru: Note: It is recommended that infusion be complete within 2 hours of preparation.
Injection sites: Abdomen, thighs, upper arms, or lateral hip (avoid bony areas, visible blood vessels, and areas that are scarred, inflamed, or infected); ≤4 simultaneous injection sites (spaced 4 inches apart or more).
Maximum infusion rate: 10 to 20 mL/hour per injection site (first 2 infusions); may be increased to 60 mL/hour per injection site (as tolerated) for subsequent infusions.
Maximum infusion volume:
Patients <40 kg: 20 mL per injection site (first 2 infusions); may increase to 60 mL per site for subsequent infusions.
Patients ≥40 kg: 60 mL per injection site.
Gammagard Liquid:
Injection sites: Abdomen, thighs, upper arms, or lower back (avoid bony areas, visible blood vessels, and areas that are scarred, inflamed, or infected); ≤8 simultaneous injection sites (spaced ≥2 inches apart).
Recommended infusion rate:
<40 kg: Initial infusion: 15 mL/hour per injection site; subsequent infusions: 15 to 20 mL/hour per injection site; maximum: 160 mL/hour for all simultaneous sites combined.
≥40 kg: Initial infusion: 20 mL/hour per injection site; subsequent infusions: 20 to 30 mL/hour per injection site; maximum: 240 mL/hour for all simultaneous sites combined.
Maximum infusion volume:
<40 kg: 20 mL per injection site.
≥40 kg: 30 mL per injection site.
Gammaked, Gamunex-C:
Injection sites: Abdomen, thighs, upper arms, and/or lateral hip; ≤6 simultaneous injection sites (spaced ≥2 inches apart) (≤8 sites may be used in adults).
Recommended infusion rate:
<25 kg: 10 mL/hour per infusion site.
≥25 kg: Initial: 15 mL/hour per infusion site; may increase up to 20 mL/hour per infusion site.
Hizentra:
Injection sites: Abdomen, thigh, upper arm, and/or lateral hip (avoid scars, stretch marks, and areas that are tender, bruised, red, or hard); ≤8 simultaneous injection sites (spaced ≥2 inches apart).
Maximum infusion rate: First infusion: 15 mL/hour per injection site (primary humoral immunodeficiency) or 20 mL/hour per injection site (CIDP); subsequent infusions: 25 mL/hour per injection site (primary humoral immunodeficiency) or 50 mL/hour per injection site (CIDP).
Maximum infusion volume: First infusions: 15 mL per injection site (primary humoral immunodeficiency) or 20 mL per injection site (CIDP); subsequent infusions: 25 mL per injection site (primary humoral immunodeficiency) or 50 mL per injection site (CIDP).
HyQvia: Administer the two components of HyQvia (immune globulin and hyaluronidase) sequentially, beginning with the hyaluronidase; do not use either component alone. Infusion pump capable of infusing rates up to 300 mL/hour/site required; must also have the ability to titrate the flow rate. Use a 24-gauge subcutaneous needle set labeled for high flow rates. Infusion site leakage can occur; consider using longer needles (14 mm or 12 mm) and/or more than one infusion site. Initiate the infusion of the full dose of the immune globulin through the same subcutaneous needle set within ~10 minutes of hyaluronidase infusion. For each full or partial vial of immune globulin used, administer the entire contents of the hyaluronidase vial. A second site can be used based on tolerability and total volume; if a second site is used, it should be placed on the opposite side of the body; administer half of total volume of the hyaluronidase in each site. Flush the infusion line with NS or D5W if required.
Injection sites: Middle to upper abdomen or thigh (avoid bony prominences or areas that are scarred, inflamed, or infected).
Volume per site:
<40 kg: ≤300 mL per injection site.
≥40 kg: ≤600 mL per injection site.
Infusion rate:
Immune globulin:
First 2 infusions:
<40 kg: 5 mL/hour for 5 to 15 minutes; 10 mL/hour for 5 to 15 minutes; 20 mL/hour for 5 to 15 minutes; 40 mL/hour for 5 to 15 minutes; then 80 mL/hour for remainder of infusion.
≥40 kg: 10 mL/hour for 5 to 15 minutes; 30 mL/hour for 5 to 15 minutes; 60 mL/hour for 5 to 15 minutes; 120 mL/hour for 5 to 15 minutes; then 240 mL/hour for remainder of infusion.
Next 2 or 3 infusions:
<40 kg: 10 mL/hour for 5 to 15 minutes; 20 mL/hour for 5 to 15 minutes; 40 mL/hour for 5 to 15 minutes; 80 mL/hour for 5 to 15 minutes; then 160 mL/hour for remainder of infusion.
≥40 kg: 10 mL/hour for 5 to 15 minutes; 30 mL/hour for 5 to 15 minutes; 120 mL/hour for 5 to 15 minutes; 240 mL/hour for 5 to 15 minutes; then 300 mL/hour for remainder of infusion.
Xembify: Note: It is recommended that infusion be complete within 2 hours of preparation to avoid the potential formation of particles caused by siliconized syringes.
Injection sites: Abdomen, thigh, upper arm, sides, back, and/or lateral hip (avoid bony prominence or areas that are scarred, inflamed, or infected); ≤6 simultaneous injection sites (spaced ≥2 inches apart).
Maximum infusion rate: 25 mL/hour per injection site.
Maximum infusion volume: 25 mL per injection site.
Note: If plasmapheresis employed for treatment of condition, administer immune globulin after completion of plasmapheresis session.
IM: Administer IM in the anterolateral aspects of the upper thigh or deltoid muscle of the upper arm. Avoid gluteal region due to risk of injury to sciatic nerve. Divide doses >10 mL and inject in multiple sites.
GamaSTAN and GamaSTAN S/D [Canadian product] are for IM administration only.
IV infusion: Infuse over 2 to 24 hours; administer in separate infusion line from other medications; if using primary line, flush with NS or D5W (product specific; consult product prescribing information) prior to administration. Decrease dose, rate and/or concentration of infusion in patients who may be at risk of renal failure. Decreasing the rate or stopping the infusion may help relieve some adverse effects (flushing, changes in pulse rate, changes in blood pressure). Epinephrine should be available during administration. For initial treatment or in elderly patients, a lower concentration and/or a slower rate of infusion should be used. Initial rate of administration and titration is specific to each IGIV product. Refrigerated product should be warmed to room temperature prior to infusion. Some products require filtration; refer to individual product labeling. Antecubital veins should be used, especially with concentrations ≥10% to prevent injection-site discomfort.
Asceniv: Primary humoral immunodeficiency: Initial (first 15 minutes): 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase every 15 minutes (if tolerated) up to 8 mg/kg/minute (4.8 mL/kg/hour).
Bivigam 10%: Primary humoral immunodeficiency: Initial (first 10 minutes): 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase every 20 minutes (if tolerated) by 0.8 mg/kg/minute (0.48 mL/kg/hour) up to 6 mg/kg/minute (3.6 mL/kg/hour).
Carimune NF: Refer to product labeling.
Flebogamma DIF 5%: Primary humoral immunodeficiency: Initial: 0.5 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase slowly (if tolerated) up to 5 mg/kg/minute (6 mL/kg/hour).
Flebogamma DIF 10%: Primary humoral immunodeficiency or immune thrombocytopenia: Initial: 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase slowly (if tolerated) up to 8 mg/kg/minute (4.8 mL/kg/hour).
Gammagard Liquid 10%:
Multifocal motor neuropathy: Initial: 0.8 mg/kg/minute (0.5 mL/kg/hour); Maintenance: Increase gradually (if tolerated) up to 9 mg/kg/minute (5.4 mL/kg/hour).
Primary humoral immunodeficiency: Initial (first 30 minutes): 0.8 mg/kg/minute (0.5 mL/kg/hour); Maintenance: Increase every 30 minutes (if tolerated) up to: 8 mg/kg/minute (5 mL/kg/hour).
Gammagard S/D [Canadian product]: 5% solution: Initial: 0.5 mL/kg/hour; may increase (if tolerated) to a maximum rate of 4 mL/kg/hour. If 5% solution is tolerated at maximum rate, may administer 10% solution with an initial rate of 0.5 mL/kg/hour; may increase (if tolerated) to a maximum rate of 8 mL/kg/hour.
Gammaked 10%:
Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial (first 30 minutes): 2 mg/kg/minute (1.2 mL/kg/hour); Maintenance: Increase gradually (if tolerated) to a maximum of 8 mg/kg/minute (4.8 mL/kg/hour).
Primary humoral immunodeficiency or immune thrombocytopenia (ITP): Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase gradually (if tolerated) to a maximum of 8 mg/kg/minute (4.8 mL/kg/hour).
Gammaplex 5%: Primary humoral immunodeficiency or ITP: Initial (first 15 minutes): 0.5 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase every 15 minutes (if tolerated) up to 4 mg/kg/minute (4.8 mL/kg/hour).
Gammaplex 10%: Primary humoral immunodeficiency or ITP: Initial (first 15 minutes): 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase every 15 minutes (if tolerated) up to 8 mg/kg/minute (4.8 mL/kg/hour).
Gamunex-C 10%:
CIDP: Initial (first 30 minutes): 2 mg/kg/minute (1.2 mL/kg/hour); Maintenance: Increase gradually (if tolerated) to a maximum of 8 mg/kg/minute (4.8 mL/kg/hour).
Primary humoral immunodeficiency or ITP: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase gradually (if tolerated) to a maximum of 8 mg/kg/minute (4.8 mL/kg/hour).
Octagam 5%: Primary humoral immunodeficiency: Initial (first 30 minutes): 0.5 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Double infusion rate (if tolerated) every 30 minutes up to a maximum rate of <3.33 mg/kg/minute (4.2 mL/kg/hour).
Octagam 10%: ITP: Initial (first 30 minutes):1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Double infusion rate (if tolerated) every 30 minutes up to a maximum rate of 12 mg/kg/minute (7.2 mL/kg/hour).
Panzyga:
CIDP: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase gradually (if tolerated) every 15 to 30 minutes up to 12 mg/kg/minute (7.2 mL/kg/hour).
ITP: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: May increase gradually (if tolerated) every 15 to 30 minutes up to 8 mg/kg/minute (4.8 mL/kg/hour).
Primary humoral immunodeficiency: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: May increase gradually (if tolerated) every 15 to 30 minutes up to 14 mg/kg/minute (8.4 mL/kg/hour).
Privigen 10%:
ITP: Initial: 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase gradually (if tolerated) up to 4 mg/kg/minute (2.4 mL/kg/hour).
CIDP/Primary humoral immunodeficiency: Initial: 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase gradually (if tolerated) up to 8 mg/kg/minute (4.8 mL/kg/hour).
SUBQ infusion: Initial dose should be administered in a health care setting capable of providing monitoring and treatment in the event of hypersensitivity. Using aseptic technique, follow the infusion device manufacturer's instructions for filling the reservoir and preparing the pump. Remove air from administration set and needle by priming. After the administration sites are clean and dry, insert subcutaneous needle and prime administration set. Attach sterile needle to administration set, gently pull back on the syringe to assure a blood vessel has not been inadvertently accessed (do not use needle and tubing if blood present). Repeat for each injection site; deliver the dose following instructions for the infusion device. Rotate the site(s) between successive infusions. Treatment may be transitioned to the home/home care setting in the absence of adverse reactions.
Cutaquig:
Injection sites: Abdomen, thigh, upper arm, and/or upper leg/hip; ≤6 simultaneous injection sites (spaced ≥2 inches apart).
Maximum infusion rate: 20 mL/hour per injection site (first 2 infusions); may be increased to 52 mL/hour per injection site (as tolerated) for subsequent infusions.
Maximum infusion volume: 25 mL per injection site (first 2 infusions); may increase to 40 mL per site for subsequent infusions.
Cuvitru: Note: Manufacturer recommends to complete administration within 2 hours due to the potential formation of particles caused by siliconized syringes.
Injection sites: Abdomen, thigh, upper arm, lateral hip (avoid bony prominences); ≤4 simultaneous injection sites (spaced ≥4 inches apart).
Maximum infusion rate: 10 to 20 mL/hour per injection site (first 2 infusions); may be increased to 60 mL/hour per injection site (as tolerated) for subsequent infusions.
Maximum infusion volume:
Patients <40 kg: 20 mL per injection site (first 2 infusions); may increase to 60 mL per site for subsequent infusions.
Patients ≥40 kg: 60 mL per injection site.
Gammagard Liquid:
Injection sites: Abdomen, thigh, upper arm, lower back (avoid bony prominences); ≤8 simultaneous injection sites (spaced ≥2 inches apart).
Initial infusion rate:
<40 kg: 15 mL/hour per injection site (maximum volume: 20 mL per injection site).
≥40 kg: 20 mL/hour per injection site (maximum volume: 30 mL per injection site).
Maintenance infusion rate:
<40 kg: 15 to 20 mL/hour per injection site (maximum volume: 20 mL per injection site).
≥40 kg: 20 to 30 mL/hour per injection site (maximum volume: 30 mL per injection site).
Gammaked, Gamunex-C:
Injection sites: Abdomen, thigh, upper arm, lateral hip; ≤8 simultaneous injection sites (spaced ≥2 inches apart).
Recommended infusion rate: 20 mL/hour per infusion site.
Hizentra:
Injection sites: Abdomen, thigh, upper arm, lateral hip; ≤8 simultaneous injection sites in parallel (spaced ≥2 inches apart).
Maximum infusion rate: First infusion: 15 mL/hour per injection site (primary humoral immunodeficiency) or 20 mL/hour per injection site (CIDP); subsequent infusions: 25 mL/hour per injection site (primary humoral immunodeficiency) or 50 mL/hour per injection site (CIDP).
Maximum infusion volume: First infusion: 15 mL per injection site (primary humoral immunodeficiency) or 20 mL per injection site (CIDP); subsequent infusions: 25 mL per injection site (primary humoral immunodeficiency) or 50 mL per injection site (CIDP).
HyQvia: Infuse the two components of HyQvia (immune globulin and hyaluronidase) sequentially, beginning with hyaluronidase; do not use either component alone. Infusion pump capable of infusing rates up to 300 mL/hour/site is required; must also have the ability to titrate the flow rate. Use a 24 gauge subcutaneous needle set labeled for high flow rates. Infusion site leakage can occur; consider using longer needles (14 mm or 12 mm) and/or more than one infusion site. Initiate the infusion of the full dose of the immune globulin through the same subcutaneous needle set within ~10 minutes of hyaluronidase infusion. For each full or partial vial of immune globulin used, administer the entire contents of the hyaluronidase vial. A second site can be used based on tolerability and total volume; if a second site is used, administer half of total volume of the hyaluronidase in each site. Flush the infusion line with NS or D5W if required.
Injection sites: Middle to upper abdomen or thigh (avoid bony prominences, or areas that are scarred, inflamed, or infected). If two sites are used simultaneously, the two infusion sites should be on opposite sides of the body.
Volume per site:
<40 kg: ≤300 mL per injection site.
≥40 kg: ≤600 mL per injection site.
Infusion rate:
Hyaluronidase: ~1 to 2 mL/minute, or as tolerated.
Immune globulin:
First 2 infusions:
<40 kg: 5 mL/hour for 5 to 15 minutes; 10 mL/hour for 5 to 15 minutes; 20 mL/hour for 5 to 15 minutes; 40 mL/hour for 5 to 15 minutes; then 80 mL/hour for remainder of infusion.
≥40 kg: 10 mL/hour for 5 to 15 minutes; 30 mL/hour for 5 to 15 minutes; 60 mL/hour for 5 to 15 minutes; 120 mL/hour for 5 to 15 minutes; then 240 mL/hour for remainder of infusion.
Next 2 or 3 infusions:
<40 kg: 10 mL/hour for 5 to 15 minutes; 20 mL/hour for 5 to 15 minutes; 40 mL/hour for 5 to 15 minutes; 80 mL/hour for 5 to 15 minutes; then 160 mL/hour for remainder of infusion.
≥40 kg: 10 mL/hour for 5 to 15 minutes; 30 mL/hour for 5 to 15 minutes; 120 mL/hour for 5 to 15 minutes; 240 mL/hour for 5 to 15 minutes; then 300 mL/hour for remainder of infusion.
Xembify: Note: Manufacturer recommends to complete administration within 2 hours due to the potential formation of particles caused by siliconized syringes.
Injection sites: Abdomen, thigh, upper arm, sides, back, lateral hip (avoid bony prominences or areas that are scarred, inflamed, or infected); ≤6 simultaneous injection sites (spaced ≥2 inches apart).
Maximum infusion rate: 25 mL/hour per injection site.
Maximum infusion volume: 25 mL per injection site.
Stability is dependent upon the manufacturer and brand. Do not freeze (do not use if previously frozen). Do not shake. Do not heat (do not use if previously heated).
Asceniv: Store under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture; may store at ≤25°C (≤77°F) for up to 4 weeks during the first 24 months from the date of manufacture (after 4 weeks at room temperature, discard).
Bivigam: Store under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture; may store at ≤25°C (≤77°F) for up to 4 weeks during the first 24 months from the date of manufacture (after 4 weeks at room temperature, discard).
Carimune NF: Prior to reconstitution, store at or below 30°C (86°F). Following reconstitution in a sterile laminar air flow environment, store under refrigeration.
Cutaquig: Store at 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture or at room temperature (≤25°C [≤77°F]) for up to 9 months; do not return vial to refrigerator after it has been stored at room temperature. Keep in original carton to protect from light.
Cuvitru: Store at 2°C to 8°C (36°F to 46°F) for up to 36 months or at room temperature (≤25°C [≤77°F]) for up to 24 months; do not return vial to refrigerator after it has been stored at room temperature. Keep in original carton to protect from light.
Flebogamma DIF: Store at 2°C to 25°C (36°F to 77°F). Keep in original carton to protect from light.
GamaSTAN: Store at 2°C to 8°C (36°F to 46°F).
GamaSTAN S/D [Canadian product]: Store under refrigeration at 2°C to 8°C (36°F to 46°F).
Gammagard Liquid: Prior to use, may store at 2°C to 8°C (36°F to 46°F) for up to 36 months or at ≤ 25°C (≤77°F) for up to 24 months.
Gammagard S/D: Store at ≤25°C (≤77°F) for up to 24 months. May store diluted solution under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 24 hours if originally prepared in a sterile laminar air flow environment.
Gammaked: Store at 2°C to 8°C (36°F to 46°F); may be stored at ≤25°C (≤77°F) for up to 6 months.
Gammaplex: Store at 2°C to 25°C (36°F to 77°F) for up to 36 months from the date of manufacture. Keep in original carton to protect from light.
Gamunex-C: Store at 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture; within this time, may store for up to 6 months at ≤25°C (≤77°F); after storage at ≤25°C (≤77°F) the product must be used or discarded. Protect from light.
Hizentra: Store at ≤25°C (≤77°F). Keep in original carton to protect from light.
HyQvia: Store at 2°C to 8°C (36°F to 46°F) for up to 36 months; may store at ≤25°C (≤77°F) for up to 3 months during the first 24 months from the date of manufacture (after 3 months at room temperature, discard); do not return vial to refrigerator after it has been stored at room temperature.
Octagam 5%: Store at 2°C to 8°C (36°F to 46°F) for 36 months from the date of manufacture; within the first 24 months, may store at ≤25°C (≤77°F); after storage at ≤25°C (≤77°F), the product must be used or discarded.
Octagam 10%: Store at 2°C to 8°C (36°F to 46°F) for 24 months from the date of manufacture; within these first 12 months, may store up to 9 months at ≤25°C (77°F); after storage at ≤25°C (77°F), the product must be used or discarded.
Panzyga: Store at 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture; within this time, may store up to 12 months at ≤25°C (≤77°F); after storage at ≤25°C (≤77°F) the product must be used or discarded. Protect from light.
Privigen: Store at ≤25°C (≤77°F). Protect from light.
Xembify: Store at 2°C to 8°C (36°F to 46°F); may be stored at ≤25°C (≤77°F) for up to 6 months; after storage at ≤25°C (≤77°F) the product must be used or discarded. Administer within 8 hours after beginning infusion preparation (ie, once transferred from the vial into a syringe).
Treatment of primary humoral immunodeficiency syndromes (may include but not limited to: Congenital agammaglobulinemia, severe combined immunodeficiency syndromes [SCIDS], common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome); acute and chronic immune thrombocytopenia (ITP); chronic inflammatory demyelinating polyneuropathy (CIDP); and multifocal motor neuropathy. Prevention of coronary artery aneurysms associated with Kawasaki syndrome (in combination with aspirin).
Adjunctive treatment of bacterial infection in patients with hypogammaglobulinemia and/or recurrent bacterial infections with B-cell chronic lymphocytic leukemia (CLL); and serious infection in immunoglobulin deficiency (select agammaglobulinemias).
To provide passive immunity for prophylaxis in the following susceptible individuals: Hepatitis A (preexposure and postexposure [within 14 days and prior to manifestation of disease]); measles (postexposure [within 6 days] in an unvaccinated or nonimmune person); rubella (postexposure during early pregnancy); and varicella zoster (immunosuppressed patients when varicella zoster immune globulin is unavailable).
See table for product specific indications, FDA approved age ranges, and routes of administration.
|
Product |
Indication |
FDA Approval Ages |
Route(s) |
|---|---|---|---|
|
Asceniv |
Primary immunodeficiency (treatment) |
≥12 years and adults |
Intravenous |
|
Bivigam |
Primary immunodeficiency (treatment) |
≥6 years and adults |
Intravenous |
|
Carimune NF |
Primary immunodeficiency (treatment) |
Pediatric patients (age not specified) and adults |
Intravenous |
|
Acute and chronic ITP (treatment) | |||
|
Cutaquig |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Subcutaneous |
|
Cuvitru |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Subcutaneous |
|
Flebogamma 5% DIF |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Intravenous |
|
Flebogamma 10% DIF |
Primary immunodeficiency (treatment) |
Adults |
Intravenous |
|
Chronic ITP (treatment) |
≥2 years and adults | ||
|
GamaSTAN |
Passive immunity - Hepatitis A |
Adults |
Intramuscular |
|
Passive immunity - Measles |
Pediatric patients (age not specified) and adults | ||
|
Passive immunity - Rubella |
Adults | ||
|
Passive immunity - Varicella |
Adults | ||
|
Gammagard Liquid |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Intravenous, Subcutaneous |
|
Multifocal motor neuropathy (MMN) |
Adults |
Intravenous | |
|
Gammagard S/D |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Intravenous |
|
B-cell chronic lymphocytic leukemia (CLL) |
Adults | ||
|
Chronic ITP (treatment) |
Adults | ||
|
Kawasaki syndrome |
Pediatric patients (age not specified) | ||
|
Gammaked |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Intravenous, Subcutaneous |
|
Acute and chronic ITP (treatment) |
Pediatric patients (age not specified) and adults |
Intravenous | |
|
Chronic inflammatory demyelinating polyneuropathy (CIDP) |
Adults |
Intravenous | |
|
Gammaplex 5% |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Intravenous |
|
Chronic ITP (treatment) |
Adults | ||
|
Gammaplex 10% |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Intravenous |
|
Chronic ITP (treatment) |
Adults | ||
|
Gamunex-C |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Intravenous, Subcutaneous |
|
Acute and chronic ITP (treatment) |
Pediatric patients (age not specified) and adults |
Intravenous | |
|
Chronic inflammatory demyelinating polyneuropathy (CIDP) |
Adults |
Intravenous | |
|
Hizentra |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Subcutaneous |
|
Chronic inflammatory demyelinating polyneuropathy (CIDP) |
Adults |
Subcutaneous | |
|
HyQvia |
Primary immunodeficiency (treatment), in conjunction with recombinant human hyaluronidase |
Adults |
Subcutaneous |
|
Octagam 5% |
Primary immunodeficiency (treatment) |
6 to 16 years and adults |
Intravenous |
|
Octagam 10% |
Chronic ITP (treatment) |
Adults |
Intravenous |
|
Panzyga |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Intravenous |
|
Chronic ITP (treatment) |
Adults |
Intravenous | |
|
Privigen |
Primary immunodeficiency (treatment) |
≥3 years and adults |
Intravenous |
|
Chronic ITP (treatment) |
≥15 years and adults | ||
|
Chronic inflammatory demyelinating polyneuropathy (CIDP) |
Adults | ||
|
Xembify |
Primary immunodeficiency (treatment) |
≥2 years and adults |
Subcutaneous |
Has also been used for acute disseminated encephalomyelitis (ADEM), acute myocarditis, chronic Clostridioides difficile colitis, Guillain-Barré syndrome, hematopoietic stem cell transplantation with hypogammaglobulinemia, isoimmune hemolytic disease (Rh-incompatibility), multiple sclerosis, multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2, myasthenia gravis, neonatal sepsis, pediatric HIV infection and associated thrombocytopenia, refractory dermatomyositis, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), and refractory polymyositis.
Gamimune N may be confused with CytoGam
Immune globulin (intravenous) may be confused with hepatitis B immune globulin
Privigen (immune globulin) may be confused with Albuminar-25 (albumin) due to similar packaging
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse effects are reported as class effects rather than for specific products in adult and pediatric patients.
>10%:
Cardiovascular: Chest pain, decreased heart rate, hypertension, hypotension, increased heart rate, tachycardia
Dermatologic: Dermatitis, ecchymoses, injection site pruritus
Gastrointestinal: Abdominal pain, diarrhea, nausea, upper abdominal pain, viral gastroenteritis, vomiting
Hematologic & oncologic: Anemia, hemolysis, positive direct Coombs test
Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum bilirubin (increased direct serum bilirubin or increased indirect serum bilirubin)
Immunologic: Antibody development
Local: Bruising at injection site, erythema at injection site, injection site nodule, irritation at injection site, pain at injection site, swelling at injection site
Nervous system: Chills, dizziness, fatigue, headache, increased body temperature, pain, rigors
Neuromuscular and skeletal: Asthenia, back pain, limb pain, myalgia
Respiratory: Asthma, bronchitis, cough, epistaxis, nasal congestion, nasopharyngitis, pharyngitis, rhinitis, sinusitis (including acute sinusitis), upper respiratory tract infection, wheezing
Miscellaneous: Fever
1% to 10%:
Cardiovascular: Chest discomfort, flushing, heart murmur, peripheral edema
Dermatologic: Allergic dermatitis, eczema, erythema of skin, hyperhidrosis, pruritus, skin rash, urticaria, xeroderma
Endocrine & metabolic: Dehydration, increased lactate dehydrogenase, thyroiditis
Gastrointestinal: Abdominal distention, aphthous stomatitis, dyspepsia, flatulence, gastritis, stomach discomfort
Genitourinary: Cystitis, dysuria, urinary tract infection
Hematologic & oncologic: Bruise, hematoma, hemolytic anemia, leukopenia, neutropenia
Hepatic: Increased serum aspartate aminotransferase
Hypersensitivity: Hypersensitivity reaction
Infection: Influenza, viral infection
Local: Induration at injection site, inflammation at injection site
Nervous system: Depression, falling, fibromyalgia syndrome (exacerbation), hypertonia, lethargy, malaise, migraine, myasthenia, sensation of cold, vertigo
Neuromuscular & skeletal: Arthralgia, joint effusion, joint swelling, muscle spasm, musculoskeletal pain, neck pain
Otic: Otalgia
Respiratory: Dyspnea, flu-like symptoms, oropharyngeal pain, pharyngolaryngeal pain, pneumonia, viral upper respiratory tract infection
<1%:
Cardiovascular: Transient ischemic attacks
Gastrointestinal: Anorexia
Infection: Subcutaneous abscess
Nervous system: Anxiety, aseptic meningitis, chronic inflammatory demyelinating polyneuropathy (exacerbation)
Renal: Nephrolithiasis
Frequency not defined:
Cardiovascular: Facial flushing, thrombosis
Dermatologic: Cellulitis, diaphoresis, localized erythema, papule of skin, urticaria at injection site
Genitourinary: Proximal tubular nephropathy
Hematologic & oncologic: Exacerbation of autoimmune pure red cell aplasia, hyperproteinemia, increased serum immunoglobulins (hyperviscosity), local hemorrhage
Local: Hematoma at injection site, local irritation, residual mass at injection site
Nervous system: Drowsiness
Neuromuscular & skeletal: Lower limb cramp
Ophthalmic: Blurred vision
Renal: Increased blood urea nitrogen, increased serum creatinine, renal tubular necrosis
Respiratory: Bronchopneumonia, non-cardiogenic pulmonary edema
Postmarketing:
Cardiovascular: Acute myocardial infarction, angina pectoris, arterial thrombosis, bradycardia, cerebrovascular accident, circulatory shock, deep vein thrombosis, edema, facial edema, hot and cold flashes, oxygen saturation decreased, palpitations, peripheral vascular insufficiency, phlebitis, pulmonary embolism, syncope, thromboembolism, thrombophlebitis, venous thrombosis (retinal vein thrombosis)
Dermatologic: Alopecia, bullous dermatitis, epidermolysis, erythema multiforme, erythematous rash, exfoliation of skin, pallor, rash at injection site, skin discoloration, skin ulceration at injection site, Stevens-Johnson syndrome
Endocrine & metabolic: Decreased haptoglobins, hypervolemia, hyponatremia (Daphnis 2007; Nguyen 2006; Steinberger 2003), pseudohyponatremia (Daphnis 2007; Nguyen 2006; Steinberger 2003), translocational hyponatremia (Daphnis 2007; Nguyen 2006; Steinberger 2003)
Gastrointestinal: Oral paresthesia
Genitourinary: Hematuria, hemoglobinuria, osmotic nephrosis, urine discoloration
Hematologic & oncologic: Acute intravascular hemolysis, decreased neutrophils, disseminated intravascular coagulation, increased hemoglobin, lymphadenopathy, pancytopenia, thrombocytopenia
Hepatic: Hepatic insufficiency, hepatitis (noninfectious)
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, nonimmune anaphylaxis
Local: Tissue necrosis at injection site, warm sensation at injection site
Nervous system: Agitation, burning sensation, coma, confusion, hypoesthesia, loss of consciousness, nervousness, paresthesia, restlessness, seizure, speech disturbance, voice disorder
Neuromuscular & skeletal: Laryngospasm, muscle rigidity, polymyositis, tremor
Ophthalmic: Eye pain, photophobia, visual disturbance
Renal: Acute kidney injury, renal failure syndrome, renal insufficiency, renal pain
Respiratory: Acute respiratory distress syndrome, apnea, bronchospasm, cyanosis, hyperventilation, hypoxemia, hypoxia, pharyngeal edema, pulmonary edema, respiratory failure, transfusion-related acute lung injury
Hypersensitivity to immune globulin or any component of the formulation; IgA deficiency (with anti-IgA antibodies and history of hypersensitivity [excluding Gammagard S/D]); hyperprolinemia (Hizentra, Privigen); hypersensitivity to corn (Octagam 5%); hereditary intolerance to fructose (Gammaplex 5%); infants/neonates for whom sucrose or fructose tolerance has not been established (Gammaplex 5%); hypersensitivity to hyaluronidase, human albumin, or any component of the hyaluronidase formulation (HyQvia).
Canadian labeling: Additional contraindications (not in US labeling): GamaSTAN S/D: Severe thrombocytopenia or coagulation disorders where IM injections are contraindicated.
Documentation of allergenic cross-reactivity for immune globulins is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur (some severe); patients with known antibodies to IgA are at greater risk; a severe fall in blood pressure may rarely occur with anaphylactic reaction; discontinue therapy and institute immediate treatment (including epinephrine 1 mg/mL) should be available.
• Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with immune globulin administration; may occur with high doses (≥1 g/kg) and/or rapid infusion. Syndrome usually appears within several hours to 2 days following treatment; usually resolves within several days after product is discontinued. Female patients or patients with a migraine history may be at higher risk for AMS.
• Hematoma: Do not administer subcutaneously for the treatment of immune thrombocytopenia because of the risk of hematoma formation.
• Hemolysis: Intravenous immune globulin has been associated with antiglobulin hemolysis (acute or delayed). Cases of hemolysis-related renal impairment/failure or disseminated intravascular coagulation have been reported. Risk factors associated with hemolysis include high doses (≥2 g/kg) given either as a single administration or divided over several days, underlying associated inflammatory conditions, and non-O blood type (FDA 2012). An underlying inflammatory state (eg, elevated C-reactive protein or erythrocyte sedimentation rate) may also increase the risk. Closely monitor patients for signs of hemolytic anemia, particularly in patients with preexisting anemia and/or cardiovascular or pulmonary compromise.
• Hereditary fructose intolerance: Immune globulin may contain sorbitol. The presence of sorbitol presents a risk to those with hereditary fructose intolerance (HFI). The incidence of HFI is estimated at 1 in 20,000 births and is usually diagnosed at the time of weaning when fructose or sucrose is introduced into the diet. Clinical symptoms include recurrent vomiting, abdominal pain, and hypoglycemia. Immune globulin containing sorbitol must not be administered to patients with HFI.
• Hyperproteinemia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur; distinguish hyponatremia from pseudohyponatremia to prevent volume depletion, a further increase in serum viscosity and a higher risk of thrombotic events.
• Hypertension: Elevations of blood pressure (systolic ≥180 mm Hg and/or diastolic >120 mm Hg) have been observed during and/or shortly following infusion of Panzyga and Privigen, which resolved with either observation or changes in oral antihypertensive therapy.
• Infusion reactions: Patients should be monitored for adverse events during and after the infusion. Stop administration with signs of infusion reaction (fever, chills, nausea, vomiting, and rarely shock). Risk may be increased with initial treatment, when switching brands of immune globulin, and with treatment interruptions of >8 weeks.
• Pulmonary edema: Monitor for transfusion-related acute lung injury (TRALI); noncardiogenic pulmonary edema has been reported with immune globulin use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function. Usually occurs within 1 to 6 hours after infusion.
• Renal dysfunction and acute renal failure: [US Boxed Warning]: IV administration only: Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure, osmotic nephrosis) can rarely occur and has been associated with fatalities in predisposed patients. Patients predisposed to renal dysfunction include elderly patients, patients with renal disease, diabetes mellitus, hypovolemia, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications due to risk of renal dysfunction. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. (Note: The following IV products do not contain sucrose: Asceniv, Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam 5%, Octagam 10%, Panzyga, and Privigen). In patients at risk of renal dysfunction or acute renal failure, ensure adequate hydration prior to administration; the dose, rate of infusion, and concentration of solution should be minimized. Assess renal function prior to treatment and periodically thereafter. Discontinue if renal function deteriorates.
• Thromboembolic events: [US Boxed Warning]: Thrombosis may occur with immune globulin products even in the absence of risk factors for thrombosis. For patients at risk of thrombosis (eg, advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors), administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity, such as those with cryoglobulins, fasting chylomicronemia/severe hypertriglyceridemia, or monoclonal gammopathies.
Disease-related concerns:
• Fluid overload: High-dose regimens (1 g/kg for 1 to 2 days) are not recommended for individuals with fluid overload or where fluid volume may be of concern.
• IgA deficiency: Increased risk of hypersensitivity, especially in patients with anti-IgA antibodies; use is contraindicated in patients with IgA deficiency (with antibodies against IgA and history of hypersensitivity) or isolated IgA deficiency (GamaSTAN S/D [Canadian product]).
• Renal impairment: Use with caution; ensure adequate hydration prior to administration; the rate of infusion and concentration of solution should be minimized.
Special populations:
• Older adult: Use with caution in elderly patients; may be at increased risk for renal dysfunction/failure and thromboembolic events.
Dosage form specific issues:
• Human plasma: Product of human plasma; may potentially contain infectious agents (eg, viruses, the variant Creutzfeldt Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt Jakob disease [CJD] agent) that could transmit disease, including unknown or emerging viruses and other pathogens. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.
• L-proline: Hizentra and Privigen contain the stabilizer L-proline and are contraindicated in patients with hyperprolinemia.
• Maltose: Some products may contain maltose, which may result in falsely elevated blood glucose readings. Maltose-containing products may be contraindicated with patients with corn allergy.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
• Skin testing: Skin testing should not be performed with GamaSTAN or GamaSTAN S/D [Canadian product] as local irritation can occur and be misinterpreted as a positive reaction.
• Sodium: Some products may contain sodium.
• Sorbitol: Some products may contain sorbitol; do not use immune globulin in patients with hereditary fructose intolerance.
• Sucrose: Some products may contain sucrose.
Other warnings/precautions:
• Administration: Do not infuse into or around an infected area due to the risk of spreading a localized infection.
• High-dose regimen: Consider risk versus benefit for high-dose regimen in patients with increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Estrogen Derivatives: May enhance the thrombogenic effect of Immune Globulin. Risk C: Monitor therapy
Ravulizumab: Immune Globulin may decrease the serum concentration of Ravulizumab. Management: Administer a supplemental dose of ravulizumab (600 mg) within 4 hours of completion of the immune globulin cycle. Risk D: Consider therapy modification
Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification
Some products may contain sodium.
Placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009). In a study of two women treated with IV immune globulin (IVIG) for common variable immunodeficiency, exogenous immune globulin was shown to cross the placenta similar to endogenous immune globulin (Palmeira 2012).
IV immune globulin has been recommended for use in fetal-neonatal alloimmune thrombocytopenia and pregnancy-associated immune thrombocytopenia (ITP) (ACOG 207 2019; Anderson 2007; Neunert 2011); use is appropriate for ITP in cases refractory to corticosteroids, when side effects to corticosteroids are significant, or when a rapid increase in platelets is needed (ACOG 207 2019). Intravenous immune globulin is recommended to prevent measles in nonimmune women exposed during pregnancy (CDC 2013). May also be used in postexposure prophylaxis for rubella to reduce the risk of infection and fetal damage in exposed pregnant females who will not consider therapeutic abortion (per GamaSTAN product labeling; use for postexposure rubella prophylaxis is not currently recommended [CDC 2013]). IV immune globulin may be used when a prompt response for the treatment of myasthenia gravis is needed during pregnancy (Sanders 2016).
HyQvia: Data collection to monitor pregnancy and infant outcomes following exposure to HyQvia is ongoing. Patients may enroll themselves in the HyQvia pregnancy registry by calling (866) 424-6724.
Renal function (prior to initial infusion and at appropriate intervals), urine output, IgG concentrations, hemoglobin and hematocrit, platelets (in patients with ITP); infusion- or injection-related adverse reactions, anaphylaxis, signs and symptoms of hemolysis; blood viscosity (in patients at risk for hyperviscosity); presence of antineutrophil antibodies (if TRALI is suspected); volume status; neurologic symptoms (if aseptic meningitis syndrome suspected); pulmonary adverse reactions; clinical response (as defined by disease state); monitor for fluid overload in patients with cardiac dysfunction being treated for multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2 (ACR [Henderson 2022]; NIH 2022).
For patients at high risk of hemolysis (dose ≥2,000 mg/kg, given as a single dose or divided over several days, and non-O blood type): Hemoglobin or hematocrit prior to and 36 to 96 hours postinfusion.
SubQ infusion: Primary immunodeficiency: Monitor IgG trough levels every 2 to 3 months before/after conversion from IV; subcutaneous infusions provide more constant IgG levels than usual IV immune globulin treatments.
Replacement therapy for primary and secondary immunodeficiencies, and IgG antibodies against bacteria, viral, parasitic and mycoplasma antigens; interference with Fc receptors on the cells of the reticuloendothelial system for autoimmune cytopenias and ITP; provides passive immunity by increasing the antibody titer and antigen-antibody reaction potential
Onset of action: IV: Provides immediate antibody levels.
Immune thrombocytopenia: Initial response: 1 to 3 days; Peak response: 2 to 7 days (Neunert 2011).
Duration: IM, IV: Immune effect: 3 to 4 weeks (variable).
Distribution: Vd: 0.05 to 0.13 L/kg.
Intravascular portion (primarily): Healthy subjects: 41% to 57%; Patients with congenital humoral immunodeficiencies: ~70%.
Half-life elimination: IM: ~23 days; SUBQ: ~59 days (HyQvia); IV: IgG (variable among patients): Healthy subjects: 14 to 24 days; Patients with congenital humoral immunodeficiencies: 26 to 40 days; hypermetabolism associated with fever and infection have coincided with a shortened half-life.
Time to peak:
Plasma: SUBQ: Cutaquig: ~2 days; Cuvitru: ~4.4 days; Gammagard Liquid: 2.9 days; Hizentra: 2.9 days; HyQvia: ~5 days; Xembify: ~3 days.
Serum: IM: ~48 hours.
IM: When administering immune globulin for hepatitis A prophylaxis, use should be considered for the following close contacts of persons with confirmed hepatitis A: Unvaccinated household and sexual contacts, persons who have shared illicit drugs, regular babysitters, staff and attendees of child care centers, food handlers within the same establishment (CDC 2006).
DIF: Dual inactivation plus nanofiltration.
NF: Nanofiltered.
S/D: Solvent detergent treated.
Octagam contains sodium 30 mmol/L.
IgA content:
Asceniv: ≤200 mcg/mL.
Bivigam: ≤200 mcg/mL.
Carimune NF: Manufacturer's labeling: Trace amounts; others have reported 1,000 to 2,000 mcg/mL in a 6% solution (Siegel 2011).
Cutaquig: ≤600 mcg/mL.
Cuvitru: Average 80 mcg/mL.
Flebogamma 5% DIF: <50 mcg/mL.
Flebogamma 10% DIF: <100 mcg/mL.
GamaSTAN: Not specified.
Gammagard Liquid: Average 37 mcg/mL.
Gammagard S/D 5% solution: <1 mcg/mL (see Note).
Gammaked: Average 46 mcg/mL.
Gammaplex 5%: <10 mcg/mL.
Gammaplex 10%: <20 mcg/mL.
Gamunex-C: Average 46 mcg/mL.
Hizentra: ≤50 mcg/mL.
HyQvia: Average 37 mcg/mL.
Octagam 5%: ≤200 mcg/mL.
Octagam 10%: Average 106 mcg/mL.
Panzyga 10%: Average 100 mcg/mL.
Privigen: ≤25 mcg/mL.
Xembify: Not specified.
Note: Manufacturer has discontinued Gammagard S/D 5% solution; however, the lower IgA product may be available by special request for patients with known reaction to IgA or IgA deficiency with antibodies.
Kit (Hyqvia Subcutaneous)
2.5 g/25 mL (per mL): $26.65
5 gm/50 mL (per mL): $26.65
10 g/100 mL (per mL): $26.65
20 g/200 mL (per mL): $26.65
30 g/300 mL (per mL): $26.65
Solution (Asceniv Intravenous)
5 gm/50 mL (per mL): $111.26
Solution (Bivigam Intravenous)
5 gm/50 mL (per mL): $16.52
10 g/100 mL (per mL): $16.52
Solution (Cutaquig Subcutaneous)
1GM/6ML (per mL): $38.87
1.65 g/10 mL (per mL): $38.48
2GM/12ML (per mL): $38.87
3.3 g/20 mL (per mL): $38.48
4GM/24ML (per mL): $38.87
8GM/48ML (per mL): $38.87
Solution (Cuvitru Subcutaneous)
1 g/5 mL (per mL): $50.82
2 g/10 mL (per mL): $50.82
4 g/20 mL (per mL): $50.82
8 g/40mL (per mL): $50.82
10 gm/50 mL (per mL): $50.82
Solution (Flebogamma DIF Intravenous)
0.5 g/10 mL (per mL): $6.35
2.5 gm/50 mL (per mL): $6.35
5 g/100 mL (per mL): $6.35
5 gm/50 mL (per mL): $12.71
10 g/100 mL (per mL): $12.71
10 g/200 mL (per mL): $6.35
20 g/200 mL (per mL): $12.71
20 g/400 mL (per mL): $6.35
Solution (Gammagard Injection)
1 g/10 mL (per mL): $19.37
2.5 g/25 mL (per mL): $19.37
5 gm/50 mL (per mL): $19.37
10 g/100 mL (per mL): $19.37
20 g/200 mL (per mL): $19.37
30 g/300 mL (per mL): $19.37
Solution (Gammaked Injection)
1 g/10 mL (per mL): $22.54
5 gm/50 mL (per mL): $22.54
10 g/100 mL (per mL): $22.54
20 g/200 mL (per mL): $22.54
Solution (Gammaplex Intravenous)
5 g/100 mL (per mL): $12.33
5 gm/50 mL (per mL): $24.65
10 g/100 mL (per mL): $24.65
10 g/200 mL (per mL): $12.33
20 g/200 mL (per mL): $24.65
20 g/400 mL (per mL): $12.33
Solution (Gamunex-C Injection)
1 g/10 mL (per mL): $16.43
2.5 g/25 mL (per mL): $16.43
5 gm/50 mL (per mL): $16.43
10 g/100 mL (per mL): $16.43
20 g/200 mL (per mL): $16.43
40 g/400 mL (per mL): $16.43
Solution (Hizentra Subcutaneous)
1 g/5 mL (per mL): $50.48
2 g/10 mL (per mL): $50.48
4 g/20 mL (per mL): $50.48
10 gm/50 mL (per mL): $50.48
Solution (Octagam Intravenous)
1 g/20 mL (per mL): $11.21
2 g/20 mL (per mL): $22.41
2.5 gm/50 mL (per mL): $11.21
5 g/100 mL (per mL): $11.21
5 gm/50 mL (per mL): $22.41
10 g/100 mL (per mL): $22.41
10 g/200 mL (per mL): $11.21
20 g/200 mL (per mL): $22.41
30 g/300 mL (per mL): $22.41
Solution (Panzyga Intravenous)
1 g/10 mL (per mL): $23.86
2.5 g/25 mL (per mL): $23.86
5 gm/50 mL (per mL): $23.86
10 g/100 mL (per mL): $23.86
20 g/200 mL (per mL): $23.86
30 g/300 mL (per mL): $23.86
Solution (Privigen Intravenous)
5 gm/50 mL (per mL): $20.10
10 g/100 mL (per mL): $20.10
20 g/200 mL (per mL): $20.10
40 g/400 mL (per mL): $20.10
Solution (Xembify Subcutaneous)
1 g/5 mL (per mL): $42.29
2 g/10 mL (per mL): $42.29
4 g/20 mL (per mL): $42.29
10 gm/50 mL (per mL): $42.29
Solution (reconstituted) (Gammagard S/D Less IgA Intravenous)
5 g (per each): $1,293.78
10 g (per each): $2,587.56
Solution Prefilled Syringe (Hizentra Subcutaneous)
1 g/5 mL (per mL): $50.48
2 g/10 mL (per mL): $50.48
4 g/20 mL (per mL): $50.48
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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