Version May 2024
Infant botulism: Dosage is specific to the manufactured lot; refer to product-specific labeling.
IV: 50 mg/kg as a single IV infusion; begin as soon as diagnosis of infant botulism is made.
Infant botulism: Dosage is specific to the manufactured lot; refer to product-specific labeling.
Infants: IV: 50 mg/kg as a single IV infusion; begin as soon as diagnosis of infant botulism is made.
Infants: There are no dosage adjustments provided in the manufacturer's labeling. Use with caution; the rate of infusion and concentration of solution should be minimized in patients with renal impairment or those at risk for renal dysfunction.
Infants: There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not always defined. Percentages reported in open-label study except where otherwise noted; may reflect pathophysiology of infant botulism.
>10%:
Cardiovascular: Increased blood pressure (transient, 75%), edema (18%), decreased blood pressure (transient, 16%), heart murmur (15%)
Central nervous system: Irritability (41%), decreased body temperature (16%)
Dermatologic: Pallor (28%), contact dermatitis (24%), erythematous rash (22%, reported as 14% vs 8% in placebo-controlled study)
Gastrointestinal: Dysphagia (65%), loose stools (25%), vomiting (20%), abdominal distension (11%)
Otic: Otitis media (11%, reported in placebo-controlled study)
Respiratory: Atelectasis (39%), rhonchi (34%), nasal congestion (18%), oxygen saturation decreased (17%), cough (13%), rales (13%)
Miscellaneous: Fever (17%)
1% to 10%:
Cardiovascular: Cold extremities (7%), tachycardia (7%)
Central nervous system: Agitation (10%), neurologic abnormality (neurogenic bladder)
Endocrine & metabolic: Dehydration (10%), hyponatremia (6%), metabolic acidosis (5%)
Gastrointestinal: Oral candidiasis (8%)
Hematologic & oncologic: Decreased hemoglobin (9%), anemia (5%)
Local: Injection site reaction (7%), erythema at injection site (5%)
Respiratory: Abnormal breath sounds (decreased: 10%), stridor (9%), lower respiratory tract infection (8%), dyspnea (6%), tachypnea (5%)
Miscellaneous: Infusion related reaction (related to rate: <5%, includes back pain, chills, fever, muscle cramps, nausea, vomiting, wheezing)
Hypersensitivity to human immune globulin preparations or any component of the formulation; selective immunoglobulin A deficiency
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 rapid infusion and/or high doses of intravenous immune globulin (IGIV, ≥1 g/kg). 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.
• Hemolysis: IGIV has been associated with antiglobulin hemolysis (acute or delayed). Cases of hemolysis-related renal impairment/failure or disseminated intravascular coagulation (DIC) 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.
• 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.
• 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). With other immune globulin products, 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 IGIV 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 impairment: 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 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. 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.
• Thrombotic events: Thrombosis may occur with immune globulin products even in the absence of risk factors for thrombosis. For patients at risk of thrombosis (eg, hypercoagulable conditions, history of venous or arterial thrombosis, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors, use of estrogens, prolonged immobilization, and advanced age), 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:
• Renal impairment: Use with caution; ensure adequate hydration prior to administration; the rate of infusion and concentration of solution should be minimized.
Special populations:
• Adults: Not indicated for use in adults.
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.
Other warnings/precautions:
• Administration: For IV infusion only; do not exceed recommended rate of administration.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
BabyBIG: 100 mg (1 ea) [contains albumin human]
No
Solution (reconstituted) (BabyBIG Intravenous)
100 mg (per each): $57,300.00
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.
Access to botulism immune globulin is restricted through the Infant Botulism Treatment and Prevention Program (IBTPP). Healthcare providers must contact the IBTPP on-call physician at (510) 231-7600 to review treatment indications and to obtain the medication. For more information, refer to http://www.infantbotulism.org or contact [email protected].
IV infusion: Infusion should be started within 2 hours of reconstitution and be completed within 4 hours of reconstitution. Do not administer IM or SubQ.
Initial: Begin at 25 mg/kg/hour (0.5 mL/kg/hour) for the first 15 minutes; if well tolerated, may increase to a maximum rate of 50 mg/kg/hour (1 mL/kg/hour). Use low volume tubing for administration via a separate line. If this is not possible, piggyback BabyBIG into a preexisting line containing either NS or a dextrose solution (D2.5W, D5W, D10W, or D20W) with or without added NaCl. Do not dilute more than 1:2 with any of the above solutions. Drug concentration should be no less than 25 mg/mL. Administer via an in-line or syringe-tip filter (18 micron). Do not administer if solution is turbid. Epinephrine should be available for the treatment of acute allergic reaction.
Infusion reactions: Slow the infusion rate or temporarily interrupt infusion for minor reaction (ie, flushing). Discontinue infusion and administer epinephrine for anaphylactic reaction or significant hypotension.
Prior to reconstitution, store between 2°C to 8°C (36°F to 46°F). Infusion should begin within 2 hours of reconstitution and be completed within 4 hours of reconstitution.
Treatment of infant botulism caused by toxin type A or B (FDA approved in ages <1 year)
BabyBIG may be confused with HBIG
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
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
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
Botulism immune globulin is only indicated for use in infants <1 year of age.
Vital signs and blood pressure monitored continuously during the infusion. BUN and serum creatinine should be monitored prior to initial infusion. Periodic monitoring of renal function tests and urine output in patients at risk for developing renal failure. Aseptic meningitis syndrome (may occur hours to days following IGIV therapy). Signs of relapse (may occur up to 1 month following recovery).
BIG-IV is purified immunoglobulin derived from the plasma of adults immunized with botulinum toxoid types A and B. BIG-IV provides antibodies to neutralize circulating toxins.
Half-life elimination: Infants: 28 days
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