Version October 2023
Note: Screen for tuberculosis and hepatitis prior to abatacept treatment initiation.
Graft-versus-host disease, acute, prophylaxis:
Note: Use in combination with a calcineurin inhibitor and methotrexate (Ref). Prior to administering abatacept, initiate antiviral prophylaxis for Epstein-Barr virus (EBV) reactivation, according to clinical/institutional practice guidelines; continue antiviral prophylaxis for 6 months following hematopoietic stem cell transplant (HSCT). Consider prophylactic antivirals for cytomegalovirus (CMV) infection/reactivation during abatacept treatment and for 6 months following HSCT.
IV: 10 mg/kg (maximum: 1,000 mg/dose) on the day prior to transplant (day -1), followed by 10 mg/kg (maximum: 1,000 mg/dose) on days 5, 14, and 28 post-transplant (Ref).
Psoriatic arthritis:
Note: IV dosing is according to body weight. Following the initial IV infusion (using the weight-based dosing), repeat IV infusion (using the same weight-based dosing) at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.
IV:
<60 kg: 500 mg.
60 to 100 kg: 750 mg.
>100 kg: 1,000 mg.
SUBQ: 125 mg once weekly. Note: Administer without an IV loading dose.
If transitioning from IV therapy to SUBQ therapy, administer the first SUBQ dose instead of the next scheduled IV dose.
Rheumatoid arthritis:
Note: For use as an alternative to methotrexate in disease-modifying antirheumatic drug–naive patients with moderate to high disease activity, or as adjunctive therapy in patients who have not met treatment goals despite maximally tolerated methotrexate therapy (Ref).
Note: IV dosing is according to body weight. Following the initial IV infusion (using the weight-based dosing), repeat IV infusion (using the same weight-based dosing) at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.
IV:
<60 kg: 500 mg.
60 to 100 kg: 750 mg.
>100 kg: 1,000 mg.
SUBQ: 125 mg once weekly. Note: SUBQ dosing may be initiated with or without an IV loading dose.
If initiating with an IV loading dose, administer the initial IV infusion (using the weight-based dosing), then administer 125 mg subcutaneously within 24 hours of the infusion, followed by 125 mg subcutaneously once weekly thereafter.
If transitioning from IV therapy to SUBQ therapy, administer the first SUBQ dose instead of the next scheduled IV dose.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hypersensitivity reaction: If an anaphylactic or other serious allergic reaction occurs, immediately and permanently discontinue abatacept administration and manage as clinically appropriate.
Serious infection: Discontinue abatacept in patients who develop a serious infection.
Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
(For additional information see "Abatacept: Pediatric drug information")
Note: Dosing presented in mg/kg and fixed mg; use extra caution to ensure correct dosing units.
Graft-versus-host disease, acute; prophylaxis in patients receiving hematopoietic stem cell transplantation (HSCT):
Note: Use in combination with calcineurin inhibitors and methotrexate. Prior to administering abatacept, initiate antiviral prophylaxis for Epstein-Barr virus (EBV) reactivation according to clinical/institutional practice guidelines; continue antiviral prophylaxis for 6 months following HSCT. Consider prophylactic antivirals for cytomegalovirus (CMV) infection/reactivation during abatacept treatment and for 6 months following HSCT. Efficacy shown in patients undergoing HSCT from a matched donor or 1 allele-mismatched unrelated donor.
Children 2 to <6 years: IV: 15 mg/kg on day −1 (day before transplantation) followed by 12 mg/kg on days 5, 14, and 28 post-transplant.
Children ≥6 years and Adolescents: IV: 10 mg/kg on day −1 (day before transplantation) followed by 10 mg/kg on days 5, 14, and 28 post-transplant; maximum dose: 1,000 mg/dose.
Juvenile idiopathic arthritis: Note: Dosing varies by route of administration (IV or SUBQ); use extra precaution.
IV: Children ≥6 years and Adolescents: Note: Dose is based on body weight at each dose administration. Following the initial IV infusion, repeat IV dose at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.
Patient weight:
<75 kg: IV: 10 mg/kg.
75 to 100 kg: IV: 750 mg.
>100 kg: IV: 1,000 mg.
SUBQ: Children ≥2 years and Adolescents: Note: Administer without an IV loading dose and use the following weight-based dosing. The autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.
Patient weight:
10 to <25 kg: SUBQ: 50 mg once weekly.
≥25 to <50 kg: SUBQ: 87.5 mg once weekly.
≥50 kg: SUBQ: 125 mg once weekly.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity: Children ≥2 years and Adolescents: Discontinue in patients who develop serious infection.
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults, unless otherwise noted. Reported adverse reactions are for infusion administration for rheumatoid arthritis (RA) unless noted to be for acute graft vs host disease (aGVHD) prophylaxis. Incidences may include concomitant therapies.
>10%:
Cardiovascular: Hypertension (aGVHD: 43%; RA: 7%)
Endocrine & metabolic: Hypermagnesemia (aGVHD: 18%)
Gastrointestinal: Nausea (RA: ≥10%; severe nausea: aGVHD: 5%)
Hematologic & oncologic: Anemia (aGVHD: 69%; grade 3/4: 69%), decreased CD-4 cell count (aGVHD: 14%; grade 3/4: 14%)
Immunologic: Antibody development (RA and aGVHD: 1% to 10%; neutralizing: 67%)
Infection: Cytomegalovirus disease (aGVHD: 32%, including reactivation; systemic cytomegalovirus disease: aGVHD: 7%), infection (54%; serious infection: 3%), influenza (5% to 13%)
Nervous system: Headache (18%)
Renal: Acute kidney injury (aGVHD: 15%)
Respiratory: Bronchitis (5% to 13%), epistaxis (aGVHD: 16%), nasopharyngitis (12%), pneumonia (aGVHD: 12%; RA: <5%), sinusitis (5% to 13%), upper respiratory tract infection (5% to 13%)
Miscellaneous: Fever (aGVHD: 19%)
1% to 10%:
Dermatologic: Skin rash (4%)
Gastrointestinal: Dyspepsia (6%), severe diarrhea (aGVHD: 6%)
Genitourinary: Urinary tract infection (6%)
Hematologic & oncologic: Lymphoproliferative disorder (aGVHD: Post-transplant: 3%)
Infection: Herpes simplex infection (<5%), reactivation of latent Epstein-Barr virus (aGVHD: <10%)
Nervous system: Dizziness (9%)
Neuromuscular & skeletal: Back pain (7%), limb pain (3%)
Respiratory: Cough (8%), rhinitis (<5%), severe hypoxia (aGVHD: 5%)
Miscellaneous: Infusion related reaction (including flushing, hypotension, and dyspnea: 9%)
<1%:
Dermatologic: Cellulitis (severe)
Gastrointestinal: Diverticulitis of the gastrointestinal tract (severe)
Hematologic & oncologic: Malignant lymphoma, malignant neoplasm of lung
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Renal: Pyelonephritis (severe)
Frequency not defined:
Genitourinary: Malignant neoplasm of cervix
Hematologic & oncologic: Endometrial carcinoma, malignant melanoma, malignant neoplasm of bladder, malignant neoplasm of breast, malignant neoplasm of kidney, malignant neoplasm of ovary, malignant neoplasm of prostate, malignant neoplasm of skin, malignant neoplasm of the bile duct, malignant neoplasm of thyroid, malignant neoplasm of uterus, myelodysplastic syndrome
Postmarketing:
Cardiovascular: Hypersensitivity angiitis, vasculitis
Dermatologic: Exacerbation of psoriasis, psoriasis
Hematologic & oncologic: Basal cell carcinoma of skin, squamous cell carcinoma of skin
Hypersensitivity: Angioedema
Infection: Sepsis
There are no contraindications listed within the manufacturer's US labeling.
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to abatacept or any component of the formulation; patients with or at risk of sepsis syndrome (eg, immunocompromised, HIV positive).
Concerns related to adverse effects:
• Hypersensitivity reactions: Rare cases of hypersensitivity, anaphylaxis, or anaphylactoid reactions, including fatalities, have been reported with IV administration; may occur with first infusion. Some reactions (angioedema, hypotension, urticaria, dyspnea) occurred within 24 hours of infusion, but may also have a delayed onset. Discontinue treatment if anaphylaxis or other serious allergic reaction occurs; medication for the treatment of hypersensitivity reactions should be available for immediate use.
• Infections: Serious and potentially fatal infections (including tuberculosis and sepsis) have been reported, particularly in patients receiving concomitant immunosuppressive therapy. Patients with rheumatoid arthritis (RA) receiving a concomitant tumor necrosis factor (TNF) antagonist experienced an even higher rate of serious infection; monitor for signs and symptoms of infection when transitioning from TNF-blocking agents to abatacept. Concomitant use of abatacept with TNF antagonists or Janus kinase inhibitors is not recommended. Caution should be exercised when considering the use in any patient with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued.
• Malignancy: Use may affect defenses against malignancies (via T-cell inhibition); impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma and lung cancer has been noted in clinical trials; however, RA has been previously associated with an increased rate of lymphoma. Malignancies, including skin cancer, have been reported with abatacept therapy; periodic skin examinations are recommended.
Disease-related concerns:
• Chronic obstructive pulmonary disease: Use caution with chronic obstructive pulmonary disease (COPD); higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Special populations:
• Hematopoietic stem cell transplantation: Posttransplant lymphoproliferative disorder (PTLD) has been reported in a small percentage of patients who received abatacept for acute graft-versus-host disease (aGVHD) prophylaxis following unrelated hematopoietic stem cell transplantation (HSCT). All PTLD cases were associated with Epstein-Barr virus (EBV) infection; the majority of patients were EBV serology positive at baseline, and most discontinued acyclovir prophylaxis at day 30 post-transplant. The time to PTLD onset ranged from 49 to 89 days post-transplant. Cytomegalovirus (CMV) invasive disease also occurred in some patients who received abatacept for aGVHD prophylaxis following unrelated HSCT; all patients who had CMV invasive disease were CMV serology positive at baseline. The median time to CMV onset was 91 days post-transplant (range: up to 225 days post-transplant). CMV invasive disease primarily involved the GI tract.
• Older age: Use with caution; higher incidences of infection and malignancy were observed in patients ≥65 years of age.
• Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery: Hold biologic disease-modifying antirheumatic drugs (DMARDs) prior to surgery and plan surgery after the next dose is due. Surgery can occur after holding medication for 1 full dosing cycle (eg, for medications administered every 4 weeks, schedule surgery 5 weeks from last administered dose); therapy can be restarted once surgical wound shows evidence of healing (eg, no swelling, erythema, or drainage), sutures/staples are removed, and no ongoing nonsurgical site infections (typically ~14 days to reduce infection risk). Decisions to withhold therapy should be based on shared decision making; ensure the patient and their provider weigh risks of interrupting therapy and disease control versus risks of continuing therapy and surgical complications (ACR/AAHKS [Goodman 2022]).
• Tuberculosis-positive patients: Safety has not been established in patients who are tuberculosis-positive; screen for latent tuberculosis infection prior to initiating therapy. Treat patients testing positive according to standard therapy prior to initiating abatacept.
Dosage form specific issues:
• Maltose: Powder for injection may contain maltose, which may result in falsely elevated serum glucose readings on the day of infusion.
Other warnings/precautions:
• Hepatitis screening: Patients should be screened for viral hepatitis prior to use; antirheumatic therapy may cause reactivation of hepatitis B.
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently or within 3 months of discontinuation of therapy; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
Reactivation of TB has been reported in pediatric patients receiving biologic response modifiers (infliximab and etanercept); prior to therapy, patients with no TB risk factors should be screened for latent TB infection (LTBI) with an age appropriate test (ie, <5 years of age: tuberculin skin test, and ≥5 years of age: IGRA [interferon gamma release assay]); if any TB risk factors are present or symptoms, both LTBI screening tests should be performed (AAP [Davies 2016]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous [preservative free]:
Orencia ClickJect: 125 mg/mL (1 mL)
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Orencia: 50 mg/0.4 mL (0.4 mL); 87.5 mg/0.7 mL (0.7 mL); 125 mg/mL (1 mL)
Solution Reconstituted, Intravenous [preservative free]:
Orencia: 250 mg (1 ea)
No
Solution (reconstituted) (Orencia Intravenous)
250 mg (per each): $1,655.88
Solution Auto-injector (Orencia ClickJect Subcutaneous)
125 mg/mL (per mL): $1,611.87
Solution Prefilled Syringe (Orencia Subcutaneous)
50 mg/0.4 mL (per 0.4 mL): $1,611.87
87.5 mg/0.7 mL (per 0.7 mL): $1,611.87
125 mg/mL (per mL): $1,611.87
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous:
Orencia: 125 mg/mL (1 mL)
Solution Reconstituted, Intravenous:
Orencia: 250 mg (1 ea)
Do not administer if solution is discolored or contains particulate matter.
IV: Infuse over 30 minutes (psoriatic arthritis and rheumatoid arthritis) or 60 minutes (acute graft-versus-host disease prophylaxis). Administer through a 0.2- to 1.2-micron sterile, nonpyrogenic, low protein-binding filter. Do not infuse other medications through the same IV line with abatacept.
SUBQ: Allow prefilled syringe and autoinjector to warm to room temperature (for 30 to 60 minutes and 30 minutes, respectively) prior to administration. Inject full amount into the front of the thigh (preferred), abdomen (except for 2-inch area around the navel), or the outer area of the upper arms (if administered by a caregiver). Rotate injection sites (≥1 inch apart); do not administer into tender, bruised, red, or hard skin.
IV: Administer through a 0.2 to 1.2 micron low protein-binding filter. Rate of administration varies by indication:
Graft-versus-host disease, acute; prophylaxis: Infuse over 60 minutes.
Juvenile idiopathic arthritis: Infuse over 30 minutes.
SUBQ: Allow prefilled syringe to warm to room temperature for 30 minutes prior to administration. Inject into the front of the thigh (preferred), abdomen (except for 2-inch area around the navel), or the outer area of the upper arms (if administered by a caregiver). Rotate injection sites (≥1 inch apart); do not administer into tender, bruised, red, or hard skin. Pediatric doses may be administered by a trained caregiver (parent) or pediatric patient; for self-administration, the health care provider and caregiver (parent) should determine it to be appropriate.
Graft-versus-host disease, acute, prophylaxis: Prophylaxis of acute graft-versus-host disease (in combination with a calcineurin inhibitor and methotrexate) in adults and pediatric patients ≥2 years of age undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor.
Juvenile idiopathic arthritis: Treatment of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ≥2 years of age; may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis: Treatment of active psoriatic arthritis in adults.
Rheumatoid arthritis: Treatment of moderately to severely active rheumatoid arthritis in adults; may be used as monotherapy or in combination with other disease-modifying antirheumatic drugs (DMARDs).
Limitations of use: The concomitant use of abatacept with other potent immunosuppressants (eg, biologic DMARDs, Janus kinase inhibitors) is not recommended.
Abatacept may be confused with etanercept.
Orencia may be confused with Oracea.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
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.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Anifrolumab: Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Anti-TNF Agents: May enhance the immunosuppressive effect of Abatacept. Risk X: Avoid combination
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Belimumab: May enhance the immunosuppressive effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification
Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): May enhance the immunosuppressive effect of other Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccines: Abatacept may diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding SQ abatacept for 1 to 2 weeks after each vaccine dose and timing vaccine dose so that it is given 1 week prior to the next IV abatacept dose. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Based on limited data, use of abatacept may be continued through conception in patients with rheumatic and musculoskeletal diseases who are planning to become pregnant and not able to use alternative therapies; use should be discontinued once pregnancy is confirmed. Conception should be planned during a period of quiescent/low disease activity (ACR [Sammaritano 2020]).
Recommendations for use of abatacept to treat rheumatic and musculoskeletal diseases in patients who are planning to father a child are not available due to limited data (ACR [Sammaritano 2020]).
Outcome data related to the use of abatacept in pregnancy are limited (Dernoncourt 2023; Ghalandari 2022; Kumar 2015; Ojeda-Uribe 2013).
Until additional data are available, abatacept is not currently recommended for the treatment of rheumatic and musculoskeletal diseases during pregnancy. Abatacept should be discontinued once pregnancy is confirmed (ACR [Sammaritano 2020]).
Abatacept is present in human milk.
Breast milk concentrations were measured in one patient administered abatacept 2.5 mg/kg (125 mg) SUBQ weekly, restarted 2 days postpartum for rheumatoid arthritis. Maternal serum and breast milk were sampled 63 and 71 days after delivery, after doses 9 and 10, respectively. Breast milk concentrations peaked ~3 days after the injection (256.2 ng/mL) then declined gradually (169.5 ng/mL prior to next treatment). Authors of the report calculated the relative infant dose of abatacept to be 1.02% to 1.54% of the weight adjusted maternal dose, providing an estimated infant dose via breast milk of 0.025 to 0.038 mg/kg/day. Adverse events were not observed in the infant exclusively breastfed for 12 months (Saito 2019).
Concentrations of abatacept are expected to be limited in breast milk due to large molecular weight. Also, because abatacept is unlikely to be absorbed by the infant GI tract following exposure via breast milk, treatment with abatacept may be continued or initiated in breastfeeding patients with rheumatic and musculoskeletal diseases (ACR [Sammaritano 2020]).
Monitor for signs/symptoms of infection and/or hypersensitivity reaction. Conduct hepatitis and tuberculosis screening prior to therapy initiation. Perform periodic skin examinations. In patients receiving abatacept for prophylaxis of acute graft-versus-host disease following hematopoietic stem cell transplant, monitor for cytomegalovirus infection/reactivation for 6 months post-transplant; monitor for Epstein-Barr virus reactivation and for posttransplant lymphoproliferative disorder.
For prophylaxis of acute graft-versus-host disease: The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Abatacept is a selective costimulation modulator; it inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis. Costimulation blockade has a role in preventing graft-versus-host disease (Watkins 2021).
Distribution: Vss: Rheumatoid arthritis (RA): IV: 0.07 L/kg (range: 0.02 to 0.13 L/kg); acute graft-versus-host disease (aGVHD) prophylaxis: 0.13 to 0.17 L/kg
Bioavailability: SUBQ: 78.6% (relative to IV administration).
Half-life elimination: RA: IV: 13.1 days (range: 8 to 25 days); aGVHD prophylaxis: ~21 days.
Clearance: Note: Clearance increases with increasing body weight. Population pharmacokinetic analyses in patients receiving abatacept for aGVHD prophylaxis showed that 7 of 8 HLA-matched hematopoietic stem cell transplant (HSCT) recipients had 29% lower clearance compared to 8 of 8 HLA-matched HSCT recipients.
Children 6 to 17 years of age: Juvenile idiopathic arthritis: 0.4 mL/hour/kg (0.2 to 1.12 mL/hour/kg).
Adults: RA: 0.22 mL/hour/kg (0.13 to 0.47 mL/hour/kg); aGVHD prophylaxis: 0.26 to 0.32 mL/hour/kg.
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