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Abatacept

    Brands

    DEA Class; Rx

    Common Brand Names; Orencia, Orencia ClickJect

    • DMARDs, Immunomodulators; 
    • Immunosuppressants

    Human recombinant fusion protein; a co-stimulatory or second-signal blocker of T cell activation
    Used for moderate to severe rheumatoid arthritis and active psoriatic arthritis in adults, moderately to severely active polyarticular juvenile idiopathic arthritis in children 2 years and older, and as prophylaxis of acute graft versus host disease, in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem-cell transplantation from a matched or 1 allele-mismatched unrelated donor
    May increase risk for serious infection

    Indicated for moderately to severely active rheumatoid arthritis (RA) in adults

    Indicated for adults with active psoriatic arthritis; may be used with or without nonbiologic DMARDs

    Indicated for the prophylaxis of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor and methotrexate, in adults undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor

    Orphan designation for treatment of type 1 diabetes mellitus in patients with residual beta cell function

    Orphan designation for giant cell arteritis

    None listed by the manufacturer

    • Headache (18%)
    • Nasopharyngitis (12%)
    • Nausea (>10%)
    • Infection (54% for adults & 36% for children)
    • Dizziness (9%)
    • Cough (8%)
    • Back pain (7%)
    • Hypertension (7%)
    • Dyspepsia (6%)
    • Urinary Tract Infection (6%)
    • Rash (4%)
    • Pain in extremety (3%)

    Appropriate medical support measures for treatment of hypersensitivity reactions should be available for immediate use in event of reaction; if an anaphylactic or other serious allergic reaction occurs, stop administration immediately; institute appropriate therapy; permanently discontinue therapy

    Higher risk for serious infections; concomitant use with a TNF antagonist can also increase risk of infections and serious infections; concurrent therapy with another TNF antagonist not recommended; discontinue if serious infections develop

    Serious infections, including sepsis and pneumonia, reported; some of these infections have been fatal; many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infection; a higher rate of serious infections has been observed in adult RA patients treated with concurrent TNF antagonists

    Healthcare providers should exercise caution when considering therapy in patients with a history of recurrent infections, underlying conditions which may predispose them to infections, or chronic, latent, or localized infections; patients who develop a new infection while undergoing treatment should be monitored closely; administration should be discontinued if a patient develops a serious infection

    Antirheumatic therapies have been associated with hepatitis B reactivation; screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to therapy during pregnancy

    There is no information regarding presence of abatacept in human milk, effects on breastfed infant, or effects on milk production; however, abatacept was present in the milk of lactating rats dosed with abatacept.

    Adults

    Rheumatoid arthritis (RA) or Psoriatic Arthritis (PsA)
    125 mg per week subcutaneously
    OR
    Weight more than 100 kg: 1,000 mg IV
    Weight 60 to 100 kg: 750 mg IV
    Weight less than 60 kg: 500 mg IV
     
    Acute graft-versus-host disease (aGVHD) prophylaxis:
    10 mg/kg (Max: 1,000 mg) IV

    Geriatric

    Rheumatoid arthritis (RA) or Psoriatic Arthritis (PsA)
    125 mg per week subcutaneously
    OR
    Weight more than 100 kg: 1,000 mg IV
    Weight 60 to 100 kg: 750 mg IV
    Weight less than 60 kg: 500 mg IV
     
    Acute graft-versus-host disease (aGVHD) prophylaxis:
    10 mg/kg (Max: 1,000 mg) IV

    Adolescents

    Polyarticular juvenile idiopathic arthritis (pJIA)
    Weight 50 kg or more: 125 mg per week subcutaneously
    Weight 25 kg to less than 50 kg: 87.5 mg per week subcutaneously
    Weight 10 kg to less than 25 kg: 50 mg per week subcutaneously
    OR
    Weight more than 100 kg: 1,000 mg IV
    Weight 75 kg to 100 kg: 750 mg IV
    Weight less than 75 kg: 10 mg/kg IV
     
    aGVHD prophylaxis
    10 mg/kg (Max: 1,000 mg) IV.

    Children

    Polyarticular juvenile idiopathic arthritis (pJIA)
    2 years and older:
    Weight 50 kg or more: 125 mg per week subcutaneously
    Weight 25 kg to less than 50 kg: 87.5 mg per week subcutaneously
    Weight 10 kg to less than 25 kg: 50 mg per week subcutaneously
    Safety and efficacy of subcutaneous use have not been established in children less than 2 years of age.
    6 years and older:
    Weight more than 100 kg: 1,000 mg IV
    Weight 75 kg to 100 kg: 750 mg IV
    Weight less than 75 kg: 10 mg/kg IV
    Safety and efficacy of IV use have not been established in children less than 6 years of age.
     
    aGVHD prophylaxis
    6 years and older: 10 mg/kg (Max: 1,000 mg) IV.
    2 years to less than 6 years: 15 mg/kg IV (first dose); 12 mg/kg IV (second, third, and fourth dose).
    Safety and efficacy for aGVHD prophylaxis have not been established in children less than 2 years of age.

    Infants

    Use not established.

    Neonates

    Use not established

    abatacept

    injection, lyophilized powder for reconstitution

    • 250mg/vial

    solution for SC injection

    • 125mg/mL prefilled syringe
    • 125mg/mL autoinjector