Classes
DEA Class; Rx
Common Brand Names; Orencia, Orencia ClickJect
- DMARDs, Immunomodulators;
- Immunosuppressants
Description
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
Indications
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
Contraindications
None listed by the manufacturer
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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.
Maximum Dosage
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
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
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.
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.
Use not established.
Use not established
How supplied
abatacept
injection, lyophilized powder for reconstitution
- 250mg/vial
solution for SC injection
- 125mg/mL prefilled syringe
- 125mg/mL autoinjector