Orencia FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 16, 2021.
FDA Approved: Yes (First approved December 23, 2005)
Brand name: Orencia
Generic name: abatacept
Dosage form: Injection
Company: Bristol-Myers Squibb Company
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Graft Versus Host Disease - Prophylaxis
Orencia (abatacept) is a selective T cell costimulation modulator indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and the prophylaxis of acute graft versus host disease (aGVHD).
- Orencia is indicated for:
- the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
- the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).
- the treatment of adult patients with active psoriatic arthritis (PsA).
- the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.
- Orencia is administered via intravenous infusion or subcutaneous injection.
- Common adverse reactions in RA are headache, upper respiratory tract infection, nasopharyngitis, and nausea. Common adverse reactions in prophylaxis of aGVHD are anemia, hypertension, CMV reactivation/CMV infection, pyrexia, pneumonia, epistaxis, CD4 lymphocytes decreased, hypermagnesemia, and acute kidney injury.
Development timeline for Orencia
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