ORENCIA(Abatacept) Injection

Basic Drug Information
Generic Name‌: abatacept
Brand Name‌: ORENCIA
Dosage Form & Strength‌:
lyophilized powder for injection: 250mg single-use vial
injection solution: 125mg/0.95mL in prefilled syringe
Initial U.S. Approval‌: 2005
Packager‌: E.R. Squibb & Sons, L.L.C. (Bristol-Myers Squibb)
Indications and Usage
Adult Rheumatoid Arthritis (RA)‌: ORENCIA is indicated for treatment of ‌moderately to severely active RA in adults‌. It can be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.
Polyarticular Juvenile Idiopathic Arthritis‌: ORENCIA is indicated for treatment of ‌moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 6 years of age and older‌. It can be used as monotherapy or concomitantly with methotrexate (MTX).
Important Limitations of Use‌: ORENCIA should not be given concomitantly with TNF antagonists.
Dosage and Administration
For Intravenous Infusion (Adult RA) based on body weight‌:
< 60 kg: 500mg per dose
60 to 100 kg: 750mg per dose

100kg: 1000mg per dose

Dosing Schedule‌: Administer as a 30-minute intravenous infusion; Following initial dose, give at 2 and 4 weeks, then every 4 weeks thereafter
For Subcutaneous Injection (Adult RA)‌: 125mg once weekly by subcutaneous injection, after a single intravenous loading dose based on body weight
Preparation Note‌: Prepare ORENCIA using only silicone-free disposable syringes
Contraindications

None

Warnings and Precautions
Concomitant use with TNF antagonist‌: Can increase the risk of infections and serious infections, so concomitant use is not recommended.
Hypersensitivity‌: Hypersensitivity, anaphylaxis, and anaphylactoid reactions have been reported.
Infection Risk‌: Patients with a history of recurrent infections or underlying conditions predisposing to infections may have higher risk of infections during treatment.