ORENCIA- abatacept injection, powder, lyophilized, for solution
ORENCIA- abatacept injection, solution

Bristol Myers Squibb

1.1 Adult Rheumatoid Arthritis
ORENCIA® is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1.2 Polyarticular Juvenile Idiopathic Arthritis
ORENCIA is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

1.3 Psoriatic Arthritis
ORENCIA is indicated for the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA).

1.4 Prophylaxis for Acute Graft versus Host Disease
ORENCIA is indicated for 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.

1.5 Limitations of Use
The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDs), Janus kinase (JAK) inhibitors] is not recommended.

2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Adult Rheumatoid Arthritis
For adult patients with RA, administer as an intravenous infusion or as a subcutaneous injection. ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than JAK inhibitors or bDMARDs (e.g., TNF antagonists).

Refrigerate ORENCIA lyophilized powder supplied in a vial at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date on the vial. Protect the vials from light by storing in the original package until time of use.

Refrigerate ORENCIA solution supplied in a prefilled syringe or ClickJect autoinjector at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date on the prefilled syringe or autoinjector. Protect from light by storing in the original package until time of use. Do not allow the prefilled syringe or autoinjector to freeze.