Used to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis. Can be used alone or with other DMARDs other than tumor necrosis factor (TNF) blocking agents.
Do not use concomitantly with TNF blocking agents (e.g., adalimumab, certolizumab pegol, etanercept, infliximab); concomitant use with other biologic antirheumatic drugs (e.g., anakinra) not recommended. (See Infectious Complications under Cautions and see Specific Drugs and Laboratory Tests under Interactions.)
Juvenile Arthritis
Management of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children. Can be use alone or with methotrexate.
Do not use concomitantly with TNF blocking agents (e.g., adalimumab, certolizumab pegol, etanercept, infliximab); concomitant use with other biologic antirheumatic drugs (e.g., anakinra) not recommended. (See Infectious Complications under Cautions and see Specific Drugs and Laboratory Tests under Interactions.)
Dosage and Administration
Administration
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Administer by IV infusion.
Administer with an in-line, sterile, nonpyrogenic, low-protein-binding filter with a pore diameter ≤1.2 mcm.
Consult manufacturer’s labeling for additional information on reconstitution, dilution, and administration.
Reconstitution
Reconstitute the appropriate number of vials containing 250 mg of abatacept lyophilized powder with 10 mL of sterile water for injection to provide a solution containing 25 mg/mL.
Use only the silicone-free disposable syringe provided by the manufacturer and an 18–21 gauge needle. If a siliconized syringe is inadvertently used, translucent particles may develop and solution should be discarded.
Direct sterile water for injection toward the side of the vial during reconstitution; swirl gently to minimize foaming. Do not shake. Upon dissolution, insert a vented needle into the vial to dissipate foam. Must be diluted further before IV administration.
Dilution
Remove the volume of diluent equal to the total required volume of reconstituted abatacept solution from a 100 mL bag of 0.9% sodium chloride injection.
Using same silicone-free disposable syringe used for reconstitution, slowly add reconstituted abatacept to the bag to a total volume of 100 mL; mix gently.
Rate of Administration
Infuse over 30 minutes.
Dosage
Dosage is based on patient's weight.
Pediatric Patients
Juvenile Arthritis
IV
Children 6–17 years of age weighing <75 kg: 10 mg/kg at 0, 2, and 4 weeks, then every 4 weeks.
Children 6–17 years of age weighing ≥75 kg: Use adult dosage.
Adults
Rheumatoid Arthritis
IV
Adults weighing <60 kg: 500 mg at 0, 2, and 4 weeks, then every 4 weeks.
Adults weighing 60–100 kg: 750 mg at 0, 2, and 4 weeks, then every 4 weeks.
Adults weighing >100 kg: 1 g at 0, 2, and 4 weeks, then every 4 weeks.
Prescribing Limits
Pediatric Patients
Juvenile Arthritis
IV
Children 6–17 years of age weighing ≥75 kg: Maximum dose is 1 g.
Special Populations
No special population dosage recommendations at this time.
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