Monograph Details
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Musculoskeletal Disorders
> Arthritis/rheumatic disorders
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ORENCIA |
| Manufacturer |
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Bristol-Myers Squibb |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Selective costimulation modulator. |
| Generic Name |
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Abatacept 250mg/vial; pwd for IV infusion after reconstitution and dilution; preservative-free. |
| Indications |
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To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in patients with moderately-to-severely active rheumatoid arthritis; may be used alone or with DMARDS other than TNF antagonists. To reduce signs/symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients ≥6 years of age; may be used alone or with methotrexate. |
| Children |
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Give as an IV infusion over 30 minutes at weeks 0, 2, and 4, then every 4 weeks thereafter. <6yrs: not recommended. 6–17yrs: (<75kg): 10mg/kg; (≥75kg): use adult dose; max 1g. |
| Adults |
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Give as an IV infusion over 30 minutes at weeks 0, 2, and 4, then every 4 weeks thereafter. <60kg: 500mg. 60–100kg: 750mg. >100kg: 1g. |
| Precautions |
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Chronic or history of recurring infections. Conditions that predispose to infection. Test for tuberculosis, treat TB first. Monitor closely if new infection develops; discontinue if serious infection occurs. COPD (monitor). Immunosuppression. Juvenile arthritis: follow up on current immunizations before starting therapy. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Concomitant TNF antagonists, anakinra, live vaccines: not recommended (see literature). |
| Adverse Reactions |
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Infusion reactions, infections (may be serious), headache, GI upset, dizziness, cough, back pain, hypertension, rash, UTI, malignancies (eg, lymphoma, lung cancer). Children: pyrexia, abdominal pain. |
| Extra Text |
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Note: Reconstitute with silicone-free disposable syringes only. |
| How Supplied |
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Single-use vial—1 (w. silicone-free disposable syringe) |
| Additional Resources |
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• Related Prescribing Note |
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