ORENCIA is a selective T cell costimulation modulator indicated for:
Adult Rheumatoid Arthritis (RA) (1.1)

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moderately to severely active RA in adults. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists (1.1).

Juvenile Idiopathic Arthritis (1.2)

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moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 6 years of age and older. ORENCIA may be used as monotherapy or concomitantly with methotrexate (1.2).

Important Limitations of Use (1.3)

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should not be given concomitantly with TNF antagonists (1.3, 5.1).

Intravenous Administration for Adult RA (2.1)

Subcutaneous Administration for Adult RA (2.1)

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Administer by subcutaneous injection once weekly with or without an intravenous loading dose. For patients initiating therapy with an intravenous loading dose, administer a single intravenous infusion (as per body weight categories above), followed by the first 125 mg subcutaneous injection given within a day of the intravenous infusion.

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Patients transitioning from ORENCIA intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Intravenous Administration for Juvenile Idiopathic Arthritis (2.2)

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Pediatric patients weighing less than 75 kg receive 10 mg/kg intravenously based on the patient's body weight. Pediatric patients weighing 75 kg or more should be administered ORENCIA following the adult intravenous dosing regimen, not to exceed a maximum dose of 1000 mg (2.2).

General Dosing Information for Intravenous Administration (2.1)

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Administer as a 30-minute intravenous infusion (2.1)

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Following initial dose, give at 2 and 4 weeks, then every 4 weeks (2.1)

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Prepare ORENCIA using only the silicone-free disposable syringe (2.3)

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Use only sterile water to reconstitute the powder (2.3)

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The reconstituted product must be administered using a filter (2.3)

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250 mg lyophilized powder in a single-use vial for intravenous infusion (3)

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125 mg/mL solution in a single-dose prefilled syringe (3)
CONTRAINDICATIONS

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None (4)
WARNINGS AND PRECAUTIONS

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Concomitant use with a TNF antagonist can increase the risk of infections and serious infections (5.1)

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Hypersensitivity, anaphylaxis, and anaphylactoid reactions (5.2)

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Patients with a history of recurrent infections or underlying conditions predisposing to infections may experience more infections (5.3, 8.5)

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Discontinue if a serious infection develops (5.3)

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Screen for latent TB infection prior to initiating therapy. Patients testing positive should be treated prior to initiating ORENCIA (5.3)

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Live vaccines should not be given concurrently or within 3 months of discontinuation (5.4)

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Patients with juvenile idiopathic arthritis should be brought up to date with all immunizations prior to ORENCIA therapy (5.4)

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Based on its mechanism of action, ORENCIA may blunt the effectiveness of some immunizations (5.4)

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COPD patients may develop more frequent respiratory adverse events (5.5)

Most common adverse events (≥10%) are headache, upper respiratory tract infection, nasopharyngitis, and nausea (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Pregnancy: Registry available. Based on animal data, may cause fetal harm (8.1).