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ORENCIA
Arthritis/rheumatic disorders
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Drug Name:

ORENCIA Rx

Generic Name and Formulations:
Abatacept 250mg/vial; pwd for IV infusion after reconstitution and dilution; 50mg/0.4mL, 87.5mg/0.7mL, 125mg/mL prefilled syringe or 125mg/mL ClickJect autoinjector; soln for SC inj; All: preservative-free. IV form: contains maltose.

Company:
Bristol-Myers Squibb

Therapeutic Use:

Indications for ORENCIA:

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 (RA); 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 ≥2 years of age; may be used alone or with methotrexate. Treatment of active psoriatic arthritis (PsA) in adults.

Adult:

See full labeling. IV regimen (RA and PsA): give as IV infusion over 30 mins at weeks 0, 2, and 4, then every 4 weeks thereafter. <60kg: 500mg. 60–100kg: 750mg. >100kg: 1g. SC regimen: For RA (may initiate with or without an IV loading dose): if using an IV loading dose, administer a single IV loading dose (based on body wt listed above), following by the first 125mg SC inj given within a day, then subsequently 125mg SC inj once weekly; rotate inj sites. For PsA: administer once weekly SC inj without an IV loading dose. Switching from IV to SC regimen: give the first SC dose instead of the next scheduled IV dose.

Children:

See full labeling. IV regimen: give as an IV infusion over 30 mins at weeks 0, 2, and 4, then every 4 weeks thereafter. <6yrs: not studied. 6–17yrs: (<75kg): 10mg/kg; (≥75kg): use adult dose; max 1g. SC regimen (initiate without an IV loading dose): <2yrs: not studied. ≥2yrs: (10–<25kg): 50mg once weekly; (25–<50kg): 87.5mg once weekly; (≥50kg); 125mg once weekly. Rotate inj sites. ClickJect autoinjector: not studied in patients <18yrs.

Warnings/Precautions:

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. Screen for viral hepatitis prior to initiation. COPD (monitor). Immunosuppression. Juvenile arthritis: follow up on current immunizations before starting therapy. Elderly. Pregnancy. Nursing mothers.

Interactions:

Concomitant TNF antagonists, other biologics (eg, anakinra), live vaccines: not recommended (see full labeling).

Pharmacological Class:

Selective costimulation modulator.

Adverse Reactions:

Headache, upper respiratory tract infection, nasopharyngitis, nausea, infusion site reactions; infections (may be serious), malignancies (eg, lymphoma, lung cancer), hypersensitivity reactions (discontinue if occurs). Children: pyrexia, abdominal pain.

Note:

Reconstitute with silicone-free disposable syringes only.

Generic Availability:

NO

How Supplied:

Single-use vial—1 (w. silicone-free disposable syringe); Single-dose prefilled syringe—4; Single-dose prefilled ClickJect autoinjector—4

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