Arthritis/rheumatic disorders:

Indications for ORENCIA:

Treatment of adults with moderately to severely active rheumatoid arthritis (RA); may be used alone or with DMARDS, other than JAK inhibitors or TNF antagonists. Moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 years of age; may be used alone or with methotrexate. 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), followed by the first 125mg SC inj given within one 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 established. ≥2yrs: (10–<25kg): 50mg once weekly; (25–<50kg): 87.5mg once weekly; (≥50kg); 125mg once weekly. Rotate inj sites. ClickJect autoinjector: not studied in pediatrics.

Warnings/Precautions:

Chronic, latent, localized, or history of recurring infections. Conditions that predispose to infection. Screen for tuberculosis (TB), hepatitis prior to initiation; treat TB if positive. Monitor closely if new infection develops; discontinue if serious infection occurs. COPD (monitor). Update vaccinations according to current guidelines prior to starting. Immunosuppression. Do periodic skin exams (esp. in those with risks for skin cancer). Elderly. Pregnancy. Nursing mothers.

Pharmacologic Class:

Selective costimulation modulator.

Interactions:

Concomitant TNF antagonists, other biologics (eg, anakinra), JAK inhibitors, live vaccines (or within 3 months of discontinuation): not recommended (see full labeling).

Adverse Reactions:

Headache, upper respiratory tract infection, nasopharyngitis, nausea, infusion-related reactions; infections (may be serious), malignancies (eg, lymphoma, lung cancer), hypersensitivity reactions (permanently discontinue if occurs). Children: diarrhea, cough, 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 syringes—4; Single-dose ClickJect autoinjectors—4

Pricing for ORENCIA

4 syringes of 125mg/ml carton (Qty: 1)
Appx. price $4744
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