ORENCIA DOSAGE AND ADMINISTRATION

 Adult Rheumatoid Arthritis

For adult patients with RA, ORENCIA may be administered as an intravenous infusion or as a subcutaneous injection.

ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.
Intravenous Dosing Regimen

ORENCIA lyophilized powder should be reconstituted and administered after dilution [see Adult Psoriatic Arthritis] as a 30-minute intravenous infusion utilizing the weight range-based dosing specified in Table 1. Following the initial intravenous administration, an intravenous infusion should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter.

ORENCIA 125 mg in prefilled syringes or in ORENCIA ClickJect™ autoinjector should be administered by subcutaneous injection once weekly [see Preparation And Administration Instructions For Intravenous Infusion] and may be initiated with or without an intravenous loading dose. For patients initiating therapy with an intravenous loading dose, ORENCIA should be initiated with a single intravenous infusion (as per body weight categories listed in Table 1), followed by the first 125 mg subcutaneous injection administered within a day of the intravenous infusion.

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

Juvenile Idiopathic Arthritis

For patients with juvenile idiopathic arthritis (JIA), ORENCIA may be administered as an intravenous infusion (6 years of age and older) or a subcutaneous injection (2 years of age and older). Intravenous dosing has not been studied in patients younger than 6 years of age.

ORENCIA may be used as monotherapy or concomitantly with methotrexate.
Intravenous Dosing Regimen

ORENCIA should be administered as a 30-minute intravenous infusion based on body weight. Pediatric patients with:

    body weight less than 75 kg should be administered ORENCIA at a dose of 10 mg/kg [see Adult Psoriatic Arthritis].
    body weight of 75 kg or more should be administered ORENCIA following the adult intravenous dosing regimen (see Table 1), not to exceed a maximum dose of 1000 mg.

Following the initial administration, ORENCIA should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter. Any unused portions in the vials must be immediately discarded.