INDICATIONS AND USAGE
Adult Rheumatoid Arthritis (RA)
ORENCIA® is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
Juvenile Idiopathic Arthritis
ORENCIA is indicated for reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX).
Important Limitations of Use
ORENCIA should not be administered concomitantly with TNF antagonists. ORENCIA is not recommended for use concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
DOSAGE AND ADMINISTRATION
Adult Rheumatoid Arthritis
For adult patients with RA, ORENCIA should be administered as a 30-minute intravenous infusion utilizing the weight range-based dosing specified in Table 1. Following the initial administration, ORENCIA should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.
For pediatric juvenile idiopathic arthritis, a dose calculated based on each patient’s body weight is used [see Dosage and Administration ].
Table 1: Dose of ORENCIA in Adult RA
| Body Weight of Patient || Dose || Number of Vialsa |
|a Each vial provides 250 mg of abatacept for administration.|
|<60 kg||500 mg||2|
|60 to 100 kg||750 mg||3|
|>100 kg||1000 mg||4|
Juvenile Idiopathic Arthritis
The recommended dose of ORENCIA for patients 6 to 17 years of age with juvenile idiopathic arthritis who weigh less than 75 kg is 10 mg/kg calculated based on the patient’s body weight at each administration. Pediatric patients weighing 75 kg or more should be administered ORENCIA following the adult dosing regimen, not to exceed a maximum dose of 1000 mg. ORENCIA should be administered as a 30-minute intravenous infusion. 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.
Preparation and Administration Instructions
Use aseptic technique.
ORENCIA is provided as a lyophilized powder in preservative-free, single-use vials. Each ORENCIA vial provides 250 mg of abatacept for administration. The ORENCIA powder in each vial must be reconstituted with 10 mL of Sterile Water for Injection, USP, using ONLY the SILICONE-FREE DISPOSABLE SYRINGE PROVIDED WITH EACH VIAL and an 18- to 21- gauge needle. After reconstitution, the concentration of abatacept in the vial will be 25 mg/mL. If the ORENCIA powder is accidentally reconstituted using a siliconized syringe, the solution may develop a few translucent particles. Discard any solutions prepared using siliconized syringes.
If the SILICONE-FREE DISPOSABLE SYRINGE is dropped or becomes contaminated, use a new SILICONE-FREE DISPOSABLE SYRINGE from inventory. For information on obtaining additional SILICONE-FREE DISPOSABLE SYRINGES, contact Bristol-Myers Squibb 1-800-ORENCIA™.
During reconstitution, to minimize foam formation in solutions of ORENCIA, the vial should be rotated with gentle swirling until the contents are completely dissolved. Avoid prolonged or vigorous agitation. DO NOT SHAKE. Upon complete dissolution of the lyophilized powder, the vial should be vented with a needle to dissipate any foam that may be present. The solution should be clear and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.
- 1)To reconstitute the ORENCIA powder, remove the flip-top from the vial and wipe the top with an alcohol swab. Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Do not use the vial if the vacuum is not present. Rotate the vial with gentle swirling until the contents are completely dissolved.
- 2)Upon complete dissolution of the lyophilized powder, the vial should be vented with a needle to dissipate any foam that may be present. After reconstitution, each milliliter will contain 25 mg (250 mg/10 mL).
- 3)The reconstituted ORENCIA solution must be further diluted to 100 mL as follows. From a 100 mL infusion bag or bottle, withdraw a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of the reconstituted ORENCIA solution required for the patient’s dose. Slowly add the reconstituted ORENCIA solution into the infusion bag or bottle using the same SILICONE-FREE DISPOSABLE SYRINGE PROVIDED WITH EACH VIAL. Gently mix. DO NOT SHAKE THE BAG OR BOTTLE. The final concentration of abatacept in the bag or bottle will depend upon the amount of drug added, but will be no more than 10 mg/mL. Any unused portions in the vials must be immediately discarded.
- 4)Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discoloration. Discard the solution if any particulate matter or discoloration is observed.
- 5)The entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a STERILE, NON-PYROGENIC, LOW-PROTEIN-BINDING FILTER (pore size of 0.2 µm to 1.2 µm).
- 6)The infusion of the fully diluted ORENCIA solution must be completed within 24 hours of reconstitution of the ORENCIA vials. The fully diluted ORENCIA solution may be stored at room temperature or refrigerated at 2°C to 8°C (36°F to 46°F) before use.
- 7)ORENCIA should not be infused concomitantly in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of ORENCIA with other agents.
DOSAGE FORMS AND STRENGTHS
250 mg single-use vial
HOW SUPPLIED/STORAGE AND HANDLING
ORENCIA® (abatacept) lyophilized powder for intravenous infusion is supplied as an individually packaged, single-use vial with a silicone-free disposable syringe. The product is available in the following strength: NDC 0003-2187-10, providing 250 mg of abatacept in a 15-mL vial.
Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date. Protect the vials from light by storing in the original package until time of use.