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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 may be administered as an intravenous infusion or a subcutaneous injection.
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 Juvenile Idiopathic Arthritis below].
Intravenous Dosing Regimen
ORENCIA intravenous should be administered 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.
Table 1: Dose of ORENCIA for Intravenous Infusion in
Adult RA Patients
|Body Weight of Patient||Dose||Number of Vialsa|
|Less than 60 kg||500 mg||2|
|60 to 100 kg||750 mg||3|
|More than 100 kg||1000 mg||4|
|a Each vial provides 250 mg of abatacept for administration.|
Subcutaneous Dosing Regimen
ORENCIA 125 mg should be administered by subcutaneous injection once weekly 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
Intravenous Dosing Regimen
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 intravenously 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 intravenous 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.
Subcutaneous Dosing Regimen
The safety and efficacy of subcutaneous ORENCIA injection has not been studied in patients under 18 years of age.
Preparation And Administration Instructions For Intravenous Infusion
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.
- Use 10 mL of Sterile Water for Injection, USP to reconstitute the ORENCIA powder. 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 to minimize foam formation, until the contents are completely dissolved. Do not shake. Avoid prolonged or vigorous agitation.
- 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). The solution should be clear and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.
- 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.
- 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.
- 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).
- 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. Discard the fully diluted solution if not administered within 24 hours.
- 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.
General Considerations For Subcutaneous Administration
ORENCIA Injection, 125 mg/syringe is not intended for intravenous infusion.
ORENCIA Injection is intended for use under the guidance of a physician or healthcare practitioner. After proper training in subcutaneous injection technique, a patient may self-inject with ORENCIA if a physician/healthcare practitioner determines that it is appropriate. Patients should be instructed to follow the directions provided in the Instructions for Use for additional details on medication administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use ORENCIA prefilled syringes exhibiting particulate matter or discoloration. ORENCIA should be clear and colorless to pale yellow.
Patients using ORENCIA for subcutaneous administration should be instructed to inject the full amount in the syringe (1 mL), which provides 125 mg of ORENCIA, according to the directions provided in the Instructions for Use.
Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red, or hard.
Dosage Forms And Strengths
- Lyophilized Powder for Intravenous Infusion
250 mg single-use vial
- Solution for Subcutaneous Injection
125 mg/mL single-dose prefilled glass syringe
Storage And Handling
For Intravenous Infusion
ORENCIA®(abatacept) lyophilized powder for intravenous infusion is supplied as an individually packaged, single-use vial with a silicone-free disposable syringe, providing 250 mg of abatacept in a 15-mL vial: NDC 0003-2187-10.
For Subcutaneous Injection
ORENCIA® (abatacept) injection solution for subcutaneous administration is supplied either as a single-dose disposable prefilled glass syringe with UltraSafe Passive® needle guard with flange extenders or as a single-dose disposable prefilled glass syringe with flange extender. The Type I glass syringe has a coated stopper and fixed stainless steel needle (5 bevel, 29-gauge thin wall, ½-inch needle) covered with a rigid needle shield. The prefilled syringe provides 125 mg of abatacept in 1 mL and is provided in the following packages:
NDC 0003-2188-11: pack of 4 syringes with a passive
needle safety guard
NDC 0003-2188-31: pack of 4 syringes without a passive needle safety guard
ORENCIA lyophilized powder supplied in a vial should be refrigerated at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date on the vial. Protect the vials from light by storing in the original package until time of use.
ORENCIA solution supplied in a prefilled syringe should be refrigerated at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date on the prefilled syringe. Protect from light by storing in the original package until time of use. Do not allow the prefilled syringe to freeze.
Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA. Rev October 2014
Last reviewed on RxList: 1/15/2015
This monograph has been modified to include the generic and brand name in many instances.
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