Orencia

Orencia Manufacturers

• E.r. Squibb & Sons, L.l.c.
  

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  Orencia | E.r. Squibb & Sons, L.l.c.

  

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  2.1 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 Dosage and Administration (2.2)].

  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 a   Each vial provides 250 mg of abatacept for administration.

  Less than 60 kg

  500 mg

  2

  60 to 100 kg

  750 mg

  3

  More than 100 kg

  1000 mg

  4

  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.

  2.2 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 have not been studied in patients under 18 years of age.

  2.3 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.

  1) 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.
  
  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). The solution should be clear and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.
  
  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. Discard the fully diluted solution if not administered within 24 hours.
  
  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.
  2.4 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.

  2.1 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 Dosage and Administration (2.2)].

  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 a   Each vial provides 250 mg of abatacept for administration.

  Less than 60 kg

  500 mg

  2

  60 to 100 kg

  750 mg

  3

  More than 100 kg

  1000 mg

  4

  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.

  2.2 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 have not been studied in patients under 18 years of age.

  2.3 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.

  1) 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.
  
  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). The solution should be clear and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.
  
  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. Discard the fully diluted solution if not administered within 24 hours.
  
  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.
  2.4 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.

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