Immunex Corporation

Immunex Corporation Drugs

• Enbrel
  

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  Enbrel

  

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  Table 1. Dosing and Administration for Adult Patients    Patient Population   Recommended Dosage Strength and Frequency    Adult RA, AS, and PsA Patients   50 mg weekly    Adult PsO Patients   Starting Dose: 50 mg twice weekly for 3 months

  Maintenance Dose: 50 mg once weekly

  See the Enbrel(etanercept) “Instructions for Use” insert for detailed information on injection site selection and dose administration [see Dosage and Administration (2.4) and Patient Counseling Information (17.2)].

  2.1 Adult Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients

  MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with Enbrel.

  Based on a study of 50 mg Enbrel twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar American College of Rheumatology (ACR) response rates, doses higher than 50 mg per week are not recommended.

  2.2 Adult Plaque Psoriasis Patients

  In addition to the 50 mg twice weekly recommended starting dose, starting doses of 25 mg or 50 mg per week were shown to be efficacious. The proportion of responders was related to Enbrel dosage [see Clinical Studies (14.5)].

  2.3 JIA Patients

  Table 2. Dosing and Administration for Juvenile Idiopathic Arthritis     Pediatric Patients Weight     Recommended Dose     63 kg (138 pounds) or more     50 mg weekly     Less than 63 kg (138 pounds)     0.8 mg/kg weekly

  In JIA patients, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with Enbrel. Higher doses of Enbrel have not been studied in pediatric patients.

  2.4 Preparation of Enbrel

  Enbrel is intended for use under the guidance and supervision of a physician.  Patients may self‑inject when deemed appropriate and if they receive medical follow‑up, as necessary.  Patients should not self‑administer until they receive proper training in how to prepare and administer the correct dose. Injections should occur in the thigh, abdomen or outer area of the upper arm.

  The Enbrel (etanercept) “Instructions for Use” insert for each presentation contains more detailed instructions on injection site selection and the preparation of Enbrel.

  Preparation of Enbrel Using the Single-use Prefilled Syringe For a more comfortable injection, leave Enbrel at room temperature for about 15 to 30 minutes before injecting.  DO NOT remove the needle cover while allowing the prefilled syringe to reach room temperature.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.  There may be small white particles of protein in the solution.  This is not unusual for proteinaceous solutions.  The solution should not be used if discolored or cloudy, or if foreign particulate matter is present.

  When using the Enbrel single-use prefilled syringe, check to see if the amount of liquid in the prefilled syringe falls between the two purple fill level indicator lines on the syringe.  If the syringe does not have the right amount of liquid, DO NOT USE THAT SYRINGE.

  Preparation of Enbrel Using the Single-use Prefilled SureClick AutoinjectorLeave the autoinjector at room temperature for at least 30 minutes before injecting.  DO NOT remove the needle cover while allowing the prefilled syringe to reach room temperature.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.  There may be small white particles of protein in the solution.  This is not unusual for proteinaceous solutions.  The solution should not be used if discolored or cloudy, or if foreign particulate matter is present.

  Preparation of Enbrel Using the Multiple-use VialEnbrel should be reconstituted aseptically with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), giving a solution of 1.0 mL containing 25 mg of Enbrel.

  A vial adapter is supplied for use when reconstituting the lyophilized powder.  However, the vial adapter should not be used if multiple doses are going to be withdrawn from the vial.  If the vial will be used for multiple doses, a 25‑gauge needle should be used for reconstituting and withdrawing Enbrel, and the supplied “Mixing Date:” sticker should be attached to the vial and the date of reconstitution entered.  Reconstituted solution must be refrigerated at 36°F to 46°F (2°C to 8°C) and used within 14 days.  Discard reconstituted solution after 14 days because product stability and sterility cannot be assured after 14 days.  DO NOT store reconstituted Enbrel solution at room temperature.

  For a more comfortable injection, leave the Enbrel dose tray at room temperature for about 15 to 30 minutes before injecting. 

  If using the vial adapter, twist the vial adapter onto the diluent syringe.  Then, place the vial adapter over the Enbrel vial and insert the vial adapter into the vial stopper.  Push down on the plunger to inject the diluent into the Enbrel vial.  If using a 25‑gauge needle to reconstitute and withdraw Enbrel, the diluent should be injected very slowly into the Enbrel vial.  It is normal for some foaming to occur.  Keeping the diluent syringe in place, gently swirl the contents of the Enbrel vial during dissolution.  To avoid excessive foaming, do not shake or vigorously agitate.

  Generally, dissolution of Enbrel takes less than 10 minutes.  Do not use the solution if discolored or cloudy, or if particulate matter remains.

  Withdraw the correct dose of reconstituted solution into the syringe. Some foam or bubbles may remain in the vial.  Remove the syringe from the vial adapter or remove the 25‑gauge needle from the syringe.  Attach a 27‑gauge needle to inject Enbrel.

  The contents of one vial of Enbrel solution should not be mixed with, or transferred into, the contents of another vial of Enbrel.  No other medications should be added to solutions containing Enbrel, and do not reconstitute Enbrel with other diluents.  Do not filter reconstituted solution during preparation or administration.

  2.5 Monitoring to Assess Safety

  Prior to initiating Enbrel and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection [see Warnings and Precautions (5.1)].

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