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Amevive (Alefacept) - Indications and Dosage

 
 



   INDICATIONS AND USAGE

AMEVIVE® is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

DOSAGE AND ADMINISTRATION

AMEVIVE® should only be used under the guidance and supervision of a physician.

The recommended dose of AMEVIVE® is 7.5 mg given once weekly as an IV bolus or 15 mg given once weekly as an IM injection. The recommended regimen is a course of 12 weekly injections. Retreatment with an additional 12-week course may be initiated provided that CD4+ T lymphocyte counts are within the normal range, and a minimum of a 12-week interval has passed since the previous course of treatment. Data on retreatment beyond two cycles are limited.

The CD4+ T lymphocyte counts of patients receiving AMEVIVE® should be monitored weekly before initiating dosing and throughout the course of the 12-week dosing regimen. Dosing should be withheld if CD4+ T lymphocyte counts are below 250 cells/µL. The drug should be discontinued if the counts remain below 250 cells/µL for one month (see PRECAUTIONS, Laboratory Tests).

PREPARATION INSTRUCTIONS

AMEVIVE® should be reconstituted by a health care professional using aseptic technique. Each vial is intended for single patient use only.

Do not use an AMEVIVE® dose tray beyond the date stamped on the carton, dose tray lid, AMEVIVE® vial label, or diluent container label.

AMEVIVE® 15 mg lyophilized powder for IM administration should be reconstituted with 0.6 mL of the supplied diluent (Sterile Water for Injection, USP). 0.5 mL of the reconstituted solution contains 15 mg of alefacept.

AMEVIVE® 7.5 mg lyophilized powder for IV administration should be reconstituted with 0.6 mL of the supplied diluent. 0.5 mL of the reconstituted solution contains 7.5 mg of alefacept.

Do not add other medications to solutions containing AMEVIVE® . Do not reconstitute AMEVIVE® with other diluents. Do not filter reconstituted solution during preparation or administration.

All procedures require the use of aseptic technique. Using the supplied syringe and one of the supplied needles, withdraw only 0.6 mL of the supplied diluent, (Sterile Water for Injection, USP). Keeping the needle pointed at the sidewall of the vial, slowly inject the diluent into the vial of AMEVIVE® . Some foaming will occur, which is normal. To avoid excessive foaming, do not shake or vigorously agitate. The contents should be swirled gently during dissolution. Generally, dissolution of AMEVIVE® takes less than two minutes. The solution should be used as soon as possible after reconstitution.

The reconstituted solution should be clear and colorless to slightly yellow. Visually inspect the solution for particulate matter and discoloration prior to administration. The solution should not be used if discolored or cloudy, or if undissolved material remains.

Following reconstitution, the product should be used immediately or within 4 hours if stored in the vial at 2-8°C (36-46°F). AMEVIVE® NOT USED WITHIN 4 HOURS OF RECONSTITUTION SHOULD BE DISCARDED.

Remove the needle used for reconstitution and attach the other supplied needle. Withdraw 0.5 mL of the AMEVIVE® solution into the syringe. Some foam or bubbles may remain in the vial.

ADMINISTRATION INSTRUCTIONS

For intramuscular use, inject the full 0.5 mL of solution. Rotate injection sites so that a different site is used for each new injection. New injections should be given at least 1 inch from an old site and never into areas where the skin is tender, bruised, red, or hard.

FOR INTRAVENOUS USE,

  • Prepare 2 syringes with 3.0 mL Normal Saline, USP for pre- and post-administration flush.
  • Prime the winged infusion set with 3.0 mL saline and insert the set into the vein.
  • Attach the AMEVIVE® -filled syringe to the infusion set and administer the solution over no more than 5 seconds.
  • Flush the infusion set with 3.0 mL saline, USP.

HOW SUPPLIED

AMEVIVE® for IV administration is supplied in either a carton containing four administration dose packs, or in a carton containing one administration dose pack. Each dose pack contains one 7.5-mg single-use vial of AMEVIVE® , one 10 mL single-use diluent vial (Sterile Water for Injection, USP), one syringe, one 23 gauge, ¾ inch winged infusion set, and two 23 gauge, 1 ¼ inch needles. The NDC number for the four administration dose pack carton is 59627-020-01 The NDC number for the one administration dose pack carton is 59627-020-02.

AMEVIVE® for IM administration is supplied in either a carton containing four administration dose packs, or in a carton containing one administration dose pack. Each dose pack contains one 15-mg single-use vial of AMEVIVE® , one 10 mL single-use diluent vial (Sterile Water for Injection, USP), one syringe, and two 23 gauge, 1 ¼ inch needles. The NDC number for the four administration dose pack carton is 59627-021-03. The NDC number for the one administration dose pack carton is 59627-021-04

AMEVIVE® is reconstituted with 0.6 mL of the 10 mL single-use diluent.

Storage

The dose tray containing AMEVIVE® (lyophilized powder) should be stored at controlled room temperature (15-30°C; 59-86°F). PROTECT FROM LIGHT. Retain in carton until time of use.

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