Alefacept
Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: 1-92-LFA-3 (Antigen) (human) fusion protein with immunoglobulin G1 (human hinge CH2-CH3 γ1-chain) dimer
CAS Number: 222535-22-0
Brands: Amevive
Introduction
Immunosuppressive agent; recombinant dimeric fusion protein.
Uses for Alefacept
Psoriasis
Management of moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Do not use concomitantly with other immunosuppressive agents or in patients currently receiving phototherapy; concomitant use of low-potency topical corticosteroids was permitted in clinical studies.
Alefacept Dosage and Administration
Administration
Use only under supervision of a clinician.
Administer IV or IM; components for either IV or IM reconstitution and administration are supplied with the vials. (See Preparations.)
Use strict aseptic technique, since drug product contains no preservative.
Do not filter reconstituted solution during preparation or administration.
Do not admix with other drugs.
IV Administration
Administer once weekly by rapid IV injection for a 12-week course.
Before administration, remove needle used for reconstitution, attach second needle provided by manufacturer, and withdraw 0.5 mL of alefacept solution into syringe.
Prepare 2 syringes containing 3 mL of 0.9% sodium chloride injection for use as pre- and post-administration flushes. Prime administration set with 3 mL 0.9% sodium chloride injection and insert into vein, then attach syringe containing alefacept to administration set and administer solution. After alefacept administration, flush with 3 mL 0.9% sodium chloride injection.
Reconstitution
Reconstitute vial containing 7.5 mg of alefacept with only 0.6 mL of diluent, to provide a solution containing 7.5 mg per 0.5 mL. Use only the diluent supplied by manufacturer (sterile water for injection in a 10-mL single-use vial).
With needle pointed toward side of vial, slowly inject diluent into vial. Swirl contents gently (dissolution generally takes <2 minutes). To avoid excessive foaming, do not shake vial and avoid vigorous agitation.
Preferably, prepare immediately before use. Discard if not used within 4 hours. (See Storage under Stability.)
Rate of Administration
Administer by rapid IV injection over ≤5 seconds.
IM Administration
Administer once weekly by IM injection for a 12-week course.
Inject full 0.5 mL of reconstituted solution.
Rotate injection sites; give new injections ≥2.54 cm (1 inch) from old site; do not inject in areas where skin is tender, bruised, red, or hard.
Reconstitution
Reconstitute vial containing 15 mg of alefacept with only 0.6 mL of diluent, to provide a solution containing 15 mg per 0.5 mL. Use only the diluent supplied by manufacturer (sterile water for injection in a 10-mL single-use vial).
With needle pointed toward side of vial, slowly inject diluent into vial. Swirl contents gently (dissoluti...
