DrugindexOnline^{2nd edition}

Pronouncation: (ah-LEE-fah-sept)
Class: Anti-Psoriatic, Immunosuppressive

Trade Names:
Amevive
- Powder for injection, lyophilized 15 mg

Mechanism of Action

Pharmacology

Interferes with lymphocyte activation.

Pharmacokinetics

Absorption

Bioavailability of alefacept after IM injection is 63%.

Distribution

The mean Vd of alefacept is 94 mL/kg after IV injection.

Elimination

The mean elimination t _½ and Cl are approximately 270 h and 0.25 mL/kg, respectively, following IV injection.

Indications and Usage

Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Contraindications

HIV infection; hypersensitivity to any component of the product.

Dosage and Administration

Adults

IV/IM 7.5 mg once weekly as an IV bolus or 15 mg once weekly as an IM injection for 12 weekly injections. After a minimum of a 12-wk interval since the initial treatment, re-treatment with an additional 12-wk course may be initiated, provided the CD4+ T-lymphocyte counts are within the normal range.

General Advice

• Reconstitute powder for injection following manufacturer's instructions.
• Do not shake or vigorously agitate vial during reconstitution.
• Do not filter solution during preparation or administration.
• Do not administer if particulate matter, cloudiness, or discoloration noted.
• Rotate IM injection sites (abdomen, thigh, upper arm). Give new injections at least 1 inch from old site and never into areas where the skin is bruised, hard, red, or tender.
• Administer IV dose over no more than 5 sec using 3 mL normal saline for pre- and postadministration flush.
• Do not add other medications to solutions containing alefacept and do not reconstitute with other diluents.
• Discard any unused solution. Do not save unused solution for later administration.

Storage/Stability

Refrigerate dose tray with lyophilized powder at 36° to 46°F. Store in original carton until time of use. Protect from light. Use reconstituted product immediately or within 4 h if stored in refrigerator. Discard if not used within 4 h of reconstitution.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Dizziness, nausea.

Dermatologic

Pruritus.

Hepatic

Acute liver failure, asymptomatic transaminase elevation, decompensation of cirrhosis with liver failure, fatty infiltration of the liver, hepatitis (postmarketing).

Respiratory

Increased cough, pharyngitis.

Miscellaneous

Accidental injury, chills, hypersensitivity reactions (eg, anaphylactic reactions, angioedema, urticaria), injection-site reactions (eg, bleeding, edema, inflammation, mass, nonspecific reaction, pain, skin hypersensitivity), lymphopenia, malignancies, myalgia, serious infections.

Precautions

Monitor Ensure CD4+ T-lymphocyte counts are determined prior to starting therapy and every 2 wk throughout entire 12-wk course of therapy.

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Use with caution because the incidence of infection and certain malignancies is higher.

Hypersensitivity

May occur.

Hepatic injury

May occur. Discontinue therapy in patients who develop significant clinical signs of liver injury.

Immunosuppression

Do not use with other immunosuppressive agents or phototherapy.

Lymphopenia

Do not initiate therapy in patients with a CD4+ T-lymphocyte count below normal. Withhold therapy if CD4+ T-lymphocyte count is below 250 cells/mcL. Discontinue therapy if CD4+ T-lymphocyte counts are below 250 cells/mcL for 1 mo.

Malignancies

May increase the risk of malignancies.

Serious infections

May increase the risk of infection and reactivate latent, chronic infections.

Overdosage

Symptoms

Arthralgia, chills, headache, sinusitis.

Patient Information

• Advise patient that medication will be prepared and administered by a health care professional in a medical setting.
• Advise patient to report any of the following symptoms to health care provider: abdominal pain, anorexia, dark urine or pale stools, easy bruising, intolerable injection site reactions, fatigue, fever or other signs of infection, jaundice, persistent nausea, sore throat, vomiting.
• Advise women to notify health care provider if pregnant or planning to become pregnant during and for 8 wk following discontinuation of therapy.
• Instruct women to notify health care provider if considering breast-feeding while taking this medication.