Alefacept
Pronunciation: (ah-LEE-fah-sept)Class: Anti-Psoriatic, Immunosuppressive
Trade Names:
Amevive
- Powder for injection, lyophilized 15 mg
Pharmacology
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User Reviews & Ratings
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
AdultsIV/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
MonitorEnsure 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.
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