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Pronunciation:

(a LE fa sept)

U.S. Brand Names:

Amevive®

Synonyms:

B 9273; BG 9273; Human LFA-3/IgG(1) Fusion Protein; LFA-3/IgG(1) Fusion Protein, Human

Generic Available:

Use:

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Restrictions:

Alefacept will be distributed directly to physician offices or to a specialty pharmacy; injections are intended to be administered in the physician's office

Pregnancy Risk Factor:

Pregnancy Implications:

Effects in pregnancy are not known. Teratogenic effects have not been observed in animal studies. Patients who become pregnant during therapy or within 8 weeks of treatment are advised to enroll in pregnancy registry (866-263-8483).

Lactation:

Excretion in breast milk unknown/not recommended

Contraindications:

Hypersensitivity to alefacept or any component of the formulation; patients with a pretreatment depression in CD4 T-lymphocytes; history of severe malignancy; clinically-important infection

Warnings/Precautions:

Alefacept induces a decline in circulating T-lymphocytes (CD4⁺ and CD8⁺); CD4⁺ lymphocyte counts should be monitored weekly throughout therapy. Do not initiate in pre-existing depression of CD4⁺ lymphocytes and withhold treatment in any patient who develops a depressed CD4⁺ lymphocyte count (<250 cells/L) during treatment; permanently discontinue if CD4⁺ lymphocyte counts remain <250 cells/L for 1 month.

Alefacept may increase the risk of malignancies; use caution in patients at high risk for malignancy. Discontinue if malignancy develops during therapy. Alefacept may increase the risk of infection and may reactivate latent infection; monitor for new infections. Avoid use in patients receiving other immunosuppressant drugs or phototherapy. Safety and efficacy of live or attenuated vaccines have not been evaluated. Not indicated for use in pediatric patients.

Adverse Reactions:

10%:

Hematologic: Lymphopenia (up to 10% of patients required temporary discontinuation, up to 17% during a second course of therapy)

Local: Injection site reactions (up to 16% of patients; includes pain, inflammation, bleeding, edema, or other reaction)

1% to 10%:

Central nervous system: Chills (6%; primarily during intravenous administration), dizziness

Dermatologic: Pruritus

Gastrointestinal: Nausea

Neuromuscular & skeletal: Myalgia

Respiratory: Pharyngitis, cough increased

Miscellaneous: Malignancies (1% vs 0.2% in placebo), antibodies to alefacept (3%; significance unknown), infection (1% to 2% requiring hospitalization)

<1%: Anaphylaxis, allergic reaction, angioedema, headache, MI, transaminases increased (5-10 times ULN), urticaria

Overdosage/Toxicology:

No specific experience in overdose. Symptoms may include chills, headache, arthralgia, and sinusitis. Reductions in lymphocyte populations should be closely monitored. Treatment is supportive.

Drug Interactions:

No formal drug interaction studies have been completed.

Stability:

Store at 15°C to 30°C (59°F to 86°F); protect from light. Following reconstitution, may be stored for up to 4 hours at 2°C to 8°C (36°F to 46°F). Discard any unused solution after 4 hours.

Reconstitute 15 mg vial for I.M. solution with 0.6 mL of SWFI (supplied); 0.5 mL of reconstituted solution contains 15 mg of alefacept. Reconstitute 7.5 mg vial for I.V. administration with 0.6 mL of SWFI (supplied); 0.5 mL of reconstituted solution contains 7.5 mg alefacept.

Gently swirl to avoid foaming. Do not filter reconstituted solutions. Do not mix with other medications or solutions.

Mechanism of Action:

Binds to CD2, a receptor on the surface of lymphocytes, inhibiting their interaction with leukocyte functional antigen 3 (LFA-3). Interaction between CD2 and LFA-3 is important for the activation of T-lymphocytes in psoriasis. Activated T-lymphocytes secrete a number of inflammatory mediators, including interferon gamma, which are involved in psoriasis. Since CD2 is primarily expressed on T-lymphocytes, treatment results in a reduction in CD4⁺ and CD8⁺ T-lymphocytes, with lesser effects on other cell populations (NK- and B-lymphocytes).

Pharmacodynamics/Kinetics:

Distribution: Vd: 0.094 L/kg

Bioavailability: 63% (following I.M. administration)

Half-life: 270 hours (following I.V. administration)

Excretion: Clearance: 0.25 mL/hour/kg

Dosage:

Adults:

I.M.: 15 mg once weekly; usual duration of treatment: 12 weeks

I.V.: 7.5 mg once weekly; usual duration of treatment: 12 weeks

A second course of treatment may be initiated at least 12 weeks after completion of the initial course of treatment, provided CD4⁺ T-lymphocyte counts are within the normal range.

Note: CD4⁺ T-lymphocyte counts should be monitored before initiation of treatment and weekly during therapy. Dosing should be withheld if CD4⁺ counts are <250 cells/L, and dosing should be permanently discontinued if CD4⁺ lymphocyte counts remain at <250 cell/L for longer than 1 month.

Elderly: Refer to Adults dosing

Dosage adjustment in renal impairment: No dosage adjustment required

Administration:

Do not filter alefacept solutions.

I.M. injections should be administered at least 1 inch from previous administration sites.

I.V. administration set should be primed with 3 mL NS and the line should be flushed with 3 mL NS following the dose. Administer over 5 seconds.

Monitoring Parameters:

Baseline lymphocyte counts prior to initiation and weekly during treatment course; severity of psoriatic lesions; signs and symptoms of infection

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, any allergies you have, or any indication of infection you may be experiencing. This medication can only be administered by infusion or injection; report immediately any pain, redness, swelling at injection or infusion site, chills, rash, difficulty swallowing or breathing, or feelings of tightness in chest. You will need weekly blood tests while taking this medication. May cause nausea or muscle pain. Report unusual feelings of fatigue or weakness; signs of infection (eg, cough, runny nose, sore throat, unusual cough, swollen glands, mouth sores, vaginal itching or discharge, burning on urination, fever, chills, or unhealed sores). Notify prescriber if pregnancy occurs during therapy or within 8 weeks of treatment.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause dizziness

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

[DSC] = Discontinued product

Injection, powder for reconstitution: 7.5 mg [for I.V. administration; supplied with SWFI] [DSC]

Injection, powder for reconstitution: 15 mg [for I.M. administration; supplied with SWFI]

International Brand Names:

Amevive® (CH)

References

Ellis CN, Mordin MM, and Adler EY, "Effects of Alefacept on Health-Related Quality of Life in Patients with Psoriasis: Results from a Randomized, Placebo-Controlled Phase II Trial,"Am J Clin Dermatol, 2003, 4(2):131-9.

Gottlieb AB and Bos JD, "Recombinantly Engineered Human Proteins: Transforming the Treatment of Psoriasis,"Clin Immunol, 2002, 105(2):105-16.

Kraan MC, van Kuijk AW, Dinant HJ, et al, "Alefacept Treatment in Psoriatic Arthritis: Reduction of the Effector T Cell Population in Peripheral Blood and Synovial Tissue is Associated With Improvement of Clinical Signs of Arthritis,"Arthritis Rheum, 2002, 46(10):2776-84.

Krueger GG, Papp KA, Stough DB, et al, "A Randomized, Double-Blind, Placebo-controlled Phase III Study Evaluating Efficacy and Tolerability of 2 Courses of Alefacept in Patients With Chronic Plaque Psoriasis,"J Am Acad Dermatol, 2002, 47(6):821-33.

Weinberg JM and Tutrone WD, "Biologic Therapy for Psoriasis: The T-Cell-Targeted Therapies Efalizumab and Alefacept,"Cutis, 2003, 71(1):41-5.

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