ALEFACEPT

(a-le'fa-cept)

Amevive
Classifications: biologic response modifier; fusion protein;
Therapeutic: immunosuppressant
Pregnancy Category: B

Availability

15 mg vials

Action

Activation of T cells plays a role in chronic plaque psoriasis. Alefacept is thought to bind to CD2 receptors found on all peripheral T cells and to immunoglobulin receptors on cytotoxic cells, such as natural killer cells. Alefacept blocks further activation of T cells and reduces cellular-mediated apoptosis of T cells.

Therapeutic Effect

Alefacept modulates the immune response by decreasing activation of T cells that are believed to be the key mediators of psoriasis.

Uses

Treatment of moderate to severe chronic plaque psoriasis.

Unlabeled Uses

Treatment of psoriatic arthritis.

Contraindications

Hypersensitivity to alefacept; CD4+ T lymphocyte count below normal; patients with HIV, history of systemic malignancies; patients with a clinically important infection; serious infections; live or attenuated vaccines; lactation.

Cautious Use

Patients at high risk for malignancies; pregnancy (category B); elderly.

Route & Dosage

Chronic Plaque Psoriasis
Adult: IM 15 mg once/wk x 12 wk, may repeat course after 12 wk off therapy if CD4 count is above 250 cells/mcL IV 7.5 mg once/wk x 12 wk, may repeat course after 12 wk off therapy if CD4 count is above 250 cells/mcL

Administration

Administer only if CD4+ T lymphocyte count is ≥250 cells/microliter.
Reconstituted alefacept should be clear and colorless to slightly yellow.

Intramuscular

Reconstitute the 15 mg vial IM administration with 0.6 mL of the supplied diluent to yield 15 mg/0.5 mL. Gently swirl vial for about 2 min to mix, but do not shake.
Rotate the injection sites and space at least 1 inch from an old site.
Never inject into areas where the skin is tender, bruised, red, or hard.

Intravenous

PREPARE: Direct: Reconstitute the 7.5 mg vial for IV administration with 0.6 mL of the supplied diluent to yield 7.5 mg/0.5 mL. Gently swirl vial for about 2 min to mix, but do not shake.

ADMINISTER: Direct: Prime supplied infusion set with 3.0 mL of supplied diluent and insert into vein. Give reconstituted solution over ≤5 sec and do not use a filter. Follow with flush using 3 mL of supplied diluent.

INCOMPATIBILITIES Solution/additive: No data available at this time.

Store vials of powder away from light at 15°–30° C (59°–86° F).
Store reconstituted solution for up to 4 h between 2°–8° C (36°–46° F); discard solution not used within 4 h of reconstitution.

Adverse Effects (≥1%)

Body as a Whole: Secondary malignancies, serious infections, chills, injection site pain, injection site inflammation. CNS: Dizziness, headache. GI: Nausea, vomiting. Hematologic: Lymphopenia, alefacept antibody formation. Musculoskeletal: Myalgia. Respiratory: Pharyngitis, increased cough. Skin: Pruritus.

Interactions

Drug: Additive immunosuppression with other immunosuppressant drugs (e.g., corticosteroids); live vaccines increase risk of secondary transmission of infection.

Pharmacokinetics

Absorption: 63% from IM injection. Metabolism: Presumed to be broken down in plasma. Half-Life: 270 h after IV.

Nursing Implications

Assessment & Drug Effects

Discontinue drug immediately and institute supportive measures if a serious hypersensitivity reaction occurs.
Note: Drug should be discontinued if CD4+ T lymphocyte counts remain below 250 cells/mcL for 1 mo.
Lab tests: Weekly WBC with differential during 12-wk dosing period; periodic liver enzymes.
Monitor for and promptly report S&S of infection.

Patient & Family Education

Report any of the following promptly: chest pain or tightness, rapid or irregular heart beat; difficulty breathing or swallowing; swelling of face, tongue, hands, feet or ankles; rapid weight gain; signs of infection (e.g., fever, chills, cough, sore throat, pain or difficulty passing urine); skin rash or itchy skin; severe stomach pain.
Do not accept live or live-attenuated vaccines while taking this drug.
Notify physician if you become pregnant while taking this drug or within 8 wk of discontinuing drug.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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