ALEFACEPT (a-le'fa-cept) Amevive Classifications: biologic response modifier; fusion protein; Therapeutic: immunosuppressant Pregnancy Category: B
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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
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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.
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- 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.