EFALIZUMAB

EFALIZUMAB (e-fal-i-zoo'-mab) Raptiva Classifications: biologic response modifier; monoclonal antibody; immunosuppressant; Therapeutic: immunosuppressant Pregnancy Category: C

Availability

125 mg vial

Action

An anti-CD11a antibody that targets the antigen-1 subunit on the surface of T-leukocytes; inhibits binding of T-cells to endothelial cells, prevents migration of T-cells out of the bloodstream into the skin, and prevents activation of T-cells. Lymphocyte activation and movement to skin play a key role in the pathophysiology of chronic plaque psoriasis.

Therapeutic Effect

Prevents activation of T-cells and their migration out of the circulatory system to sites of inflammation, thus slowing processes that result in plaque psoriasis.

Uses

Treatment of moderate to severe plaque psoriasis.

Contraindications

Hypersensitivity to efalizumab; hamster protein hypersensitivity; severe infection or exposure to viral infections (e.g., chicken pox, herpes zoster), live vaccines; children <18 y; pregnancy (category C).

Cautious Use

History of untoward reactions to other monoclonal antibodies; lactation.

Route & Dosage

Plaque Psoriasis Adult: SC 0.7 mg/kg first dose, then 1 mg/kg (max: 200 mg) once weekly

Administration

Subcutaneous

• Note: A reduced initial dose is used to prevent first dose reaction including headache, fever, nausea, and vomiting.
• Reconstitute immediately before use. Inject 1.3 mL of the supplied diluent (using prefilled syringe with sterile water for injection) slowly into vial. Swirl gently to dissolve but DO NOT SHAKE; dissolves in <5 min. Should be clear to pale yellow and free of particulates.
• Replace needle on syringe used for reconstitution with a new needle. Insert needle into vial keeping needle below the level of the liquid; withdraw the required dose.
• Inject SC into thigh, abdomen, buttocks, or upper arm. Rotate sites.
• If reconstituted vial is not used immediately, store at room temperature but use within 8 h.
• Store powder vials at 2°–8° C (36°–46° F). Protect from light.

Adverse Effects (≥1%)

Body as a Whole: First dose reaction (headache, fever, nausea, vomiting, myalgia), increased risk of infection or reactivation of latent infection, chills, pain, myalgia, flu syndrome, asthenia, hypersensitivity reactions, peripheral edema, serious infection. CNS: Headache. GI: Nausea. Hematologic: Thrombocytopenia, hemolytic anemia. Musculoskeletal: Arthralgia. Skin: Worsening of psoriasis, acne, urticaria.

Interactions

Drug: Do not administer live or live-attenuated vaccines; increased risk of immunosuppression with other immunosuppressants.

Pharmacokinetics

Absorption: 50% absorbed from SC site. Peak: Steady-state levels reached in 4 wk. Elimination: Drug eliminated approximately 25 d after last steady-state dose.

Nursing Implications

Assessment & Drug Effects

• Monitor for S&S of infection. Withhold drug and notify physician if infection is suspected.
• Lab tests: Periodic Hgb & Hct and platelet counts.

Patient & Family Education

• Seek immediate medical attention for bleeding from gums, bruising, petechiae (numerous small red spots on skin), or S&S of an infection (fever, abscess, sore throat with breathing difficulty, etc.), or worsening of psoriasis.
• Do not accept a live virus vaccine without consulting physician.
• Notify physician immediately if you become pregnant while taking this drug, or within 6 wk of last dose of drug.

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