BASILIXIMAB

(bas-i-lix'i-mab)

Simulect
Classifications: immunosuppressant; monoclonal antibody; interleukin-2 receptor antagonist;
Therapeutic: immunosuppressant; monoclonal antibody
Pregnancy Category: B

Availability

20 mg vials

Action

Immunosuppressant agent that is an interleukin-2 receptor monoclonal antibody produced by recombinant DNA technology. Binds to and blocks interleukin-2R-alpha chain (CD-25 antibodies) on surface of activated T lymphocytes.

Therapeutic Effect

Binding to CD-25 antibodies inhibits a critical pathway in the immune response of the lymphocytes involved in allograft rejection.

Uses

Prophylaxis of acute renal transplant rejection.

Contraindications

Hypersensitivity to mannitol or murine protein; serious infection or exposure to viral infections (e.g., chickenpox, herpes zoster); lactation.

Cautious Use

History of untoward reactions to dacliximab or other monoclonal antibodies; pregnancy (category B).

Route & Dosage

Transplant Rejection Prophylaxis
Adult/Child (>35 kg): IV 20 mg times 2 doses (1st dose 2 h before surgery, 2nd dose 4 d after transplant)
Child (<35 kg, 2–15 y): IV 12 mg/m² (max: 20 mg/dose) times 2 doses (1st dose 2 h before surgery, 2nd dose 4 d after transplant)

Administration

Intravenous

PREPARE: IV infusion: ??Add 2.5 mL or 5 mL sterile water for injection to the 10 mg or 20 mg vial, respectively. Rock vial gently to dissolve. May be given as prepared direct IV as a bolus dose or further diluted in an infusion bag to a volume of 50 mL in NS or D5W. The resulting solution has a concentration of 2.5 mg/mL.??Invert IV bag to dissolve but do not shake.??Discard if diluted solution is colored or has particulate matter. Use IV solution immediately.

ADMINISTER: Direct: Give bolus over 20–30 sec. IV Infusion: Infuse the ordered dose of diluted drug over 20–30 min.

If necessary, the diluted solution may be stored at room temperature for 4 h or at 2°–8° C (36°–46° F) for 24 h. Discard after 24 h.
Store undiluted drug at 2°–8° C (36°–46° F).

Adverse Effects (≥1%)

Body as a Whole: Pain, peripheral edema, edema, fever, viral infection, asthenia, arthralgia, acute hypersensitivity reactions with any dose. CNS: Headache, tremor, dizziness, insomnia, paresthesias, agitation, depression. CV: Hypertension, chest pain, hypotension, arrhythmias. GI: Constipation, nausea, diarrhea, abdominal pain, vomiting, dyspepsia, moniliasis, flatulence, GI hemorrhage, melena, esophagitis, erosive stomatitis. Hematologic: Anemia, thrombocytopenia, thrombosis, polycythemia. Respiratory: Dyspnea, URI, cough, rhinitis, pharyngitis, bronchospasm. Skin: Poor wound healing, acne. Urogenital: Dysuria, UTI, albuminuria, hematuria, oliguria, frequency, renal tubular necrosis, urinary retention. Other: Cataract, conjunctivitis. Metabolic: Hyperkalemia, hypokalemia, hyperglycemia, hyperuricemia, hypophosphatemia, hypocalcemia, increased weight, hypercholesterolemia, acidosis.

Pharmacokinetics

Duration: 36 days. Distribution: Binds to interleukin-2R-alpha sites on lymphocytes. Half-Life: 7.2 ± 3.2 d in adults, 11.5 ± 6.3 d in children.

Nursing Implications

Assessment & Drug Effects

Monitor carefully for and immediately report S&S of opportunistic infection or anaphylactoid reaction (see Appendix F).

Patient & Family Education

Report any distressing adverse effects.
Avoid vaccination for 2 wk following last dose of 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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