BASILIXIMAB
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