• Prevention of acute organ rejection in patients undergoing renal transplantation (in combination with corticosteroids and cyclosporine).

Contraindicated in:

• Hypersensitivity
• Lactation: Lactation.

Use Cautiously in:

• Rep: Women of reproductive potential
• OB: Safety not established in pregnancy.

Noted for patients receiving corticosteroids and cyclosporine in addition to basiliximab

CV: edema, hypertension, angina, arrhythmias, HF, hypotension.

Derm: acne, wound complications, hypertrichosis, pruritus.

EENT: abnormal vision, cataracts.

Endo: hyperglycemia, hypoglycemia.

F and E: acidosis, hyperkalemia, hypocalcemia, hypokalemia, hypophosphatemia.

GI: abdominal pain, constipation, diarrhea, dyspepsia, moniliasis, nausea, vomiting, gingival hyperplasia, stomatitis.

Hemat: BLEEDING, coagulation abnormalities.

Metab: ↑ weight, hypercholesterolemia, hyperuricemia.

MS: pain.

Neuro: dizziness, headache, insomnia, tremor, weakness, neuropathy, paresthesia.

Resp: cough.

Misc: infection, chills, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

• Immunosuppression may be ↑ with other immunosuppressants.

Drug-Natural Products:

• Concurrent use with echinacea and melatonin may interfere with immunosuppression.

• Powder for injection: 10 mg/vial; 20 mg/vial;

• IV (Adults and Children ≥35 kg): 20 mg given 2 hr before transplantation; repeated 4 days after transplantation. Second dose should be withheld if complications or graft loss occurs.
• IV (Children <35 kg): 10 mg given 2 hr before transplantation; repeated 4 days after transplantation. Second dose should be withheld if complication or graft loss occurs.

Simulect

• Binds to and blocks specific interleukin-2 (IL-2) receptor sites on activated T lymphocytes.

• Prevention of acute organ rejection following renal transplantation.

Therapeutic Classification: Immunosuppressant agents

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Moderately distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: 7.2 days.

(effect on immune function)

• Explain purpose of medication to patient. Explain that patient will need to resume lifelong therapy with other immunosuppressive drugs after completion of basiliximab course.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response is known.
• Instruct patient to continue to avoid crowds and persons with known infections, because basiliximab also suppresses the immune system.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

ba-sil-IX-i-mab

NDC Code^*

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0331- Simulect
    • 0078-0331-84- 1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) > 5 mL in 1 VIAL, SINGLE-USE

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0393- Simulect
    • 0078-0393-61- 1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61) > 2.5 mL in 1 VIAL, SINGLE-USE