Simulect

• Prophylaxis of acute rejection in kidney transplantation

Basiliximab functions as an IL-2 receptor antagonist by binding with high affinity to the alpha chain of the high affinity IL-2 receptor complex and inhibiting IL-2 binding. Basiliximab is specifically targeted against IL-2Rα, which is selectively expressed on the surface of activated T-lymphocytes. This specific high affinity binding competitively inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.

While in the circulation, basiliximab impairs the response of the immune system to antigenic challenges.

Adults: Two doses of 20 mg each (intravenous). First dose within 2 hours before transplantation, second dose 4 days after transplantation.

Pediatric (weight <35 kg): Two doses of 10 mg each (intravenous). First dose within 2 hours before transplantation, second dose 4 days after transplantation.

Pediatric (weight ≥35 kg): Two doses of 20 mg each (intravenous). First dose within 2 hours before transplantation, second dose 4 days after transplantation.

Special Note: Withhold the second dose if complications such as severe hypersensitivity reactions or graft loss occur.

• Nausea
• Vomiting
• Constipation
• Abdominal pain
• Diarrhea
• Indigestion
• Weight gain
• Headache
• Pain
• Swelling of hands
• Hypertension
• Anemia
• Injection site reactions (pain, swelling, redness)

Serious: Pain/burning on urination, easy bruising/bleeding, unusual weakness, tremors, fever, chills, dyspnea, pale skin, rapid heart rate.

[SAFE IF PRESCRIBED] Basiliximab is generally considered safe during pregnancy (Category B). Animal studies showed no adverse effects on the fetus. IgG molecules cross the placental barrier. Use only if potential benefit justifies the potential risk. Women of childbearing potential should use effective contraception during therapy and for 4 months after completion.

• Extreme caution with re-exposure to a subsequent course of therapy after previous basiliximab administration (potential risk of hypersensitivity)
• Caution during pregnancy and lactation
• Caution in pediatric patients
• Avoid live vaccines (response to inactivated vaccines may be diminished)

In clinical studies, adult renal transplantation patients received single doses up to 60 mg or divided doses over 3-5 days up to 120 mg without serious adverse events. A pediatric patient who received a single 20 mg dose (2.3 mg/kg) experienced no adverse events.

Store at 2-8°C in a refrigerator. After reconstitution, use immediately. If not used immediately, can be stored at 2-8°C for 24 hours or at room temperature for 4 hours. Discard if not used within 24 hours.