Basiliximab

Basiliximab is an immunosuppressant used in combination with cyclosporine and corticosteroids to prevent acute rejection in kidney transplant recipients. It is a monoclonal antibody that binds with high affinity to the alpha chain of the IL-2 receptor complex and competitively inhibits IL-2-mediated lymphocyte activation.

Basiliximab is for intravenous administration only. The recommended adult dose is two doses of 20 mg each — the first dose within 2 hours before transplantation and the second dose 4 days after transplantation. For pediatric patients weighing less than 35 kg, the dose is 10 mg per dose; for those weighing 35 kg or more, the dose is 20 mg per dose.

Common side effects include nausea, vomiting, constipation, abdominal pain, diarrhea, headache, hypertension, and anemia. Injection site reactions may occur.

• 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.

Basiliximab binds to the alpha subunit of the IL-2 receptor on activated T-lymphocytes, competitively inhibiting IL-2-mediated lymphocyte activation. This prevents T-cell proliferation and activation, reducing the immune response against the transplanted kidney and preventing rejection.

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.

For central or peripheral intravenous administration only. Administer as a bolus injection or as a 20-30 minute intravenous infusion. Dilute reconstituted solution with normal saline or 5% dextrose (25 mL for 10 mg vial, 50 mL for 20 mg vial).

Reconstitution: Reconstitute 10 mg vial with 2.5 mL and 20 mg vial with 5 mL sterile water for injection.

Basiliximab is administered only by healthcare professionals in hospital settings. The concept of a missed dose is not applicable.

• 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.

• 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)

• Known hypersensitivity to basiliximab or any component

• Live vaccines: May enhance adverse/toxic effects; avoid concomitant administration
• Inactivated vaccines: Response may be diminished

No food restrictions (intravenous administration).

[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.

[SAFE IF PRESCRIBED] It is unknown whether basiliximab is excreted in human milk. Many drugs including human antibodies are excreted in breast milk. A decision should be made to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother.

Pediatric patients weighing <35 kg: 10 mg per dose; weighing ≥35 kg: 20 mg per dose. First dose within 2 hours before transplantation, second dose 4 days after transplantation.

No specific dose adjustment needed for elderly patients.

Renal Impairment: No dose adjustment needed (as per manufacturer's labeling).

Hepatic Impairment: No dose adjustment needed (as per manufacturer's labeling).

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.

Basiliximab