Basiliximab is an immunosuppressive agent indicated for the prevention of acute transplant rejection in patients undergoing kidney transplantation, when used in combination with other immunosuppressive therapies. Additionally, basiliximab has been reported in some cases to be effective as an alternative treatment for lichen planus when standard therapies such as ciclosporin are not suitable. No significant short-term adverse effects have been consistently reported in such cases.

Basiliximab acts as an interleukin-2 (IL-2) receptor antagonist by binding with high affinity to the alpha subunit (IL-2Rα or CD25) of the high-affinity IL-2 receptor complex. This receptor is selectively expressed on activated T-lymphocytes. By blocking IL-2 binding, basiliximab inhibits IL-2-mediated activation and proliferation of lymphocytes, which is a key step in the immune response responsible for transplant rejection. While present in circulation, basiliximab suppresses immune responses to antigenic stimulation. The extent to which normal immune responsiveness returns after the drug is cleared from the body remains uncertain.

Adults: In adult patients, the recommended regimen is two doses of 20 mg each. The first 20 mg dose should be given within 2 hours prior to transplantation surgery. The recommended second 20 mg dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Basiliximab or graft loss occur.

Pediatric: In pediatric patients weighing less than 35 kg, the recommended regimen is two doses of 10 mg each. In pediatric patients weighing 35 kg or more, the recommended regimen is two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. The recommended second dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Basiliximab or graft loss occur.

Administration

Basiliximab is used as part of an immunosuppressive regimen that includes cyclosporine (MODIFIED) and corticosteroids. Basiliximab is for central or peripheral intravenous administration only. Reconstituted Basiliximab should be given either as a bolus injection or diluted to a volume of 25 mL (10-mg vial) or 50 mL (20-mg vial) with normal saline or dextrose 5% and administered as an intravenous infusion over 20 to 30 minutes. Bolus administration may be associated with nausea, vomiting and local reactions, including pain.

Basiliximab should only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients previously administered Basiliximab should only be re-exposed to a subsequent course of therapy with extreme caution due to the potential risk of hypersensitivity.

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. After reconstitution, Basiliximab should be a clear-to-opalescent, colorless solution. If particulate matter is present or the solution is colored, do not use.

Care must be taken to assure sterility of the prepared solution because the drug product does not contain any antimicrobial preservatives or bacteriostatic agents.

Basiliximab may reduce the effectiveness of inactivated vaccines. It may also increase the risk of adverse effects when used with live vaccines; therefore, concurrent use with live vaccines should be avoided.

Basiliximab is contraindicated in patients with known hypersensitivity to basiliximab or any of its components.

Serious adverse effects may include:

• Pain or burning sensation during urination
• Easy bruising or bleeding, unusual weakness
• Tremors or shaking
• Fever, chills, body aches, flu-like symptoms, vomiting, diarrhea
• Difficulty breathing
• Pale skin, dizziness, rapid heart rate, or shortness of breath

Basiliximab is classified as Pregnancy Category B. Adequate and well-controlled studies in pregnant women are lacking. Animal studies have not demonstrated teratogenic effects; however, IgG antibodies can cross the placenta and may affect fetal immune development.

Basiliximab should be used during pregnancy only if the potential benefit outweighs the possible risk. Women of childbearing potential should use effective contraception before, during, and for at least 4 months after therapy.

Nursing Mothers: It is not known whether basiliximab is excreted in human milk. Due to the potential for adverse effects, a decision should be made to either discontinue breastfeeding or discontinue the drug, considering its importance to the mother.

Caution is advised in patients receiving repeated courses of basiliximab therapy. Special consideration should be given in children, pregnant women, and lactating mothers.

Renal Impairment: No specific dose adjustment recommendations are provided.
Hepatic Impairment: No specific dose adjustment recommendations are provided.

The maximum tolerated dose has not been clearly established. In clinical studies, single doses up to 60 mg or divided doses up to 120 mg over several days were administered without serious adverse effects. A pediatric patient receiving a single 20 mg dose (2.3 mg/kg) also showed no adverse events.

Cytotoxic immunosuppressants.

Approximately 36 days ± 14 days.