(basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids. The efficacy of itfor the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.
Cytotoxic immunosuppressants
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 of Basiliximab to IL-2Rα competitively inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection. While in the circulation, Simulect (basiliximab) impairs the response of the immune system to antigenic challenges. Whether the ability to respond to repeated or ongoing challenges with those antigens returns to normal after Simulect is cleared is unknown
(basiliximab) is used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids. itis for central or peripheral intravenous administration only. Reconstituted itshould 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. itshould only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients previously administered Simulect 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, itshould 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. It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2?C to 8?C for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours. No incompatibility between itand polyvinyl chloride bags or infusion sets has been observed. No data are available on the compatibility of itwith other intravenous substances. Other drug substances should not be added or infused simultaneously through the same intravenous line. 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 itor 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 itor graft loss occur.
May diminish response to inactivated vaccines. May enhance the adverse/ toxic effect of live vaccines, avoid concomitant admin.
(basiliximab) is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation
Pain or burning when you urinate Easy bruising or bleeding, unusual weakness Tremors, shaking Fever, chills, body aches, flu symptoms, vomiting, diarrhea Trouble breathing Pale skin, feeling light-headed or short of breath, rapid heart rate, trouble
There are no adequate and well-controlled studies in pregnant women. No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgus monkeys 100 days post coitum following dosing with basiliximab during the organogenesis period; blood levels in pregnant monkeys were 13-fold higher than those seen in human patients. Immunotoxicology studies have not been performed in the offspring. Because IgG molecules are known to cross the placental barrier, because the IL-2 receptor may play an important role in development of the immune system, and because animal reproduction studies are not always predictive of human response, itshould only be used in pregnant women when the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception before beginning ittherapy, during therapy, and for 4 months after completion of ittherapy. Nursing Mothers It is not known whether itis excreted in human milk. Because many drugs including human antibodies are excreted in human milk, and because of the potential for adverse reactions, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
A maximum tolerated dose of Basiliximab has not been determined in patients. During the course of clinical studies, Basiliximab has been administered to adult renal transplantation patients in single doses of up to 60 mg, or in divided doses over 3-5 days of up to 120 mg, without any associated serious adverse events. There has been one spontaneous report of a pediatric renal transplantation patient who received a single 20-mg dose (2.3 mg/kg) without adverse events.
Store between 2-8°C. It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2º C to 8º C for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours.
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