Simulect 20 mg/vial

Simulect 20 mg/vial | INDICATIONS AND USES

Basiliximab is an immunosuppressant agent used to prevent immediate transplant rejection in people who are receiving kidney transplants, in combination with other agents. It has been reported that some cases of lichen planus have been successfully treated with basiliximab as an alternative therapy to ciclosporin. No short-term side effects have been reported.

Simulect 20 mg/vial | PHARMACOLOGY

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

Simulect 20 mg/vial | DOSAGE

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.

Simulect 20 mg/vial | DRUG INTERACTIONS

May diminish response to inactivated vaccines. May enhance the adverse/ toxic effect of live vaccines, avoid concomitant admin.

Simulect 20 mg/vial | SIDE EFFECTS

Serious side effect such as:

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

Simulect 20 mg/vial | USE DURING PREGNANCY AND LACTATION

Pregnancy Category B. 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 immunesystem, and because animal reproduction studies are not always predictive of human response, Basiliximab should 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 Basiliximab therapy, during therapy, and for 4 months after completion of Basiliximab therapy.Nursing Mothers: It is not known whether Basiliximab is 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.

Simulect 20 mg/vial | PRECAUTIONS & WARNINGS

Re-exposure to a subsequent course of therapy in patient who has previously received basiliximab. Children, Pregnancy and lactation.

Simulect 20 mg/vial | USE IN SPECIAL POPULATIONS

Renal Impairment: There are no dosage adjustments provided in the manufacturer’s labeling.Hepatic Impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Simulect 20 mg/vial | THERAPEUTIC CLASS

Cytotoxic immunosuppressants

Simulect 20 mg/vial | STORAGE CONDITIONS

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.