Simulect Injection

Acute graft rejection in renal transplantation

Intravenous Prophylaxis of Renal Transplant Rejection 20 mg IV within 2 hr prior to transplant surgery, THEN 20 mg IV 4 days after transplant Used in regimen containing cyclosporine and corticosteroids

Prophylaxis of Renal Transplant Rejection >35 kg: Administer as in adults; 20 mg IV within 2 hr prior to transplant surgery, THEN, 20 mg IV 4 days after transplant <35 kg: 10 mg IV within 2 hr prior to transplant surgery, THEN 10 mg IV 4 days after transplant Used in regimen containing cyclosporine and corticosteroids

From the available data comparing Basiliximab and placebo-treated patients, the adverse event profile in patients >65 years of age is not different from patients <65 years of age and no age-related dosing adjustment is required. Caution must be used in giving immunosuppressive drugs to elderly patients.

IV Preparation Reconstitute vials with 5 mL SWI Dilute reconstituted contents in 50 mL NS or D5W IV Administration For central or intravenous administration only Infuse over 20-30 min

Hypersensitivity to basiliximab and murine proteins.

Should be prescribed only by physicians who have experience with immunosuppression in organ transplant recipients and can provide necessary follow-up and appropriate monitoring. Development of human antimurine antibodies reported for murine products. The risk of developing lymphoproliferative disorders may increase with immunosuppressive therapy. Immunosuppressive therapy may increase the risk of opportunistic infection.

B Pregnancy Category: B Lactation: Unknown whether excreted in milk; 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

Immunosuppressives other than ciclosporin and corticosteroids may increase the potential for over-immunosuppression. May diminish response to inactivated vaccines. May enhance the adverse/ toxic effect of live vaccines, avoid concomitant admin. Contraindicated (1) upadacitinib

Peripheral oedema, hypertension, atrial fibrillation; fever, headache, insomnia, pain; wound complication, acne; hypokalaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypercholesterolaemia; GI effects; UTI; anaemia; tremor; dyspnoea, infection. Rarely, hypersensitivity and anaphylactoid-type reactions.

Basiliximab, a chimeric murine/human monoclonal antibody, blocks the ?-chain of the interleukin-2 receptor complex on the surface of activated T-lymphocytes.

Simulect 20mg/vial Injection manufactured by Novartis Pharma AG, Switzerland. Its generic name is Basiliximab.