IntravenousProphylaxis of acute graft rejection in renal transplantationAdult: In combination with immunosuppressive regimen (e.g. ciclosporin, corticosteroids, azathioprine, mycophenolate mofetil): Initially, 20 mg given via bolus inj or IV infusion over 20-30 minutes within 2 hours prior to transplantation surgery, followed by 20 mg 4 days after transplantation. Withhold the 2nd dose if severe hypersensitivity or graft loss occurs.
Child: ≥1 year weighing <35 kg: 10 mg given via bolus inj or infusion over 20-30 minutes within 2 hours prior to transplantation surgery, followed by 10 mg 4 days after transplantation. Withhold 2nd dose if severe hypersensitivity reactions or graft loss occurs. ≥35 kg: Same as adult dose.
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Powder for solution for IV inj or infusion: Reconstitute vial labelled as containing 10 mg or 20 mg with 2.5 or 5 mL of sterile water of inj, respectively. Shake gently to dissolve. For IV infusion, the reconstituted solution must be diluted with 25 mL (for 10 mg vial) or 50 mL (for 20 mg vial) of NaCl 0.9% inj or dextrose 5% in water. Invert the bag gently when mixing to avoid foaming. Do not shake the diluted solution for infusion.
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Patients previously treated with basiliximab should only be re-exposed to subsequent course of therapy under extreme caution. Administer basiliximab only when the patient is certain to receive graft and concomitant immunosuppression. Pregnancy and lactation. Avoid vaccination with live attenuated vaccines.
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Significant: Severe hypersensitivity reactions (e.g. anaphylaxis, urticaria, pruritus, hypotension, tachycardia), new-onset diabetes, glucose intolerance, impaired fasting glucose, development of human anti-murine antibodies (HAMA), lymphoproliferative disorders (e.g. lymphoma), opportunistic infections (e.g. cytomegalovirus).
Blood and lymphatic system disorders: Anaemia.
Gastrointestinal disorders: Constipation, nausea, diarrhoea.
General disorders and administration site conditions: Pain, peripheral oedema, fever.
Infections and infestations: Viral infection, sepsis.
Injury, poisoning and procedural complications: Postoperative wound complication.
Investigations: Increased weight and blood creatinine.
Metabolism and nutrition disorders: Hyperkalaemia, hypercholesterolaemia, hypophosphataemia.
Nervous system disorders: Headache.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Rhinitis, URTI.
Skin and subcutaneous tissue disorders: Hypertrichosis, acne vulgaris.
Vascular disorders: Hypertension.
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Women of childbearing potential must use effective contraceptive measure before and during treatment, and for 4 months after treatment.
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Monitor infusion site and CV, respiratory, and renal function during infusion. Assess for signs and symptoms of acute rejection, infection, and hypersensitivity reactions.
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May decrease therapeutic effects of non-live/inactivated/non-replicating vaccines. May enhance the adverse/toxic effects of live vaccines.
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Description:
Overview: Basiliximab, a recombinant chimeric (murine/human) monoclonal antibody, is an immunosuppressant.
Mechanism of Action: Basiliximab binds with high affinity to the α-chain of interleukin-2 (IL-2) receptor complex, thereby inhibiting IL-2 binding and preventing T-lymphocyte proliferation.
Pharmacodynamics: The inhibition of IL-2 binding results in the blockade of IL-2-mediated lymphocyte activation, a critical pathway in cell-mediated allograft rejection. While in circulation, Basiliximab impairs the immune system's response to antigenic challenges. However, the ability to respond to repeated or ongoing challenges with those antigens returns to normal after basiliximab clearance is still unknown.
Duration: Mean: 36 ± 14 days.
Pharmacokinetics:
Distribution: Mean volume of distribution: 8.6 ± 4.1 L.
Excretion: Termination elimination half-life: Approx 7 days.
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Intact vial: Store between 2-8°C. Reconstituted solution: May be stored between 2-8°C for up to 24 hours or at room temperature for up to 4 hours.
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L04AC02 - basiliximab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
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Basiliximab. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/12/2025. Basiliximab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/12/2025. Brayfield A, Cadart C (eds). Basiliximab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/12/2025. Joint Formulary Committee. Basiliximab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/12/2025. Novartis New Zealand Limited. Simulect 20 mg Powder for Injection data sheet 03 October 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 10/12/2025. Simulect (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/12/2025. Simulect 10 mg Powder and Solvent for Solution for Injection or Infusion (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/12/2025. Simulect Injection, Powder, for Solution (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/12/2025.
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