Registered Rwanda · Rwanda FDA

Simulect 20 mg powder and solvent for solution for infusion or injection

BASILIXIMAB

RWANDA-FDA25/HM/0261/0039 Powder for Solution for Injection/Infusion 20mg antineoplastic and immunomodulating agents INN generic

What it does

Basiliximab is a medication used to prevent organ rejection after a kidney transplant.

Commonly used for: prevention of organ rejection after kidney transplant

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
RWANDA-FDA25/HM/0261/0039
Registration date
16/10/2025
Expiry date
15/10/2030
Status
Registered
Active ingredient
BASILIXIMAB
Strength
20mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
L04AC - Interleukin inhibitors
RxNorm RxCUI
196102
Manufacturer / MAH
Novartis Pharma
Applicant / LTR
Novartis Pharma AG
Country of origin
France
Manufacturer location
8-10 Rue Henri Sainte-Claire Deville, 92563 Rueil-Malmaison, France

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:02 · updated 2026-09-21 02:30:19

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Basiliximab is a medication used to prevent organ rejection after a kidney transplant.

What it treats

  • prevention of organ rejection after kidney transplant

How it works

Basiliximab works by blocking certain cells in the immune system that can cause rejection of the transplanted organ.

Who it's for

This medication is for individuals who have received a kidney transplant and need help keeping their body from rejecting the new organ.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Basiliximab

BNF-referenced

Basiliximab is a monoclonal antibody that acts as an interleukin-2 receptor antagonist, primarily used for the prevention of acute rejection in renal transplantation.

Indications

  • Prophylaxis of acute rejection in renal transplantation (in combination with a corticosteroid and ciclosporin)
  • Prophylaxis of acute rejection in allogeneic renal transplantation used in combination with ciclosporin and corticosteroid-containing immunosuppression

Dosage

Children: For renal transplantation: 600 mg/m2 twice daily, consult local protocol for details; maximum 2 g per day.

Adults: Initially 20 mg administered as an intravenous infusion within 2 hours prior to transplant surgery, followed by 10 mg on days 4 and 14 post-transplant.

Mechanism of action

Basiliximab binds to the alpha chain of the interleukin-2 receptor on activated T-lymphocytes, inhibiting T-lymphocyte proliferation and activation.

Pharmacodynamics

By blocking interleukin-2 signaling, Basiliximab effectively reduces the immune response against transplanted tissues, thus minimizing the risk of organ rejection.

Pharmacokinetics

Basiliximab has a half-life of approximately 7-10 days. It is administered via injection and undergoes distribution in the vascular compartment.

Adverse effects

  • Capillary leak syndrome
  • Constipation
  • Cytokine release syndrome
  • Dyspnoea
  • Fever
  • Heart failure
  • Hypersensitivity
  • Hypertension
  • Hypertrichosis
  • Hypotension
  • Increased risk of infection
  • Myocardial infarction
  • Pulmonary oedema
  • Respiratory disorders
  • Sepsis
  • Skin reactions
  • Sneezing
  • Tachycardia

Precautions

  • Informed consent should be obtained and documented.
  • Patients should be advised to seek medical attention if signs or symptoms suggestive of tuberculosis occur (e.g., persistent cough, weight loss, subfebrile temperature).
  • Patients and carers should be counselled on the effects on driving and performance of skilled tasks due to the increased risk of dizziness and drowsiness.

Pregnancy

Use with caution; weigh benefits against risks.

Breast-feeding

Use with caution; limited data available.

Storage

Store in a refrigerator (2°C to 8°C). Protect from light.

Formulations

  • Basiliximab 10 mg powder and solvent for solution for injection
  • Basiliximab 20 mg powder and solvent for solution for injection
BNF for Children 2019-2020 p.566 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.