📋 Indications & Clinical Dosage
*Prophylaxis of acute rejection in allogeneic renal transplantation used in combination with ciclosporin and corticosteroid-containing immunosuppression regimens:*
BY IV INJ OR BY IV INF: Adult: Initially 20 mg, administered within 2 hours before transplant surgery, followed by 20 mg after4 days after surgery, withhold second dose if severe hypersensitivity or graft loss occurs.
Children above 2 yrs weighing less than 40 kg: 10 mg per dose; weighing 40 kg or more, same as adult dose.
💊 Mode of Administration
For central or peripheral IV administration only. Reconstituted solution should be given either as a bolus injection or diluted and administered as an IV infusion over 20-30 min: Reconstitution: To prepare the reconstituted solution, add 2.5 ml (10 mg vial) or 5 ml (20 mg vial) of SWFI, using aseptic technique, to the vial containing the basiliximab powder. Shake the vial gently to dissolve the powder. The reconstituted solution is isotonic and may 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 NS or D5W for infusion. When mixing the solution, gently invert the bag in order to avoid foaming, do not shake.
⛔ Contraindications
Pregnancy, lactation for at least 8 weeks after the second dose.
⚠️ Adverse Reactions / Side Effects
Atrial flutter, cardiac arrest, cytokine release syndrome, palpitations, severe hypersensitivity reactions, anaphylactoid type reaction such as rash, urticaria, sneezing, wheezing, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome have been reported.
🧪 Compatibility & Storage Stability
Stability & Storage: Store lyophilized basiliximab under refrigerated conditions 2C-8C (36F-46F). It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored between 2tC-8C (35.6F-46.4F) for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.