Acute Porphyria Drug Database

L04AC02 - Basiliximab
Propably not porphyrinogenic
PNP

Important Information
Patients on immunosuppressive therapy have an increased risk of infections. Since infections have a potential to trigger acute porphyric attacks vigilance is motivated regarding signs or symptoms of infection and/or possible symptoms of a porphyric attack. Side effects like nausea and vomiting may potentially be porphyrinogenic through reduction in carbohydrate intake.
Side effects
Infections are common in patients using immunosuppressants and since infections might trigger an acute porphyric attack, vigilance regarding signs and symptoms of an infection and/ or a porphyric attack is recommended. Common adverse reactions of basiliximab that can be confused with an acute porphyric attack are nausea and vomiting. These side effects may potentially be porphyrinogenic if leading to a decrease in carbohydrate intake.
Rationale
Antibody preparation with no CYP metabolism. Based on the pharmacokinetics, basiliximab is not expected to have any porphyrinogenic effects.
Chemical description
Basiliximab is a chimeric human-murine monoclonal antibody against IL2, which inhibits IL2 - mediated lymphocyte activation.
Therapeutic characteristics
Basiliximab is used as prophylaxis of acute organ rejection in renal transplantation together with ciclosporin and steroids. It is administered as an intravenous injection or infusion.
Metabolism and pharmakokinetics
The metabolism of basiliximab is expected to be similar as for endogenous antibodies, which are metabolised to peptides and amino acids in various body tissues and in plasma by circulating phagocytic cells or by their target antigen-containing cells.

References

  1. Scientific articles
  2. Keizer, R.J., Huitema, A.D.R., Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies. Clin Pharmacokinet. 2010 Aug 1;49(8):493-507 PMID 20608753. #4607
  3. McKeage, K., McCormack, P.L.,Basiliximab: a review of its use as induction therapy in renal transplantation. BioDrugs. 2010 Feb 1;24(1):55-76 PMID 20055533. #4609
  4. Drug reference publications
  5. Sweetman SC, editor. Martindale: The complete drug reference. Basiliximab. Pharmaceutical Press 2009. #2311
  6. Summary of Product Characteristics
  7. Norwegian medicines agency. Summary of Product Characteristics (SPC). Simulect. #2309
  8. Other sources
  9. Novartis Pharmaceuticals Corporation. Simulect_ (basiliximab) for injection: prescribing information (online). Available from URL: www.pharma.us.novartis.com/product/pi/pdf/simulect.pdf #2310

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