L04AC01 - Daclizumab |
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 daclizumab 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
Daclizumab is a recombinant protein not metabolised by CYP. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Daclizumab is a recombinant humanized (human-murine) anti-CD25 monoclonal immunoglobulin G1 (IgG1) antibody.
Therapeutic characteristics
Daclizumab is an interleukin-2 receptor antagonist used in the prevention of acute organ rejection after kidney transplantation used in combination with other immunosuppressive agents. It is administered as an intravenous infusion.
Metabolism and pharmakokinetics
Daclizumab is not metabolised by CYP-enzymes. Mechanisms for elimination of monoclonal antibodies are not well documented but are reported to include proteolysis by the liver and the reticuloendothelial system, target-mediated elimination and nonspecific endocytosis (Keizer 2010).
References
- Scientific articles
- 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
- Lee, J.I., Zhang, L., CYP-Mediated Therapeutic Protein-Drug Interactions, clinical findings, proposed mechanisms and regulatory implications. Clin Pharmacokinet. 2010 May 1;49(5):295-310 PMID 20384392. #4608
- Drug reference publications
- Sweetman SC, editor. Martindale: The complete drug reference. Daclizumab. Pharmaceutical Press 2009 #2307
- Government bodies
- European Public Assessment Report, Zenapax (Scientific discussion). European Medicines Agency (EMEA). Accessible from: emea.europa.eu #2306
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