Monograph
L04AJ01 - Eculizumab |
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 eculizumab 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
Eculizumab is a protein preparation not metabolized by CYP. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Eculizumab is a recombinant humanized immunoglobulin G2/4-kappa; (IgG2/4-kappa;) monoclonal antibody.
Therapeutic characteristics
Eculizumab is used to reduce haemolysis in patients with paroxysmal nocturnal haemoglobinuria, a severe and disabling form of haemolytic anaemia. It is given by intravenous infusion.
Metabolism and pharmacokinetics
Human antibodies undergo endocytotic digestion in the cells of the reticuloendothelial system. Eculizumab contains only naturally occurring amino acids and has no known active metabolites. Human antibodies are predominately catabolized by lysosomal enzymes to small peptides and amino acids. No interaction studies have been performed.
References
| # | Citation details | PMID |
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| * | Drug reference publications | |
| 1. | McEvoy GK, editor. Eculizumab. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (31.09.10).
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| 2. | Sweetman SC, editor. Martindale: The complete drug reference. Eculizumab. Pharmaceutical Press 2009.
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| * | Government bodies | |
| 3. | European Public Assessment Report, Soliris (Scientific discussion).European Medicines Agency (EMEA). Accessible from: emea.europa.eu
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| * | Summary of Product Characteristics | |
| 4. | The electronic Medicines Compendium (eMC). Soliris. Summary of Product Characteristics (SPC).
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