L01XX05 - Hydroxycarbamide |
Propably not porphyrinogenic |
PNP |
Rationale
Low molecular weight organic molecule. No reports on CYP-related interactions despite years of use. Side effects such as nausea and vomiting may be potentially porphyrinogenic through reduction in caloric intake.
Chemical description
Hydroxycarbamide (also called hydroxyurea) is a derivative of urea. Contains one secondary aminogroup.
Therapeutic characteristics
Hydroxycarbamide is an antineoplastic agent used in the treatment of chronic myeloic leucemia, polycytemia vera and primary (essential) thrombocythaemia. It is administered orally. Common adverse reactions of hydroxycarbamide that can be confused with an acute porphyric attack are
nausea, vomiting, obstipation and diarrhoea. Side effects such as nausea and vomiting may be potentially porphyrinogenic through reduction in caloric intake.
Metabolism and pharmakokinetics
Up to 50 % of hydroxycarbamide is metabolized in the liver, however, the precise metabolic pathways have not been determined. Excreted in urine as unchanged drug and metabilites. Some is excreted as carbon dioxide by the lungs. Crosses the blood-brain barrier. CYP Interactions with CYP-metabolism of other drugs not stated. One study found that hydroxyurea had no inhibitory effect on the biotransformation of imatinib (i.e. that it did not inhibit CYP3A4) (Oostendorp, 2007). Not listed as CYP-inducer or CYP-inhibitor.
Published experience
One report of uneventful use of hydroxyurea in 16 year old woman with PV (Samuels, 1984).
IPNet drug reports
Uneventful use reported in 1 patient with acute porphyria.
References
- Scientific articles
- Oostendorp RL, Marchetti S, et al. The effect of hydroxyurea on P-glycoprotein/BCRP-mediated transport and CYP3A metabolism of imatinib mesylate. Cancer Chemother Pharmacol. 2007;59(6):855-60. Epub 2006 Dec 16. PMID 17180388. #4582
- Samuels B, Bezwoda WR,et al. Chemotherapy in porphyria. S Afr Med J. 1984;65(23):924-6. #2088
- Drug reference publications
- McEvoy GK, editor. Hydroxyurea. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (08.06.10). #2085
- Sweetman SC, editor. Martindale: The complete drug reference. Hydroxycarbamide. Pharmaceutical Press 2009. #2089
- Summary of Product Characteristics
- Norwegian medicines agency. Summary of Product Characteristics (SPC). Hydroxyurea medac. #2086
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