Monograph
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 pharmacokinetics
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
# | Citation details | PMID |
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* | Scientific articles | |
1. | The effect of hydroxyurea on P-glycoprotein/BCRP-mediated transport and CYP3A metabolism of imatinib mesylate.
Oostendorp RL, Marchetti S, et al. Cancer Chemother Pharmacol. 2007;59(6):855-60. Epub 2006 Dec 16. |
17180388 |
2. | Chemotherapy in porphyria.
Samuels B, Bezwoda WR,et al. S Afr Med J. 1984;65(23):924-6. |
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* | Drug reference publications | |
3. | McEvoy GK, editor. Hydroxyurea. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (08.06.10).
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4. | Sweetman SC, editor. Martindale: The complete drug reference. Hydroxycarbamide. Pharmaceutical Press 2009.
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* | Summary of Product Characteristics | |
5. | Norwegian medicines agency. Summary of Product Characteristics (SPC). Hydroxyurea medac.
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Similar drugs
Tradenames and packages
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Netherlands
Hydrea · Hydrea 500 mg harde capsules · Hydroxycarbamide · Hydroxycarbamide BModesto, 500 mg harde capsules · Hydroxycarbamide ERC 500 mg, harde capsules · Hydroxycarbamide Eureco-Pharma, 500 mg harde capsules · Hydroxyurea · Hydroxyurea ERC 500 mg, harde capsules · Hydroxyurea Eureco-Pharma 500 mg, harde capsules · Hydroxyurea medac, 500 mg harde capsules · Siklos · Siklos filmomhulde tabletten, 100 mg · Siklos, filmomhulde tabletten 1000 mg · Xromi · Xromi 100 mg/ml drankBelgium
Hydrea · Hydrea 500 mg gél. · Siklos · Siklos 1 000 mg compr. pellic. · Siklos 100 mg compr. pellic. · Xromi · Xromi 100 mg/ml sol. buv.United Kingdom
Droxia · Droxia 300mg capsules · Hydrea · Hydrea 500mg capsules · Hydroxycarbamide · Hydroxycarbamide 300mg capsules · Hydroxycarbamide 500mg capsules · Hydroxycarbamide 500mg/5ml oral solution · Hydroxycarbamide 500mg/5ml oral suspension · Siklos · Siklos 1000mg tablets · Siklos 100mg tablets · Xromi · Xromi 100mg/ml oral solutionDenmark
Hydroxyurea · Hydroxyurea "Medac" · Oribamide · Siklos · XromiNorway
Hydrea · Hydrea orifarm · Hydroxyurea medac · Siklos · Xromi farma mondoPoland
Hydroxycarbamid Eugia · Hydroxycarbamid Teva · Hydroxyurea medac · Siklos · XromiLuxembourg
HYDREA · Hydroxycarbamid · Hydroxycarbamid Devatis · SiklosIceland
Hydroxyurea · Hydroxyurea medac · Siklos · XromiFinland
Hydrea · Hydroxyurea medac · Oribamide · Siklos · XromiLatvia
Hydrea · Siklos · XromiSerbia
Litalir · Litalir®
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