Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2025 Publisher: Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
Pharmacotherapeutic group: other antineoplastic agents
ATC Code: L01XX05
Hydroxycarbamide is an orally active antineoplastic agent. Although the mechanism of action has not yet been clearly defined, hydroxycarbamide appears to act by interfering with synthesis of DNA.
After oral administration hydroxycarbamide is readily absorbed from the gastrointestinal tract. Peak plasma concentrations are reached in 2 hours; by 24 hours the serum concentrations are virtually zero. Approximately 80% of an oral or intravenous dose of 7 to 30 mg/kg may be recovered from the urine within 12 hours. Hydroxycarbamide crosses the blood-brain barrier. Hydroxycarbamide is well distributed throughout the body.
Hydroxycarbamide is unequivocally genotoxic and a presumed transpecies carcinogen which implies a carcinogenic risk to humans.
Hydroxycarbamide has been demonstrated to be a potent teratogen in a wide variety of animal models including mice, hamsters, rabbits, cats, miniature swine, dogs and monkeys. The spectrum of effects following prenatal exposure to hydroxycarbamide includes embryo-fetal death, numerous fetal malformations of the viscera and skeleton, growth retardation, and functional deficits.
Hydroxycarbamide administered to male rats at 60 mg/kg/day (about 0.3 times the maximum recommended human daily dose on an mg/m² basis) produced testicular atrophy, decreased spermatogenesis, and significantly reduced their ability to impregnate females.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.