Generic Medicine Info
Indications and Dosage
Chronic myeloid leukaemia, Solid tumours
Adult: 20-30 mg/kg/daily as a single dose. Alternatively (for solid tumours), 80 mg/kg as single dose every 3 days. Concomitant irradiation therapy: 80 mg/kg as single dose every 3 days, started at least 7 days before initiation of radiotherapy. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Sickle-cell disease
Adult: Initially, 15 mg/kg daily, may be increased by 2.5-5 mg/kg every 12 wk according to response and blood count. Usual dose: 15-30 mg/kg daily. Max: 35 mg/kg daily. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: >2 yr Same as adult dose.
Renal Impairment
Chronic myeloid leukaemia; Solid tumours:
CrCl (mL/min) Dosage
<60 Initially, 7.5 mg/kg daily, titrate according to response.

Sickle-cell disease:
CrCl (mL/min) Dosage
<30 Contraindicated.
30-60 Initially, 7.5 mg/kg daily, titrate according to response.
Hepatic Impairment
Sickle-cell disease: Severe (Child-Pugh class C): Contraindicated.
Severe bone marrow depression. Severe hepatic (Child-Pugh class C) and renal (CrCl <30 mL/min) impairment, when used in the treatment of sickle-cell disease. Lactation. Concomitant use w/ didanosine and stavudine.
Special Precautions
Patient w/ severe GI intolerance, history of prior cytotoxic or radiation therapy. Renal and hepatic impairment. Childn. Pregnancy.
Adverse Reactions
Significant: Bone marrow suppression (e.g leucopenia, thrombocytopenia, anaemia), cutaneous vasculitic toxicities (e.g. vasculitic ulcerations or gangrene), erythrocyte abnormalities (e.g. self-limiting macrocytosis/megaloblastic erythropoiesis), secondary neoplasms, tumour lysis syndrome.
Nervous: Peripheral neuropathy, acute delirium, headache, dizziness, disorientation, malaise, asthenia, hallucination, seizure.
CV: Peripheral oedema, hypersentisitivity angiitis.
GI: Acute mucocutaneous toxicity, diarrhoea, gastric distress, nausea, oral mucosa ulcer, anorexia, constipation, GI irritation, mucositis, stomatitis, vomiting.
Resp: Diffuse pulmonary infiltrates, dyspnoea, pulmonary fibrosis, asthma.
Hepatic: Elevated liver enzyme, hepatic failure.
Genitourinary: Dysuria, increased BUN and creatinine, renal tubular disease.
Endocrine: Hyperuricaemia.
Haematologic: Leukaemia, abnormal erythropoiesis, macrocytosis, reticulocytopenia, cytopenia, myeloproliferative disorder (e.g. polycythemia, secondary leukaemia).
Musculoskeletal: Panniculitis, weakness.
Dermatologic: Maculopapular rash, skin ulceration, dermatomyositis-like skin changes, facial oedema, rash, pruritus, alopecia, hyperpigmentation, skin and nails atrophy, violet papules, cutaneous leg ulcers and skin carcinoma, eczema, desquamation, peripheral and facial erythema.
Others: Fever, chills.
Potentially Fatal: Severe myelosuppression.
Patient Counseling Information
This drug may cause dizziness and drowsiness, if affected, do not drive or operate machinery. Avoid sun exposure.
Monitoring Parameters
Monitor CBC w/ differential and platelet (once wkly for antineoplastic indication, every 2 wk initially for sickle cell anaemia), hepatic and renal function, LFT, serum uric, cutaneous toxicities and onset of secondary malignancies. Correct anaemia prior and during therapy.
Symptoms: Acute mucocutaneous toxicity, soreness, violet erythema, oedema on palms and foot soles followed by scaling of hands and feet, intense generalised hyperpigmentation of skin and severe acute stomatitis. Management: Perform gastric lavage immediately, followed by symptomatic and supportive treatment. Monitor haematologic toxicity, if necessary, blood should be transfused.
Drug Interactions
Increased risk of cutaneous vasculitic ulcerations w/ prior or concomitant use of interferon. Admin of live vaccine may cause severe infection due to the decreased patient’s antibody response.
Potentially Fatal: Increased risk of pancreatitis and hepatotoxicity when used in combination w/ didanosine and stavudine.
Lab Interference
False negative triglyceride measurement using glycerol oxidase method. May result in false elevation of lactic acid, urea and uric acid due to analytical interference between hydroxycarbamide and enzymes (e.g. lactate dehydrogenase, urease and uricase).
Mechanism of Action: Hydroxycarbamide is an S-phase specific DNA synthesis inhibitor. It acts as a ribonucleoside diphosphate reductase inhibitor, thus preventing conversion of ribonucleotides to deoxyribonucleotides causing cell death. In sickle cell anaemia, it can stimulate the production and increase of the concentration of foetal Hb.
Onset: 4-12 wk (foetal Hb production).
Absorption: Readily absorbed from the GI tract. Time to peak plasma concentration: W/in 1-4 hr.
Distribution: Well distributed throughout the body. Crosses blood-brain barrier and placenta; enters breast milk. Volume of distribution: Approx 20 L/m2. Plasma protein binding: 75-80%.
Metabolism: Metabolised in the liver by urease to acetohydroxamic acid.
Excretion: Mainly via urine (approx 80%, as metabolites and unchanged drug); via lungs (as carbon dioxide). Elimination half-life: 1.9-3.9 hr.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Hydroxyurea, CID=3657, https://pubchem.ncbi.nlm.nih.gov/compound/Hydroxyurea (accessed on Jan. 23, 2020)

Store between 25-30°C.
Avoid inhalation and contact w/ skin or mucous membranes by wearing gloves and protective equipment. Wash hands before and after handling.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01XX05 - hydroxycarbamide ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Anon. Hydroxyurea. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 20/06/2017.

Buckingham R (ed). Hydroxycarbamide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/06/2017.

Droxia (E.R. Squibb & Sons LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 20/06/2017.

Joint Formulary Committee. Hydroxycarbamide (Hydroxyurea). British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/06/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Hydroxyurea. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 20/06/2017.

Disclaimer: This information is independently developed by MIMS based on Hydroxycarbamide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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