Drug reference

Hydroxycarbamide

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1007, 1008

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Polycythaemia vera (specialist use only) ▶BY MOUTH ▶Adult: Initially 15–20 mg/kg daily, adjusted according to response, for information on dose adjustment based on haematocrit and platelet count—consult product literature; usual dose 500–1000 mg daily, dosage should be based on actual or ideal body weight, whichever is less Essential thrombocythaemia (specialist use only) ▶BY MOUTH ▶Adult: Initially 15 mg/kg daily, adjusted according to response, for information on dose adjustment based on platelet count and white cell count—consult product literature, dosage should be based on actual or ideal body weight, whichever is less Chronic myeloid leukaemia (specialist use only) ▶BY MOUTH ▶Adult: Initially 40 mg/kg daily, then reduced to 20 mg/kg daily, adjusted according to response, for information on dose adjustment based on white cell count—consult product literature, dosage should be based on actual or ideal body weight, whichever is less HYDREA ® Chronic myeloid leukaemia (specialist use only) | Cancer of the cervix (specialist use only) ▶BY MOUTH ▶Adult: 20–30 mg/kg daily, alternatively 80 mg/kg every 3 days, for information on dose adjustment based on platelet count, white cell count and actual or ideal body continued → weight—consult product literature SIKLOS ® Sickle-cell disease [prevention of recurrent vaso-occlusive crises] (initiated by a specialist) ▶BY MOUTH ▶Adult: Initially 15 mg/kg daily, increased in steps of 2.5–5 mg/kg daily, dose to be increased every 12 weeks according to response; usual dose 15–30 mg/kg daily; maximum 35 mg/kg per day XROMI ® Sickle-cell disease [prevention of vaso-occlusive complications] (specialist use only) ▶BY MOUTH Immune system and malignant disease ▶Adult: Initially 15 mg/kg daily, increased in steps of 5 mg/kg daily, dose to be increased every 8 weeks according to response; usual maintenance 20–25 mg/kg daily; maximum 35 mg/kg per day

PDF pages 1007, 1008

Cautions

Leg ulcers (review treatment if cutaneous vasculitic ulcerations develop)

PDF page 1008

Safety

Important Safety Information

RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.

PDF page 1008

Interactions

→Appendix 1: hydroxycarbamide

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Side Effects

▶Common or very common Alopecia. anaemia. appetite decreased. asthenia. bone marrow disorders. chills. constipation. cutaneous vasculitis. dermatomyositis. diarrhoea. disorientation. dizziness. drowsiness. dyspnoea. dysuria. fever. gastrointestinal discomfort. haemorrhage. hallucination. headache. hepatic disorders . leucopenia. malaise. mucositis. nail discolouration. nail disorder. nausea. neoplasms. neutropenia. oral disorders . pancreatitis. peripheral neuropathy. pulmonary oedema . red blood cell abnormalities. respiratory disorders. seizure. skin reactions. skin ulcers. sperm abnormalities. thrombocytopenia. vomiting ▶Rare or very rare Cutaneous lupus erythematosus. gangrene. systemic lupus erythematosus (SLE) ▶Frequency not known Amenorrhoea. gastrointestinal disorders. hypomagnesaemia. Parvovirus B19 infection. vitamin D deﬁciency. weight increased

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Conception And Contraception

Manufacturer advises effective contraception before and during treatment.

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Pregnancy

Avoid (teratogenic in animal studies). See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

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Breast Feeding

Discontinue breast-feeding.

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Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (unless used for malignant conditions).

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Renal Impairment

In sickle-cell disease, avoid if eGFR less than 30 mL/minute/1.73 m2. Use with caution in malignant disease. Dose adjustments In sickle-cell disease, reduce initial dose by 50% if eGFR less than 60 mL/minute/1.73 m2.

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Monitoring Requirements

▶Monitor renal and hepatic function before and during treatment. ▶Monitor full blood count before treatment, and repeatedly throughout use; in sickle-cell disease monitor every 2 weeks for the ﬁrst 2 months and then every 2 to 3 months thereafter (or every 2 weeks if on maximum dose). ▶Patients receiving long-term therapy for malignant disease should be monitored for secondary malignancies.

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: capsule, oral suspension, oral solution Oral solution CAUTIONARY AND ADVISORY LABELS 27 EXCIPIENTS: May contain Hydroxybenzoates (parabens) ▶Xromi (Nova Laboratories Ltd) Hydroxycarbamide 100 mg per 1 ml Xromi 100mg/ml oral solution sugar-free | 150 ml P £250.00 Tablet ▶Siklos (Masters Pharmaceuticals Ltd) Hydroxycarbamide 100 mg Siklos 100mg tablets | 60 tablet P £100.00 DT = £100.00 Hydroxycarbamide 1 gram Siklos 1000mg tablets | 30 tablet P £500.00 DT = £500.00 Capsule ▶Hydroxycarbamide (Non-proprietary) Hydroxycarbamide 500 mg Hydroxycarbamide 500mg capsules | 100 capsule P £86.00 DT = £12.14 ▶Droxia (Imported (United States)) Hydroxycarbamide 300 mg Droxia 300mg capsules | 60 capsule P s ▶Hydrea (Bristol-Myers Squibb Pharmaceuticals Ltd) Hydroxycarbamide 500 mg Hydrea 500mg capsules | 100 capsule P £10.47 DT = £12.14

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Clinical care

Patient And Carer Advice

Patients receiving long-term therapy with hydroxycarbamide should be advised to protect skin from sun exposure.

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Dose text by age group

Adult

Initially 15–20 mg/kg daily, adjusted according

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1007

Adult

Initially 15 mg/kg daily, adjusted according to

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1007

Adult

Initially 40 mg/kg daily, then reduced to

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1007

Adult

20–30 mg/kg daily, alternatively 80 mg/kg every

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1007

Adult

Initially 15 mg/kg daily, increased in steps of

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1008

Adult

Initially 15 mg/kg daily, increased in steps of

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1008

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Hydroxycarbamide

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1007, 1008

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF pages 1007, 1008

Cautions

Leg ulcers (review treatment if cutaneous vasculitic ulcerations develop)

PDF page 1008

Safety

Important Safety Information

RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.

PDF page 1008

Interactions

→Appendix 1: hydroxycarbamide

PDF page 1008

Side Effects

PDF page 1008

Conception And Contraception

Manufacturer advises effective contraception before and during treatment.

PDF page 1008

Pregnancy

Avoid (teratogenic in animal studies). See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

PDF page 1008

Breast Feeding

Discontinue breast-feeding.

PDF page 1008

Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (unless used for malignant conditions).

PDF page 1008

Renal Impairment

PDF page 1008

Monitoring Requirements

PDF page 1008

Dose and formulations

Medicinal Forms

PDF page 1008

Clinical care

Patient And Carer Advice

Patients receiving long-term therapy with hydroxycarbamide should be advised to protect skin from sun exposure.

PDF page 1008

Dose text by age group

Adult

Initially 15–20 mg/kg daily, adjusted according

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1007

Adult

Initially 15 mg/kg daily, adjusted according to

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1007

Adult

Initially 40 mg/kg daily, then reduced to

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1007

Adult

20–30 mg/kg daily, alternatively 80 mg/kg every

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1007

Adult

Initially 15 mg/kg daily, increased in steps of

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1008

Adult

Initially 15 mg/kg daily, increased in steps of

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1008

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.