hydroxycarbamide: clinical use

Prescribing considerations

• Confirm the indication, patient age and formulation-specific licence.
• Treatment should be initiated and supervised by clinicians experienced in the relevant haematological condition or cancer treatment.
• Assess haematological, renal and hepatic status before treatment; consider renal clearance and product-specific restrictions.
• Discuss reproductive risks, contraception and possible sperm preservation before treatment.
• Review vaccination status, skin surveillance, safe handling and ability to follow monitoring instructions.

Contraindications and cautions

• Hypersensitivity to hydroxycarbamide or formulation excipients.
• Marked or toxic bone-marrow suppression.
• Severe renal or hepatic impairment for Xromi and Siklos.
• Pregnancy and breastfeeding restrictions vary by product; Xromi contraindicates both.
• Xromi contraindicates concomitant antiretroviral treatment for HIV disease.

Monitoring

• Full blood count with differential, platelets and reticulocytes where appropriate.
• Renal and hepatic function.
• Evidence of infection, bleeding, anaemia, mucositis, skin ulcers and pulmonary toxicity.
• Long-term skin examination and routine surveillance for secondary malignancy.
• Visual symptoms suggestive of limbal stem-cell deficiency.
• CGM reliability and alternative glucose measurements when relevant.

Clinical pharmacology

An orally absorbed antineoplastic agent that inhibits ribonucleotide reductase and DNA synthesis. Renal excretion contributes to elimination. In sickle cell disease, increased fetal haemoglobin and additional effects on blood-cell adhesion and inflammation reduce sickling-related vaso-occlusion.

Formulation and product differences

• Selected hard capsules are licensed mainly for malignant or myeloproliferative indications and should be swallowed whole.
• Xromi is an oral solution licensed for sickle cell disease in patients older than 9 months and requires accurate measurement with its supplied syringes.
• Siklos is a scored film-coated tablet licensed for symptomatic sickle cell syndrome in patients older than 2 years; it may be divided or dispersed in water.
• Product contraindications, excipients, storage, pregnancy wording and handling requirements are not interchangeable.

Capsule

Route: Oral

Strengths: 500 mg

Oral solution

Route: Oral

Strengths: 100 mg/mL

Tablet

Route: Oral

Strengths: 100 mg, 1000 mg