Europe — EMA
Hydrea (Hydroxycarbamide)
Hydroxycarbamide (Hydrea) is an oral antineoplastic drug used for CML, polycythemia vera, essential thrombocythemia, and sickle cell disease.
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What is Hydroxycarbamide?
Hydrea is a prescription medication whose active ingredient is hydroxycarbamide. It is supplied in oral form and marketed in the European Union. As an antimetabolite and ribonucleotide reductase inhibitor, Hydrea belongs to the antineoplastic and myelosuppressive therapeutic class. The drug is used under medical supervision to manage certain blood‑cell disorders and hematologic cancers. It is typically prescribed by hematologists and oncologists after confirming diagnosis through laboratory and imaging studies.
What is Hydroxycarbamide used for?
Hydrea is indicated for several hematologic conditions where reduction of abnormal cell proliferation is required.
- Chronic myelogenous leukemia (CML) – often in combination with other therapies. - Polycythemia vera – to control elevated red blood cell mass. - Essential thrombocythemia – to lower platelet counts. - Sickle cell disease – to reduce frequency of painful crises. - Certain myeloproliferative neoplasms – as part of disease‑modifying regimens.
What are the side effects of Hydroxycarbamide?
Like many antineoplastic agents, Hydrea may cause a range of adverse reactions, from mild to potentially serious.
Common: - Nausea or vomiting. - Fatigue or weakness. - Low white blood cell count (neutropenia). - Mild skin rash.
Serious: - Severe bone marrow suppression (anemia, thrombocytopenia). - Acute kidney injury. - Pulmonary toxicity (interstitial pneumonitis).
What precautions apply to Hydroxycarbamide?
Healthcare providers should evaluate several safety considerations before prescribing Hydrea and monitor patients throughout therapy.
- Pregnancy Category D; avoid use unless benefits outweigh risks. - Regular complete blood count monitoring to detect marrow suppression. - Assess renal and hepatic function prior to initiation and periodically. - Counsel patients on infection risk and advise prompt reporting of fever. - Avoid use in patients with known hypersensitivity to hydroxycarbamide. - Use caution in elderly patients due to increased susceptibility to toxicity.
What does Hydroxycarbamide interact with?
Hydrea can interact with other medicines, affecting its efficacy or increasing toxicity.
Avoid: - Live vaccines, because immunosuppression may lead to infection. - Strong nephrotoxic agents (e.g., aminoglycosides) that may worsen kidney injury. - Concurrent use with other myelosuppressive chemotherapy without dose adjustment.
Use with caution: - Antifungal agents such as azoles, which may alter hydroxycarbamide metabolism. - Allopurinol, which can increase hydroxycarbamide plasma levels. - NSAIDs, as they may exacerbate renal effects. - Drugs that cause bone marrow suppression (e.g., methotrexate) requiring close monitoring.



