Europe — EMA
Hydrea
Hydroxycarbamide (Hydrea) is an oral antineoplastic tablet used for sickle cell disease, CML, and other blood disorders. Learn uses, side effects, and precautions.
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What is Hydroxycarbamide?
Hydrea is the brand name for the oral tablet formulation of hydroxycarbamide, an antimetabolite used as an antineoplastic agent. It is available in the European market and is prescribed by healthcare professionals. The medication is supplied as a tablet for oral administration, with the exact strength varying by product specification. It belongs to the ATC class L01XX02 and is classified as a prescription‑only product with no controlled schedule.
What is Hydroxycarbamide used for?
Hydrea (hydroxycarbamide) is indicated for several hematologic and oncologic conditions where reduction of abnormal cell proliferation is required, and it may be used alone or in combination with other therapies.
- Sickle cell disease to reduce frequency of painful crises and decrease need for blood transfusions. - Chronic myelogenous leukemia (CML) as part of disease‑modifying therapy, often combined with tyrosine‑kinase inhibitors. - Essential thrombocythemia for control of platelet counts and prevention of thrombotic events. - Polycythemia vera to maintain hematocrit within target range and reduce risk of thrombosis. - Melanoma as an adjunctive antineoplastic agent, particularly in combination regimens. - Myeloproliferative neoplasms to control leukocytosis and reduce splenomegaly.
What are the side effects of Hydroxycarbamide?
Hydroxycarbamide can produce a variety of adverse reactions, ranging from mild, frequently observed effects to rare but potentially serious complications.
Common: - Nausea, vomiting, or loss of appetite. - Fatigue, generalized weakness, or dizziness. - Mild skin rash, itching, or photosensitivity. - Decreased white blood cell count (leukopenia) leading to mild infection risk. - Mouth sores or oral mucositis.
Serious: - Severe bone marrow suppression causing pancytopenia, which may require transfusion support. - Life‑threatening allergic reactions, including anaphylaxis and angioedema. - Significant liver toxicity manifested by markedly elevated transaminases or hepatitis. - Rare but serious cutaneous reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Renal impairment manifested by increased serum creatinine levels.
What precautions apply to Hydroxycarbamide?
When prescribing or taking Hydrea, several precautions should be considered to minimize risks and ensure safe use. - Pregnancy Category D: drug may cause fetal harm; avoid use unless benefits outweigh risks. - Monitor complete blood counts regularly to detect bone marrow suppression. - Assess liver function before initiation and periodically during therapy. - Use caution in patients with pre‑existing renal impairment; dose adjustments may be required. - Avoid in individuals with known hypersensitivity to hydroxycarbamide or its excipients. - Evaluate for potential teratogenic effects and advise effective contraception during treatment. - Consider risk of secondary malignancies with long‑term use; conduct appropriate surveillance.
What does Hydroxycarbamide interact with?
Hydroxycarbamide can interact with several medicines, affecting its efficacy or safety profile.
Avoid: - Concurrent use with other myelosuppressive agents (e.g., azacitidine) due to additive bone marrow toxicity. - Co‑administration with allopurinol, which may increase hydroxycarbamide plasma levels. - Combining with live vaccines, as immunosuppression can reduce vaccine effectiveness.
Use with caution: - Antacids containing aluminum or magnesium may reduce oral absorption; separate dosing by at least 2 hours. - NSAIDs (e.g., ibuprofen) may increase risk of gastrointestinal bleeding in the context of thrombocytopenia. - CYP2C9 substrates (e.g., warfarin) may have altered metabolism; monitor INR closely. - Drugs that affect renal function (e.g., ACE inhibitors) may require dose adjustment of hydroxycarbamide.
Frequently asked questions
What conditions is hydroxycarbamide (Hydrea) prescribed for?+
How does hydroxycarbamide work at the cellular level?+
What monitoring is recommended while taking Hydrea?+
Can hydroxycarbamide be used during pregnancy?+
What are common side effects of hydroxycarbamide?+
What serious adverse reactions may occur with hydroxycarbamide?+
Which drugs should be avoided while taking hydroxycarbamide?+
Which medications require caution when combined with hydroxycarbamide?+
How should hydroxycarbamide be stored?+
Is dose adjustment needed for patients with kidney problems?+
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