Europe — EMA
Hydrea
Hydrea (hydroxycarbamide) is an oral antineoplastic drug for sickle cell disease, CML, polycythemia vera, and essential thrombocythemia.
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What is Hydroxycarbamide?
Hydrea, containing the active ingredient hydroxycarbamide, is an oral antimetabolite medication used in the European market. It belongs to the antineoplastic drug class and works by interfering with DNA synthesis. Hydrea is prescribed under a prescription-only status and is indicated for several hematologic conditions, offering a targeted approach to disease management.
What is Hydroxycarbamide used for?
Hydrea is prescribed for specific blood disorders where controlling abnormal cell proliferation is essential. It is used in both adult and pediatric patients under medical supervision.
- Management of sickle cell disease to reduce painful crises. - Treatment of chronic myelogenous leukemia (CML) as part of disease control. - Therapy for polycythemia vera to lower elevated red blood cell counts. - Management of essential thrombocythemia to decrease platelet production. - Off‑label use in certain myeloproliferative neoplasms as determined by a specialist.
What are the side effects of Hydroxycarbamide?
Hydrea may cause a range of adverse reactions, varying from mild to severe. Patients should be monitored regularly for any signs of toxicity.
Common: - Nausea or vomiting, often mild to moderate in intensity. - Fatigue or general weakness that may affect daily activities. - Mild hair thinning or temporary loss of scalp hair. - Skin discoloration or hyperpigmentation, especially on the hands.
Serious: - Severe bone marrow suppression leading to anemia, neutropenia, or thrombocytopenia. - Acute renal impairment manifested by reduced urine output. - Pulmonary toxicity presenting as shortness of breath or cough. - Severe gastrointestinal ulceration or bleeding. - Life‑threatening allergic reactions such as anaphylaxis.
What precautions apply to Hydroxycarbamide?
Before starting Hydrea, several safety considerations should be addressed to minimize risk.
- Baseline complete blood count and renal function tests are required. - Avoid use in patients with known hypersensitivity to hydroxycarbamide. - Monitor for signs of infection due to possible neutropenia. - Use caution in pregnant or breastfeeding women; the safety profile is not well established. - Adjust dose in patients with pre‑existing kidney disease. - Regular ophthalmologic examinations are advised for long‑term therapy.
What does Hydroxycarbamide interact with?
Hydrea can interact with other medications, altering its effectiveness or increasing toxicity.
Avoid: - Concurrent use with other myelosuppressive agents such as azacitidine, which may exacerbate bone marrow suppression. - Co‑administration with high‑dose vitamin C supplements, which can increase oxidative stress. - Use with strong CYP450 inducers that may reduce hydroxycarbamide plasma levels.
Use with caution: - Anticoagulants (e.g., warfarin) as Hydrea may affect platelet counts and bleeding risk. - Allopurinol, which can increase the risk of hypersensitivity reactions. - NSAIDs, which may worsen renal impairment when combined with Hydrea.
Frequently asked questions
What is the primary active ingredient in Hydrea?+
For which blood disorders is Hydrea commonly prescribed?+
How does hydroxycarbamide affect red blood cell production?+
Can Hydrea be used during pregnancy?+
What laboratory tests are required before starting Hydrea?+
What are common side effects of Hydrea?+
What serious adverse reactions should patients be aware of?+
Should Hydrea be taken with other myelosuppressive drugs?+
How often should blood counts be monitored while on Hydrea?+
Is there a need for dose adjustment in patients with kidney disease?+
Can Hydrea interact with over‑the‑counter supplements?+
What should a patient do if they experience signs of infection while on Hydrea?+
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