Europe — EMA
Hydrea
Hydrea (hydroxyurea) is an oral antineoplastic tablet used for CML, sickle cell disease, and other myeloproliferative disorders. Learn uses, side effects, and precautions.
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What is Hydroxycarbamide?
Hydrea is a prescription oral tablet containing the active ingredient hydroxyurea, an antimetabolite classified as an antineoplastic agent. The product is marketed in the European Union and is supplied in tablet form; specific strength information is not disclosed in this summary. Hydroxyurea works by inhibiting ribonucleotide reductase, which reduces DNA synthesis in rapidly dividing cells, making Hydrea useful for several clinical hematologic and oncologic conditions.
What is Hydroxycarbamide used for?
Hydrea is indicated for several hematologic disorders and selected malignancies, where inhibition of DNA synthesis helps control abnormal cell proliferation and improve disease‑related outcomes.
- Chronic myelogenous leukemia (CML): used as part of therapy to suppress leukemic cell growth. - Sickle cell disease: administered to increase fetal hemoglobin and lower the rate of vaso‑occlusive episodes. - Polycythemia vera: helps reduce elevated red blood cell mass. - Essential thrombocythemia: used to control excessive platelet production. - Other myeloproliferative neoplasms: may be employed when standard therapies are insufficient.
What are the side effects of Hydroxycarbamide?
Like many antineoplastic agents, Hydrea may cause a range of adverse reactions, which are generally categorized by frequency and severity. These reactions can vary in intensity and may require monitoring or medical intervention.
Common: - Nausea, vomiting, or mild gastrointestinal upset - Decreased appetite and weight loss - Transient reduction in white blood cells (leukopenia) or platelets (thrombocytopenia) - Skin changes such as darkening or hyperpigmentation, especially on the face or hands
Serious: - Significant bone marrow suppression causing anemia, neutropenia, or severe thrombocytopenia - Acute kidney injury or worsening renal function - Severe hypersensitivity reactions, including Stevens‑Johnson syndrome or toxic epidermal necrolysis
What precautions apply to Hydroxycarbamide?
Hydrea requires careful patient assessment and ongoing monitoring because of its potential impact on blood counts, organ function, and reproductive health.
- Baseline and periodic complete blood counts to detect bone marrow suppression. - Regular renal and hepatic function tests, especially in patients with pre‑existing impairment. - Contraindicated in pregnancy; women of childbearing potential must use effective contraception. - Caution in patients with a history of severe hypersensitivity or skin reactions. - Dose adjustments may be needed for elderly patients or those with reduced kidney function. - Avoid use in individuals with active infections until resolved. - Monitor for signs of fetal hemoglobin increase in sickle cell disease therapy.
What does Hydroxycarbamide interact with?
Hydroxyurea can interact with other medicines, affecting its efficacy or increasing toxicity; awareness of key interactions helps optimize safety.
Avoid: - Concurrent use with other myelosuppressive agents (e.g., azacitidine, cytarabine) that may exacerbate bone marrow depression. - Live vaccines while on therapy, due to impaired immune response.
Use with caution: - Antiretroviral drugs such as zidovudine, which may increase hematologic toxicity. - NSAIDs or aspirin, which can heighten the risk of gastrointestinal bleeding. - Drugs that affect renal clearance (e.g., probenecid) may alter hydroxyurea levels. - Phenytoin or other enzyme‑inducing anticonvulsants that could reduce hydroxyurea exposure.
Frequently asked questions
What medical conditions is Hydrea prescribed for in the European Union?+
How does hydroxyurea, the active ingredient in Hydrea, work at the cellular level?+
Can Hydrea be used during pregnancy?+
What monitoring is recommended for patients taking Hydrea?+
What are the most common side effects reported with Hydrea?+
Which serious adverse reactions require immediate medical attention while on Hydrea?+
Should live vaccines be avoided while taking Hydrea?+
Are there any drug classes that should not be combined with Hydrea?+
How does Hydrea benefit patients with sickle cell disease?+
What precautions are recommended for elderly patients taking Hydrea?+
Can Hydrea interact with antiretroviral medications?+
Is it necessary to adjust Hydrea dosage in patients with kidney impairment?+
Product details
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