GNH USA

Europe — EMA

Hydrea

Hydrea (hydroxycarbamide) is an oral antineoplastic drug used for CML, polycythemia vera, essential thrombocythemia, sickle cell disease, and melanoma.

Hydroxycarbamide

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What is Hydroxycarbamide?

Hydrea is a prescription oral medication whose active ingredient is hydroxycarbamide (hydroxyurea). It is supplied in tablet form, with strength not specified in the available data, and is marketed in the European Union. Hydroxycarbamide belongs to the antineoplastic and myelosuppressive drug class and is used under medical supervision for several hematologic and oncologic conditions. The medication is regulated as a prescription‑only product and is not classified as a controlled substance.

What is Hydroxycarbamide used for?

Hydrea (hydroxycarbamide) is indicated for several hematologic malignancies and blood disorders, as well as for specific solid tumor indications, under the direction of a qualified health professional.

- Chronic myelogenous leukemia (CML), especially in patients who have failed or are intolerant to tyrosine‑kinase inhibitors - Polycythemia vera (PV) to control elevated red blood cell mass - Essential thrombocythemia (ET) for reduction of platelet counts and thrombotic risk - Sickle cell disease (SCD) to decrease frequency of vaso‑occlusive crises - Melanoma, often as part of combination chemotherapy regimens

What are the side effects of Hydroxycarbamide?

Hydroxycarbamide may cause a range of adverse reactions, varying from mild to potentially life‑threatening. These effects can be dose‑related and may require monitoring of laboratory parameters during therapy.

Common: - Nausea or vomiting - Mild skin rash or pruritus - Transient elevation of liver enzymes (ALT/AST) - Decreased blood counts (neutropenia, thrombocytopenia) - Mouth ulcers or stomatitis

Serious: - Severe bone marrow suppression leading to pancytopenia - Acute hemolytic crisis in patients with G6PD deficiency - Pulmonary toxicity, including interstitial pneumonitis - Renal impairment or failure - Severe cutaneous reactions such as Stevens‑Johnson syndrome

What precautions apply to Hydroxycarbamide?

When prescribing or taking Hydrea, several precautions should be observed to minimize risks and ensure safe use.

- Pregnancy is contraindicated (Category D); avoid use unless benefits outweigh risks - Perform baseline and periodic complete blood counts to monitor for myelosuppression - Assess liver and renal function before initiation and during treatment - Screen for glucose‑6‑phosphate dehydrogenase deficiency to prevent hemolysis - Counsel patients on the importance of contraception and avoiding pregnancy - Monitor for signs of infection, fever, or bleeding - Adjust dose in patients with significant hepatic or renal impairment

What does Hydroxycarbamide interact with?

Hydroxycarbamide can interact with other medicines, affecting its efficacy or increasing toxicity.

Avoid: - Concurrent use with other myelosuppressive agents (e.g., cytarabine, azacitidine) due to additive bone‑marrow suppression - Combining with live vaccines, as immunosuppression may reduce vaccine effectiveness

Use with caution: - Antiretroviral drugs such as zidovudine, which may enhance hematologic toxicity - NSAIDs or aspirin, which can increase risk of gastrointestinal bleeding - Drugs that affect renal excretion (e.g., probenecid) may alter hydroxycarbamide levels - Vitamin C supplements, which may increase hydroxycarbamide absorption

Frequently asked questions

What is the generic name of Hydrea?+
The generic name of Hydrea is hydroxycarbamide, also known as hydroxyurea.
Which route of administration is used for Hydrea?+
Hydrea is administered orally, typically in tablet form.
Is Hydrea prescribed for chronic myelogenous leukemia?+
Yes, Hydrea is indicated for the treatment of chronic myelogenous leukemia, especially in patients who are resistant or intolerant to other therapies.
Can Hydrea be used during pregnancy?+
Hydrea is classified as pregnancy category D, meaning it should be avoided during pregnancy unless the potential benefit justifies the risk to the fetus.
What monitoring is required while a patient is on Hydrea?+
Regular complete blood counts, liver function tests, and renal function assessments are recommended to detect myelosuppression or organ toxicity.
Does Hydrea have activity against sickle cell disease?+
Yes, Hydroxycarbamide is used in sickle cell disease to increase fetal hemoglobin levels and reduce vaso‑occlusive crises.
What are common side effects of Hydrea?+
Common side effects include nausea, mild skin rash, transient liver enzyme elevation, decreased blood cell counts, and mouth ulcers.
What serious adverse reactions can occur with Hydrea?+
Serious reactions may include severe bone‑marrow suppression, acute hemolysis in G6PD‑deficient patients, pulmonary toxicity, renal failure, and severe skin reactions such as Stevens‑Johnson syndrome.
Should patients avoid live vaccines while taking Hydrea?+
Yes, because Hydrea can suppress the immune system, live vaccines should be avoided during treatment.
Are there any drug interactions that increase the risk of bleeding with Hydrea?+
Concurrent use of NSAIDs or aspirin can increase the risk of gastrointestinal bleeding and should be used with caution.
How does Hydroxycarbamide work at the cellular level?+
Hydroxycarbamide inhibits ribonucleotide reductase, decreasing deoxyribonucleotide synthesis and impairing DNA replication, which leads to cell cycle arrest in rapidly dividing cells.
Is dose adjustment needed for patients with kidney disease?+
Dose adjustments may be required for patients with significant renal impairment to avoid accumulation and increased toxicity.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Hydroxycarbamide
Route
Oral Use
Manufacturer
Cheplapharm Arzneimittel Gmbh
Origin
EU

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