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Europe — EMA

Hydrea

Hydrea (hydroxycarbamide) is an oral antimetabolite used for sickle cell disease, CML, polycythemia vera, and essential thrombocythemia. Learn uses, side effects, and precautions.

Hydroxycarbamide

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What is Hydroxycarbamide?

Hydrea is a prescription tablet containing the active ingredient hydroxycarbamide. It is supplied in an oral tablet form, marketed in the European Union. Hydroxycarbamide belongs to the antimetabolite class and acts as a ribonucleotide reductase inhibitor, used as an antineoplastic and cytoreductive agent. It is classified under ATC code L01XX02 and is prescribed for several hematologic disorders. The medication is available only with a doctor's prescription.

What is Hydroxycarbamide used for?

Hydrea is indicated for the management of several blood‑related conditions where reduction of abnormal cell proliferation is required.

- Sickle cell disease to reduce the frequency of painful crises. - Chronic myelogenous leukemia (CML) as part of disease‑modifying therapy. - Polycythemia vera to control elevated red blood cell mass. - Essential thrombocythemia to lower platelet counts. - Myeloproliferative neoplasms not otherwise specified, to achieve cytoreduction. - Certain solid tumor protocols where hydroxycarbamide is used off‑label for its antiproliferative effect.

What are the side effects of Hydroxycarbamide?

Hydrea may cause a range of adverse reactions, varying from mild to potentially serious. Patients should report any new or worsening symptoms promptly.

Common: - Nausea or vomiting, often transient and manageable with anti‑emetics. - Fatigue and generalized weakness that may affect daily activities. - Decreased white blood cell count (leukopenia), increasing infection risk. - Skin rash or discoloration, sometimes pruritic.

Serious: - Severe bone marrow suppression leading to pancytopenia, which may require transfusion. - Acute renal impairment, indicated by rising creatinine levels. - Life‑threatening allergic reactions such as anaphylaxis with airway swelling.

What precautions apply to Hydroxycarbamide?

Before initiating Hydrea, several precautionary considerations should be reviewed to ensure safe use.

- Baseline complete blood count and renal function tests are required. - Monitor blood counts regularly during therapy to detect cytopenias early. - Use caution in patients with pre‑existing liver disease. - Avoid use during pregnancy unless benefits outweigh risks; discuss contraception. - Assess for history of hypersensitivity to hydroxycarbamide or related compounds. - Adjust dose in patients with impaired renal function. - Inform healthcare providers of any upcoming surgeries or invasive procedures.

What does Hydroxycarbamide interact with?

Hydrea can interact with other medicines, affecting its efficacy or safety profile.

Avoid: - Concurrent use with strong myelosuppressive agents (e.g., chemotherapy) that may exacerbate bone‑marrow toxicity. - Combination with nephrotoxic drugs (e.g., aminoglycosides) that increase risk of renal impairment.

Use with caution: - Anticoagulants (e.g., warfarin) as hydroxycarbamide may alter bleeding risk. - Allopurinol, which can increase hydroxycarbamide plasma levels. - Live vaccines, because immunosuppression may reduce vaccine effectiveness. - Drugs that affect hepatic metabolism (e.g., azole antifungals) may modify drug clearance. - Non‑steroidal anti‑inflammatory drugs (NSAIDs) as they may increase gastrointestinal toxicity.

Frequently asked questions

What is the generic name of Hydrea?+
The generic name of Hydrea is hydroxycarbamide.
For which blood disorders is Hydrea prescribed?+
Hydrea is prescribed for sickle cell disease, chronic myelogenous leukemia (CML), polycythemia vera, and essential thrombocythemia.
How does hydroxycarbamide work in treating sickle cell disease?+
Hydroxycarbamide increases fetal hemoglobin production, which reduces sickling of red blood cells and decreases the frequency of painful crises.
Is Hydrea taken with food or on an empty stomach?+
Hydrea tablets can be taken with or without food; follow the prescribing physician’s instructions.
What laboratory tests are needed before starting Hydrea?+
Baseline complete blood count, renal function (creatinine), and liver function tests are typically required before initiating therapy.
How often should blood counts be monitored while on Hydrea?+
Blood counts are usually monitored every 1–2 weeks initially, then at longer intervals once a stable response is achieved.
Can Hydrea be used during pregnancy?+
Hydrea is generally avoided during pregnancy unless the potential benefits outweigh the risks; contraception is recommended for women of childbearing potential.
What are common side effects of Hydrea?+
Common side effects include nausea, vomiting, fatigue, leukopenia, and skin rash.
What serious adverse reactions require immediate medical attention?+
Serious reactions such as severe bone marrow suppression (pancytopenia), acute kidney injury, or signs of anaphylaxis should be reported promptly.
Should Hydrea be stopped before surgery?+
Physicians often advise pausing Hydrea before major surgery to reduce the risk of bleeding and infection, based on individual risk assessment.
Are there any dietary restrictions while taking Hydrea?+
No specific dietary restrictions are required, but maintaining adequate hydration and nutrition supports overall health during treatment.
How does Hydroxycarbamide differ from other chemotherapy agents?+
Hydroxycarbamide is an antimetabolite that specifically inhibits ribonucleotide reductase, whereas many chemotherapy agents target DNA directly or interfere with microtubule formation.
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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