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Hydrea

Active Ingredient:
Hydroxycarbamide
Origin:
EU

Hydrea (Hydroxycarbamide)

Hydrea is an oral tablet formulation of hydroxycarbamide (hydroxyurea) with an unspecified strength, marketed in the European Union as a prescription antineoplastic agent. It belongs to the antimetabolite drug class and is used under medical supervision for several hematologic and oncologic conditions. The tablet is taken by mouth and requires a health‑care provider’s prescription. The medication is regulated as a prescription‑only product and is not available over the counter.

Manufacturer / TM Owner

Cheplapharm Arzneimittel Gmbh

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Indications & Clinical Uses

Hydrea is indicated for several chronic blood disorders and selected solid tumors, where it helps control abnormal cell proliferation.

  • Chronic myeloid leukemia (CML) in patients who have not responded adequately to other therapies.
  • Polycythemia vera to reduce elevated red blood cell mass and lower risk of thrombosis.
  • Essential thrombocythemia for managing high platelet counts and preventing thrombotic events.
  • Sickle cell disease to increase fetal hemoglobin levels and reduce vaso‑occlusive crises.
  • Melanoma as part of combination chemotherapy regimens in certain clinical settings.

How It Works

  • Hydroxycarbamide inhibits the enzyme ribonucleotide reductase, the key catalyst for converting ribonucleotides to deoxyribonucleotides. By limiting the intracellular pool of deoxyribonucleotides, DNA synthesis is slowed, leading to reduced replication of rapidly dividing cells such as malignant leukocytes and erythroid precursors. The resulting cytostatic effect contributes to disease control in hematologic malignancies and to increased fetal hemoglobin production in sickle cell disease.

Side Effects

Hydrea may cause a range of adverse reactions, which are generally categorized by frequency and severity.

Common

  • Nausea, vomiting, or loss of appetite.
  • Mild to moderate bone marrow suppression leading to anemia, neutropenia, or thrombocytopenia.
  • Skin changes such as hyperpigmentation or rash.
  • Elevated liver enzymes indicating hepatic irritation.

Serious

  • Severe bone marrow failure with pancytopenia.
  • Acute renal impairment or nephrotoxicity.
  • Life‑threatening infections due to profound neutropenia.
  • Pulmonary toxicity, including interstitial pneumonitis.

Precautions & Warnings

Before starting Hydrea, clinicians should evaluate several safety considerations to minimize risk.

  • Perform baseline complete blood count and liver function tests.
  • Monitor blood counts regularly during therapy to detect marrow suppression early.
  • Use caution in patients with pre‑existing renal or hepatic impairment.
  • Avoid use during pregnancy; the drug is classified as pregnancy category D.
  • Counsel women of child‑bearing potential about effective contraception throughout treatment and for a defined period after discontinuation.
  • Assess for history of hypersensitivity to hydroxyurea or related compounds.

Avoid Interactions

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

Avoid

  • Concurrent use of other myelosuppressive agents (e.g., chemotherapy, azathioprine) that may exacerbate bone marrow depression.
  • Strong CYP2C9 inhibitors that could increase hydroxycarbamide plasma levels.
  • Live vaccines, because immunosuppression may reduce vaccine effectiveness and increase infection risk.

Use with caution

  • Allopurinol, which may enhance hematologic toxicity.
  • NSAIDs or aspirin, which can increase the risk of gastrointestinal bleeding.
  • Antiretroviral drugs such as zidovudine, which may have additive bone marrow effects.

Frequently Asked Questions

The generic name of Hydrea is hydroxycarbamide, also known as hydroxyurea.

Hydrea is taken orally in tablet form as prescribed by a health‑care professional.

Hydrea is used to treat chronic myeloid leukemia, polycythemia vera, essential thrombocythemia, and sickle cell disease.

Yes, Hydrea may be included in combination chemotherapy regimens for certain cases of melanoma.

Regular complete blood counts and liver function tests are recommended to monitor for bone marrow suppression and hepatic effects.

Hydrea is classified as pregnancy category D and should be avoided during pregnancy due to potential risks to the fetus.

Common side effects include nausea, vomiting, loss of appetite, mild bone marrow suppression, skin rash, and elevated liver enzymes.

Serious reactions may include severe bone marrow failure, pancytopenia, acute kidney injury, life‑threatening infections, and pulmonary toxicity.

Yes, effective contraception is advised during treatment and for a period after stopping Hydrea to prevent pregnancy.

Concurrent use of other myelosuppressive agents, strong CYP2C9 inhibitors, and live vaccines should be avoided.

Allopurinol can be used with caution, as it may increase hematologic toxicity.

Hydroxycarbamide inhibits ribonucleotide reductase, reducing deoxyribonucleotide synthesis and impairing DNA replication in rapidly dividing cells.

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GNH India Pharmaceuticals Limited

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Last updated:

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