Product image of Hydrea (Hydroxycarbamide) supplied by GNH India

Hydrea

Active Ingredient:
Hydroxycarbamide
Origin:
EU

Hydrea (Hydroxycarbamide)

Hydrea is the brand name for the oral tablet formulation of hydroxycarbamide, an antimetabolite used as an antineoplastic agent. It is available in the European market and is prescribed by healthcare professionals. The medication is supplied as a tablet for oral administration, with the exact strength varying by product specification. It belongs to the ATC class L01XX02 and is classified as a prescription‑only product with no controlled schedule.

Manufacturer / TM Owner

Cheplapharm Arzneimittel Gmbh

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Indications & Clinical Uses

Hydrea (hydroxycarbamide) is indicated for several hematologic and oncologic conditions where reduction of abnormal cell proliferation is required, and it may be used alone or in combination with other therapies.

  • Sickle cell disease to reduce frequency of painful crises and decrease need for blood transfusions.
  • Chronic myelogenous leukemia (CML) as part of disease‑modifying therapy, often combined with tyrosine‑kinase inhibitors.
  • Essential thrombocythemia for control of platelet counts and prevention of thrombotic events.
  • Polycythemia vera to maintain hematocrit within target range and reduce risk of thrombosis.
  • Melanoma as an adjunctive antineoplastic agent, particularly in combination regimens.
  • Myeloproliferative neoplasms to control leukocytosis and reduce splenomegaly.

How It Works

  • Hydroxycarbamide exerts its antineoplastic activity by inhibiting the enzyme ribonucleotide reductase, which is essential for conversion of ribonucleotides to deoxyribonucleotides. This inhibition decreases the intracellular pool of deoxyribonucleotides, impairing DNA synthesis and repair in rapidly dividing cells. The resulting DNA replication stress leads to cell cycle arrest, particularly in the S phase, and promotes apoptosis of malignant or abnormal hematopoietic cells.

Side Effects

Hydroxycarbamide can produce a variety of adverse reactions, ranging from mild, frequently observed effects to rare but potentially serious complications.

Common

  • Nausea, vomiting, or loss of appetite.
  • Fatigue, generalized weakness, or dizziness.
  • Mild skin rash, itching, or photosensitivity.
  • Decreased white blood cell count (leukopenia) leading to mild infection risk.
  • Mouth sores or oral mucositis.

Serious

  • Severe bone marrow suppression causing pancytopenia, which may require transfusion support.
  • Life‑threatening allergic reactions, including anaphylaxis and angioedema.
  • Significant liver toxicity manifested by markedly elevated transaminases or hepatitis.
  • Rare but serious cutaneous reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Renal impairment manifested by increased serum creatinine levels.

Precautions & Warnings

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

  • Pregnancy Category D: drug may cause fetal harm; avoid use unless benefits outweigh risks.
  • Monitor complete blood counts regularly to detect bone marrow suppression.
  • Assess liver function before initiation and periodically during therapy.
  • Use caution in patients with pre‑existing renal impairment; dose adjustments may be required.
  • Avoid in individuals with known hypersensitivity to hydroxycarbamide or its excipients.
  • Evaluate for potential teratogenic effects and advise effective contraception during treatment.
  • Consider risk of secondary malignancies with long‑term use; conduct appropriate surveillance.

Avoid Interactions

Hydroxycarbamide can interact with several medicines, affecting its efficacy or safety profile.

Avoid

  • Concurrent use with other myelosuppressive agents (e.g., azacitidine) due to additive bone marrow toxicity.
  • Co‑administration with allopurinol, which may increase hydroxycarbamide plasma levels.
  • Combining with live vaccines, as immunosuppression can reduce vaccine effectiveness.

Use with caution

  • Antacids containing aluminum or magnesium may reduce oral absorption; separate dosing by at least 2 hours.
  • NSAIDs (e.g., ibuprofen) may increase risk of gastrointestinal bleeding in the context of thrombocytopenia.
  • CYP2C9 substrates (e.g., warfarin) may have altered metabolism; monitor INR closely.
  • Drugs that affect renal function (e.g., ACE inhibitors) may require dose adjustment of hydroxycarbamide.

Frequently Asked Questions

Hydroxycarbamide is prescribed for sickle cell disease, chronic myelogenous leukemia, essential thrombocythemia, polycythemia vera, melanoma, and other myeloproliferative disorders.

It inhibits ribonucleotide reductase, reducing the pool of deoxyribonucleotides needed for DNA synthesis, which limits replication of rapidly dividing cells.

Regular complete blood counts, liver function tests, and renal function assessments are recommended to detect bone marrow suppression or organ toxicity.

Hydroxycarbamide is classified as pregnancy category D, indicating potential risk to the fetus; it should be avoided unless the benefit outweighs the risk.

Common adverse effects include nausea, vomiting, loss of appetite, fatigue, dizziness, mild skin rash, itching, photosensitivity, and leukopenia.

Serious reactions can include severe bone marrow suppression leading to pancytopenia, life‑threatening allergic reactions, significant liver toxicity, Stevens‑Johnson syndrome, renal impairment, and rare secondary malignancies.

Avoid concurrent use with other myelosuppressive agents, allopurinol, and live vaccines because of additive toxicity or reduced vaccine efficacy.

Use caution with antacids containing aluminum or magnesium, NSAIDs, CYP2C9 substrates such as warfarin, and drugs affecting renal function like ACE inhibitors.

Store tablets at room temperature, away from moisture and heat, and keep out of reach of children.

Patients with pre‑existing renal impairment may require dose adjustments and closer monitoring of renal function.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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