Product image of Hydreasyn (Hydroxycarbamide) supplied by GNH India

Hydreasyn

Active Ingredient:
Hydroxycarbamide
Origin:
EU

Hydreasyn (Hydroxycarbamide)

Hydreasyn is an oral prescription medication that contains the active ingredient hydroxycarbamide. It is marketed in the European Union and is supplied as tablets, although the specific strength is not disclosed in the available product information. Hydroxycarbamide belongs to the antimetabolite class and is used under medical supervision for several hematologic conditions. The drug is classified under ATC code L01XX02 and is intended for oral administration only.

Manufacturer / TM Owner

Farmasyn S.A.

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Indications & Clinical Uses

Hydreasyn is indicated for the management of several chronic blood disorders where reduction of abnormal cell proliferation is required.

  • Sickle cell disease, to reduce the frequency of painful vaso‑occlusive crises.
  • Chronic myelogenous leukemia (CML), as part of disease‑modifying therapy.
  • Polycythemia vera, to control elevated red‑cell mass.
  • Essential thrombocythemia, to lower platelet counts.
  • Off‑label use in certain myeloproliferative neoplasms under specialist supervision.

How It Works

  • Hydroxycarbamide inhibits the enzyme ribonucleotide reductase, which is essential for converting ribonucleotides to deoxyribonucleotides. By limiting the pool of deoxyribonucleotides, the drug decreases DNA synthesis and slows the replication of rapidly dividing cells, particularly abnormal hematopoietic cells. This antimetabolic action underlies its cytoreductive and antineoplastic effects in the indicated blood disorders. The inhibition is dose‑dependent and results in a reversible S‑phase cell‑cycle arrest, allowing normal marrow recovery while suppressing malignant clones.

Side Effects

Hydroxycarbamide may cause a range of adverse reactions, varying from mild to severe.

Common

  • Nausea, vomiting, or loss of appetite that may affect nutrition.
  • Skin hyperpigmentation, often appearing as a brownish discoloration on the palms, soles, or nails.
  • Mild, reversible reduction in white‑blood cell (leukocyte) counts, typically detected in routine labs.
  • Temporary thinning or loss of hair, which usually regrows after discontinuation.

Serious

  • Significant neutropenia or agranulocytosis, increasing susceptibility to bacterial and fungal infections.
  • Acute hemolytic episodes in individuals with glucose‑6‑phosphate dehydrogenase (G6PD) deficiency.
  • Development of pulmonary arterial hypertension, presenting with shortness of breath and fatigue.
  • Renal dysfunction manifested by rising serum creatinine or reduced glomerular filtration rate.

Precautions & Warnings

Because hydroxycarbamide affects blood cell production and DNA synthesis, several precautions should be observed before and during therapy.

  • Perform baseline and periodic complete blood counts to monitor for cytopenias.
  • Assess renal and hepatic function prior to initiation and at regular intervals.
  • Avoid use during pregnancy; the drug is classified as pregnancy category D and may cause fetal harm.
  • Counsel women of childbearing potential about effective contraception throughout treatment and for a defined period after discontinuation.
  • Use caution in patients with known G6PD deficiency due to risk of hemolysis.
  • Monitor for signs of pulmonary hypertension, such as unexplained dyspnea or edema.
  • Review any history of malignancies, as the drug may influence tumor dynamics.

Avoid Interactions

Hydroxycarbamide can interact with other medicines, altering its effectiveness or increasing toxicity.

Avoid

  • Concurrent use with strong CYP2C9 inhibitors (e.g., fluconazole) that may raise hydroxycarbamide plasma levels.
  • Co‑administration with other myelosuppressive agents (e.g., azacitidine, chemotherapy) that can exacerbate bone‑marrow suppression.
  • Combining with drugs that increase risk of hemolysis in G6PD‑deficient patients, such as primaquine.

Use with caution

  • Anticoagulants (e.g., warfarin) – hydroxycarbamide may affect INR; monitor clotting parameters.
  • Allopurinol or febuxostat – may increase risk of hypersensitivity reactions; observe for rash or fever.
  • Vaccines containing live attenuated organisms – immunosuppression may reduce vaccine efficacy; consider timing.
  • NSAIDs – may worsen renal function when used together; monitor kidney markers.

Frequently Asked Questions

The generic name of Hydreasyn is hydroxycarbamide.

In sickle cell disease, hydroxycarbamide increases fetal hemoglobin production, which reduces red‑cell sickling and the frequency of painful vaso‑occlusive episodes.

Hydroxycarbamide is commonly used for sickle cell disease, chronic myelogenous leukemia, polycythemia vera, and essential thrombocythemia.

Common side effects include nausea, skin hyperpigmentation, mild reductions in white‑blood cell counts, and temporary hair thinning.

Patients should have regular complete blood counts, renal and liver function tests, and periodic assessment for pulmonary hypertension or other serious complications.

Hydroxycarbamide is classified as pregnancy category D, indicating potential risk to the fetus; it should be avoided unless clearly needed and prescribed by a specialist.

Concurrent use with other myelosuppressive chemotherapy agents can increase bone‑marrow toxicity and should generally be avoided or closely monitored.

Baseline complete blood count, serum creatinine, liver enzymes, and assessment for G6PD deficiency are recommended before initiating therapy.

Hydroxycarbamide can cause a mild, reversible decrease in white‑blood cell (leukocyte) counts, which is monitored through regular blood tests.

The patient should contact their healthcare provider immediately; evaluation may include echocardiography and adjustment or discontinuation of the drug.

No specific dietary restrictions are required, but patients should maintain adequate nutrition and report any severe nausea or vomiting to their clinician.

Hair regrowth usually begins within a few weeks to months after discontinuation, though the exact timeline varies among individuals.

Published by

GNH India Pharmaceuticals Limited

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Last updated:

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