Product image of Hidroxicarbamida Hikma (Hydroxycarbamide) supplied by GNH India

Hidroxicarbamida Hikma

Active Ingredient:
Hydroxycarbamide
Origin:
EU

Hidroxicarbamida Hikma (Hydroxycarbamide)

Hidroxicarbamida Hikma is an oral prescription medication containing the active ingredient hydroxycarbamide. The product is supplied in an unspecified strength and dosage form and is marketed in the European Union. Hydroxycarbamide is an antineoplastic ribonucleotide reductase inhibitor used under medical supervision for selected myeloproliferative disorders and sickle cell disease, requiring regular monitoring of blood counts and organ function through periodic laboratory assessments and clinical review.

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Hidroxicarbamida Hikma is indicated for several hematologic and oncologic conditions where reduction of abnormal cell proliferation is required.

  • Sickle cell disease (to reduce vaso‑occlusive crises)
  • Polycythemia vera (to control elevated red blood cell mass)
  • Essential thrombocythemia (to lower platelet counts)
  • Chronic myelogenous leukemia (as part of disease‑modifying therapy)
  • Melanoma (in selected cases as adjunctive treatment)
  • Myelodysplastic syndromes (for patients with high‑risk disease)

How It Works

  • Hydroxycarbamide exerts its antineoplastic effect by binding to the M2 subunit of ribonucleotide reductase, the enzyme responsible for converting ribonucleotides to deoxyribonucleotides. Inhibition of this enzyme lowers intracellular deoxyribonucleotide pools, which slows DNA synthesis and limits the replication of rapidly dividing cells, including abnormal hematopoietic and malignant cells. The resulting cytoreduction underlies its therapeutic benefit in myeloproliferative disorders and sickle cell disease.

Side Effects

Adverse reactions to Hidroxicarbamida Hikma vary in frequency and severity.

Common

  • Nausea or vomiting
  • Abdominal pain or dyspepsia
  • Loss of appetite
  • Mild fatigue
  • Low white blood cell count (leukopenia)
  • Elevated liver enzymes

Serious

  • Severe neutropenia or agranulocytosis
  • Acute hemolytic crisis (especially in G6PD deficiency)
  • Renal impairment or failure
  • Severe skin reactions such as Stevens‑Johnson syndrome
  • Life‑threatening infection due to immunosuppression

Precautions & Warnings

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

  • Assess baseline complete blood count and liver and kidney function.
  • Avoid use in pregnant women; the drug is classified as pregnancy category D.
  • Use only when the benefits outweigh risks in patients with known G6PD deficiency.
  • Monitor blood counts regularly during therapy to detect cytopenias early.
  • Counsel patients on signs of infection, bleeding, or severe fatigue.
  • Adjust dose or discontinue if significant organ toxicity develops.
  • Ensure adequate hydration to reduce risk of renal complications.

Avoid Interactions

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

Avoid

  • Concurrent use with other myelosuppressive agents (e.g., chemotherapy, azathioprine) that may exacerbate bone‑marrow suppression.
  • Live vaccines, because immunosuppression can increase risk of infection.
  • Strong CYP2C9 inhibitors (e.g., fluconazole) that may raise hydroxycarbamide levels.

Use with caution

  • Allopurinol or febuxostat, which may increase risk of hypersensitivity reactions.
  • NSAIDs, as they can worsen gastrointestinal irritation.
  • Anticoagulants (e.g., warfarin), because altered platelet counts may affect bleeding risk.
  • Antiretroviral drugs metabolized by similar pathways, requiring monitoring.

Frequently Asked Questions

Hidroxicarbamida Hikma is an oral prescription drug that contains hydroxycarbamide, an antineoplastic agent used to treat certain blood disorders and sickle cell disease.

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

It is prescribed for sickle cell disease, polycythemia vera, essential thrombocythemia, chronic myelogenous leukemia, melanoma, and selected myelodysplastic syndromes.

Common adverse effects include nausea, abdominal discomfort, loss of appetite, mild fatigue, leukopenia, and mild elevations in liver enzymes.

Baseline complete blood count, liver and kidney function tests are recommended before therapy, followed by regular monitoring (often every 2–4 weeks) to detect cytopenias or organ toxicity.

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

Live vaccines are usually avoided because hydroxycarbamide can suppress the immune system, increasing the risk of vaccine‑derived infection.

Concurrent use with other myelosuppressive chemotherapy can intensify bone‑marrow suppression, so dose adjustments or close monitoring are required.

Contact a healthcare professional promptly; infections can progress quickly in immunosuppressed patients and may require temporary discontinuation of the drug.

Renal impairment has been reported, especially with dehydration; patients should stay well‑hydrated and have kidney function checked periodically.

No specific dietary restrictions are required, but avoiding excessive alcohol and maintaining adequate hydration can help reduce liver and kidney stress.

In the European Union, hydroxycarbamide is a prescription‑only medication (Rx) and is dispensed by a pharmacist after a qualified prescriber’s order.

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