Hydrea: Precision Chemotherapy for Chronic Myeloproliferative Disorders
| Product dosage: 500mg | |||
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Synonyms | |||
Hydrea (hydroxyurea) is an oral chemotherapeutic agent specifically formulated for the management of certain chronic blood disorders and solid tumors. As an antimetabolite, it exerts its therapeutic effects by inhibiting ribonucleotide reductase, a key enzyme in DNA synthesis, thereby selectively targeting rapidly dividing cells. This mechanism allows for precise control over abnormal cell proliferation, making it a cornerstone in the treatment of conditions like chronic myeloid leukemia, sickle cell anemia, and essential thrombocythemia. Its well-established efficacy and manageable safety profile have cemented its role in both adult and pediatric hematology-oncology practice.
Features
- Active Ingredient: Hydroxyurea
- Available Strengths: 500 mg capsules
- Administration: Oral
- Pharmacologic Class: Antimetabolite, ribonucleotide reductase inhibitor
- Bioavailability: Rapid and nearly complete absorption from the gastrointestinal tract
- Half-life: Approximately 3–4 hours
- Metabolism: Hepatic; partially metabolized to urea
- Excretion: Primarily renal (approx. 50% unchanged)
- Manufacturing Standards: Produced under current Good Manufacturing Practices (cGMP)
Benefits
- Effectively reduces elevated white blood cell, platelet, and red blood cell counts in myeloproliferative disorders
- Decreases frequency of painful vaso-occlusive crises in sickle cell disease by elevating fetal hemoglobin levels
- Offers oral convenience compared to intravenous chemotherapies, supporting outpatient management
- Demonstrates selective cytotoxicity toward malignant cells while sparing most normal tissues
- Provides predictable dose-response relationship allowing for tailored therapeutic regimens
- Established long-term safety data across multiple patient populations
Common use
Hydrea is primarily indicated for the treatment of chronic myelogenous leukemia (CML), particularly in the chronic phase when patients cannot tolerate or have failed interferon therapy. It is also widely used in polycythemia vera to control erythrocytosis and thrombocytosis, and in essential thrombocythemia to reduce thrombotic risk associated with extreme thrombocytosis. In sickle cell disease, Hydrea is prescribed to reduce the frequency of painful crises and the need for blood transfusions. Off-label uses include combination therapy with radiation for cervical cancer and treatment of certain resistant psoriasis forms.
Dosage and direction
Dosage must be individualized based on patient diagnosis, hematological parameters, and tolerance. For solid tumors: 80 mg/kg as a single dose every third day, or 20-30 mg/kg daily. For resistant sickle cell anemia: Initial dose of 15 mg/kg/day, increased by 5 mg/kg/day every 12 weeks to maximum of 35 mg/kg/day. For leukemia: 20-30 mg/kg/day as a single daily dose. Capsules should be swallowed whole with water; if unable to swallow whole, contents may be emptied into water and consumed immediately. Regular monitoring of complete blood counts is essential, with dosage adjustments based on hematological response.
Precautions
Hydrea is a potent cytotoxic agent that requires careful handling. Healthcare providers should wear gloves when handling bottles or capsules. Patients should be advised to wash hands after contact with capsules or urine. Hydrea may cause bone marrow suppression; complete blood counts should be monitored weekly during initial therapy and periodically thereafter. Use with caution in patients with renal impairment as excretion is primarily renal. Hydrea may impair fertility in both males and females. Patients should avoid vaccination with live vaccines during treatment. Pregnancy should be avoided during treatment and for at least 6 months after discontinuation.
Contraindications
Hydrea is contraindicated in patients with severe bone marrow depression evidenced by leukopenia (<2500 WBC/mm³), thrombocytopenia (<100,000/mm³), or severe anemia. It should not be used in patients with hypersensitivity to hydroxyurea or any component of the formulation. The drug is contraindicated in women who are pregnant or breastfeeding due to potential fetal harm. Patients with severe renal impairment (creatinine clearance <30 mL/min) should not receive Hydrea without careful risk-benefit assessment and dose adjustment.
Possible side effect
- Hematologic: Myelosuppression (leukopenia, anemia, thrombocytopenia), megaloblastic erythropoiesis
- Gastrointestinal: Nausea, vomiting, diarrhea, constipation, stomatitis, anorexia
- Dermatologic: Maculopapular rash, facial erythema, dry skin, nail discoloration, alopecia
- Neurological: Headache, dizziness, drowsiness, disorientation
- Other: Fever, chills, malaise, elevated hepatic enzymes, renal impairment
- Serious but rare: Pulmonary fibrosis, hepatotoxicity, vasculitic ulcerations, secondary malignancies
Drug interaction
Hydrea interacts with several medications requiring careful monitoring. Concurrent use with other myelosuppressive agents (e.g., azathioprine, cladribine) may potentiate bone marrow suppression. Live vaccines should be avoided due to potential for enhanced replication of vaccine virus. Hydrea may enhance the toxicity of antiretroviral drugs like didanosine and stavudine. Drugs that affect renal function (e.g., NSAIDs, aminoglycosides) may alter Hydrea excretion. Radiation therapy may be potentiated when administered concurrently with Hydrea.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should never take a double dose to make up for a missed one. If multiple doses are missed, patients should contact their healthcare provider for guidance on resuming therapy. Consistent dosing is important for maintaining therapeutic effect, particularly in sickle cell disease management.
Overdose
Acute overdose may manifest as exacerbation of adverse effects, particularly myelosuppression, mucositis, nausea, vomiting, and diarrhea. Management is primarily supportive and should include hospitalization for close monitoring. Hematologic parameters should be monitored daily until recovery occurs. Hemodialysis may be considered in severe cases as Hydrea is partially dialyzable. There is no specific antidote for Hydrea overdose. Treatment should include transfusion support for significant cytopenias and aggressive management of mucositis and gastrointestinal symptoms.
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep container tightly closed and protect from moisture. Dispense in original container with child-resistant closure. Keep out of reach of children and pets. Do not use if capsules are discolored or show signs of deterioration. Properly dispose of any unused medication after expiration date or treatment completion according to local regulations for cytotoxic drugs.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Hydrea is a prescription medication that should only be used under the supervision of a qualified healthcare professional. Treatment decisions should be based on individual patient characteristics and professional medical judgment. Patients should consult their healthcare provider for complete prescribing information and personalized medical advice. The manufacturer and distributor are not liable for any outcomes resulting from the use or misuse of this information.
Reviews
Clinical studies have demonstrated Hydrea’s efficacy across multiple indications. In chronic myeloid leukemia, response rates of 50-80% have been reported for hematological remission. For sickle cell disease, the Multicenter Study of Hydroxyurea showed a 44% reduction in painful crises and reduced need for transfusions. In polycythemia vera, Hydrea effectively controls hematocrit in >80% of patients. Most reviews note predictable myelosuppression as the primary limitation, but overall describe favorable benefit-risk profile compared to alternative therapies. Long-term follow-up studies confirm maintained efficacy with appropriate monitoring.