Introduction
Hydrea 500 mg (Hydroxyurea) Capsule is a well-established antineoplastic agent used to manage a variety of hematologic malignancies and genetic blood disorders. Manufactured by Everest Pharmaceuticals Ltd., a WHO-GMP-compliant pharmaceutical company, and supplied globally by Onco Solution, Hydrea offers effective disease control by inhibiting DNA synthesis and increasing fetal hemoglobin production. It plays a critical role in treating polycythemia vera, essential thrombocythemia, sickle cell anemia, and resistant chronic myeloid leukemia (CML), as well as locally advanced squamous cell carcinomas when used in combination with chemoradiation.
Key Benefits and Mechanism of Action
Hydrea 500 mg (Hydroxyurea) works through two core mechanisms that help manage both cancer progression and sickle cell-related complications.
DNA Synthesis Inhibition
Hydroxyurea enters cells and deactivates ribonucleotide reductase, an enzyme essential for DNA replication. This disruption halts cancer cell division during the S-phase, leading to targeted cancer cell death.
Fetal Hemoglobin Induction
In patients with sickle cell disease, Hydrea increases levels of fetal hemoglobin (HbF), which reduces the sickling of red blood cells and decreases the frequency of painful vaso-occlusive crises.
Radiation Sensitization
Hydroxyurea enhances the effects of radiotherapy by impairing cancer cells’ ability to repair DNA damage, making it effective in combination treatment for head and neck cancers.
Indications
Hydrea 500 mg is indicated for the treatment of:
- Polycythemia Vera
- Essential Thrombocythemia
- Sickle Cell Anemia
- Resistant Chronic Myeloid Leukemia (CML)
- Locally Advanced Squamous Cell Carcinoma of the Head and Neck (with chemoradiation)
Dosage and Administration
Dosing must be customized by the physician based on diagnosis, response to therapy, and patient tolerance.
- Polycythemia Vera and Essential Thrombocythemia: 15 to 20 mg/kg orally once daily
- Chronic Myeloid Leukemia (resistant): 20 to 40 mg/kg orally once daily
- Sickle Cell Anemia: Start with 15 mg/kg/day; titrate every 12 weeks by 5 mg/kg/day as needed (not to exceed 35 mg/kg/day)
- Solid Tumors – Intermittent Therapy: 80 mg/kg orally every 3 days
- Solid Tumors – Continuous Therapy: 20 to 30 mg/kg orally once daily
- Head and Neck Cancer: 80 mg/kg orally every 3 days starting 7 days before radiation therapy
Patients should take the capsule with a full glass of water and maintain regular blood count monitoring throughout therapy.
Pharmacology
Hydroxyurea is metabolized to nitric oxide (NO) in vivo. It inhibits the activity of ribonucleotide reductase by quenching the tyrosyl radical at the active site of the M2 subunit. This leads to suppression of DNA synthesis and S-phase cell cycle arrest.
Additionally, Hydroxyurea enhances fetal hemoglobin production through activation of soluble guanylyl cyclase, especially beneficial in sickle cell disease.
It also impairs DNA repair mechanisms, providing a synergistic effect when used with radiation therapy or alkylating agents.
Contraindications
- Known hypersensitivity to Hydroxyurea or any component of the formulation
- Severe bone marrow suppression
- Pregnancy and lactation due to risk of fetal harm and adverse reactions in breastfed infants
Drug Interactions
Hydrea may interact with several drugs, requiring careful monitoring:
- In combination with antiretroviral drugs, Hydrea may increase hematologic toxicity
- May interfere with laboratory test results, especially for uric acid, urea, or lactic acid
- Other cytotoxic or bone marrow-suppressing agents may increase the risk of severe myelosuppression
Side Effects
Common side effects include:
- Fatigue, fever, chills
- Gastrointestinal disturbances (nausea, vomiting, diarrhea)
- Skin changes such as rash or hyperpigmentation
- Mouth ulcers
- Hair thinning
Serious adverse effects:
- Myelosuppression, including leukopenia, thrombocytopenia, and anemia
- Secondary malignancies such as leukemia or skin cancer with long-term use
- Pulmonary toxicity and skin ulcers (less common)
Regular monitoring of complete blood counts and liver/kidney function is essential.
Precautions and Warnings
- Hydrea causes bone marrow suppression. Treatment should not begin in patients with significantly low blood counts.
- Hydrea is classified as a human carcinogen. Prolonged use may increase the risk of developing secondary malignancies, including leukemia and skin cancer.
- Patients should be advised to avoid sun exposure and use sun protection.
- Embryo-fetal toxicity is a concern; effective contraception is necessary during treatment.
- Breastfeeding should be discontinued during treatment due to the drug’s presence in breast milk and potential for carcinogenicity.
Use in Special Populations
Pregnant Women: Contraindicated due to potential fetal harm.
Lactating Mothers: Breastfeeding is not recommended during treatment.
Geriatric Patients: May be more susceptible to side effects; monitor closely.
Patients with Renal or Hepatic Impairment: May require dosage adjustments.
Overdose Management
There is no specific antidote for Hydroxyurea overdose. Symptoms may include:
- Severe mucocutaneous toxicity
- Painful redness and swelling of the palms and soles
- Skin peeling and darkened pigmentation
- Stomatitis
In the event of an overdose, discontinue treatment and initiate symptomatic and supportive care.
Storage and Handling
- Store below 25°C in a cool, dry place
- Keep in original packaging to protect from light and moisture
- Keep out of reach of children
Manufacturer Information
Hydrea 500 mg (Hydroxyurea) Capsule is manufactured by Everest Pharmaceuticals Ltd., a globally recognized pharmaceutical company based in Bangladesh. With WHO-GMP certification and a strong reputation for producing high-quality oncology medicines, Everest maintains the highest manufacturing standards.
Learn more: www.everestpharmabd.com
Supplier Profile
Onco Solution is a trusted global supplier of oncology medicines, providing timely and compliant access to essential cancer therapies across more than 50 countries. As the supplier of Hydrea 500 mg, Onco Solution offers:
- Bulk procurement solutions for hospitals, clinics, and distributors
- End-to-end cold-chain logistics and global delivery
- Access to dosing and usage guidelines through www.oncosolution.com
Conclusion
Hydrea 500 mg (Hydroxyurea) Capsule remains a vital therapy in the management of chronic myeloproliferative diseases and sickle cell anemia. With its dual action in suppressing tumor growth and boosting fetal hemoglobin, Hydrea continues to be a mainstay in hematologic and oncologic treatment plans. Manufactured by Everest Pharmaceuticals Ltd. and distributed worldwide by Onco Solution, this medicine reflects a commitment to quality and global cancer care access.
