Hydroxyurea – Generic Drug Info

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Hydroxyurea

Cytotoxic Chemotherapy

Generic drug information & available brands

AI Summary Generated by AI for informational purposes only

This medicine is used to treat certain types of cancer and sickle cell anemia. It works by slowing or stopping the growth of cancer cells and helps prevent painful episodes in sickle cell disease. It is not safe to use during pregnancy or while breastfeeding.

Indications

Hydroxyurea is indicated for the treatment of:
  • Polycythaemia vera
  • Essential thrombocythemia
  • Sickle cell anemia
  • Resistant chronic myeloid leukemia
  • Locally advanced squamous cell carcinomas of the head and neck in combination with chemoradiation.

Pharmacology

Hydroxyurea is converted to a free radical nitroxide (NO) in vivo, and transported by diffusion into cells where it quenches the tyrosyl free radical at the active site of the M2 protein subunit of ribonucleotide reductase, inactivating the enzyme. The entire replicase complex, including ribonucleotide reductase, is inactivated and DNA synthesis is selectively inhibited, producing cell death in S phase and synchronization of the fraction of cells that survive. Repair of DNA damaged by chemicals or irradiation is also inhibited by hydroxyurea, offering potential synergy between hydroxyurea and radiation or alkylating agents. Hydroxyurea also increases the level of fetal hemoglobin, leading to a reduction in the incidence of vasoocclusive crises in sickle cell anemia. Levels of fetal hemoglobin increase in response to activation of soluble guanylyl cyclase (sGC) by hydroxyurea-derived NO.

Dosage & Administration

Important:
Do not take any medication without a doctor's prescription. Self-medication can be dangerous.
Polycythaemia Vera: Administer 15-20 mg/kg orally once daily.

Essential Thrombocythemia: Administer 15 mg/kg orally once daily.

Solid Tumors- Intermittent Therapy: Administer 80 mg/kg orally every three days. Continuous Therapy: Administer 20-30 mg/kg orally once daily (qDay)

Head & Neck Tumors: Start 80 mg/kg orally every three days (q3days) seven days before initiating irradiation.

Chronic Myelocytic Leukemia, Resistant: Administer 20-40 mg/kg orally once daily.

Sickle Cell Disease: Initiate at 15 mg/kg/day as a single dose; monitor blood cell counts every two weeks. Titrate by 5 mg/kg/day every 12 weeks, but do not exceed 35 mg/kg/day.

Interaction

Hydroxyurea can enhance toxicity when used alongside antiretroviral drugs and may also interfere with laboratory tests measuring uric acid, urea, or lactic acid levels.

Contraindications

Hydroxyurea is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

Side Effects

  • Fever
  • Feeling very tired
  • Chills
  • Shortness of breath
  • Body aches
  • Bleeding or unexplained bruising

Pregnancy & Lactation

Pregnancy category D. There are no adequate and well-controlled studies in pregnant women. There are potential risk to fetus and women should avoid becoming pregnant while being treated with hydroxyurea. It is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed infant from hydroxyurea, including carcinogenicity, patients should be discontinue breastfeeding during treatment with hydroxyurea.

Precautions & Warnings

Myelosuppression: Hydroxyurea causes severe myelosuppression. Treatment with hydroxyurea should not be initiated if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia is generally its first and most common manifestation. Some patients, treated at the recommended initial dose of 15 mg/kg/day, have experienced severe or life-threatening myelosuppression.

Malignancies: Hydroxyurea is a human carcinogen. In patients receiving long-term hydroxyurea for myeloproliferative disorders, secondary leukemia has been reported. Skin cancer has also been reported in patients receiving long-term hydroxyurea. Advise protection from sun exposure and monitor for the development of secondary malignancies.

Embryo-Fetal Toxicity: Based on the mechanism of action and findings in animals, Hydroxyurea can cause fetal harm when administered to a pregnant woman.

Use in Special Populations

Hydroxyurea can cause fetal harm based on findings from animal studies and the drug’s mechanism of action. There are no data with hydroxyurea use in pregnant women to inform a drug-associated risk. Hydroxyurea is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed infant from hydroxyurea, including carcinogenicity, discontinue breastfeeding during treatment with hydroxyurea.

Overdose Effects

Acute mucocutaneous toxicity has been reported in patients receiving hydroxyurea at dosages several times the therapeutic dose. Soreness, violet erythema, edema on palms and soles followed by scaling of hands and feet, severe generalized hyperpigmentation of the skin, and stomatitis have also been observed.

Storage Conditions

Store at or below 25°C, in a cool and dry place. Keep away from light. Keep out of the reach of children.

The information provided on this page is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before starting, stopping, or changing any medication. All brands listed might have copyright or trademark of their respective owners. Listed information may not be up-to-date or accurate. We do not guarantee the availability, quality, price or safety of any medication. Use at your own risk.

Available Brands

3 found
Brand Strength Type
500 mg Capsule 15.00
500 mg Capsule 18.00
500 mg Capsule 15.00
1–3 of 3