Generic
Hydroxyurea (Hydroxycarbamide)
2 brands available in the market
At a glance
Hydroxyurea (Hydroxycarbamide) is used in the treatment of cancer and sickle cell anemia.
Description
Hydroxyurea (Hydroxycarbamide) is a cytotoxic chemotherapy drug that prevents cancer cells from growing and multiplying. It blocks the enzyme ribonucleotide reductase, inhibiting DNA synthesis and causing cell death in S phase. In sickle cell anemia, it increases fetal hemoglobin (HbF) levels, helping RBCs maintain normal shape, improving blood flow and protecting against painful sickle cell episodes.
Indications
- 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)
Therapeutic class
Cytotoxic Chemotherapy
Pharmacological class
Antineoplastic Agent (Ribonucleotide Reductase Inhibitor)
Pharmacology
Hydroxyurea is converted to a free radical nitroxide (NO) in vivo and transported 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 is inactivated and DNA synthesis is selectively inhibited, producing cell death in S phase. Hydroxyurea also increases fetal hemoglobin levels, leading to a reduction in vasoocclusive crises in sickle cell anemia.
Mechanism of action
Blocks ribonucleotide reductase enzyme to inhibit DNA synthesis; increases fetal hemoglobin (HbF) levels in sickle cell anemia.
Dosage
Adult Dose (Oral):
- Polycythaemia Vera: 15-20 mg/kg once daily
- Essential Thrombocythemia: 15 mg/kg once daily
- Solid Tumors (Intermittent): 80 mg/kg every three days; (Continuous): 20-30 mg/kg once daily
- Head & Neck Tumors: 80 mg/kg every three days (7 days before irradiation)
- Chronic Myelocytic Leukemia: 20-40 mg/kg once daily
- Sickle Cell Disease: Start 15 mg/kg/day; titrate by 5 mg/kg/day every 12 weeks (max 35 mg/kg/day)
Administration
Take this medicine in the dose and duration as advised by your doctor; swallow it as a whole; do not chew, crush or break; may be taken with or without food, but better to take at a fixed time.
Missed dose
If you miss a dose, take it as soon as possible; if it is almost time for your next dose, skip the missed dose and go back to regular schedule; do not double the dose.
Side effects
Common Side Effects:
- Increased bleeding tendency
- Loss of appetite
- Low blood platelets
- Nausea
- Upset stomach
- Vomiting
- Diarrhea
- Sore mouth
Others: Fever, fatigue, chills, shortness of breath, body aches, unexplained bruising
Precautions & warnings
Precautions:
- Hydroxyurea may affect your ability to drive (drowsiness, dizziness)
- Causes severe myelosuppression; regular blood tests required (WBC, RBC, platelets)
- Long-term use associated with secondary leukemia and skin cancer
- Protect from sun exposure
- Embryo-fetal toxicity: can cause fetal harm in pregnant women
- Regular monitoring of kidney, liver and heart function
- May enhance toxicity with antiretroviral drugs
Contraindications
Contraindications:
- Previous hypersensitivity to hydroxyurea or any other component
Drug interactions
Hydroxyurea can enhance toxicity with antiretroviral drugs and may interfere with laboratory tests measuring uric acid, urea, or lactic acid levels.
Food interactions
Food Interactions: It is not known whether it is safe to consume alcohol with Hydroxyurea; consult your doctor.
Use in pregnancy
Use in Pregnancy: Category D; unsafe during pregnancy; animal studies show fetal harm; avoid becoming pregnant while being treated.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Excreted in human milk; discontinue breastfeeding due to potential for serious adverse reactions, including carcinogenicity.
Pediatric use
Safety and efficacy in pediatric patients have not been established.
Geriatric use
No specific dosage adjustment needed for elderly; however caution is advised.
Renal / hepatic impairment
Renal Impairment: Caution in kidney disease; dose adjustment may be needed; regular kidney function tests advised.
Hepatic Impairment: Caution in liver disease; dose adjustment may be needed; regular liver function tests advised.
Overdose effects
Overdose: Acute mucocutaneous toxicity (soreness, violet erythema, edema on palms and soles, severe hyperpigmentation, stomatitis) has been reported.
Storage conditions
Store at or below 25°C, in a cool and dry place; keep away from light; keep out of reach of children.
Chemical structure
Hydroxyurea (Hydroxycarbamide)