Hydroxyurea

About Hydroxyurea

• Hydroxyurea stands as a versatile and multifunctional drug with a longstanding history of use in the United States. 
• Initially approved in 1967 as an antineoplastic medication, it demonstrated efficacy in treating various cancers, including melanoma, ovarian cancer, and notably, chronic myeloid leukemia (CML). 
• With its diverse applications, Hydrea, classified as an antimetabolite, finds indication for the treatment of resistant chronic myeloid leukemia and locally advanced squamous cell carcinomas affecting the head and neck (excluding the lip) when used in conjunction with concurrent chemoradiation. 
• The drug’s approval and continued use highlight its enduring significance in the medical field. 
• Hydroxycarbamide reduces the generation of deoxyribonucleotides by inhibiting the enzyme ribonucleotide reductase. 
• This inhibition occurs through the scavenging of tyrosyl free radicals, which play a role in the reduction of nucleoside diphosphates (NDPs).

Strength: 

Hydroxyurea capsules are available in strengths of 500 mg.

Recommended Dosage:

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Hydroxyurea is usually taken once per day at the same time of day, with or without food. Swallow the pill whole with a glass of water.

Hydrea is employed either as a standalone treatment or in combination with other antitumor agents or radiation therapy to address neoplastic diseases. Regular monitoring for myelosuppression and cutaneous vasculitis is crucial, and the dose of Hydrea may need to be reduced or discontinued accordingly. Blood counts should be monitored at least weekly during Hydrea therapy, with the correction of severe anemia required before initiating treatment. Considerations for dose modifications should also be made for other potential toxicities. Prophylactic administration of folic acid is recommended in conjunction with Hydrea.

• Tailor the treatment approach by considering factors such as tumor type, disease status, response to treatment, patient risk factors, and prevailing clinical practice standards.
• In cases of renal impairment, it is advisable to decrease the Hydrea dose by 50% for patients with a creatinine clearance of less than 60 mL/min.

Important:

It is vital to uphold precise adherence to prescribed Hydroxyurea protocols to ensure effective treatment. Healthcare providers should consistently monitor and promptly manage any potential adverse reactions. Conducting regular follow-up assessments and maintaining transparent communication contribute to a responsible and efficient treatment approach. Before initiating treatment, it is imperative to inform your doctor about any pre-existing conditions to proactively address the possibility of adverse effects.

Warnings & Precaution:

• Do not take Hydroxyurea because it should be avoided in individuals who have previously shown hypersensitivity to hydroxyurea or any other component present in its formulation.
• Hydrea should be avoided in cases of significant bone marrow function impairment to prevent myelosuppression. Routine monitoring of hematology labs is crucial, with adjustments to the dose or treatment interruption as necessary. Additionally, individuals should be advised on sun protection and closely monitored for the potential development of secondary malignancies. A clear understanding of the embryo-fetal toxicity is essential, emphasizing the risk to a developing fetus and advocating for the use of effective contraception. If vasculitic toxicities occur, immediate discontinuation of Hydrea is recommended, and appropriate treatment should be initiated. Caution should be exercised when considering live vaccinations for patients on Hydrea. Furthermore, individuals with HIV infection using antiretroviral drugs should be closely monitored for signs of pancreatitis, hepatotoxicity, and neuropathy. In case of symptoms, discontinuation of Hydrea is advised, followed by the implementation of appropriate treatment. For patients with a history of radiation therapy, monitoring for skin erythema is essential, and any symptoms should be managed accordingly.

Common Hydroxyurea Side Effects:

• Hematological, gastrointestinal symptoms
• Anorexia
• Loss of appetite
• Nausea
• Constipation
• Diarrhea
• Low blood cell counts
• Bleeding
• Mouth sores

Use in Specific Population

• Hydrea poses a risk of fetal harm, as evidenced by animal studies and the drug’s mechanism of action. Due to the potential for serious adverse reactions, including carcinogenicity, Hydrea should not be used during breastfeeding; breastfeeding should be discontinued during treatment. Prior to initiating Hydrea therapy, it is essential to confirm the pregnancy status of females of reproductive potential.
• For females of reproductive potential, effective contraception is advised during and for at least 6 months after Hydrea therapy. Immediate reporting of pregnancy is recommended. 
• In males, Hydrea may damage spermatozoa and testicular tissue, potentially leading to genetic abnormalities. Male patients with female partners of reproductive potential should use effective contraception during and for at least 1 year after Hydrea therapy. 
• Sperm conservation options should be discussed before initiating therapy, as azoospermia or oligospermia, though sometimes reversible, has been observed in men.

• The safety and efficacy of Hydroxyurea in pediatric patients are yet to be established, and caution is warranted in elderly patients who may be more sensitive to its effects. 
• Elderly patients, particularly those with impaired renal function, should be carefully monitored, and dosage adjustments may be necessary. 
• While there is no specific guidance for dosage adjustment in patients with hepatic impairment, close monitoring of hematologic parameters is advised.

Storage and Handling

• Store Hydroxyurea capsules in a dry location at the temperature of 25°C (77°F), ensuring the container is tightly closed. 
• Excursions within the range of 15°C to 30°C (59°F to 86°F) are permitted.
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.