Hydroxyurea (Hydroxycarbamide)

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Generic Name of Hydroxyurea (Hydroxycarbamide) - Learn More

Hydroxyurea (Hydroxycarbamide)

Hydroxyurea (Hydroxycarbamide) Precaution - What You Need to Know

Hydroxyurea (also known as hydroxycarbamide) is an antineoplastic agent used primarily for the treatment of certain cancers and chronic conditions like sickle cell anemia. Despite its therapeutic benefits, there are important precautions for its use.

- Pregnancy and breastfeeding: Hydroxyurea is classified as a pregnancy category D drug, which means it has been shown to cause fetal harm and should be avoided during pregnancy unless absolutely necessary. It can cause birth defects, and its use is contraindicated during the first trimester. If the medication is deemed essential, pregnancy should be avoided during treatment, and proper contraception should be used. Hydroxyurea is excreted in breast milk, and breastfeeding is generally not recommended while using this drug due to the potential risks to the infant.

- Pre-existing conditions: Caution is advised in patients with pre-existing kidney or liver disease, as hydroxyurea is metabolized by the liver and excreted through the kidneys. It may require dose adjustments and frequent monitoring in patients with these conditions. Additionally, hydroxyurea can suppress bone marrow function, leading to decreased blood cell counts, and may cause anemia, neutropenia, and thrombocytopenia. Blood cell counts should be monitored regularly during treatment.

- Carcinogenic potential: Hydroxyurea has been associated with an increased risk of secondary malignancies, such as leukemia, especially in long-term use. It is important to balance the benefits of therapy with the potential risks of cancer development. Regular screening for secondary cancers is recommended for long-term users.

- Monitoring parameters: Patients using hydroxyurea should undergo routine blood tests, including complete blood count (CBC) to monitor for bone marrow suppression. Kidney and liver function should be monitored regularly to assess drug safety. Patients should also be monitored for any signs of skin reactions, such as rashes or ulcers.

Hydroxyurea (Hydroxycarbamide) Indication - Uses and Benefits

Hydroxyurea is used for the treatment of several medical conditions, particularly those associated with blood disorders and cancer.

- FDA-approved indications:
- Chronic myelogenous leukemia (CML): Hydroxyurea is used to manage chronic phase CML by reducing excessive white blood cell production.
- Polycythemia vera: This condition involves an overproduction of red blood cells, and hydroxyurea is used to reduce blood viscosity and lower the risk of thrombosis.
- Sickle cell anemia: Hydroxyurea has shown benefit in patients with sickle cell disease by increasing fetal hemoglobin levels, reducing painful crises, and improving overall quality of life.
- Essential thrombocythemia: It is used in some cases of this condition to lower high platelet counts.

- Off-label uses:
- Ovarian cancer: Hydroxyurea is sometimes used in the treatment of ovarian cancer, often in combination with other chemotherapy agents.
- Cervical cancer: Similarly, hydroxyurea is sometimes used as part of a regimen for cervical cancer.
- HIV-related Kaposi’s sarcoma: In some cases, hydroxyurea has been used off-label for treating Kaposi’s sarcoma, a cancer often seen in immunocompromised individuals, such as those with HIV.

- Evidence-based context: Clinical studies have supported the use of hydroxyurea in various hematologic and oncologic conditions, particularly in sickle cell disease and polycythemia vera. Its use in sickle cell disease has significantly reduced morbidity and hospitalizations, and it has been shown to reduce the frequency of painful episodes in these patients.

Hydroxyurea (Hydroxycarbamide) Contraindications - Important Warnings

Hydroxyurea is contraindicated in certain medical conditions due to potential risks.

- Hypersensitivity: Hydroxyurea is contraindicated in patients with a known hypersensitivity or allergy to the drug or any of its components. An allergic reaction could lead to serious side effects, such as skin rashes, difficulty breathing, or anaphylaxis.

- Severe bone marrow suppression: Hydroxyurea is contraindicated in patients with significant bone marrow suppression, as the drug further depresses hematopoiesis. Conditions like neutropenia, thrombocytopenia, or anemia are considered contraindications.

- Severe renal or hepatic impairment: In cases of severe renal or hepatic impairment, hydroxyurea should generally be avoided, as it may worsen kidney or liver function. Adjustments to the dosage may be necessary in patients with mild to moderate liver or kidney dysfunction, but hydroxyurea should not be used in severe cases without careful monitoring.

- Pregnancy: Hydroxyurea is contraindicated during pregnancy due to its teratogenic effects, especially during the first trimester. As it may cause fetal harm, it should only be used if absolutely necessary and with a discussion of potential risks to the pregnancy.

Hydroxyurea (Hydroxycarbamide) Side Effects - What to Expect

Hydroxyurea, like other chemotherapy agents, can cause a range of side effects. These side effects can vary from mild to severe.

- Common side effects:
- Bone marrow suppression: This is one of the most common and significant side effects, leading to low white blood cell counts (neutropenia), low red blood cells (anemia), and low platelet counts (thrombocytopenia). Regular blood tests are essential to monitor bone marrow function.
- Gastrointestinal effects: Nausea, vomiting, diarrhea, and loss of appetite are common, especially at higher doses.
- Skin reactions: Rash, pigmentation changes, or skin ulcers may develop in some patients.

- Serious side effects:
- Severe bone marrow toxicity: This can lead to life-threatening infections, bleeding, or anemia. It requires close monitoring and dose adjustments based on blood counts.
- Liver toxicity: Liver enzyme elevations may occur in some patients, and hepatotoxicity can be severe. Monitoring liver function is essential.
- Secondary malignancies: Long-term use of hydroxyurea has been associated with an increased risk of secondary cancers, including leukemia and other malignancies. This risk should be discussed with patients, particularly those receiving hydroxyurea as part of long-term treatment.
- Teratogenic effects: Hydroxyurea can cause birth defects and should not be used during pregnancy.

- Mitigation and management: Regular blood count monitoring is crucial to detect bone marrow suppression early. Liver and kidney function should also be tested regularly. If severe bone marrow suppression or liver toxicity occurs, dose reduction or discontinuation of the drug may be necessary.

Hydroxyurea (Hydroxycarbamide) Pregnancy Category ID - Safety Information

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Hydroxyurea (Hydroxycarbamide) Mode of Action - How It Works

Hydroxyurea is an antineoplastic and immunosuppressive agent that works by inhibiting DNA synthesis and cell division, which is why it is effective in both cancer therapy and in the management of sickle cell disease.

- Mechanism of action in cancer: Hydroxyurea exerts its antineoplastic effects by inhibiting ribonucleotide reductase, an enzyme that is crucial for the synthesis of deoxyribonucleotides. This inhibition disrupts DNA synthesis, ultimately causing cell death, particularly in rapidly dividing cancer cells. It is particularly effective in diseases like chronic myelogenous leukemia, where abnormal white blood cell proliferation occurs.

- Mechanism of action in sickle cell anemia: In patients with sickle cell anemia, hydroxyurea increases the production of fetal hemoglobin (HbF). HbF is known to reduce the sickling of red blood cells, thus preventing vaso-occlusive crises and improving blood flow. Additionally, it reduces the adhesion of sickled red blood cells to blood vessel walls, further improving circulation.

- Pharmacokinetics: Hydroxyurea is well absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 1-4 hours. It has a long half-life, which allows for once-daily dosing in most cases. The drug is metabolized in the liver and excreted via the kidneys.

Hydroxyurea (Hydroxycarbamide) Drug Interactions - What to Avoid

Hydroxyurea interacts with several drugs, and these interactions can alter the efficacy of hydroxyurea or increase the risk of adverse effects.

- Drug-drug interactions:
- Chemotherapeutic agents: Hydroxyurea can interact with other chemotherapy agents, potentially increasing the risk of toxicity or bone marrow suppression. For example, using hydroxyurea with cytotoxic agents like methotrexate can increase the risk of severe neutropenia and thrombocytopenia.
- Antiretroviral drugs: When used with certain antiretroviral agents for HIV, the combined use with hydroxyurea may increase toxicity. Specific interactions with drugs like zidovudine have been noted, and patients should be monitored closely.
- Gout medications: Hydroxyurea can affect uric acid levels and may interact with medications used to treat gout, such as allopurinol. Hydroxyurea’s effect on uric acid metabolism can increase the risk of gout flares in some patients.

- Food interactions: There are no significant food interactions with hydroxyurea, but taking it with food may reduce gastrointestinal irritation.

- Alcohol: Alcohol does not have a direct interaction with hydroxyurea, but patients should be cautious of potential liver toxicity, especially when hydroxyurea is combined with other hepatotoxic agents. Alcohol can exacerbate liver damage, and regular liver function tests are recommended.

Hydroxyurea (Hydroxycarbamide) Adult Dose - Recommended Dosage

The dosing of hydroxyurea depends on the condition being treated.

- Chronic myelogenous leukemia: The usual starting dose for CML is 15 mg/kg daily, which may be adjusted based on patient response and tolerance. Dosing can be adjusted upward to achieve therapeutic effects while monitoring for bone marrow suppression.
- Polycythemia vera: The recommended starting dose for polycythemia vera is typically 500-1000 mg daily, with dose adjustments made based on clinical response.
- Sickle cell anemia: For sickle cell disease, the usual dose is 15 mg/kg/day, with adjustments based on response and side effects. The maximum recommended dose is generally 35 mg/kg/day.

Hydroxyurea (Hydroxycarbamide) Child Dose - Dosage for Children

Hydroxyurea dosing in children is based on weight.

- Sickle cell anemia: The usual pediatric dose for sickle cell disease is 20 mg/kg/day, not exceeding 35 mg/kg/day. Regular blood counts should be monitored for any signs of bone marrow suppression.
- Cancer treatment: Dosing for pediatric patients with cancer will vary depending on the specific condition and therapeutic regimen, and it is usually based on body surface area or weight.

Hydroxyurea (Hydroxycarbamide) Renal Dose - Dosage for Kidney Conditions

Hydroxyurea is primarily excreted by the kidneys, so dose adjustments may be needed in patients with renal impairment.

- Renal considerations: In patients with moderate to severe renal impairment (e.g., CrCl < 30 mL/min), the dose of hydroxyurea should be reduced to avoid drug accumulation and toxicity. Close monitoring of renal function is essential.