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Hydroxyurea

    Brands

    DEA Class; Rx

    Common Brand Names; Droxia, Siklos, hydroxycarbamide, Hydrea

    • Antineoplastics, Antimetabolite

    Oral antimetabolite
    Used for resistant chronic myelogenous leukemia, locally advanced squamous cell carcinomas of head and neck, and to reduce frequency of painful crises and blood transfusions in sickle cell anemia
    Associated with severe myelosuppression

    Indicated for the treatment of resistant chronic myelogenous leukemia (CML).

    For the treatment of locally advanced squamous cell head and neck cancer (excluding the lip) in combination with chemoradiation therapy.
    For the treatment of sickle cell disease to reduce the frequency of painful crises and need for blood transfusions in persons with recurrent moderate to severe painful crises.
    For the treatment of acute myelogenous leukemia (AML).
    For the treatment of advanced non-small cell lung cancer (NSCLC), in combination with chemotherapy.
    For the treatment of polycythemia vera.
    For the prevention of thrombosis in patients with essential thrombocytosis.
    For the treatment of psoriasis.
    For the adjuvant treatment of high-grade malignant glioma, as part of the 8-in-1 regimen.

    Hypersensitivity

    Severe anemia, bone marrow depression

    WBC <2500/mm³, platelets <100,000/mm³

    Pregnancy, lactation

    • Infections (39.8%)
    • Other infections (22.7%)
    • Bacterial infections (16%)
    • Gastrointestinal disorders (13.1%)
    • Neutropenia (12.6%)
    • Viral infections (9.9%)
    • Fever (7.7%)
    • Thrombocytopenia (7.4%)
    • Other gastrointestinal disorders (7.4%)
    • Headache (7.4%)
    • Vitamin D deficiency (6.2%)
    • Other not SCD-related reactions (5.7%)
    • Anemia (4.2%) Skin reactions (3.7%)
    • Parvovirus B19 infections (3.7%)
    • Other skin and subcutaneous tissue disorders (3.2%)
    • Other nervous system disorders (2.7%)
    • Respiratory thoracic and mediastinal disorders (2.7%)
    • Constipation (2.5%)
    • Nausea (2.5%)
    • Other metabolic and nutrition disorders (2%)
    • Weight gain (2%)
    • Renal and urinary disorders (2%)

    Risk of cutaneous vasculitic toxicities in patients with myeloproliferative disorders, especially with history of or concurrent interferon therapy; avoid use in patients with wounds on the legs (leg ulcers)

    Erythrocyte abnormalities reported; self-limiting megaloblastic erythropoiesis reported early in treatment, unrelated to vitamin B12 or folic acid deficiency

    Hyperuricemia may occur; adequate hydration, dosage adjustment, or initiation of uricosuric agents may be necessary

    Interferes with analytical analyses of the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid and lactic acid, rendering falsely elevated results

    Macrocytosis is often seen early in the course of treatment; morphologic change resembles pernicious anemia, but is not related to vitamin B12 or folic acid deficiency; prophylactic folic acid is recommended

    Skin cancer reported in patients receiving long-term therapy; advise protection from sun exposure and monitor for development of secondary malignancies

    Fetal harm may occur when hydroxyurea is administered to a pregnant woman (see Pregnancy)

    There are no studies with the use in pregnant females

    Not recommended during treatment

    Adults

    80 mg/kg PO.

    Geriatric

    80 mg/kg PO.

    Adolescents

    35 mg/kg/day PO for sickle cell disease. Safety and efficacy have not been established for other indications; doses up to 3,000 mg/m2 PO have been given off-label for malignant glioma.

    Children

    2 to 12 years: 35 mg/kg/day PO for sickle cell disease. Safety and efficacy have not been established for other indications; doses up to 3,000 mg/m2 PO have been given off-label for malignant glioma.
    1 year: Safety and efficacy have not been established; doses up to 3,000 mg/m2 PO have been given off-label for malignant glioma.

    Hydroxyurea

    capsule

    • 200mg (Droxia)
    • 300mg (Droxia)
    • 400mg (Droxia)
    • 500mg (Hydrea, generic)

    tablet

    • 100mg (Siklos)
    • 1000mg (tripled-scored) (Siklos)