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Droxia Generic Name & Formulations
Legal Class
Rx
General Description
Hydroxyurea 200mg, 300mg, 400mg; caps.
Pharmacological Class
Antimetabolite.
How Supplied
Caps—60
Manufacturer
Generic Availability
NO
Droxia Indications
Indications
To reduce the frequency of painful crises and to reduce the need for blood transfusions in adults with sickle cell anemia with recurrent moderate to severe painful crises.
Droxia Dosage and Administration
Adult
Base dose on ideal or actual weight, whichever is less. Initially 15mg/kg/day as a single dose. May increase dose by 5mg/kg/day every 12 weeks to maximum tolerated dose or 35mg/kg/day achieved; do not increase dose if blood counts are between acceptable and toxic range. If blood counts toxic, discontinue until hematologic recovery, see full labeling for dosage adjustments. Renal impairment (CrCl <60mL/min or ESRD): initially 7.5mg/kg/day; give dose following dialysis (monitor).
Children
Not established.
Droxia Contraindications
Not Applicable
Droxia Boxed Warnings
Boxed Warning
Myelosuppression. Malignancies.
Droxia Warnings/Precautions
Warnings/Precautions
Risk of severe myelosuppression. Markedly depressed bone marrow function: do not initiate. Monitor CBCs prior to and during therapy; interrupt, reduce dose, or discontinue as needed. Hemolytic anemia. Monitor for secondary malignancies (eg, leukemia, skin cancer). Avoid sun exposure. Macrocytosis may mask folic acid deficiency; prophylactic folic acid is recommended. Pulmonary toxicity. Myeloproliferative disorders; discontinue if cutaneous vasculitic ulcerations occur. Obtain fetal hemoglobin (HbF) levels every 3–4 months; may be used to assess efficacy. Renal or hepatic impairment. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or ≥1 year (males) after therapy. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.
Droxia Pharmacokinetics
See Literature
Droxia Interactions
Interactions
Avoid concomitant didanosine, with or without stavudine, or other antiretrovirals (may cause pancreatitis [monitor], fatal hepatotoxicity, peripheral neuropathy). Avoid live vaccines. Increased risk of vasculitic toxicities with interferon therapy. May cause falsely elevated results in urea, uric acid, and lactic acid assays.
Droxia Adverse Reactions
Adverse Reactions
Leukopenia, thrombocytopenia, anemia, neutropenia, GI upset, anorexia, hair loss, macrocytosis, bleeding, melanonychia; interstitial lung disease.
Droxia Clinical Trials
See Literature
Droxia Note
Notes
Wear disposable gloves when handling caps or bottle.
Droxia Patient Counseling
See Literature
