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DROXIA
Anemias
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Drug Name:

DROXIA Rx

Generic Name and Formulations:
Hydroxyurea 200mg, 300mg, 400mg; caps.

Company:
Bristol-Myers Squibb

Therapeutic Use:

Indications for DROXIA:

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.

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.

Warnings/Precautions:

Risk of severe myelosuppression. Monitor blood counts at baseline and during therapy; interrupt or reduce dose if necessary. Markedly depressed bone marrow function: do not initiate. Monitor for malignancies. Avoid sun exposure. Macrocytosis may mask folic acid deficiency; prophylactic folic acid is recommended. 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. Pregnancy; avoid. Exclude pregnancy prior to initiating; use effective contraception during and for ≥6 months (females) or ≥1 year (males) after therapy. Nursing mothers: not recommended.

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.

Pharmacological Class:

Antimetabolite.

Adverse Reactions:

Leukopenia, thrombocytopenia, anemia, neutropenia, GI upset, anorexia, hair loss, macrocytosis, bleeding, melanonychia; secondary malignancies.

Note:

Wear disposable gloves when handling caps or bottle.

How Supplied:

Caps—60

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