Monograph Details

Hematology > Anemias
DROXIA
Manufacturer
Bristol-Myers Squibb
Legal Classification
Rx
Pharmacological Class
Substituted urea.
Generic Name
Hydroxyurea 200mg, 300mg, 400mg; caps.
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.
Children
Not recommended.
Adults
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 range and toxic. If blood counts toxic, discontinue until hematologic recovery, see literature for dosage adjustments. Renal impairment (CrCl <60mL/min or ESRD): initially 7.5mg/kg per day; give dose following dialysis.
Precautions
Markedly depressed bone marrow function: not recommended. Monitor hematologic, renal, and liver function before and during therapy. Renal dysfunction. Macrocytosis may mask folic acid deficiency; prophylactic folic acid is recommended. Pregnancy (Cat.D); avoid use. Nursing mother: not recommended.
Interactions
Avoid concomitant didanosine, with or without stavudine, other antiretrovirals (may cause pancreatitis, fatal hepatotoxicity, peripheral neuropathy). Concomitant interferon: increased risk of vasculitic toxicities; discontinue hydroxyurea if cutaneous vasculitis ulcerations develop.
Adverse Reactions
Neutropenia, thrombocytopenia, low reticulocyte count, hair loss, rash, fever, GI upset, weight gain, bleeding, parvovirus B-19 infection, melanonychia, erythema, CNS effects, temporary renal impairment, acute pulmonary reactions, secondary leukemias.
Extra Text
Note: Wear disposable gloves when handling caps or bottle.
How Supplied
Caps—60