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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (H's) » Hydroxyurea



DESCRIPTION


WARNING

Treatment of patients with DROXIA ® (hydroxyurea capsules, USP) may be complicated by severe, sometimes life-threatening, adverse effects. DROXIA should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.

Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumed transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea whether this leukemogenic effect is secondary to hydroxyurea or is associated for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported. It is unknown with the patients underlying disease. The physician and patient must very carefully consider the potential benefits of DROXIA relative to the undefined risk of developing secondary malignancies.


DROXIA ® (hydroxyurea capsules, USP) is available for oral use as capsules providing 200 mg, 300 mg and 400 mg hydroxyurea. Inactive ingredients: citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide and capsule colorants: FD& C Blue #1 and FD& C Green #3 (200 mg capsules); D& C Red #28, D& C Red #33 and FD& C Blue #1 (300 mg capsules); D& C Red #28, D& C Red #33 and D& C Yellow #10 (400 mg capsules). Hydroxyurea is an essentially tasteless, white crystalline powder.

CAUTION: Federal law prohibits dispensing without prescription.





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