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Droxia (Hydroxyurea) - Summary



Treatment of patients with DROXIA 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 for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient’s 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 a cytotoxic and cytoreductive agent. It is available for oral use as capsules providing 200 mg, 300 mg and 400 mg hydroxyurea.

DROXIA (hydroxyurea capsules, USP) is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises (generally at least 3 during the preceding 12 months).

See all Droxia indications & dosage >>


Published Studies Related to Droxia (Hydroxyurea)

Hydroxyurea and growth in young children with sickle cell disease. [2014]
Effects of hydroxyurea (HU) on growth in very young children are not known... CONCLUSIONS: Both groups had normal or near normal anthropometric measures during

Immunologic effects of hydroxyurea in sickle cell anemia. [2014]
maturation and vaccine responses... CONCLUSIONS: Hydroxyurea does not appear to have significant deleterious effects

Impact of hydroxyurea on clinical events in the BABY HUG trial. [2012]
The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups...

Effect of hydroxyurea treatment on renal function parameters: results from the multi-center placebo-controlled BABY HUG clinical trial for infants with sickle cell anemia. [2012]
CONCLUSION: Treatment with hydroxyurea for 24 months did not influence GFR in

Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: results from the BABY-HUG Phase III Clinical Trial. [2012]
CONCLUSIONS: These data provide additional support to the safety profile of

more studies >>

Clinical Trials Related to Droxia (Hydroxyurea)

Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma [Completed]
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with hydroxyurea may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with hydroxyurea works in treating patients with recurrent or progressive meningioma.

Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma [Completed]
Primary Objective To determine maximum tolerated dose & dose limiting toxicity of Zactima when combined w standard dosing of imatinib mesylate & hydroxyurea among pts w recurrent malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety & tolerability of Zactima + imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of Zactima among MG pts on & not on enzyme inducing anti-epileptic drugs (EIAEDs) when combo w imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of imatinib mesylate among MG pts on & not on EIAEDs when combo w Zactima & hydroxyurea Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among recurrent malignant glioma (RMG) pts including radiographic response rate, 6-month progression free survival (PFS) rate & median PFS

Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia [Completed]
Hydroxyurea (HU) is approved by the United States Food and Drug Administration (FDA) to treat adults with sickle cell anemia. Hydroxyurea has also been tested and used with children with sickle cell anemia. However, there are not many studies describing the disposition of drug in children less than 5 years old. The FDA has requested this study to better understand how children ages 2 to 17 years with sickle anemia absorb and eliminate the drug (this is called pharmacokinetics). The investigators will measure how much Hydroxyurea (HU) gets into the bloodstream at different time points after taking this medication.

Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG [Completed]
Primary objective To determine maximum tolerated dose & dose limiting toxicity of imatinib mesylate & RAD001 when combined w fixed doses of hydroxyurea among pts w recurrent GBM who are on & not on enzyme-inducing anti-convulsants including pts not on anti-epileptic drugs Secondary objective To assess safety & tolerability of imatinib mesylate in combo w RAD001 & hydroxyurea in this population To characterize single-dose & repeated-dose pharmacokinetic profiles of imatinib mesylate & RAD001 combo therapy in this pt population. To assess antiangiogenic effects, pre- and post-treatment, of imatinib mesylate, RAD001 & hydroxyurea combo therapy, using DCE-MRI to evaluate changes in extent of vascular permeability, perfusion & relative tumor blood volume; to explore assessment of tumor cellularity & tumor cell death by changes in DWI-MRI as quantitated by apparent diffusion coefficient maps.

Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG) [Completed]
Primary objective:

- To evaluate activity of imatinib mesylate and hydroxyurea among patients with

progressive/recurrent grade II low-grade glioma (LGG) as measured by 12-month progression free survival Secondary objectives:

- To evaluate progression-free survival (PFS), overall survival and objective response

rate among patients with progressive/recurrent grade II LGG treated with imatinib mesylate plus hydroxyurea

- To assess safety and tolerability of imatinib mesylate + hydroxyurea in this population

more trials >>

Page last updated: 2015-08-10

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