WARNING
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.
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DROXIA SUMMARY
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).
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NEWS HIGHLIGHTS
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
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
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