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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)

Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent MG [Recruiting]
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 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 RMG pts including radiographic response rate, 6-month progression free survival rate & median PFS

Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera [Recruiting]
This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Recruited patients will be randomly assigned to one of the following treatment groups:

- group A: 50 mg o. d. of oral GIVINOSTAT (ITF2357) in combination with the maximum

tolerated dose of hydroxyurea monotherapy already in use before admission to the study;

- group B: 50 mg b. i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum

tolerated dose of hydroxyurea monotherapy already in use before admission to the study.

The two groups will be balanced for number and for Centre in order to provide valuable information on both treatment regimens.

In both groups assigned doses shall remain stable until week 12, which is when the primary endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.

After the primary endpoint assessment at week 12, one of the following treatment schedules will be chosen case by case on the basis of the achieved clinical response and continued for up to 12 further weeks:

- Partial or Complete Response at week 12:

- group A: continue 50 mg o. d.;

- group B: continue 50 mg b. i.d.;

- No Response at week 12:

- group A: increase to 50 mg b. i.d.;

- group B: increase to 50 mg t. i.d.. At any time during study course, if toxicity is

observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then restarted at a reduced dose level. The drug will be definitively withdrawn in case of reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last up to a maximum of 24 cumulative weeks of drug administration.

The study will recruit subjects of both genders with an established diagnosis of JAK2V617F positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Inflammatory Response to Hydroxyurea Therapy in Sickle Cell Disease [Recruiting]
In sickle cell disease (SCD), polymerisation of haemoglobin S and the resulting shape change of the red blood cells (RBC) lead to vascular occlusion and severe painful crises. Permanent inflammatory state and abnormal RBC adhesion to the endothelium trigger these phenomenon. Hydroxyurea (HU) is the only drug that has been shown to reduce clinical severity of SCD, and this was initially attributed to the stimulation of foetal haemoglobin (HbF). However, the clinical response does not correlate consistently with the degree and time of HbF increment, suggesting that HU clinical benefits may involve other mechanisms such as the induction of natural anti-inflammatory response via the hypothalami-pituitary-adrenal axis.

Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea [Recruiting]
The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently receive chronic transfusions to reduce the risk of primary stroke. For the alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must have a mean TCD velocity similar to that observed with transfusion prophylaxis.

Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma [Completed]
This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma.

more trials >>

Page last updated: 2015-08-10

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