Hydrea
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
HYDREA is indicated for the treatment of:
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- Resistant chronic myeloid leukemia.
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- Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.
History
There is currently no drug history available for this drug.
Other Information
HYDREA (hydroxyurea capsules, USP) is an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea. Inactive ingredients include citric acid, colorants (D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, and D&C Red No. 28), gelatin, lactose, magnesium stearate, sodium phosphate, and titanium dioxide.
Hydroxyurea is a white crystalline powder. It has a molecular weight of 76.05. Its structural formula is:
Sources
Hydrea Manufacturers
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E.r. Squibb & Sons, L.l.c.
![Hydrea (Hydroxyurea) Capsule [E.r. Squibb & Sons, L.l.c.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hydrea | E.r. Squibb & Sons, L.l.c.
2.1 Dosing InformationHYDREA is used alone or in conjunction with other antitumor agents or radiation therapy to treat neoplastic diseases. Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards.
Base all dosage on the patient’s actual or ideal weight, whichever is less.
HYDREA is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15)].
Prophylactic administration of folic acid is recommended [see Warnings and Precautions (5.7)].
2.2 Dose Modifications for ToxicityMonitor for the following and reduce the dose or discontinue HYDREA accordingly:
• Myelopression [seeWarnings and Precautions (5.1)] • Cutaneous vasculitis [seeWarnings and Precautions (5.4)]Monitor blood counts at least once a week during HYDREA therapy. Severe anemia must be corrected before initiating therapy with HYDREA. Consider dose modifications for other toxicities.
2.3 Dose Modifications for Renal ImpairmentReduce the dose of HYDREA by 50% in patients with measured creatinine clearance of less than 60 mL/min or with end-stage renal disease (ESRD) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Creatinine Clearance
(mL/min) Recommended HYDREA Initial Dose
(mg/kg daily)≥60
15
<60 or ESRD*
7.5
* On dialysis days, administer HYDREA to patients following hemodialysis.
Close monitoring of hematologic parameters is advised in these patients.
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