Dosing Information

HYDREA 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)].

Swallow HYDREA capsules whole. Do NOT open, break, or chew capsules because HYDREA is a cytotoxic drug.

Prophylactic administration of folic acid is recommended [see Warnings and Precautions (5.8)].

Monitor blood counts at least once a week during HYDREA therapy. Severe anemia must be corrected before initiating therapy with HYDREA.

Dose Modifications for Toxicity

Monitor for the following and reduce the dose or discontinue HYDREA accordingly:

• Myelosuppression [see Warnings and Precautions (5.1)]
• Cutaneous vasculitis [see Warnings and Precautions (5.5)]

Consider dose modifications for other toxicities.

Dose Modifications for Renal Impairment

Reduce 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)].

* On dialysis days, administer HYDREA to patients following hemodialysis.

Close monitoring of hematologic parameters is advised in these patients.