HYDREA Capsule Ref.[10824] Active ingredients: Hydroxycarbamide

2.1 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 (5.7)].

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

2.2 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 (5.4)]

Consider dose modifications for other toxicities.

2.3 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.

Acute mucocutaneous toxicity has been reported in patients receiving hydroxyurea at dosages several times the therapeutic dose. Soreness, violet erythema, edema on palms and soles followed by scaling of hands and feet, severe generalized hyperpigmentation of the skin, and stomatitis have also been observed.

Store at 20-25°C (68-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Handling and Disposal

HYDREA is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15)].

To decrease the risk of contact, advise caregivers to wear disposable gloves when handling HYDREA or bottles containing HYDREA. Wash hands with soap and water before and after contact with the bottle or capsules when handling HYDREA. Do not open HYDREA capsules. Avoid exposure to crushed or opened capsules. If contact with crushed or opened capsules occurs on the skin, wash affected area immediately and thoroughly with soap and water. If contact with crushed or opened capsules occurs on the eye(s), the affected area should be flushed thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes. If the powder from the capsule is spilled, immediately wipe it up with a damp disposable towel and discard in a closed container, such as a plastic bag; as should the empty capsules. The spill areas should then be cleaned three times using a detergent solution followed by clean water. Keep the medication away from children and pets. Contact your doctor for instructions on how to dispose of outdated capsules.