KYTRIL (granisetron hydrochloride) is indicated for the prevention of:

• Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
• Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

Emetogenic Chemotherapy

The recommended adult dosage of oral KYTRIL (granisetron hydrochloride) is 2 mg once daily or 1 mg twice daily. In the 2 mg once-daily regimen, two 1 mg tablets or 10 mL of KYTRIL Oral Solution (2 teaspoonfuls, equivalent to 2 mg of granisetron) are given up to 1 hour before chemotherapy. In the 1 mg twice-daily regimen, the first 1 mg tablet or one teaspoonful (5 mL) of KYTRIL Oral Solution is given up to 1 hour before chemotherapy, and the second tablet or second teaspoonful (5 mL) of KYTRIL Oral Solution, 12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given. Continued treatment, while not on chemotherapy, has not been found to be useful.

Use in the Elderly, Pediatric Patients, Renal Failure Patients or Hepatically Impaired Patients

No dosage adjustment is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)

The recommended adult dosage of oral KYTRIL is 2 mg once daily. Two 1 mg tablets or 10 mL of KYTRIL Oral Solution (2 teaspoonfuls, equivalent to 2 mg of granisetron) are taken within 1 hour of radiation.

Pediatric Use

There is no experience with oral KYTRIL in the prevention of radiation-induced nausea and vomiting in pediatric patients.

Use in the Elderly

No dosage adjustment is recommended.

Tablets

White, triangular, biconvex, film-coated tablets; tablets are debossed K1 on one face.

1 mg Unit of Use 2's: NDC 0004-0241-33

1 mg Single Unit Package 20's: NDC 0004-0241-26 (intended for institutional use only)

Storage

Store between 15º and 30ºC (59º and 86ºF). Keep container closed tightly. Protect from light.

Oral Solution

Clear, orange-colored, orange-flavored, 2 mg/10 mL, in 30 mL amber glass bottles with child-resistant closures: NDC 0004-0237-09

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep bottle closed tightly and stored in an upright position. Protect from light.

Roche Laboratories Inc., 340 Kingsland Street Nutley, New Jersey 07110-1199. Revised: November 2005. FDA Rev date: 11/23/2005

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