Kytril Injection (Granisetron Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

KYTRIL Injection is indicated for:

• The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
• The prevention and treatment of postoperative nausea and vomiting. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, KYTRIL Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

DOSAGE AND ADMINISTRATION

NOTE: KYTRIL 1 MG/1 ML CONTAINS BENZYL ALCOHOL (see PRECAUTIONS).

Prevention of Chemotherapy-Induced Nausea and Vomiting

The recommended dosage for KYTRIL Injection is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given.

Infusion Preparation

KYTRIL Injection may be administered intravenously either undiluted over 30 seconds, or diluted with 0.9% Sodium Chloride or 5% Dextrose and infused over 5 minutes.

Stability

Intravenous infusion of KYTRIL Injection should be prepared at the time of administration. However, KYTRIL Injection has been shown to be stable for at least 24 hours when diluted in 0.9% Sodium Chloride or 5% Dextrose and stored at room temperature under normal lighting conditions.

As a general precaution, KYTRIL Injection should not be mixed in solution with other drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Pediatric Patients

The recommended dose in pediatric patients 2 to 16 years of age is 10 mcg/kg (see CLINICAL TRIALS). Pediatric patients under 2 years of age have not been studied.

Geriatric Patients, Renal Failure Patients or Hepatically Impaired Patients

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

Prevention and Treatment of Postoperative Nausea and Vomiting

The recommended dosage for prevention of postoperative nausea and vomiting is 1 mg of KYTRIL, undiluted, administered intravenously over 30 seconds, before induction of anesthesia or immediately before reversal of anesthesia.

The recommended dosage for the treatment of nausea and/or vomiting after surgery is 1 mg of KYTRIL, undiluted, administered intravenously over 30 seconds.

Pediatric Patients

Safety and effectiveness of KYTRIL Injection have not been established in pediatric patients for the prevention or treatment of postoperative nausea or vomiting.

Geriatric Patients, Renal Failure Patients or Hepatically Impaired Patients

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

HOW SUPPLIED

KYTRIL Injection, 1 mg/1 mL (free base), is supplied in 1 mL Single-Use Vials and 4 mL Multi-Use Vials. CONTAINS BENZYL ALCOHOL.

NDC 0004-0239-09 (package of 1 Single-Use Vial)
NDC 0004-0240-09 (package of 1 Multi-Use Vial)

KYTRIL Injection, 0.1 mg/1 mL (free base), is supplied in 1 mL Single-Use Vials. CONTAINS NO PRESERVATIVE.

NDC 0004-0242-08 (package of 5 Single-Use Vials)

Storage

Store single-use vials and multi-use vials at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]

Once the multi-use vial is penetrated, its contents should be used within 30 days.

Do not freeze. Protect from light.

Distributed by:

Copyright © 1998-2005 by Roche Laboratories Inc. All rights reserved.