Kytril

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Oral:

Kytril as a solution or tablet is used to prevent nausea and vomiting caused by cancer chemotherapy and radiation therapy. 

Injectable:

The injectable form is used to prevent nausea and vomiting related to chemotherapy and surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Antiemetic; selective inhibitor of type 3 serotonergic (5-HT3) receptors.1 2 3

Granisetron injection is used to prevent nausea and vomiting that may occur after treatment with cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This medicine is also used to prevent and treat nausea and vomiting that may happen after surgery.

Granisetron is a selective 5-HT3 receptor antagonist. It works in the stomach to block the signals to the brain that cause nausea and vomiting.

This medicine is to be given only by or under the immediate supervision of your doctor.

There is no specific treatment for granisetron hydrochloride overdosage. In case of overdosage, symptomatic treatment should be given. Overdosage of up to 38.5 mg of granisetron hydrochloride injection has been reported without symptoms or only the occurrence of a slight headache.

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)

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

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.

Distributed by:
Roche Pharmaceuticals
Roche Laboratories Inc.
340 Kingsland Street
Nutley, New Jersey 07110-1199

KLT_243421_PI_032010_K

Revised: March 2010

Copyright © 1999-2010 by Roche Laboratories Inc. All rights reserved.

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

Kytril blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Kytril is used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy or radiation).

Kytril may be used for other purposes not listed in this medication guide.

Take Kytril exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Kytril is usually started up to 1 hour before chemotherapy. Follow your doctor's instructions.

Measure the liquid form of Kytril with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store Kytril at room temperature away from moisture and heat.

Applies to granisetron: intravenous solution, oral solution, oral tablet, subcutaneous suspension extended release, transdermal film extended release

Nervous system

Nervous system side effects have been reported the most frequently. These have included headache (up to 15% to 52.2%), dizziness (5% to 26.1%), insomnia (5%), anxiety (2%), somnolence (1%), asthenia, agitation, and stimulation. Headache (0.7%) has been reported in patients using the granisetron (the active ingredient contained in Kytril) transdermal system. One case compatible with, but not diagnostic of, extrapyramidal symptoms has been reported.[Ref]

Granisetron-induced headache is generally mild. In clinical trials, headache typically resolved spontaneously or was relieved by analgesics.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (20%), constipation (3% to 50%), vomiting (12%), diarrhea (4% to 9%), abdominal pain (4% to 6%), dyspepsia (4% to 6%), flatulence, dry mouth, and taste disturbances. Constipation (5.4%) has been reported in patients using the granisetron (the active ingredient contained in Kytril) transdermal system.[Ref]

Constipation appears to be dose related. In dose-finding studies, constipation occurred in up to 50% of patients treated with single doses of granisetron 300 mcg/kg. If necessary, constipation may be alleviated by the use of laxatives.[Ref]

Hepatic

Hepatic side effects have been reported rarely. These have included elevations in serum transaminases (two times normal values). Causality is unknown. Acute pancreatitis has also been reported.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension in 1% of patients. Atrial fibrillation, angina pectoris, and syncope have been reported rarely. Hypotension, sinus bradycardia, A-V block, ventricular ectopy, QT prolongation, and ECG changes have been reported as well, although causality is unknown.[Ref]

Results of a review of the cardiovascular effects of the drug class 5-hydroxytryptamine 3 receptor antagonists in the literature reported that electrocardiographic (ECG) changes were so small to be considered clinically insignificant. ECG changes were most noticeable between 1 to 2 hours after a dose of granisetron and returned to baseline within 24 hours. To date, no serious cardiac side effects (including torsades de pointes) triggered by ECG interval changes have been connected with the use of 5-HT 3 receptor antagonists.[Ref]

Hypersensitivity

Hypersensitivity side effects have been reported rarely. These have included skin rashes, facial flushing, anaphylactoid reactions, shortness of breath, hypotension, and urticaria. One report suggests hypersensitivity reactions with 5-HT 3-antagonists may be a class effect and cross-reactive.[Ref]

Other

Other side effects including asthenia (5% to 18%) and fever (up to 8%) have been reported.[Ref]

Some side effects of Kytril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.