Dispense in a tight container, USP.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4

Gleevec tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly as outlined in the references. Personnel should avoid exposure to crushed tablets. [see Nonclinical Toxicology (13.1)].

17PATIENT COUNSELING INFORMATION
17.1 Dosing and Administration
Patients should be informed to take Gleevec exactly as prescribed, not to change their dose or to stop taking Gleevec unless they are told to do so by their doctor. Ifpatients miss a dose they should be advised to take their dose as soon as possible unless it is almost time for their next dose in which case the missed dose should not be taken. A double dose should not be taken to make up for any missed dose.Patients should be advised to take Gleevec with a meal and a large glass of water.

17.2 Pregnancy and Breast-Feeding
Patients should be advised to inform their doctor if they are or think they may be pregnant. Patients should also be advised not to breast feed while taking Gleevec.

17.3 Adverse Reactions
Patients should be advised to tell their doctor if they experience side effects during Gleevec therapy including fever, shortness of breath, blood in their stools, jaundice, sudden weight gain,symptoms of cardiac failure, or if they have a history of cardiac disease or risk factors for cardiac failure.

17.4 Drug Interactions
Patients should be advised not to take any other medications, including over-the-counter medications such as acetaminophen or herbal products without talking to their doctor or pharmacist first. Examples of other medications that should not be taken with Gleevec are warfarin, erythromycin, and phenytoin. Patients should also be advised to tell their doctor if they are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods known to inhibit CYP3A4 while taking Gleevec.

T2010-21

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey07936

© Novartis
PRINCIPAL DISPLAY PANEL
Package Label – 100 mg Tablets

Rx Only
GLEEVEC® (imatinib mesylate)

100 mg

Each tablet contains 100 mg of imatinib free base

 
PRINCIPAL DISPLAY PANEL
Package Label – 400 mg Tablets

Rx Only
GLEEVEC® (imatinib mesylate)

400 mg

Each tablet contains 400 mg of imatinib free base

 
GLEEVEC
imatinib mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54868-5289(0078-0401)
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMATINIB MESYLATE(IMATINIB) IMATINIB 100mg
 
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE 
CROSPOVIDONE 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
TALC 
HYPROMELLOSE 
FERRIC OXIDE YELLOW 
 
Product Characteristics
Color yellow (Very dark yellow to brownish orange)  Score 2pieces
Shape ROUND (biconvex with bevelled edges)