Imatinib Mesylate: Package Insert and Label Information (Page 6 of 6)

15 REFERENCES

  1. OSHA Hazardous Drugs. OSHA. [Accessed on 20-September- 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]

16 HOW SUPPLIED/STORAGE AND HANDLING

Each film-coated tablet contains 100 mg or 400 mg of Imatinib free base.

100 mg film coated tablets

Dark yellow to brownish orange colored, film-coated tablets, round, biconvex with bevelled edges, debossed with ‘S’ and ’1′ on either side of break line on one side and plain on other side.

Bottles of 90 tablets…………………………… NDC 72606-556-01

400 mg film coated tablets

Dark yellow to brownish orange colored, film-coated tablets, capsule shaped, biconvex with bevelled edges debossed with ‘S’ and ’2′ on either side of break line on one side and plain on other side.

Bottles of 30 tablets…………………………… NDC 72606-557-01

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C — 30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight container, USP.

Do not crush Imatinib mesylate tablets. Avoid direct contact of crushed tablets with the skin or mucous membranes. If such contact occurs, wash thoroughly as outlined in the references. Avoid exposure to crushed tablets .

17 PATIENT COUNSELING INFORMATION

Dosing and Administration

Advise patients to take imatinib mesylate tablets exactly as prescribed, not to change their dose or to stop taking imatinib mesylates tablet unless they are told to do so by their doctor. If the patient missed a dose of imatinib mesylate tablets, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time. Advise patients to take imatinib mesylate tablets with a meal and a large glass of water. [See Dosage and Administration (2.1) ].

Fluid Retention and Edema

Inform patients of the possibility of developing edema and fluid retention. Advise patients to contact their health care provider if unexpected rapid weight gain occurs [see Warnings and Precautions (5.1)].

Hepatotoxicity

Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their health care provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising [see Warnings and Precautions (5.4)].

Pregnancy and Breast-Feeding

Advise patients to inform their doctor if they are or think they may be pregnant. Advise women of reproductive potential to avoid becoming pregnant while taking imatinib mesylate tablets. Female patients of reproductive potential taking imatinib mesylate tablets should use highly effective contraception during treatment and for fourteen days after stopping treatment with imatinib mesylate tablets [see Use in Specific Populations (8.3)]. Avoid breastfeeding during treatment and for 1 month after the last dose [see Use in Specific Populations (8.2)].

Drug Interactions

Imatinib mesylate tablet and certain other medicines such as warfarin, erythromycin, and phenytoin, including over-the-counter medications such as herbal products, can interact with each other. Advise patients to tell their doctor if they are taking or plan to take iron supplements. Avoid grapefruit juice and other foods known to inhibit CYP3A4 while taking imatinib mesylate tablets.[See Drug Interactions (7)].

Pediatric

Advise patients that growth retardation has been reported in children and pre-adolescents receiving imatinib mesylate tablets. The long term effects of prolonged treatment with imatinib mesylate tablets on growth in children are unknown. Therefore, closely monitoring of growth in children under imatinib mesylate tablets treatment. [See Warnings and Precautions (5.11)].

Driving and Using Machines

Advise patients that they may experience side effects such as dizziness, blurred vision or somnolence during treatment with imatinib mesylate tablets. Therefore, caution patients about driving a car or operating machinery. [See Warnings and Precautions (5.13)].


Manufactured by:

Shilpa Medicare Limited

Jadcherla -509301

INDIA

Distributed by:

Celltrion USA, Inc.

Jersey City, NJ 07302

USA

Revised: 11/2019

Packaging

image description
(click image for full-size original)

image description
(click image for full-size original)
IMATINIB MESYLATE imatinib mesylate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72606-556
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMATINIB MESYLATE (IMATINIB) IMATINIB 100 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color YELLOW (dark yellow to brownish orange) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code S;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72606-556-01 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208302 11/06/2019
IMATINIB MESYLATE imatinib mesylate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72606-557
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMATINIB MESYLATE (IMATINIB) IMATINIB 400 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color yellow (dark yellow to brownish orange) Score 2 pieces
Shape capsule Size 16mm
Flavor Imprint Code S;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72606-557-01 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208302 11/06/2019
Labeler — CELLTRION USA, INC. (116587378)
Establishment
Name Address ID/FEI Operations
Shilpa Medicare Ltd. 650644136 manufacture (72606-556), manufacture (72606-557)

Revised: 11/2019 CELLTRION USA, INC.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2019. All Rights Reserved.