TASIGNA CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE)

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

L01EA03

INN (International Name):

NILOTINIB

Dosage:

150MG

Pharmaceutical form:

CAPSULE

Composition:

NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152484002; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-06-22

Summary of Product characteristics

_Tasigna_
_® _
_(nilotinib, as nilotinib hydrochloride monohydrate) _
_Page 1 of 85 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TASIGNA
®
(Nilotinib Capsules)
Capsules, 50 mg, 150 mg and 200 mg nilotinib (as nilotinib
hydrochloride
monohydrate), Oral use
Novartis Standard
Protein kinase inhibitor
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St., Suite 100
Montreal, Quebec, H2Y 0C1
www.novartis.ca
Date of Initial Authorization:
SEP 30, 2008
Submission Control No: 273430
Date of Revision:
JUL 20, 2023
_ _
_ _
_TASIGNA is a registered trademark _
_Tasigna_
_® _
_(nilotinib, as nilotinib hydrochloride monohydrate) _
_Page 2 of 85 _
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization _ (Migration to the
Product Monograph Master _
_Template)_.
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................................................4
1
INDICATIONS
.................................................................................................................4
1.1 Pediatrics
..........................................................................................................................
4
1.2 Geriatrics
..........................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................5
4
DOSAGE AND ADMINISTRATION
....................................................................................5
4.1 Dosing Considerations
......................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................ 6
4.4 Administration
..............................................................................................