ICLUSIG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PONATINIB (PONATINIB HYDROCHLORIDE)

Available from:

TAKEDA PHARMACEUTICALS U.S.A., INC.

ATC code:

L01EA05

INN (International Name):

PONATINIB

Dosage:

45MG

Pharmaceutical form:

TABLET

Composition:

PONATINIB (PONATINIB HYDROCHLORIDE) 45MG

Administration route:

ORAL

Units in package:

30/90

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0156590002; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-04-02

Summary of Product characteristics

_ICLUSIG_
_®_
_ (ponatinib) – Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ICLUSIG®
Ponatinib Tablets
Tablets,
15 mg and 45 mg (as ponatinib hydrochloride), oral
Protein-tyrosine kinase inhibitor
ATC code: L01EA05
Takeda Pharmaceuticals U.S.A., Inc.
95 Hayden Ave.
Lexington, MA, United States
02421
Imported and distributed by:
Paladin Labs Inc.,
Saint-Laurent, QC
H4M 2P2
Date of Initial Authorization:
MAR 31, 2015
Date of Revision:
OCT 03, 2022
Submission Control Number: 258641
ICLUSIG
®
is a registered trademark of ARIAD Pharmaceuticals, Inc.
©2022 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.
_ _
_ICLUSIG_
_®_
_ (ponatinib) – Product Monograph _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
10/2022
4.1 Dosing Considerations
10/2022
4.2 Dosage and Administration
10/2022
7 Warnings and Precautions
10/2022
7 Warnings and Precautions, 7.1.1 Pregnant Women
10/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
10/2022
7 Warnings and Precautions, 7.1.8 Renal Impairment
10/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
..........................................................................................................
5
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
....................................................................................