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:

15MG

Pharmaceutical form:

TABLET

Composition:

PONATINIB (PONATINIB HYDROCHLORIDE) 15MG

Administration route:

ORAL

Units in package:

60/180

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0156590001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-04-02

Summary of Product characteristics

_ICLUSIG_
_®_
_ (ponatinib) – Product Monograph _
_Page 1 of 55_
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:
SEP 29, 2023
Submission Control Number: 277221
ICLUSIG
®
is a registered trademark of ARIAD Pharmaceuticals, Inc.
©2023 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.
_ _
_ICLUSIG_
_®_
_ (ponatinib) – Product Monograph _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
09/2023
4.1 Dosing Considerations
09/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
5
1
INDICATIONS
...............................................................................................................
5
1.1
Pediatrics
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
.....................................................................