XELJANZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TOFACITINIB (TOFACITINIB CITRATE)

Available from:

PFIZER CANADA ULC

ATC code:

L04AF01

INN (International Name):

TOFACITINIB

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

TOFACITINIB (TOFACITINIB CITRATE) 5MG

Administration route:

ORAL

Units in package:

56/60/180

Prescription type:

Prescription

Therapeutic area:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0155550001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-04-17

Summary of Product characteristics

_XELJANZ/XELJANZ XR (tofacitinib citrate) - Product Monograph_
_ _
_Page 1 of 87_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XELJANZ
®
tofacitinib, tablets, oral
5 mg tofacitinib (as tofacitinib citrate)
10 mg tofacitinib (as tofacitinib citrate)
PR
XELJANZ
® XR
tofacitinib extended-release, tablets, oral
11 mg tofacitinib (as tofacitinib citrate)
Selective Immunosuppressant
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
TM
PF PRISM C.V.
c/o Pfizer Manufacturing Holdings LLC
Pfizer Canada ULC, Licensee
© Pfizer Canada ULC, 2023
Date of Initial Authorization:
APR 16, 2014
Date of Revision:
AUG 11, 2023
Submission Control Number: 272662
_XELJANZ/XELJANZ XR (tofacitinib citrate) - Product Monograph_
_ _
_Page 2 of 87_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, ANKYLOSING SPONDYLITIS
05/2023
1.2 INDICATIONS, GERIATRICS
12/2021
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, MALIGNANCIES
12/2021
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, MAJOR ADVERSE
CARDIOVASCULAR EVENTS
12/2021
7 WARNINGS AND PRECAUTIONS, CARCINOGENESIS AND MUTAGENESIS
12/2021
7 WARNINGS AND PRECAUTIONS, CARDIOVASCULAR
12/2021
7 WARNINGS AND PRECAUTIONS, RETINAL VENOUS THROMBOSIS
08/2023
7 WARNINGS AND PRECAUTIONS, GASTROINTESTINAL
12/2021
7 WARNINGS AND PRECAUTIONS, IMMUNE
12/2021
7 WARNINGS AND PRECAUTIONS, FRACTURES
04/2022
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
.....................................................................................................
4
1
INDICATIONS
....................................................................................................................