SUTENT CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SUNITINIB (SUNITINIB MALATE)

Available from:

PFIZER CANADA ULC

ATC code:

L01EX01

INN (International Name):

SUNITINIB

Dosage:

37.5MG

Pharmaceutical form:

CAPSULE

Composition:

SUNITINIB (SUNITINIB MALATE) 37.5MG

Administration route:

ORAL

Units in package:

28/30

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0151642004; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-07-07

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
SUTENT
®
Sunitinib capsules
12.5 mg, 25 mg, 37.5 mg, 50 mg sunitinib per capsule (as sunitinib
malate)
Tyrosine Kinase Inhibitor, Anti-Tumour Agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Revision:
July 11, 2019
®
C.P. Pharmaceuticals International C.V.
Pfizer Canada Inc., Licensee
Submission Control No.: 226908
_ _
_SUTENT Product Monograph _
_Page 2 of 68 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
17
DRUG INTERACTIONS
.................................................................................................
32
DOSAGE AND ADMINISTRATION
.............................................................................
33
OVERDOSAGE
................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 34
STORAGE AND STABILITY
.........................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
38
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 38
PART II: SCIENTIFIC INFORMATION
..............................................................................
40
PHARMACEUTICAL INFORMATION
..................................................