TARO-SUNITINIB CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SUNITINIB (SUNITINIB MALATE)

Available from:

TARO PHARMACEUTICALS INC

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:

100

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-01-07

Summary of Product characteristics

_Pr_
_TARO-SUNITINIB Product Monograph _
_ Page 1 of 65_
PRODUCT MONOGRAPH
PR
TARO-SUNITINIB
Sunitinib
Capsules
12.5 mg, 25 mg, 37.5 mg, 50 mg sunitinib
per capsule (as sunitinib
malate)
Tyrosine Kinase Inhibitor, Anti-Tumour Agent
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, ON
L6T 1C1
Date of Preparation:
January 5, 2022
Submission
Control No.: 235867
_Pr_
_TARO-SUNITINIB Product Monograph _
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_Page 2 of 65 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND
PRECAUTIONS....................................................................................
4
ADVERSE
REACTIONS....................................................................................................15
DRUG INTERACTIONS
....................................................................................................30
DOSAGE AND ADMINISTRATION
.................................................................................31
OVERDOSAGE
..................................................................................................................32
ACTION AND CLINICAL
PHARMACOLOGY...............................................................32
STORAGE AND STABILITY
............................................................................................36
SPECIAL HANDLING
INSTRUCTIONS..........................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................36
PART II: SCIENTIFIC INFORMATION
.............................................................................37
PHARMACEUTICAL INFORMATION
.............