INLYTA TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-09-2021
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Active ingredient:
AXITINIB
Available from:
PFIZER CANADA ULC
ATC code:
L01EK01
INN (International Name):
AXITINIB
Dosage:
7MG
Pharmaceutical form:
TABLET
Composition:
AXITINIB 7MG
Administration route:
ORAL
Units in package:
28/56/60
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0153228004; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-03-24
Summary of Product characteristics
_ _
_INLYTA_
®
_ (axitinib) Product Monograph _
_Page 1 of 52_
PRODUCT MONOGRAPH
Pr
INLYTA
®
Axitinib
Tablets, 1 mg, 3 mg, 5 mg and 7 mg
Kinase Inhibitor, Anti-Tumour Agent
®
Pfizer Products ULC
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
©
Pfizer Canada ULC, 2021
Date of Revision:
28 September 2021
Submission
Control No: 245813
_ _
_INLYTA_
®
_ (axitinib) Product Monograph _
_Page 2 of 52_
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
............................................................................................14
DRUG INTERACTIONS
............................................................................................25
DOSAGE AND ADMINISTRATION
.........................................................................26
OVERDOSAGE
..........................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
.........................................................29
STORAGE AND STABILITY
....................................................................................31
DOSAGE FORMS, COMPOSITION AND
PACKAGING...........................................32
PART II: SCIENTIFIC INFORMATION
.........................................................................
34
PHARMACEUTICAL INFORMATION
.....................................................................34
CLINICAL
TRIALS....................................................................................................35
DETAILED PHARMACOLOGY
.........................
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