AFINITOR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EVEROLIMUS

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

L04AH02

INN (International Name):

EVEROLIMUS

Dosage:

7.5MG

Pharmaceutical form:

TABLET

Composition:

EVEROLIMUS 7.5MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152682009; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-07-09

Summary of Product characteristics

_AFINITOR and AFINITOR DISPERZ Product Monograph _
_Page 1 of 115_
PRODUCT MONOGRAPH
Pr
AFINITOR
®
(everolimus tablets)
2.5 mg, 5 mg, 7.5 mg and 10 mg
Pr
AFINITOR
® DISPERZ
TM
(everolimus tablets for oral suspension)
2 mg, 3 mg and 5 mg
Antineoplastic Agent
(mTOR kinase inhibitor)
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.,
_ _
Dorval, Quebec
H9S 1A9
Date of Revision:
November 16, 2017
Submission Control No: 200814
AFINITOR is a registered trademark.
_AFINITOR and AFINITOR DISPERZ Product Monograph _
_Page 2 of 115_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................6
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................42
DOSAGE AND ADMINISTRATION
..............................................................................45
OVERDOSAGE
................................................................................................................57
ACTION AND CLINICAL PHARMACOLOGY
............................................................57
STORAGE AND STABILITY
..........................................................................................61
SPECIAL HANDLING INSTRUCTIONS
.......................................................................61
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................61
PART II: SCIENTIFIC INFORMATION
................................................