AFINITOR DISPERZ TABLET FOR SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EVEROLIMUS

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

L04AH02

INN (International Name):

EVEROLIMUS

Dosage:

3MG

Pharmaceutical form:

TABLET FOR SUSPENSION

Composition:

EVEROLIMUS 3MG

Administration route:

ORAL

Units in package:

90

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152682008; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-06-11

Summary of Product characteristics

_AFINITOR (everolimus) and AFINITOR DISPERZ Product Monograph _
_Page 1 of 123_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AFINITOR
®
Everolimus
Tablets, 2.5 mg, 5 mg and 10 mg, Oral
PR
AFINITOR
®
DISPERZ
®
Everolimus
Tablets for oral suspension, 2 mg, 3 mg and 5 mg, Oral
Protein kinase inhibitors
ATC Code: L01XE10
_ _
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd., Dorval, Quebec
H9S 1A9
_ _
_ _
Date of Initial Authorization:
December 11, 2009
Date of Revision:
November 30, 2021_ _
_ _
Submission Control Number: 255457
_AFINITOR_
_ _
_(everolimus) and AFINITOR DISPERZ Product Monograph _
_Page 2 of 123 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Radiation Sensitization and
Radiation Recall
11/2021
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
........................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ........................................................5
1
INDICATIONS ............................................................................................................5
1.1
Pediatrics
............................................................................................................6
1.2
Geriatrics.............................................................................................................7
2
CONTRAINDICATIONS ............................................................................................7
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ...............................................8
4
DOSAGE AND ADMINISTRATION ..........................................................................9
4.1
Dosing Considerations
.........................................................................................9
4.2
Recommended Dose and Dosage
Adjustment..............