BYETTA SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EXENATIDE

Available from:

ASTRAZENECA CANADA INC

ATC code:

A10BJ01

INN (International Name):

EXENATIDE

Dosage:

5MCG

Pharmaceutical form:

SOLUTION

Composition:

EXENATIDE 5MCG

Administration route:

SUBCUTANEOUS

Units in package:

1.2ML PREFILLED PEN

Prescription type:

Prescription

Therapeutic area:

INCRETIN MIMETICS

Product summary:

Active ingredient group (AIG) number: 0152872003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-01-06

Summary of Product characteristics

_ _
COPYRIGHT 2014 - 2019 ASTRAZENECA CANADA INC.
Page 1 of 47
PRODUCT MONOGRAPH
BYETTA
®
exenatide injection
250 µg/mL
1.2 mL prefilled pen (60 doses of 5 µg/dose)
and
2.4 mL prefilled pen (60 doses of 10 µg/dose)
ANTIHYPERGLYCEMIC AGENT
Glucagon-Like Peptide-1 (GLP-1) receptor agonist
AstraZeneca Canada Inc.
1004 Middlegate Road, Suite 5000
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
December 18, 2019
Submission Control No: 233128
BYETTA
®
is a registered trademark of Amylin Pharmaceuticals LLC used under
license by AstraZeneca Canada
Inc
.
_ _
COPYRIGHT 2014 - 2019 ASTRAZENECA CANADA INC.
Page 2 of 47
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.......................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................