REPATHA SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EVOLOCUMAB

Available from:

AMGEN CANADA INC

ATC code:

C10AX13

INN (International Name):

EVOLOCUMAB

Dosage:

140MG

Pharmaceutical form:

SOLUTION

Composition:

EVOLOCUMAB 140MG

Administration route:

SUBCUTANEOUS

Units in package:

1ML

Prescription type:

Prescription

Therapeutic area:

PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9) INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0157370001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-09-10

Summary of Product characteristics

_REPATHA (evolocumab injection) _
_Page 1 of 82 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
REPATHA
®
evolocumab injection
Solution for Subcutaneous Injection
140 mg in 1.0 mL (140 mg/mL)
420 mg in 3.5 mL (120 mg/mL)
anti-Proprotein Convertase Subtilisin/Kexin Type 9 (anti-PCSK9)
Monoclonal Antibody produced
in Chinese hamster ovary (CHO) cells by recombinant DNA technology
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, ON L5N 0A4
Date of Initial Authorization:
September 10, 2015
Date of Revision:
September 27, 2023
Submission Control Number: 269049
© 2015-2023 Amgen Canada Inc. All Rights Reserved.
_ _
_REPATHA (evolocumab injection) _
_Page 2 of 82_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
12/2021
1 INDICATIONS, 1.1 Pediatrics
12/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
12/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose
Adjustment
12/2021
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
12/2021
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
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1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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