PRALUENT SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALIROCUMAB

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

C10AX14

INN (International Name):

ALIROCUMAB

Dosage:

75MG

Pharmaceutical form:

SOLUTION

Composition:

ALIROCUMAB 75MG

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: 0158030001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-04-11

Summary of Product characteristics

_Product Monograph – Praluent _
_ _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRALUENT
®
alirocumab injection
solution for subcutaneous injection, 75 mg/mL and 150 mg/mL,
subcutaneous
Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor
produced by recombinant DNA
technology in Chinese Hamster Ovary cell suspension culture
ATC Code: C10AX14
Sanofi-aventis Canada Inc.
2905 Place Louis-R-Renaud
Laval, Quebec H7V0A3
Date of Initial Approval:
April 11, 2016
Date of Revision:
February 17, 2023
Submission Control No: 261559
_ _
_Product Monograph – Praluent _
_ _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
01/2023
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
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics
.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration
.....................................................................................................5
4.5
Missed Dose
..........................