REBLOZYL POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LUSPATERCEPT

Available from:

CELGENE INC

ATC code:

B03XA06

INN (International Name):

LUSPATERCEPT

Dosage:

75MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

LUSPATERCEPT 75MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTIANEMIA DRUGS

Product summary:

Active ingredient group (AIG) number: 0162498002; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-09-25

Summary of Product characteristics

_REBLOZYL_
_®_
_ Product Monograph _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
REBLOZYL®
luspatercept for injection
25 mg / vial, 75 mg / vial
lyophilized powder for solution for subcutaneous injection
Erythroid Maturation Agent
Bristol-Myers Squibb Canada
2344 Alfred-Nobel Blvd
Suite 300
Montreal, Canada
H4S 0A4
Date of Initial Authorization:
September 25, 2020
Date of Revision:
March 26, 2024
Submission Control Number: 283802
®Reblozyl is a registered trademark of Celgene Corporation used under
license by Bristol-Myers Squibb
Canada.
_ _
_REBLOZYL_
_®_
_ Product Monograph _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
02/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
06/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
02/2021
7 WARNINGS AND PRECAUTIONS
06/2022
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
.................................................................................
4
4.1
Dosing Considerations
............................................................