BENLYSTA POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BELIMUMAB

Available from:

GLAXOSMITHKLINE INC

ATC code:

L04AG04

INN (International Name):

BELIMUMAB

Dosage:

400MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

BELIMUMAB 400MG

Administration route:

INTRAVENOUS

Units in package:

20ML

Prescription type:

Prescription

Therapeutic area:

IMMUNOSUPPRESSIVE AGENTS

Product summary:

Active ingredient group (AIG) number: 0152941001; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-07-06

Summary of Product characteristics

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_BENLYSTA, Belimumab _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BENLYSTA
Belimumab for injection
120 mg in 5 mL vial lyophilized powder for intravenous infusion
400 mg in 20 mL vial lyophilized powder for intravenous infusion
Belimumab injection
200 mg in 1 mL for subcutaneous injection
Selective Immunosuppressant
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
July 06, 2011
Date of Revision:
March 6, 2024
Submission Control Number: 279901
_©_
_2024 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_ _
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_BENLYSTA, Belimumab _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS
10/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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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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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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4.2
Recommended Dose and Dosage Adjustment .......................... 5