SPEVIGO SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SPESOLIMAB

Available from:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC code:

L04AC22

INN (International Name):

SPESOLIMAB

Dosage:

60MG

Pharmaceutical form:

SOLUTION

Composition:

SPESOLIMAB 60MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0164521001; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-03-22

Summary of Product characteristics

_Product Monograph _
_ _
_Spevigo (spesolimab) _
_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SPEVIGO®
spesolimab for injection
Concentrate for solution for intravenous infusion
450 mg/7.5 mL (60 mg/mL)
Interleukin-36 Inhibitor
ATC code: L04AC22
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
www.boehringer-ingelheim.ca
Date of Initial Authorization:
MAR 22, 2023
Submission Control Number: 267362
BICL #0174-01
Spevigo® is a registered trademark of Boehringer Ingelheim
International GmbH, used under
license.
_ _
_Product Monograph _
_ _
_Spevigo (spesolimab) _
_Page 2 of 21_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics (<18 years of age)
....................................................................................
4
1.2
Geriatrics (≥65 years of age)
....................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.3
Reconstitution
..........................................................................................................
5
4.4
Administration
.......................................................................