VENCLEXTA KIT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VENETOCLAX; VENETOCLAX; VENETOCLAX

Available from:

ABBVIE CORPORATION

ATC code:

L01XX52

INN (International Name):

VENETOCLAX

Dosage:

10MG; 50MG; 100MG

Pharmaceutical form:

KIT

Composition:

VENETOCLAX 10MG; VENETOCLAX 50MG; VENETOCLAX 100MG

Administration route:

ORAL

Units in package:

4 BLISTER PACKS

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0358491001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-09-30

Summary of Product characteristics

_VENCLEXTA (venetoclax) _
_Date of Revision: APR 05, 2022 _
_Submission Control No.: 253017 _
_Page 1 of 85 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VENCLEXTA®
venetoclax tablets
Tablets, 10 mg, 50 mg and 100 mg, oral
Other Antineoplastic Agent (ATC Code: L01XX52)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Qc H4S 1Z1
Date of Initial Authorization:
SEP 27, 2016
Date of Revision:
APR 05, 2022
Submission Control Number: 253017
_VENCLEXTA (venetoclax) _
_Date of Revision: APR 05, 2022 _
_Submission Control No.: 253017 _
_Page 2 of 85 _
RECENT MAJOR LABEL CHANGES
1 Indications
12/2020
1 Indications, 1.2 Geriatrics
04/2020
3 Serious Warnings and Precautions Box
12/2020
4 Dosage and Administration, 4.1 Dosing Considerations
12/2020
4 Dosage and Administration, 4.2 Recommended Dose and Dose
Adjustment
12/2020
7 Warnings and Precautions, Carcinogenesis and Mutagenesis
01/2020
7 Warnings and Precautions, Endocrine and Metabolism
12/2020
7 Warnings and Precautions, Hematologic
12/2020
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic
01/2020
7 Warnings and Precautions, Immune
12/2020
7 Warnings and Precautions, Renal
01/2020
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
.................................................................... 5
1
INDICATIONS
.............................................................................................................
5
1.1
Pediatrics
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICAT