Country: Canada
Language: English
Source: Health Canada
VENETOCLAX
ABBVIE CORPORATION
L01XX52
VENETOCLAX
10MG
TABLET
VENETOCLAX 10MG
ORAL
2/14
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0158490001; AHFS:
APPROVED
2016-09-30
_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 Read the complete document