Country: Canada
Language: English
Source: Health Canada
LISOCABTAGENE MARALEUCEL
CELGENE INC
L01X
OTHER ANTINEOPLASTIC AGENTS
120000000CELLS
SUSPENSION
LISOCABTAGENE MARALEUCEL 120000000CELLS
INTRAVENOUS
100
Schedule D
Active ingredient group (AIG) number: 0163641001; AHFS:
APPROVED
2022-05-06
_ _ _BREYANZI (lisocabtagene maraleucel) _ _Page 1 of 39_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr BREYANZI TM lisocabtagene maraleucel Cell suspension in patient-specific single-dose vials, 60 x 10 6 to 120 x 10 6 chimeric antigen receptor (CAR)-positive viable T cells (consisting of CD4 and CD8 components at a ratio range from 0.8 to 1.2), for intravenous infusion Professed Standard Other antineoplastic agent (Anatomical Therapeutic Chemical index code: L01X) Celgene Inc., a Bristol Myers Squibb company 2344 Alfred-Nobel Suite 300 Saint-Laurent, Quebec H4S 0A4 Date of Initial Authorization: May 6, 2022 Submission Control Number: 247562 ©2021 Bristol-Myers Squibb Company BREYANZI is a trademark of Juno Therapeutics, Inc., used under license by Celgene Inc. _ _ _ _ _BREYANZI (lisocabtagene maraleucel) _ _Page 2 of 39_ RECENT MAJOR LABEL CHANGES [Section number and heading], [Subsection number and heading] [MM/YYYY] TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . TABLE OF CONTENTS 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSA Read the complete document