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BREYANZI is a brand name for Lisocabtagene Maraleucel, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 09/2024 1 INDICATIONS, 1.2 Geriatrics 09/2024 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 06/2024 7 WARNINGS AND PRECATIONS 09/2024 7 WARNINGS AND PRECATIONS, 7.1.4 Geriatrics 09/2024 7 WARNINGS AND PRECAUTIONS 06/2024 7 WARNINGS AND PRECAUTIONS 06/2025 7 WARNINGS AND PRECAUTIONS 10/2025 8 ADVERSE REACTIONS 06/2024 Table…
Verbatim from this product's HC label. Tap a section to expand.
1. of the PM Guidance) or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. Recent Major Label Changes .................................................................................................
2 Table of Contents ................................................................................................................. 2 Part 1: Healthcare Professional Information..........................................................................
5 1. Indications..................................................................................................................... 1. Pediatrics....................................................................................................................
2. Geriatrics .................................................................................................................... 5 2. Contraindications ..........................................................................................................
5 3. Serious Warnings and Precautions Box ........................................................................... 5 4. Dosage and Administration ............................................................................................
1. Dosing Considerations ............................................................................................... 2. Recommended Dose and Dosage Adjustment .......................................................... 3. Reconstitution ............................................................................................................
4. Administration ........................................................................................................... 5. Missed Dose .............................................................................................................
11 5. Overdose ..................................................................................................................... 11 6. Dosage Forms, Strengths, Composition, and Packaging ................................................
11 7. Warnings and Precautions ........................................................................................... 12 BREYANZI (lisocabtagene maraleucel) Page 3 of 49 General .................................................................................................................................
06/2024 7 WARNINGS AND PRECAUTIONS 06/2025 7 WARNINGS AND PRECAUTIONS 10/2025
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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12 Carcinogenesis and Genotoxicity ......................................................................................... 13 Driving and Operating Machinery ........................................................................................
13 Endocrine and Metabolism .................................................................................................. 13 Immune ................................................................................................................................
13 Neurologic ............................................................................................................................ 18 Reproductive Health.............................................................................................................
1. Special Populations .................................................................................................. 1. Pregnancy.........................................................................................................
2. Breastfeeding ................................................................................................... 3. Pediatrics..........................................................................................................
4. Geriatrics .......................................................................................................... 21 8. Adverse Reactions .......................................................................................................
1. Adverse Reaction Overview ..................................................................................... 2. Clinical Trial Adverse Reactions ............................................................................... 3. Less Common Clinical Trial Adverse Reactions ........................................................
4.
Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry, and Other Quantitative Data ................................................................................................................. 5. Post-Market Adverse Reactions...............................................................................
30 9. Drug Interactions ......................................................................................................... 2. Drug Interactions Overview .....................................................................................
4. Drug-Drug Interactions ............................................................................................ 5. Drug-Food Interactions ............................................................................................
6. Drug-Herb Interactions ............................................................................................ 7. Drug-Laboratory Test Interactions........................................................................... 30 10.
Clinical Pharmacology .................................................................................................. 1. Mechanism of Action ...............................................................................................
2. Pharmacodynamics .................................................................................................. 3. Pharmacokinetics […]