Prescribing information

 

   

Kymriah® is indicated for the treatment of paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, and adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.1

View the safety profile of Kymriah from the JULIET clinical trial (Go to Kymriah efficacy for study information). For further information, please refer to the Summary of Product Characteristics for full safety information.

Summary of the safety profile1

DLBCL 115 patients infused with Kymriah in a global, multicentre, international study; JULIET (CCTL019C2201)
  All Grades Grade 3/4
Most common non-haematological adverse reactions
Cytokine release syndrome 57% 23%
Infections 58% 34%
Pyrexia 35%  
Diarrhoea 31%  
Nausea 29%  
Fatigue 27%  
Hypotension 25%  
Most common haematological adverse reactions
Decreased lymphocytes 100% 95%
Decreased white blood cells 99% 78%
Decreased haemoglobin 99% 59%
Decreased neutrophils 97% 82%
Decreased platelets 95% 56%

Description of selected adverse drug reactions1

DLBCL 115 patients infused with Kymriah in a global, multicentre, international study; JULIET(CCTL019C2201)
  All Grades Grade 3/4 Grade 3  or higher
Prolonged cytopenias*   100%  
WBC   21%  
Neutrophils   25%  
Lymphocytes   29%  
Thrombocytes   39%  
Decreased haemoglobin   14%  
Cytokine Release Syndrome 57% 23%  
Febrile Neutropenia   17%  
Neurological adverse reactions§ –  encephalopathy and/or delirium 20% 11%  
Hypogammaglobulinaemia 17%    
Infections 58%   34%

*All adult DLBCL patients had Grade 3 and 4 cytopenias at some time after Kymriah infusion.
Not resolved by Day 28.
CRS was graded according to the PENN scale.
§Majority of neurological events occurred within 8 weeks following infusion and were transient.
37% of DLBCL patients experienced an infection of any type within 8 weeks.

CRS, cytokine release syndrome; DLBCL, diffuse large B-cell lymphoma; PENN scale, University of Pennsylvania grading scale; WBC, white blood cell.

Reference

  1. Kymriah Summary of Product Characteristics; Novartis Pharmaceuticals UK Ltd.
Rate this content: 
Average: 5 (1 vote)
UK | October 2021 | 144099
×

Ask Speakers

×

Medical Information Request

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]