Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion * Pharmacy Only: Prescription
Company:
Novartis Ireland LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 14 November 2022
File name
63723a2920da8.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2: The B-cell ALL subsection of “Paediatric Population” section has been updated with “Currently available data in this age group are described in sections 4.8 and 5.1”
Section 4.8: Updated to include a new section on the safety of tisagenlecleucel in r/r B-cell ALL paediatric patients
Section 5.1: Updated to include paediatric data from the observational study B2401.
Updated on 19 October 2022
File name
634fcd1469b32.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC update with pooled safety data from the 3 ALL studies CCTL019B2202, CCTL019B2205J and CCTL019B2001X
Section 4.2: Information for pediatric populations amended
Section 4.4: Amendments to sections on ‘Neurological events’ and ‘Prior treatment with anti‑CD19 therapy’
Section 4.8: Updated to reflect data from studies CCTL019B2205J and CCTL019B2001X
Section 5.1: Updated to include pediatric data from Phase II study BIANCA C2022
Updated on 19 October 2022
File name
634fca3776204.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Use in Children & Adolescents amended to refer to limited experience in pediatric patients below 3 years of age in B ALL. Kymriah is not recommended to be used in children and adolescents below 18 years of age to treat DBLCL due to limited experience. Kymriah should not be used in children and adolescents below 18 years of age to treat FL. This is because Kymriah has not been studied in this age group.
Changes to frequency of following side effects: 'Raised blood pressure' (changed from 'common' to 'very common') and 'Abnormal blood test results (high level of magnesium)' (change from 'very common' to 'uncommon') and "low levels of magnesium' (from 'very common' to 'common')
Updated on 05 May 2022
File name
Kymriah REG SPC PF21-203 April 2022_clean IPHA_1651750810.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes due to ne Follicular Lymphoma indicaiton
Updated on 05 May 2022
File name
Kymriah REG PIL PF21-203 April 2022_clean IPHA_1651749545.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Changes due to new Follicular Lymphoma indication
Updated on 15 February 2022
File name
Kymriah REG SPC PF22-037 February 2022_clean_1644914849.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor amendments to reflect change in shipping configuration without metal cassette
Updated on 31 January 2022
File name
Kymriah REG PIL PF22-003 January 2022_clean IPHA_1643620170.pdf
Reasons for updating
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Update to 'Information for Healthcare Professionals' section to include instuctions for CRS management in the event of a tocilizumab shortage.
Updated on 31 January 2022
File name
Kymriah REG SPC PF22-003 January 2022_clean IPHA_1643619310.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to SmPC supporting treatment with Kymriah in the event of tocilizumab EU shortage:
- Section 4.2: In the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, suitable alternative measures to treat CRS instead of tocilizumab must be available prior to infusion.
- Section 4.4: In the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, the treatment centre must have access to suitable alternative measures instead of tocilizumab to treat CRS.
Updated on 24 June 2021
File name
Kymriah REG SPC PF21-154 June 2021_clean IPHA_1624540473.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 5.1: Updated to with revised efficacy information based on data presented in the iCSR of study CCTL019C2201.
Updated on 31 March 2021
File name
Kymriah REG SPC PF21-057 & 21-062 March 2021 IPHA_1617189515.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 5.1: Updated to include the new clinical efficacy results of CCTL019B2205J & ATC code
- Section 6.4 & 6.5: Description of the shipping configuration updated due to approval of an alternate dry shipper for the shipment of leukapheresis material and final Kymriah product.
Updated on 28 April 2020
File name
Kymriah REG SPC PF20-078 March 2020 clean_1588068057.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 April 2020
File name
Kymriah REG SPC PF20-078 March 2020 clean_unsigned_1587027293.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 April 2020
File name
Kymriah REG PIL PF2-078 March 2020_IPHA_1587027241.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product