Blincyto
*Company:
Amgen Ireland LtdStatus:
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 21 March 2024
File name
en_blincyto_approved_spc_CDSv14v15v16 Clean (IE + XI).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changed wording in dosage table from patient to body
Updated pharmacotherapeutic group wording
Added E number for polysorbate 80
Qualifying line in Table 14 added: The safety of the administration of BLINCYTO for BSA of less than 0.4 m2 has not been established.
Administrative updates, nomenclature update to B-cell precursor,
Updated on 21 March 2024
File name
en_blincyto_approved_pil_CDSv14v15v16 Clean (IE + XI).pdf
Reasons for updating
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Added E number for polysorbate 80
nomenclature update to B-cell precursor
Changed wording in dosage table from patient to body
Qualifying line in Table 14 added: The safety of the administration of BLINCYTO for BSA of less than 0.4 m2 has not been established.
Updated on 26 February 2024
File name
en_blincyto_approved_spc_TIB Section 5.1 Clean (IE and NI).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
Summarised the updated efficacy data from the final analysis of study 20120215.
Updated on 13 December 2023
File name
en_blincyto_approved__spc_CDS v13 Clean (IE and NI).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated information on the of anti-blinatumomab antibodies under the immunogenicity sub title
Updated on 17 March 2023
File name
en_blincyto_approved__pil_r48 (IE and NI).pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 17 March 2023
File name
en_blincyto_approved__spc_r48 (IE and NI).pdf
Reasons for updating
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 September 2022
File name
en_blincyto_approved_spc_v47 (IE and NI).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Blincyto aRMMs IE (Guide for Patients-Caregivers)_v4.0 final.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to improve usability
File name
Blincyto aRMMs IE (Guide for Nurses)_v4.0 final.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to improve usability
File name
Blincyto aRMMs EU (Guide For Physicians)_pediatric indication update_v7.0 final.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to improve usability
File name
Blincyto aRMMs IE (Guide for Pharmacists)_v5.0 final.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to improve usability
File name
Blincyto aRMMs IE (Patient Card)_v3.0 final.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to improve usability
Updated on 29 June 2021
File name
en_blincyto_approved_spc_v38 (IE and NI).pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 June 2021
File name
en_blincyto_approved_pil_v38 (NI and IE).pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 01 April 2021
File name
en_blincyto_approved_pil_PSUR9+v41(IE and XI).pdf
Reasons for updating
- Change to improve clarity and readability
Free text change information supplied by the pharmaceutical company
Addition of information of risk minimisation materials for patients
Updated on 01 April 2021
File name
en_blincyto_approved_spc_PSUR9+v41 (IE and XI).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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
3816 v2 - PEB IE.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Updated in line with indication update
Updated on 23 December 2020
File name
en_blincyto_approved_pil_v30.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
Updated on 23 December 2020
File name
en_blincyto_approved_spc_v30.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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SPC |
Summary Of Changes |
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Section 4.1 Therapeutic indications |
Update to indication:
BLINCYTO is indicated as monotherapy for the treatment of adults with
BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B‑precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
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Section 4.2 Posology and method of administration |
Edits to include Ph+ within instructions for treatment within the R/R setting
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Section 4.4 Special warnings and precautions for use |
Addition of section regarding Traceability Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
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Section 4.8 Undesirable effects |
Addition of information regarding the incidence of selected adverse reactions within the Ph+ population – neurological events, cytokine release syndrome, elevated liver enzymes
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Section 5.1 Pharmacodynamic Properties |
Addition of section describing outcomes from ALCANTARA trial: Philadelphia chromosome positive relapsed or refractory B‑precursor ALL in adult patients |
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Section 10 Date of Revision |
December 2020 |
Updated on 25 October 2019
File name
en_blincyto_approved_spc_v32.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
UKIE-NPC-103-1015-116502a(4)_PEB_final_IE.pdf
Reasons for updating
- Replace File
File name
ED69528 Blincyto ROI Patient carer Brochure.pdf
Reasons for updating
- Replace File
File name
ED69528 Blincyto ROI PAC.pdf
Reasons for updating
- Replace File
File name
ED69528 Blincyto ROI Physician Brochure.pdf
Reasons for updating
- Replace File
Updated on 23 January 2019
File name
en_blincyto_approved_pil_v11.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
Updated on 23 January 2019
File name
en_blincyto_approved_spc_v11.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Pharmacist Brochure.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
This educational brochure contains important information regarding the reconstitution and preparation procedures for blinatumomab. To ensure the safe and effective use of the medicinal product and appropriate management of the important selected risks, please carefully read this material before reconstituting and preparing of the medicinal product.To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441
File name
Physician Brochure.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
This educational brochure contains important information regarding the administration of BLINCYTO and the risks of medication errors and neurologic events. This educational material is essential to ensure the safe and effective use of the product and appropriate management of the important selected risks and therefore it is advised to be read carefully before administering the medicinal product.To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441
File name
Nurse Brochure.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
This educational brochure contains important information regarding the administration of BLINCYTO and the risks of medication errors and neurologic events. This educational material is essential to ensure the safe and effective use of the product and appropriate management of the important selected risks and therefore it is advised to be read carefully before prescribing and administering the medicinal product.To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441
File name
Patient_carer Brochure.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
This educational brochure contains important information you should know before receiving BLINCYTO. This educational material is essential to ensure the safe and effective use of the drug and appropriate management of the important selected risks. Please read it carefully before taking the medicinal product. To request a copy of this guide, please contact Amgen Medical Information on +44 (0) 1223 436441
Updated on 30 August 2018
File name
en_blincyto_approved_pil_v18.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 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 30 August 2018
File name
en_blincyto_approved_spc_v18.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC updated to include paediatric indication; clarification to adult indication
File name
3024_BLICYNTO_PATIENT_CARD_IRE_021215.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
This BLINCYTO patient alert card contains a warning message for HCPs that the patient is using BLINCYTO, includes contact details of the BLINCYTO prescriber and treatment start date, and information on the importance of reporting ADRs. To request a copy of the patient card, please contact Amgen Medical Information on +44 (0) 1223 436441
File name
en_blincyto_approved_pil_09.pdf
Updated on 20 June 2018
File name
en_blincyto_approved_spc_09.docx
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of data from Phase III study
Updated on 19 June 2018
File name
en_blincyto_approved_spc_PSUR3_ataxia.docx
Reasons for updating
- 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
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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Section 4.4 Special warnings and precautions for use |
Updates to the following sections: Neurologic events
Cytokine release syndrome and infusion reactions
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Section 4.8 Undesirable effects |
Updates to the following sections: Summary of the safety profile Tabulated list of adverse reactions Description of selected adverse reactions Neurologic events Infections Cytokine release syndrome (CRS) Elevated liver enzymes Leukoencephalopathy including progressive multifocal leukoencephalopathy Immunogenicity
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Section 5.1 Pharmacodynamic properties |
Updated with data from phase III study Deletion of paragraph describing open label dose-escalating study (n=36) Deletion of text regarding conditional approval scheme
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5.2 Pharmacokinetic properties |
Update to Css |
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Section 6.6 Special precautions for disposal and other handling |
Consolidation of instruction for preparation of the solution for infusion |
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Section 10 Date of revision of the text |
June 2018 |
Updated on 19 June 2018
File name
en_blincyto_approved_pil_09.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 May 2018
File name
en_blincyto_approved_spc_PSUR3_ataxia.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 May 2018
File name
en_blincyto_approved_spc_PSUR3_ataxia.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2018
File name
en_blincyto_approved_spc_PSUR3_ataxia.docx
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of ataxia as a common adverse reaction
Date of revision updated to March 2018
Updated on 19 April 2018
File name
en_blincyto_approved_pil_PSUR3_ataxia.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 September 2017
File name
PIL_16528_908.pdf
Reasons for updating
- New PIL for new product
Updated on 26 September 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 September 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 08 August 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 07 August 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The shelf life of the unopened vials has been extended from 4 years to 5 years
Section 10 DATE OF REVISION OF THE TEXT
This section has been updated to July 2017
Updated on 04 November 2016
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Clarification to posology and method of administration (4.2)
Updated on 04 November 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 12 August 2016
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.3: Shelf life
Changed from 3 years to 4 years
Section 10: Date of revision
Updated to August 2016
Updated on 12 August 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 05 May 2016
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
"Using a syringe, aseptically transfer 3.
Updated on 05 May 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 02 December 2015
Reasons for updating
- Improved electronic presentation
Updated on 27 November 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 November 2015
Reasons for updating
- New PIL for new product