Blincyto
- Name:
Blincyto
- Company:
Amgen Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/12/20
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Amgen Ireland Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name AMGEVITA prefilled pen | Active Ingredients adalimumab |
| Medicine Name AMGEVITA prefilled syringe | Active Ingredients adalimumab |
| Medicine Name Aranesp PFS | Active Ingredients Darbepoetin alfa |
| Medicine Name ARANESP PFS with needle guard | Active Ingredients Darbepoetin alfa |
| Medicine Name Aranesp SureClick | Active Ingredients Darbepoetin alfa |
| Medicine Name Blincyto | Active Ingredients Blinatumomab |
| Medicine Name Imlygic | Active Ingredients Talimogene laherparepvec |
| Medicine Name KANJINTI | Active Ingredients Trastuzumab |
| Medicine Name Kyprolis | Active Ingredients Carfilzomib |
| Medicine Name Mimpara Granules | Active Ingredients cinacalcet hydrochloride |
| Medicine Name Mimpara tablets | Active Ingredients cinacalcet hydrochloride |
| Medicine Name MVASI | Active Ingredients Bevacizumab |
| Medicine Name Neulasta On Body Injector | Active Ingredients Pegfilgrastim |
| Medicine Name Neulasta Pre-Filled Syringe | Active Ingredients Pegfilgrastim |
| Medicine Name Neupogen 30 MU (0.3 mg/ml) solution for injection | Active Ingredients Filgrastim |
| Medicine Name Neupogen Singleject 30 MU (0.6 mg/ml) | Active Ingredients Filgrastim |
| Medicine Name Neupogen Singleject 48 MU (0.96 mg/ml) | Active Ingredients Filgrastim |
| Medicine Name Nplate reconstitution kit | Active Ingredients Romiplostim |
| Medicine Name Nplate vial | Active Ingredients Romiplostim |
| Medicine Name Otezla 10mg, 20mg, 30mg | Active Ingredients Apremilast |
| Medicine Name Parsabiv | Active Ingredients etelcalcetide |
| Medicine Name Prolia | Active Ingredients Denosumab |
| Medicine Name Repatha SureClick | Active Ingredients Evolocumab |
| Medicine Name Vectibix | Active Ingredients Panitumumab |
| Medicine Name XGEVA | Active Ingredients Denosumab |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 4 January 2021 Ed-HCP
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Updated in line with indication update
Updated on 23 December 2020 PIL
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 SPC
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
|
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 SPC
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)
Updated on 4 September 2019 Ed-HCP
Reasons for updating
- Replace document
Updated on 16 April 2019 Ed-HCP
Reasons for updating
- Replace document
Updated on 16 April 2019 Ed-Ptnt
Reasons for updating
- Replace document
Updated on 16 April 2019 Ed-Ptnt
Reasons for updating
- Replace document
Updated on 23 January 2019 PIL
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 SPC
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)
Updated on 22 November 2018 Ed-HCP
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
Updated on 22 November 2018 Ed-HCP
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
Updated on 22 November 2018 Ed-HCP
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
Updated on 22 November 2018 Ed-Ptnt
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 PIL
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 SPC
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
Updated on 28 August 2018 Ed-Ptnt
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
Updated on 3 August 2018
Updated on 20 June 2018 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 May 2018 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 September 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 September 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 26 September 2017 SPC
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 SPC
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 8 August 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 7 August 2017 SPC
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 4 November 2016 SPC
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 4 November 2016 PIL
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 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 12 August 2016 SPC
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 5 May 2016 SPC
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 5 May 2016 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 2 December 2015 PIL
Reasons for updating
- Improved electronic presentation
Updated on 27 November 2015 SPC
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 PIL
Reasons for updating
- New PIL for new product
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Blincyto patient alert cardRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines