Blincyto

  • Name:

    Blincyto

  • Company:
    info
  • Active Ingredients:

    Blinatumomab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/01/19

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Summary of Product Characteristics last updated on medicines.ie: 25/10/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Amgen Ltd

Amgen Ltd

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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 25 October 2019 SmPC

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 SmPC

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-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 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 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 SmPC

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 SmPC

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 SmPC

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

Section 4.4 Special warnings and precautions for use

Updates to the following sections:

Neurologic events

 

Cytokine release syndrome and infusion reactions

 

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

 

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

 

5.2 Pharmacokinetic properties

Update to Css

Section 6.6 Special precautions for disposal and other handling

Consolidation of instruction for preparation of the solution for infusion

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 April 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 September 2017 SmPC

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 cranial nerve disorder as an adverse reacion

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 SmPC

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
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 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 4 November 2016 SmPC

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

SPC updated to reflect risk of pancreatitis (4.4, 4.8)
Clarification to posology and method of administration (4.2)

Updated on 12 August 2016 SmPC

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 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 5 May 2016 SmPC

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

Section 6.6 - typo correction to dosing instruction in d) 5.
"Using a syringe, aseptically transfer 3.53 mL of reconstituted BLINCYTO into the infusion bag (2.0 mL from one vial and the remaining 1.53 mL from the second vial."

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 SmPC

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

None provided

Updated on 27 November 2015 PIL

Reasons for updating

  • New PIL for new product