Blincyto *

  • Company:

    Amgen Ireland Ltd
  • Status:

    No Recent Update
  • Legal 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

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 29 June 2021

File name

en_blincyto_approved_spc_v38 (IE and NI)_1624975567.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)_1624975440.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)_1617292843.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)_1617289258.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)

EDM Updated on 04 January 2021

File name

3816 v2 - PEB IE_1609769101.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_1608739480.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_1608739410.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

SPC

Summary Of Changes

Section 4.1 Therapeutic indications

Update to indication:

 

BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B‑precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.

 

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.

 

Section 4.2 Posology and method of administration

Edits to include Ph+ within instructions for treatment within the R/R setting

 

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.

 

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

 

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

Section 10 Date of Revision

December 2020

Updated on 25 October 2019

File name

en_blincyto_approved_spc_v32_1571991014.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)

EDM Updated on 04 September 2019

File name

UKIE-NPC-103-1015-116502a(4)_PEB_final_IE_1567587053.pdf

Reasons for updating

  • Replace File

EDM Updated on 16 April 2019

File name

ED69528 Blincyto ROI Physician Brochure_1552302663.pdf

Reasons for updating

  • Replace File

EDM Updated on 16 April 2019

File name

ED69528 Blincyto ROI PAC_1552302663.pdf

Reasons for updating

  • Replace File

EDM Updated on 16 April 2019

File name

ED69528 Blincyto ROI Patient carer Brochure_1552302663.pdf

Reasons for updating

  • Replace File

Updated on 23 January 2019

File name

en_blincyto_approved_pil_v11_1548239817.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_1548239669.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)

EDM Updated on 22 November 2018

File name

Pharmacist Brochure_1542821194.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

EDM Updated on 22 November 2018

File name

Physician Brochure_1542821194.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

EDM Updated on 22 November 2018

File name

Nurse Brochure_1542821194.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

EDM Updated on 22 November 2018

File name

Patient_carer Brochure_1542821194.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_1535614979.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_1535614883.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

EDM Updated on 28 August 2018

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

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

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

File name

PIL_16528_908.pdf

Reasons for updating

  • New PIL for new product

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

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 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

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 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

SPC updated to reflect risk of pancreatitis (4.4, 4.8)
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 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

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 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

None provided

Updated on 27 November 2015

Reasons for updating

  • New PIL for new product