POTELIGEO 4 mg/mL concentrate for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Kyowa Kirin International plc
  • 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 11 August 2021

File name

pl-h-4232-ie-clean - June 2021_1628687457.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2:

Do not use POTELIGEO - Removal of if you are in title and addition of 'if you are' at beginning of paragraph.

Pregnancy and breast-feeding - Removal of section titled Men

Section 5:

Paragraph starting 'Reconstituted/diluted solutions:' '...use within 4 hours.' changed to '...use within 24 hours.'

Date of revision changed from 10/2019 to 06/2021

Updated on 11 August 2021

File name

spc-h-4232-ie-clean - June 2021_1628687263.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2:

Do not use POTELIGEO - Removal of if you are in title and addition of 'if you are' at beginning of paragraph.

Pregnancy and breast-feeding - Removal of section titled Men

Section 5:

Paragraph starting 'Reconstituted/diluted solutions:' '...use within 4 hours.' changed to '...use within 24 hours.'

Date of revision changed from 10/2019 to 06/2021

 

Updated on 11 August 2021

File name

spc-h-4232-ie-clean - June 2021_1628686460.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 updates to the Poteligeo SmPC are as follows:


Section 4.4 - Special warnings and precautions for use

The following paragraph has been added:

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 4.6 - Fertility, pregnancy and lactation

The following paragraph has been changed

From:
Women of childbearing potential/Contraception in males and females
Women of childbearing potential and males of reproductive potential should use effective contraception during treatment with POTELIGEO and for at least 6 months after treatment

To:
Women of childbearing potential/Contraception in females
Women of childbearing potential should use effective contraception during treatment with POTELIGEO and for at least 6 months after treatment.


Section 4.8 - Undesirable effects

The following paragraph has been changed

From:

Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. A small percentage of patients receiving POTELIGEO tested positive for treatment emergent (treatment induced or treatment boosted) anti mogamulizumab antibodies. There were no positive neutralising antibody responses.

To:

Immunogenicity
Following infusion of POTELIGEO during clinical studies of the use of POTELIGEO in patients with adult T-cell leukaemia-lymphoma or cutaneous T-cell lymphoma, approximately 14% of patients (44 out of 313 evaluable patients) tested positive for treatment emergent anti-mogamulizumab antibodies. There were no patients identified to have positive neutralising antibody responses.

 

Section 6.3 – Shelf life

 The following paragraph has been change

 From:
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 4 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions

To:
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions

Section 10 - Date of revision of the text

Changed from: October 2019 to: June 2021

Updated on 07 October 2020

File name

pl-h-4232-ie_1602070363.pdf

Reasons for updating

  • New PIL for medicines.ie

Free text change information supplied by the pharmaceutical company

New PIL

Updated on 07 October 2020

File name

pl-h-4232-ie_1602069776.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 07 October 2020

File name

pl-h-4232-ie_1602069776.pdf

Reasons for updating

  • New PIL for medicines.ie

Free text change information supplied by the pharmaceutical company

New PIL

Updated on 07 October 2020

File name

pl-h-4232-ie_1602069776.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL

Updated on 07 October 2020

File name

spc-h-4232-ie_1602069640.pdf

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

New SPC