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

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