POTELIGEO 4 mg/mL concentrate for solution for infusion * Pharmacy Only: Prescription
Company:
Kyowa Kirin International plcStatus:
No Recent UpdateLegal 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