POTELIGEO 4 mg/mL concentrate for solution for infusion

Removal of Black Inverted Triangle and Change to section 4 - Possible side effects

removal of black inverted triangle

Removal of inverted Black Triangle

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

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

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

New PIL

New PIL

New PIL

New SPC