Kyleena 19.5 mg intrauterine delivery system

(BP20061_BEC17809)

2. What you need to know before you use Kyleena

Warnings and precautions

[…]

Use of sanitary pads is recommended. If tampons or menstrual cups are used, you should change them with care so as not to pull the threads of Kyleena. If you think you may have pulled Kyleena out of place (see list above for possible signs), avoid intercourse or use a barrier contraceptive (such as condoms), and contact your healthcare professional.

[…]

Pregnancy, breastfeeding and fertility

Pregnancy

[…]

If you become pregnant with Kyleena in place, you should see your healthcare professional immediately to have Kyleena removed. There isThe removal may cause a risk of spontaneousmiscarriage. However, if Kyleena is removed during pregnancy.

If you leave Kyleena left in place during pregnancy, not only is the risk of having a miscarriage, infection or higher, but also the risk having preterm labour. will If Kyleena cannot be increased. Talkremoved, talk with your healthcare professional about the benefits and risks of continuing the pregnancy,. and possible effects of the hormone on the developing baby.

[…]

3. How to use Kyleena

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Follow-up examination:

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Bring the patient reminder card you have received from your doctor to every scheduled appointment. If you received a patient reminder card from your doctor bring this with you to every scheduled appointment.

6. Contents of the pack and other information

Marketing Authorisation Holder

Bayer Limited,

The Atrium,

Blackthorn Road,

Dublin 18,

Ireland.

[…]

This leaflet was last revised in July 2021September 2020.

(BP20061_BEC17809)

4.6 Fertility, pregnancy and lactation

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Pregnancy

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If a woman becomes pregnant while using Kyleena ectopic pregnancy should be excluded and the system should be removed as soon as possible, timely removal of the system is recommended since any intrauterine contraceptive left in situ may increase the risk of abortion and preterm labour.

[…]

In addition, an increased risk of virilising effects in a female foetus because of the intrauterine exposure to levonorgestrel cannot be excluded. There have been isolated cases of masculinization of the external genitalia of the female foetus following local exposure to levonorgestrel during pregnancy with an LNG-IUS in place.

Because of the intrauterine administration and the local exposure to levonorgestrel, the possible occurrence of virilizing effects in a female fetus should be taken into consideration. Clinical experience of the outcomes of pregnancies under Kyleena treatment is limited due to the high contraceptive efficacy. Women should be informed that, to date, there is no evidence of birth defects caused by a levonorgestrel-releasing intrauterine system use in cases where pregnancy has continued to term with the levonorgestrel-IUS in place.

[…]

10. DATE OF REVISION OF THE TEXT

April 2021July 2021

Educational materials - HCP:

(BP21013+BP21031)

• Content updates were made to extend the duration of use of Mirena to 6 years, for the indication contraception.
• Additional information has been included on the pearl index and ectopic pregnancy rates, as observed in clinical trials and included in the respective SmPCs for Mirena, Jaydess and Kyleena.
• 2D and 3D ultrasound pictures were updated.

BEC: Renewal

Reason for change: Renewal of Marketing Authorisation

Sections updated:

7.          MARKETING AUTHORISATION HOLDER

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

9.          DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16^th December 2016

Date of last renewal: 3^rd October 2021

10.        DATE OF REVISION OF THE TEXT

April 2021 June 2020

The start of the PIL

Deletion of Patient's name, Doctor's name, Doctor's phone number, Date of insertion, Latest date of removal, First check up visit and Next visits: 1, 2, 3, 4, 5.

Section 6

Deletion of Croatia from the list of member states of the EEA.

Section 6 - date of revision

This leaflet was last revised in July 2020September 2020.

Change to information for healthcare professionals

Summary of Product Characteristics for Kyleena online at www.pi.bayer.com/kyleena/ie

(Addition of website address).

HCP brochure containing information re differentiation between Bayer's LNG-IUDs and ectopic pregnancy

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

PIL Section 2 Warnings and Precautions

[.....]

Use of sanitary pads is recommended. If tampons or menstrual cups are used, you should change them with care so as not to pull the threads of Kyleena.

PIL Section 4 Possible side effects

[.....]

Common side effects: may affect up to 1 in 10 people

Common side effects added:

'decreased libido'

'dizziness'

'increased weight'

[.....]

<'hair loss' re-located to maintain the same order of the adverse events as in the SmPC.>

[.....]

<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

[.....]

PIL Section 6:

This leaflet was last revised in April 2019 July 2020

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

SmPC Section 4.8

Tabulated summary of adverse events

 [.....]

'Deceased libido' added as a common side effect under System Organ Class: Psychiatric disorders.

'Dizziness' added as a common side effect under System organ Class: Vascular disorders

'Increased weight' added as a common side effect under System Organ Class: Investigations

[.....]

<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W  website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

[.....]

SmPC section 10, Date of revision of the text:

April 2019 June 2020

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

PIL Section 2 Warnings and Precautions

[.....]

Use of sanitary pads is recommended. If tampons or menstrual cups are used, you should change them with care so as not to pull the threads of Kyleena.

[.....]

PIL Section 4 Possible side effects

[....]

Common side effects: may affect up to 1 in 10 people

Common side effects added:

'decreased libido'

'dizziness'

'increased weight'

[.....]

[.....]

<'hair loss' re-located to maintain the same order of the adverse events as in the SmPC.>

[.....]

<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

[.....]

PIL Section 6:

[.....]

This leaflet was last revised in April 2019 July 2020

[.....]

Update to warnings and prcautions due to PRAC reccommendation

The SmPC has updated as a result of the final study report for the subgroup of EURAS-IUD. The perforation text under subsection ‘Insertion and removal/ replacement’ was adapted to current medical practice, the average estimated in vivo release rate over the 1st year was added to section 5.2 and text under 4.8 regarding sepsis was adjusted to reflect the class effect. Editorial spelling changes also made.