Kyleena 19.5 mg intrauterine delivery system *

  • Company:

    Bayer Limited
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *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.

EDM Updated on 13 October 2021

File name

Kyleena PRC_88415973_1634139201.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

"Ireland" has been added to the Marketing Authorisation Holder address. 

Updated on 28 September 2021

File name

20210924_SmPC_CC_ KYL_BP20108_1632835376.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

BEC 18535

Note:

Text in blue = added text

Text in red with strikethrough = deleted text

4.4 Special warnings and precautions for use

[….]

Expulsion

In clinical trials with Kyleena, the incidence of expulsion was low (<4% of insertions) and in the same range as that reported for other IUDs and IUSs. Symptoms of the partial or complete expulsion of Kyleena may include bleeding or pain. However, partial or complete expulsion can occur without the woman noticing it, leading to decrease or loss of contraceptive protection. As Kyleena typically decreases menstrual bleeding over time, an increase of menstrual bleeding may be indicative of an expulsion.

Risk of expulsion is increased in

- Women with history of heavy menstrual bleeding

- Women with greater than normal BMI at the time of insertion; this risk increases gradually with increasing BMI

Women should be counselled on possible signs of expulsion and how to check the threads of Kyleena and advised to contact a healthcare professional if the threads cannot be felt. A barrier contraceptive (such as a condom) should be used until the location of Kyleena has been confirmed.

A partially expelled Kyleena should be removed. A new system can be inserted at that the time of removal, provided pregnancy has been excluded.

A woman should be advised how to check the threads of Kyleena and to contact her healthcare professional if the threads cannot be felt

[….]

10. Date of revision of the text

July 2021September 2021

Updated on 28 September 2021

File name

20210907_PL&TIL_CC_KYL_BP20108_1632835222.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

BEC 18535

Note:

Text in blue = added text

Text in red with strikethrough = deleted text

2. What you need to know before you use Kyleena

General notes

Before you can begin using Kyleena, your healthcare professional will ask you some questions about your personal health history.

In this leaflet, several situations are described where Kyleena should be removed, or where the reliability of Kyleena may be decreased. In such situations you should either not have intercoursesex or you should use a condom or another barrier method.

Kyleena, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Kyleena is not suitable for use as an emergency contraceptive (postcoital contraceptive).

[….]

Warnings and precautions

[….]

Contact your healthcare professional promptly if any of the following occur (see also section 4):

[….]

  • you no longer feel the threads in your vagina. This may be a sign of expulsion or perforation. You can check by gently putting a finger into your vagina and feeling for the threads at the end of your vagina near the opening of your womb (cervix). Do not pull the threads because you may accidentally pull out Kyleena. Avoid intercourse or uUse a barrier contraceptive (such as condoms) until your healthcare professional has checked that the IUS is still in position.

[….]

4. Possible side effects

[….]

Expulsion

The muscular contractions of the womb during menstruation may sometimes push the IUS out of place or expel it. This is more likely to occur if you are overweight at the time of IUS insertion or have a history of heavy periods. If the IUS is out of place, it may not work as intended and therefore, the risk of pregnancy is increased. If the IUS is expelled, you are not protected against pregnancy anymore.It is rare but possible for Kyleena to come out during your menstural period without you noticing.

Possible symptoms of an expulsion are pain and abnormal bleeding but Kyleena may also come out without you noticing. As Kyleena typically decreases menstrual flow over time, increase of menstrual flow may be a sign that Kyleena has been expelled. See section 2 “Warnings and precautions” for how to check if Kyleena is in place and what to do if you suspect that Kyleena is no longer in place.

It is also possible for your Kyleena to partially expel from your womb, meaning that it is displaced but not completely expelled (you and your partner may notice this during sexual intercourse). If Kyleena is completely or partially expelled ,you will not be protected from pregnancy.

[….]

Section 6 Content of the pack and other information

[….]

This medicinal product is authorised in the Member States of the EEA under the following names:

  • Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Lithuania, The Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom: Kyleena

 This leaflet was last revised in July 2021September 2021.

Updated on 19 July 2021

File name

20210512_PL&TIL_CC_KYL_BP20061_reviewed_1626701397.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

(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

[…]

Follow-up examination:

[…]

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.

Updated on 19 July 2021

File name

20210512_SmPC_CC_ KYL_BP20061_reviewed_1626701269.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

(BP20061_BEC17809)

4.6 Fertility, pregnancy and lactation

[…]

Pregnancy

[…]

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

 

EDM Updated on 08 June 2021

File name

20210518_oth_em_CombHCPBroch_printer_Ecto+Pearl+6y_BP21013+BP21031_1623153440.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

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.

Updated on 21 April 2021

File name

20210416_SmPC_CC_ KYL_BP20119_1618990114.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

BEC: Renewal

Reason for change: Renewal of Marketing Authorisation

Sections updated:

  1.          MARKETING AUTHORISATION HOLDER

 

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

  1.          DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16th December 2016

Date of last renewal: 3rd October 2021

  1.        DATE OF REVISION OF THE TEXT

April 2021 June 2020

 

 

EDM Updated on 06 October 2020

File name

PRC_cropped_for medicines.ie_1601975225.pdf

Reasons for updating

  • Add New Doc

Updated on 05 October 2020

File name

20200715_PL&TIL_CC_KYL_BP20003_1601899277.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

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).

 

EDM Updated on 21 August 2020

File name

605348 - Bayer - Educational Materials Mailing - Proof 04 (HR)_1598001178.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

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

Updated on 07 July 2020

File name

20200703_PL&TIL_CC_KYL_BP20037_1594147322.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

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

Updated on 07 July 2020

File name

20200703_SmPC_CC_ KYL_BP20037_1594146172.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

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

 

Updated on 07 July 2020

File name

18292_PL&TIL_CC_KYL_20190619_1560950712.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

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

[.....]

 

Updated on 20 June 2019

File name

18292_PL&TIL_CC_KYL_20190619_1560950712.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 19 June 2019

File name

18292_SPC_KYL_CC_20190619_1560950389.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update to warnings and prcautions due to PRAC reccommendation

Updated on 10 December 2018

File name

18019_PL_CC_Kyleena_20181210_1544459240.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 10 December 2018

File name

18019_SPC_KYL_CC_20181210_1544459276.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 May 2018

File name

20180412_SPC_Kyleena_CC_17107.docx

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 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.

Updated on 26 April 2018

File name

20180312_PL_CC_Kyleena_17107.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 April 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 April 2018

Reasons for updating

  • 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

In section 6.3, the shelf-life has been changed from 2 to 3 years.

In section 10, the revision date has been updated to March 2018.

Updated on 04 April 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 April 2017

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

None provided

Updated on 03 April 2017

File name

PIL_17140_319.pdf

Reasons for updating

  • New PIL for new product