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Real World Evidence

The Kyleena
^®
(19.5mg levonorgestrel) Satisfaction Study (KYSS)

prescribing information

Kyleena satisfaction study

KYSS is a prospective, multinational, single-arm, observational study.

Kyleena^® placement was attempted in 1,129 women and successful in 1,126 women

The majority of women were between 18 and 35 years of age (67.1%, n=756).

Participants were recruited from Belgium, Canada, Germany, Mexico, Norway, Sweden, Spain and the USA, from 2017 to 2018.

† Either a COC or a POP.

‡ "Other" includes all methods with <10% of women using them: vaginal HC (3.1%), non-hormonal IUD (3.0%), natural planning (1.2%), implant (0.7%), Injectables, transdermal HC (0.2%) and backup contraception (0.09%).

COC – combined oral contraceptive; HC – hormonal contraception; IUD – intrauterine device; IUS – intrauterine system; KYSS – Kyleena Satisfaction Study;
POP – progestogen-only pill

Women want more from their contraception than just clinical efficacy

Kyleena: placement rated as easy for most women regardless of parity

Misperceptions around IUS placement may be a barrier to its use among parous and nulliparous women,

but the RWE from KYSS can bring confidence to your patients

(n=1,110)

Satisfaction was similarly high for both parous and nulliparous women

Kyleena
^®
: high satisfaction rates, irrespective of age

Percentage of women satisfied with Kyleena, by age

^{Adapted from Stovall DW et al 2021}

Most women were satisfied with Kyleena
^®
,
no matter their…

Previous contraception

^†

85.2% of women who switched from an oral HC were satisfied (n=317)

Motivation for choosing Kyleena

^®†

84.3% of women who chose Kyleena® mainly for its low-hormone dose were satisfied (n=248)

* Results shown represent women who reported being “very satisfied” or “somewhat satisfied” with Kyleena® at the end of the final visit.
† Results shown for each of the topics mentioned are representative of one of the subgroups only. Not all patients had the same previous contraception, motivation for choosing Kyleena®, or country of residency.
HC – hormonal contraception

Kyleena
^®
demonstrated a high level of satisfaction with the bleeding profile in KYSS

Bleeding profile satisfaction is important, as it can significantly impact women’s quality of life

^{* A total of 632/887 women in KYSS reported their satisfaction with their bleeding profile while on Kyleena®.}
^{KYSS – Kyleena® Satisfaction Study}

81.5% of patients in the patient safety analysis group experienced no adverse events with Kyleena
^®

Discontinued Kyleena® due to TEAEs and TESAEs, respectively

*The most common TEAEs were gastrointestinal disorders 3.3%, reproductive system and breast disorders 9.5% and infections and infestations 2.3%

SAF – safety analysis set; TEAE – treatment-emergent adverse event; TESAE – treatment-emergent serious adverse event.
Please refer to the SmPC for the full summary of Kyleena's safety profile

What side effects can patients experience from Kyleena® (19.5mg intrauterine delivery system levonorgestrel)?

The majority of patients experience changes in menstrual bleeding pattern after insertion of Kyleena^® (19.5mg intrauterine delivery system levonorgestrel). Women can experience shorter, lighter periods versus before Kyleena^® insertion, and can experience amenorrhoea over 5 years. Very common side effects (more than 1 in 10 women) include:

headache
abdominal/pelvic pain
acne/greasy skin
bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent periods and absence of bleeding
ovarian cysts
inflammation of the external genital organs and vagina (vulvovaginitis)

Common side effects (up to 1 in 10 women) include:

depressed mood/depression
migraine
feeling sick (nausea)
upper genital tract infection
painful menstruation
breast pain/discomfort
device expulsion (complete and partial)
hair loss
genital discharge
decreased libido
dizziness
increased weight

Kyleena can cause serious side effects, including:

Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you become pregnant while using Kyleena (see “What if I become pregnant while using Kyleena?”).

Life‐threatening infection. Life‐threatening infection can occur within the first few days after Kyleena is placed. Call your healthcare professional immediately if you develop severe pain or fever shortly after Kyleena is placed.

Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually caused by a sexually transmitted infection. You have a higher chance of getting PID if you or your partner has sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID may require surgery including removal of the uterus (hysterectomy). In rare cases, infections that start as PID can even cause death. Tell your healthcare professional right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, fever, genital lesions or sores.

Perforation. Kyleena may go into the wall of the uterus (become embedded) or go through the wall of the uterus. This is called perforation. If this occurs, Kyleena may no longer prevent pregnancy. If perforation occurs, Kyleena may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have Kyleena removed. Excessive pain or vaginal bleeding during placement of Kyleena, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with perforation. The risk of perforation is increased if Kyleena is inserted while you are breastfeeding, or if you have recently given birth.

Expulsion. Kyleena may come out by itself. This is called expulsion. Expulsion occurs in about 4 out of 100 women. Excessive pain or vaginal bleeding during placement of Kyleena, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with expulsion. You may become pregnant if Kyleena comes out. If you think that Kyleena has come out, avoid intercourse or use a non-hormonal back-up birth control (such as condoms or spermicide) and call your healthcare professional. The risk of expulsion is increased with insertion right after delivery or second-trimester abortion.

For a full list of potential side effects, refer to the Summary of Product Characteristics and Patient Information Leaflet .

Educational Risk Minimisation Materials can be downloaded here to help reduce the risks associated with using Kyleena^®.

If the patient does experience side effects, they should speak to a doctor, pharmacist or nurse. This includes any possible side effects not listed in the contraception package leaflet.

Reporting adverse events and quality complaints

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Bayer plc.

If you want to report an adverse event or quality complaint, reports can be directed to: Tel: 01182063500 or email: pvuk@bayer.com

Further information is available on the “contact” tab at www.bayer.co.uk.

Few women discontinued Kyleena
^®
in KYSS

Discontinuation SAF, n (%)	Total (N=1,129)
Kyleena® still in use at planned EoO	919 (81.4)
Kyleena® discontinued before planned EoO	210 (18.6)
Discontinuation due to TEAEs	69 (6.1)
Discontinuation due to TESAEs	4 (0.4)
Primary reason for discontinuation
Unsuccessful Kyleena® placement attempt	3 (0.3)
Lost to follow-up	105 (9.3)
Expulsion of Kyleena®	6 (0.5)
Removal of Kyleena®	94 (8.3)
(Serious) adverse event	62 (5.5)
Pregnancy	3 (0.3)
Wish for pregnancy	11 (1.0)
Switch contraceptive methods	6 (0.5)
Dissatisfaction with Kyleena®	9 (0.8)
Investigator decision	1 (0.09)
Not specified	0 (0.0)

Adapted from Stovall DW et al 2021

EoO – end of observation period; KYSS – Kyleena^® Satisfaction Study; SAF – safety analysis set;
TEAE – treatment-emergent adverse event; TESAE – treatment-emergent serious adverse event

KYSS: new perspectives on Kyleena
^®
Summary

Women want more from their contraception than just reliable efficacy, such as no contraceptive routine and low hormone doses.
Most Kyleena® placements were rated as easy by HCPs and associated with no or mild pain for women.
Kyleena® was associated with high levels of satisfaction, regardless of age and/or parity*
Women were generally satisfied with their bleeding profile while on Kyleena® – with only 2.5% of women discontinuing due to dissatisfaction with their bleeding profile
The number of women experiencing adverse events with Kyleena® was low overall, with few related discontinuations

PP-PF-WHC-IUS-GB-0023 | February 2024

References

1
Stovall DW et al. Eur J Contracept Reprod Health Care 2021
2
Beckert V et al. Eur J Contracept Reprod Health Care 2020;25:182–189.
3
Black K et al. Eur J Contracept Reprod Health Care 2012;17(5):340–348
4
Daniele MAS et al. Reprod Health 2017;14:119
5
Akdemir Y and Karadeniz M. Eur J Contracept Reprod Health Care 2019;24(3):240–245
6
Bayer Plc. Kyleena® 19.5mg intrauterine delivery system (levonorgestrel): Summary of Product Characteristics [online]. Updated January 2022. Available at: https://www.medicines.org.uk/emc/product/769/smpc (Last Accessed February 2024)
7
Bayer Plc. Kyleena® 19.5mg intrauterine delivery system (levonorgestrel): Patient Information Leaflet [online]. Updated September 2021. Available at: https://medicines.org.uk/emc/product/769/PIL (Last Accessed February 2024)

Footnotes

a
Stovall DW et al. Eur J Contracept Reprod Health Care 2021
b
* Results shown represent women who reported being “very satisfied” or “somewhat satisfied” with Kyleena® at the end of the final visit.1

Real World Evidence

The Kyleena® (19.5mg levonorgestrel) Satisfaction Study (KYSS)

Kyleena satisfaction study

The majority of women were between 18 and 35 years of age (67.1%, n=756).

Women want more from their contraception than just clinical efficacy

Kyleena: placement rated as easy for most women regardless of parity

Kyleena®: high satisfaction rates, irrespective of age

Most women were satisfied with Kyleena®, no matter their…

Kyleena® demonstrated a high level of satisfaction with the bleeding profile in KYSS

81.5% of patients in the patient safety analysis group experienced no adverse events with Kyleena®

Few women discontinued Kyleena® in KYSS