Kyleena

Package leaflet: Information for the user

Kyleena, 19.5 mg, intrauterine system
Levonorgestrelum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet:

1. What Kyleena is and what it is used for
2. Important information before use of Kyleena
3. How to use Kyleena
4. Possible adverse reactions
5. How to store Kyleena
6. Contents of the pack and other information

1. What Kyleena is and what it is used for

Kyleena is a T-shaped intrauterine system, also known as a hormonal intrauterine device. It prevents pregnancy for up to five years and is a contraceptive. Kyleena contains a hormone called levonorgestrel.

Figure 1: Hormonal intrauterine device Kyleena

Hormone-
containing
core
Removal
threads

How Kyleena works
Your doctor will place the Kyleena system inside your uterus. After insertion, a small amount of hormone is continuously released.
Kyleena prevents sperm from reaching the egg, thereby preventing pregnancy. It works in the following ways:

• It causes the cervical mucus to become thicker, which prevents sperm from passing through.
• It keeps the lining of the uterus (endometrium) thin.

Figure 2: Kyleena in the uterus

Fallopian tube
Kyleena
Ovary
Uterus
Endometrium
(cervix)
Cervix
Vagina
Removal
threads

2. Important information before using the Kyleena system

Important information about the Kyleena system
Your doctor must be certain that this contraceptive method is suitable for you. Therefore,
they will first ask several questions about your medical history. Only then can a prescription be issued.
As a contraceptive, Kyleena prevents pregnancy. However, no contraceptive method is 100% effective.
Each year, approximately 2–3 out of 1,000 women using the Kyleena system become pregnant.
This system does not protect against HIV infection or other sexually transmitted diseases.
This system is not emergency contraception, such as the "morning-after pill." Women who have had unprotected intercourse shortly before Kyleena insertion may become pregnant.

When NOT to use the Kyleena system:

• if the woman is pregnant (see section below "Pregnancy, breastfeeding and fertility"),
• if there is an infection of the uterus, fallopian tubes, or ovaries (pelvic inflammatory disease), or if such infections have occurred repeatedly in the past,
• if there is a condition that increases the risk of pelvic infections—for example, sexually transmitted infections or diseases that reduce the body's ability to fight infections, such as advanced stages of HIV infection,
• if there is a vaginal or cervical infection,
• if the woman has given birth, had an abortion, or miscarried within the last three months and subsequently developed a uterine infection,
• if recent Pap test (cervical screening) results were abnormal,
• if there is cancer of the uterus or cervix, or if cancer is suspected,
• if there is a tumor that grows under the influence of progestogens, such as breast cancer,
• if there is vaginal bleeding of unknown cause,
• if the cervix or uterus does not have a normal shape, for example due to non-cancerous uterine changes (fibroids),
• if there is liver disease or liver tumor,
• if the woman is allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

The Kyleena system should not be used if any of the above conditions apply to the woman.
If in doubt, consult your doctor.

Warnings and precautions
Tell your doctor before using the Kyleena system if:

• the woman has diabetes. Generally, no changes in diabetes medication will be needed during use of the Kyleena system, but your doctor may need to review this,
• the woman has epilepsy—seizures (epileptic fits) may occur during insertion or removal of the Kyleena system,
• the woman has previously had an ectopic pregnancy (pregnancy outside the uterus),
• the woman has migraines causing visual disturbances—such as sudden loss of vision in one eye—or other neurological symptoms (migraine with aura), or other severe headaches of unknown origin,
• the woman has jaundice (skin, nails, and whites of the eyes turn yellow),
• the woman has high blood pressure,
• the woman has ever had a stroke or heart attack.

If any of these conditions apply to the woman (or if she is uncertain), she should speak with her doctor before Kyleena insertion.

Tell your doctor immediately if, while using the Kyleena system:

• the woman experiences symptoms of pregnancy, or has a positive pregnancy test—see subsection below "Pregnancy, breastfeeding and fertility".
• the woman experiences symptoms of pregnancy along with abdominal pain, vaginal bleeding, or dizziness. This may indicate an ectopic pregnancy—see section 4, subsection "Ectopic pregnancy".
• the woman has abdominal pain, fever, unusual vaginal discharge, or pain during intercourse—this may indicate an infection requiring prompt treatment. See section 4, subsection "Pelvic infection".
• the woman experiences pain during intercourse—there may be a small fluid-filled sac (cyst) in the ovary. See section 4, subsection "Ovarian cyst".
• the woman experiences severe pain, very heavy bleeding, or can no longer feel the Kyleena threads in the vagina—this may indicate uterine perforation. See section 4, subsection "Perforation".

If any of the above symptoms occur, speak with your doctor immediately.

Also speak with your doctor about the Kyleena system if:

• the woman develops migraine or severe headache for the first time,
• the woman notices that her skin, nails, or the whites of her eyes have turned yellow—these are signs of jaundice,
• the woman notices increased blood pressure,
• the woman has a stroke or heart attack.

Your doctor will decide whether continued use of the Kyleena system remains safe for the woman.

Be aware of signs indicating that the Kyleena system may not be in the correct position
Signs that the Kyleena system may not be correctly positioned include:

• the woman can no longer feel the Kyleena threads with her finger in the vagina—see section 3, subsection "How to check on your own that the Kyleena system is in the correct position".
• the woman or her partner can feel the lower plastic end of the Kyleena frame—see section 3, subsection "How to check on your own that the Kyleena system is in the correct position".
• the woman experiences sudden changes in her menstrual pattern—for example, if menstruation stopped after Kyleena insertion and then suddenly returned.

These symptoms may indicate that the Kyleena system has been expelled—see section 4, subsection "Expulsion of the Kyleena system". Alternatively, they may indicate perforation—see section 4, subsection "Perforation".

If any of these signs occur, the woman should contact her doctor immediately. Sexual intercourse should be avoided unless a condom or diaphragm is used, until the doctor confirms that the system is still correctly positioned.

The woman's partner may feel the Kyleena threads during intercourse. This does not mean the system is out of place. However, if the partner feels uncomfortable, there are methods the doctor can use to help.

Hygiene products during menstruation
Pads are recommended during menstruation. If tampons or menstrual cups are used, they should be changed carefully. Otherwise, the woman may accidentally pull on the Kyleena threads. If the woman suspects that the system has been displaced (see the list of possible signs above), she should avoid sexual intercourse until she sees her doctor, unless using a condom or diaphragm.

Breast cancer
Women using oral contraceptives have a slightly increased risk of developing breast cancer. This risk returns to age-appropriate levels within 10 years after stopping the pill.
Some scientific studies suggest a slightly increased risk of breast cancer with levonorgestrel-releasing intrauterine systems such as Kyleena, while other studies do not show increased risk. If in doubt, consult your doctor.

Mental health problems
Some women using hormonal contraceptives, including the Kyleena system, experience depression or low mood. For more information, see section 4, subsection "Mental health problems".

Children and adolescents
Girls who have not yet started menstruating should not use the Kyleena system.

Kyleena and other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the woman plans to take.

Pregnancy, breastfeeding and fertility
Pregnancy
The Kyleena system must not be inserted during pregnancy.

Absence of menstrual bleeding during use of Kyleena
Some women may stop having periods while using Kyleena. If menstruation stops, this is likely due to the Kyleena system. For more information, see section 4, subsection "Irregular or infrequent menstrual bleeding".

If menstruation has not occurred for 6 weeks, a pregnancy test may be performed.
If the test shows the woman is not pregnant, there is no need to repeat the test.

If symptoms of pregnancy occur
If symptoms of pregnancy such as missed period, nausea, and tender breasts occur, the woman should:

1. take a pregnancy test,
2. contact her doctor for examination.

If pregnancy occurs
If a woman becomes pregnant while using the Kyleena system, she should contact her doctor immediately. The doctor will decide whether to remove the Kyleena system.
Removal of Kyleena during pregnancy carries a risk of miscarriage. However, leaving the Kyleena in place during pregnancy may increase the risk of:

• miscarriage,
• premature delivery.

Discuss the benefits and risks of continuing the pregnancy with the Kyleena in place with your doctor. The doctor will closely monitor the woman. Contact your doctor immediately if any of the following occur:

• abdominal cramps,
• abdominal pain,
• fever.

Kyleena contains a hormone called levonorgestrel. Ask your doctor about any potential effects this hormone may have on the developing baby. Very few cases of levonorgestrel affecting the genital organs of female fetuses in utero have been reported.

Ectopic pregnancy
The risk of pregnancy while using the Kyleena system is very low. However, if a woman does become pregnant while using Kyleena, there is an increased risk that the fertilized egg (embryo) will implant outside the uterus—such as in a fallopian tube or abdominal cavity (ectopic pregnancy). This is a serious condition requiring immediate medical intervention. Future fertility may be reduced after an ectopic pregnancy. See section 4, subsection "Ectopic pregnancy".

Breastfeeding
The Kyleena system may be used during breastfeeding. A small amount of hormone passes into human milk. However, Kyleena does not affect the quality or quantity of breast milk or the growth and development of the breastfed infant.

Fertility
If the woman wishes to become pregnant, she should contact her doctor to have the Kyleena system removed.
The Kyleena system does not affect fertility after removal.

Driving and operating machinery
The Kyleena system has no known effect on the ability to drive or operate machinery.

3. How to use Kyleena

Starting to use Kyleena

• Before inserting Kyleena, it must be confirmed that the woman is not pregnant.
• Kyleena should be inserted within 7 days of the onset of menstrual bleeding. If inserted within this time frame, Kyleena will be effective immediately and will prevent pregnancy.
• If Kyleena cannot be inserted within 7 days of the start of menstrual bleeding, or if menstruation occurs at unpredictable times, it may be inserted on any day. In this case, the woman must not have had unprotected sexual intercourse since her last menstrual period, and a negative pregnancy test must be obtained prior to insertion. Additionally, Kyleena may not provide reliable contraceptive protection immediately. Therefore, a barrier method of contraception (e.g. condoms) should be used, or sexual intercourse should be avoided, for the first 7 days after insertion.
• Kyleena is not an emergency contraceptive, such as the "day after" pill.

Starting to use Kyleena after childbirth

• Kyleena may be inserted after delivery, once the uterus has returned to its normal size, but not earlier than 6 weeks postpartum (see section 4, subsection "Perforation").
• See also "Starting to use Kyleena" above for further information on timing of insertion.

Starting to use Kyleena after miscarriage

• Kyleena may be inserted immediately after a miscarriage if the pregnancy lasted less than 3 months, provided there are no genital tract infections, and will be effective immediately.

Inserting a new Kyleena when replacing the current system

• Kyleena may be replaced with a new system on any day of the menstrual cycle and will be effective immediately.

Switching from another contraceptive method (e.g. combined hormonal contraceptives, implant)

• Kyleena may be inserted immediately if it is reasonably certain that the woman is not pregnant.
• If more than 7 days have passed since the onset of menstrual bleeding, abstinence or additional contraceptive protection should be used for the following 7 days.

What happens during insertion of Kyleena?

Examination prior to insertion

Prior to insertion of Kyleena, a healthcare provider may perform certain examinations, such as:

• Cervical smear (cytology),
• Breast examination,
• Other tests if necessary, for example for sexually transmitted infections.

Insertion of Kyleena

First, the healthcare provider will examine the size and position of the uterus (pelvic examination).
The provider will insert a speculum into the vagina and clean the cervix with an antiseptic solution. Sometimes, local anaesthesia of the cervix is used. The Kyleena system is then inserted into the uterus through a thin, flexible, plastic tube (the inserter).
Insertion of Kyleena may sometimes cause discomfort. Some women may experience dizziness or fainting. Pain or slight vaginal bleeding may also occur. This is not unusual.
After insertion, the healthcare provider will give the woman a patient reminder card. This card can be used to record dates of follow-up visits for Kyleena. The card should be brought to every visit.

Follow-up after insertion

Kyleena should be checked by a healthcare provider 4–6 weeks after insertion. The provider will decide how often follow-up visits should occur. Kyleena should be checked at least once a year. The patient reminder card should be brought to every visit.

How to check on your own that Kyleena is in the correct position

This can be checked by gently inserting a finger into the vagina. The threads should be felt at the end of the vagina near the cervix. The cervix is the entrance to the uterus.
Warning: Do not pull on the threads, as this may accidentally remove Kyleena.

If the threads cannot be felt, a healthcare provider must check whether Kyleena is still in the correct position. Sexual intercourse should be avoided unless condoms or a diaphragm with spermicide are used, until a visit to the healthcare provider.

If the woman or her partner feels the lower plastic end of the Kyleena frame, Kyleena is not in the correct position. Contact a healthcare provider immediately. Sexual intercourse should be avoided until the visit, unless condoms or a diaphragm with spermicide are used.

Removal of Kyleena

Kyleena is effective for up to 5 years. It should be removed after 5 years, but may also be removed at any time before then. A healthcare provider will remove Kyleena. After removal, pregnancy may occur.

Removal of Kyleena may be uncomfortable. Some women may experience dizziness or fainting during or immediately after removal. Slight pain or vaginal bleeding may also occur. This is not unusual.

Continuation of contraception after removal of Kyleena

If a woman does not wish to become pregnant after removal of Kyleena, it is important to know that:

• It is best to remove Kyleena within 7 days of the start of the menstrual cycle. If removed at any other time than during menstruation, condoms or a diaphragm with spermicide must be used during intercourse for 7 days prior to removal.
• If a woman has irregular or no menstrual periods, condoms or a diaphragm with spermicide must be used during intercourse for 7 days prior to removal. Irregular periods mean that the number of days between cycles is not always the same.
• A new Kyleena may also be inserted immediately after removal of the previous system. In this case, no additional contraceptive protection is needed. If the woman does not wish to continue with this method, she should consult her healthcare provider for advice on other reliable contraceptive methods.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
There are certain serious adverse effects, meaning that if any of these occur, you should contact your doctor immediately:

• abdominal pain, fever, unusual vaginal discharge or abnormal vaginal bleeding or pain during sexual intercourse – this may be an infection of the uterus, fallopian tubes or ovaries – see below "Pelvic infection".
• severe pain resembling menstrual pain, pain greater than expected or very heavy vaginal bleeding after insertion of the system. If pain or bleeding persists for longer than a few weeks, sudden changes in the menstrual cycle, pain during sexual intercourse occur, or the threads of the system are no longer detectable, these may be symptoms of perforation – see below "Perforation".
• periods have stopped, but vaginal bleeding continues or lower abdominal pain which is severe or persistent – these may be symptoms of ectopic pregnancy – see below "Ectopic pregnancy".
• mood changes and symptoms of depression – see below "Mental health problems".
• allergic reaction – such as skin rash, urticaria or swelling of the tongue, lips, face or throat. This type of reaction is very rare.

If a woman thinks any of the above points apply to her, she should contact her doctor immediately.
Other adverse effects
Below is a list of other possible adverse effects. The most common adverse effects are listed at the top, and the least common at the bottom.
Very common adverse effects: occur in more than 1 in 10 women

• headache
• abdominal or pelvic pain
• acne or oily skin
• changes in menstruation, for example:
  - heavier or lighter bleeding than usual
  - bleeding or light spotting (bleeding) without periods
  - irregular or infrequent periods
  - absence of periods altogether
  More information on this can be found in the section "Irregular or infrequent menstrual bleeding" below.
• small fluid-filled sac on the ovary (ovarian cyst). More information on this can be found in the section "Ovarian cyst" below.
• inflammation of the vulva and vagina

Common adverse effects: occur in less than 1 in 10 women

• decreased sex drive
• migraine
• dizziness
• nausea
• hair loss
• pain during menstruation
• pain or tenderness of the breasts
• spontaneous expulsion of the Kyleena system (complete or partial). More information on this can be found in the section "Expulsion of the Kyleena system" below.
• vaginal discharge
• weight gain

Uncommon adverse effects: occur in less than 1 in 100 women

• increased body hair growth

Description of selected possible adverse effects:
Ectopic pregnancy
Symptoms of ectopic pregnancy include:

• periods have stopped, but vaginal bleeding reappears and does not stop,
• severe or persistent pain in the lower abdomen,
• normal symptoms of pregnancy occur, such as nausea or tender breasts, but vaginal bleeding and dizziness also occur,
• positive pregnancy test result.

You should contact your doctor immediately if any of these symptoms occur.
The risk of becoming pregnant while using the Kyleena system is very low. However, if a woman does become pregnant while using the Kyleena system, there is an increased risk that the fertilized egg (embryo) will implant not in the uterus, but in the fallopian tube or abdominal cavity (ectopic pregnancy). Approximately 2 out of 1000 women using the Kyleena system for one year will experience an ectopic pregnancy. This type of pregnancy is a serious condition requiring immediate medical intervention. Surgery may be necessary.
Some women are at higher risk of ectopic pregnancy. These include women:

• who have previously had an ectopic pregnancy,
• who have had surgery on the fallopian tubes,
• who have had a pelvic infection.

Irregular or infrequent menstrual bleeding
It is likely that your periods will change due to using the Kyleena system. For example:

• You may experience light bleeding between periods. This type of bleeding is called spotting.
• Periods may become less regular. In this case, the number of days between menstrual cycles may not always be the same.
• Periods may be shorter or longer.
• Bleeding may be lighter or heavier than usual during periods.
• Periods may stop altogether.

Sometimes these changes occur only during the first few months after insertion. For example:

• Bleeding between periods or spotting most commonly occurs during the first 3 to 6 months.
• In some women, periods may initially be heavier than usual.

Gradually, bleeding may become lighter each month and periods may become shorter. Eventually, some women may stop having periods altogether.
No periods? This is usually normal. In most cases, it does not mean the woman is pregnant or going through menopause. Here's why: normally, the lining of the uterus thickens each month in preparation for pregnancy, and then becomes thin again due to menstruation. The Kyleena system reduces the thickening of the uterine lining. This may cause periods to stop. Hormone levels usually remain normal.
Normal periods usually return after removal of the Kyleena system. If this does not happen, contact your doctor.
Pelvic infection
The Kyleena system does not contain bacteria, viruses or fungi (it is sterile). This also applies to the applicator. Nevertheless, a pelvic infection may still occur during insertion of the Kyleena system or within the first 3 weeks after insertion. For example, infection of the lining of the uterus, fallopian tubes or ovaries. This may affect fewer than 1 in 10 women.
Symptoms may include:

• abdominal pain,
• fever,
• unusual vaginal discharge,
• pain during sexual intercourse.

The risk of pelvic infection is higher if:

• the woman has a sexually transmitted infection,
• the woman or her partner has multiple sexual partners,
• the woman has had a pelvic infection in the past.

In case of pelvic infection, it is important to contact your doctor immediately. A pelvic infection may lead to:

• fertility problems in the future. This may mean it will be more difficult to become pregnant,
• ectopic pregnancy if pregnancy occurs,
• severe infection or blood poisoning (septicaemia). This is very rare and occurs shortly after insertion of the Kyleena system. Blood poisoning means a very serious illness due to infection. Septicaemia can be fatal if not treated.

The Kyleena system must be removed if pelvic infection:

• occurs repeatedly,
• is very severe,
• does not resolve despite treatment.

Expulsion of the Kyleena system
The Kyleena system may be displaced or expelled. This is caused by contractions of the uterine muscles during menstruation. This may occur in fewer than 1 in 10 women, especially if:

• the woman is overweight at the time of insertion,
• the woman has previously had heavy periods.

If the Kyleena system is out of place, it may no longer function properly. The risk of pregnancy is then higher. If it is expelled, it will no longer prevent pregnancy.
If the Kyleena system is out of place or has been expelled, the woman may experience pain or vaginal bleeding that differs from normal. It is also possible that the Kyleena system is expelled and the woman does not notice it.
The Kyleena system usually reduces the amount of blood lost during menstruation. The longer a woman uses it, the less blood she loses during her period. This means that if a woman suddenly starts losing more blood during her period, the Kyleena system may have been expelled.
Information on how to check whether the Kyleena system is in the correct position and what to do if you suspect it is not in the correct position can be found in section 3 "How to check on your own that Kyleena is in the correct position".
Perforation
It may happen that the Kyleena system is pushed into or through the uterine wall. This is called perforation. Perforation usually occurs during insertion of the Kyleena system. Perforation does not always cause pain, so it may be noticed only later. If the system is no longer in the correct position due to perforation, it will not prevent pregnancy. The doctor must then remove it as quickly as possible. Sometimes surgery is necessary.
Perforation occurs in fewer than 1 in 1000 women. The risk of perforation is higher (in fewer than 1 in 100 women) if:

• the woman is breastfeeding at the time of insertion of the Kyleena system,
• the woman has given birth within the last 9 months before insertion of the Kyleena system.

Perforation may have occurred if:

• severe pain resembling menstrual pain or pain stronger than expected occurs,
• very heavy vaginal bleeding occurs after insertion,
• pain or bleeding persists for longer than a few weeks,
• sudden changes in the menstrual cycle occur,
• pain during sexual intercourse occurs,
• the threads of the Kyleena system are no longer detectable.

If a woman suspects that perforation may have occurred, she should contact her doctor immediately. She should inform the doctor about the Kyleena system, especially if it is not the person who inserted it.

Ovarian cyst
Sometimes, while using the Kyleena system, a small fluid-filled "sac" appears on the ovary. This sac is called an ovarian cyst.
Symptoms of an ovarian cyst may include:

• pelvic pain,
• pain or discomfort during sexual intercourse.

An ovarian cyst usually resolves spontaneously. However, it may require medical intervention. In rare cases, surgery may be necessary. If a woman suspects she may have an ovarian cyst, she should contact her doctor.
Mental health problems
Some women using hormonal contraceptives, including Kyleena, experience depression or low mood.
Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible. Depression and low mood may occur in fewer than 1 in 100 women using the Kyleena system.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorization holder. By reporting adverse effects, more information on the safety of using the medicine can be collected.
5. How to store Kyleena
No special storage conditions are required for this medicine.
Keep the medicine out of sight and reach of children.
Do not open the blister (plastic container in which the Kyleena system is stored). Only a doctor or nurse may do this.
The system should not be inserted after the expiry date stated on the carton and blister after: Expiry (EXP). The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What Kyleena contains
The active substance is levonorgestrel. The intrauterine system contains 19.5 mg of
levonorgestrel.
The other components are:

• polydimethylsiloxane elastomer
• colloidal anhydrous silica
• polyethylene
• barium sulfate
• polypropylene
• copper phthalocyanine
• silver

What Kyleena looks like and contents of the pack
Kyleena is a hormonal intrauterine device (intrauterine therapeutic system). It is T-shaped and white in colour. On the vertical part there is a small reservoir containing the hormone levonorgestrel. Attached to a loop at the bottom of the system are two blue threads, which enable the doctor to remove the Kyleena system when necessary. A silver ring located near the horizontal arms of the Kyleena system is visible to the doctor during ultrasound examination.
Pack sizes:

• 1x1 intrauterine therapeutic system.
• 5x1 intrauterine therapeutic system.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen,
Germany
Manufacturer
Bayer OY
Pansiontie 47
20210 Turku
Finland
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel. (0-22) 572 35 00
This medicinal product is authorised in the European Economic Area countries under the
following names:

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

Other sources of information
Detailed and up-to-date information on this medicinal product can be obtained by scanning the QR code included on the patient leaflet, the carton, and the patient reminder card using a smartphone. The same information is also available at the following URL: www.pi.bayer.com/kyleena/pl .
[QR code for the patient leaflet, to be added at national level]

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Information intended exclusively for healthcare professionals:

INSERTION INSTRUCTIONS
Kyleena, 19.5 mg, intrauterine system
Levonorgestrel
To be inserted by a physician using aseptic technique.
The Kyleena system is supplied in a sterile package with an integrated, single-handed inserter.
Do not open the packaging until the time of insertion. Do not re-sterilize. The Kyleena system is intended for single use only. Do not use if the blister is damaged or open. Do not insert after the expiry date stated on the carton and blister: Expiry (EXP).
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
The Kyleena system is supplied with a patient reminder card in the outer packaging.
The patient reminder card should be completed and given to the woman after insertion of the system.

Preparation for insertion

• Evaluate the woman to exclude contraindications to insertion of the Kyleena system (see Summary of Product Characteristics section 4.3 and "Examinations/consultations" in section 4.4).
• Insert a speculum, visualize the cervix, and thoroughly clean the cervix and vagina with an appropriate antiseptic solution.
• Use assistant help if needed.
• Grasp the anterior lip of the cervix with tenaculum forceps or other suitable instrument to stabilize the uterus. If the uterus is retroverted, grasping the posterior lip may be more appropriate. Gently pulling on the tenaculum may straighten the cervical canal. The tenaculum should remain in place, and gentle traction on the cervix should be maintained throughout the insertion procedure.
• Insert a uterine sound through the cervical canal to the fundus to measure uterine depth, confirm uterine direction, and exclude intrauterine abnormalities (e.g., septum, submucosal fibroids) or previously inserted intrauterine contraceptive devices not removed. If resistance is encountered, consider cervical dilation. If cervical dilation is required, consider using analgesics and/or paracervical block.

Insertion

1. First, fully open the sterile package (Figure 1). Then apply aseptic technique and wear sterile gloves.

Figure 1

Kyleena
Line mark Handle with threads
Insertion tube Plunger with
Stopper scale inside

2. Move the Figure 2

slider forward
in the direction
indicated by the
arrow until it
stops, to load
the Kyleena
system into the
insertion tube
(Figure 2).
IMPORTANT! Do not push the slider downward, as this may cause premature release of the Kyleena system. Once released, the Kyleena system cannot be reloaded.

3. While holding

Figure 3
the slider in its
most forward
position, adjust
the upper edge
of the stopper so
that it aligns
with the uterine
depth measured
by sounding
(Figure 3).

4. While holding

Figure 4
the slider in its
most forward
position, insert
the insertion tube
through the cervix
until the stopper
is approximately
1.5–2.0 cm from
the cervix
(Figure 4).
IMPORTANT! Do not force the inserter. If necessary, dilate the cervical canal.

Figure 5

5. While holding the

inserter steady,
move the slider
to the line mark
to deploy the
horizontal arms of
the Kyleena system
(Figure 5).
Wait 5–10 seconds
to allow complete
opening of the
horizontal arms.

6. Gently

advance the Figure 6
inserter toward
the fundus of the
uterine cavity until
the stopper
touches the
cervix. The
Kyleena system
is then positioned
at the fundus
(Figure 6).

7. While holding

the inserter in Figure 7
place, release the
Kyleena system
by moving the
slider completely
downward
(Figure 7).
While holding the
slider fully down,
gently remove the
inserter by pulling
it out.
Trim the threads,
leaving 2–3 cm
visible outside
the cervix.
IMPORTANT! If incorrect positioning of the system is suspected, verify its location (e.g., by ultrasound examination). Remove the system if it is not correctly placed within the uterine cavity. A removed system must not be reinserted.

Removal/replacement of the system
For removal/replacement of the system, refer to the Summary of Product Characteristics for Kyleena.

The Kyleena system
is removed by Figure 8
gently pulling on
the threads with
forceps (Figure 8).
A new Kyleena
system may be
inserted immediately
after removal of
the previous one.
After removal of
the Kyleena system,
inspect it to confirm
it is intact and has
been completely
removed.
[QR code for Summary of Product Characteristics, to be added at national level]
Summary of Product Characteristics for Kyleena available online at www.pi.bayer.com/kyleena/pl.