Kyleena

Package leaflet: Information for the user

Kyleena 19.5 mg intrauterine system

levonorgestrel
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your healthcare provider.
• This medicine has been prescribed for you only. Do not give it to other people.
• If you experience any side effects, including those not listed in this leaflet, contact your healthcare provider. See section 4.

Contents of this leaflet:

1. What Kyleena is and what it is used for
2. What you need to know before using Kyleena
3. How to use Kyleena
4. Possible side effects
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 releasing system also known as a hormonal intrauterine device. It prevents pregnancy for up to five years: it is a contraceptive. Kyleena contains a hormone called levonorgestrel.
Figure 1: The hormonal intrauterine device Kyleena

How Kyleena works
A healthcare provider will insert Kyleena into your uterus. Once in place, it continuously releases a small amount of hormone.
Kyleena prevents contact between sperm and the egg, thereby preventing pregnancy. It does this in the following ways:

• It makes the mucus in the neck of the uterus (cervix) thick, which prevents sperm from passing through.
• It keeps the lining of your uterus (endometrium) thin.

Figure 2: Kyleena inside the uterus

2. What you should know before using Kyleena

Important information about Kyleena
Your healthcare provider must ensure that this contraceptive is suitable for you. For this reason, they will initially ask you some questions about your health. Only after this assessment will a prescription be issued.
As a contraceptive, Kyleena prevents pregnancy. However, no contraceptive method is 100% effective in preventing all pregnancies. Each year, approximately 2 to 3 out of 1,000 women using Kyleena become pregnant.
Kyleena does not protect against HIV infection or other sexually transmitted infections.
Kyleena is not emergency contraception, such as the "morning-after pill." Women who have had unprotected sexual intercourse shortly before Kyleena insertion may become pregnant.

DO NOT use Kyleena if:

• you are pregnant (see section below “Pregnancy, breastfeeding and fertility”)
• you have an infection of the uterus, fallopian tubes, or ovaries (pelvic inflammatory disease), or have had repeated episodes of such infections in the past
• you have a condition that makes you more susceptible to pelvic infections. For example: sexually transmitted infections, or diseases that reduce your body’s ability to fight infections, such as advanced stages of HIV
• you have an infection of the vagina or cervix
• you have given birth, had an induced abortion, or a spontaneous miscarriage within the last 3 months and subsequently developed a uterine infection
• your most recent cervical smear test (cervical screening) results were abnormal
• you have cancer of the uterus or cervix, or your healthcare provider suspects this possibility
• you have a tumour that requires progestogenic hormones to grow, such as breast cancer
• you have unexplained vaginal bleeding
• you have an abnormally shaped cervix or uterus, for example due to benign uterine growths (fibroids)
• you have liver disease or a liver tumour
• you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Do not use Kyleena if any of the conditions listed above apply to you. If you have any doubts, consult your healthcare provider.

Warnings and precautions
Contact your healthcare provider before using Kyleena if:

• you have diabetes. Generally, no changes to diabetes treatment are needed during use of Kyleena, but your healthcare provider may need to monitor your treatment
• you have epilepsy: seizures may occur during insertion or removal of Kyleena
• you have previously had a pregnancy outside the uterus (ectopic pregnancy)
• you have migraines that cause visual disturbances, such as sudden loss of vision in one eye, or other neurological symptoms (migraine with aura), or if you have other severe headaches of unknown origin
• you have jaundice (yellowing of the skin, nails, or whites of the eyes)
• you have high blood pressure
• you have ever had a stroke or heart attack.

If any of the above conditions apply to you (or if you are unsure), speak with your healthcare provider before Kyleena insertion.

Contact your healthcare provider immediately during use of Kyleena if:

• you experience symptoms of pregnancy, or your pregnancy test is positive. See section below “Pregnancy, breastfeeding and fertility”
• you have symptoms of pregnancy along with abdominal pain, vaginal bleeding, or dizziness. This may indicate an ectopic pregnancy. See section 4, under “Ectopic pregnancy”
• you have abdominal pain, fever, unusual vaginal discharge, or pain during sexual intercourse. These may be signs of infection requiring prompt medical treatment. See section 4, under “Pelvic infection”
• you experience pain during sexual intercourse: you may have a small fluid-filled sac (cyst) in the ovary. See section 4, under “Ovarian cyst”
• you have severe pain, heavy bleeding, or can no longer feel the Kyleena threads. This may indicate uterine perforation. See section 4, under “Perforation”.

Contact your healthcare provider immediately if you experience any of the symptoms listed above.
Additionally, contact your healthcare provider about Kyleena if:

• you experience a first-time migraine or a very severe headache
• you notice yellowing of the skin, nails, or whites of the eyes – signs of jaundice
• you notice an increase in blood pressure
• you have had a stroke or heart attack.

Your healthcare provider will determine whether it is still safe for you to continue using Kyleena.

Be aware of signs indicating that Kyleena may not be correctly positioned
Signs that Kyleena may not be correctly positioned:

• you can no longer feel the Kyleena threads in your vagina with your finger – see section 3, under “How to personally check that Kyleena is correctly positioned”
• you or your partner feel the lower plastic end of Kyleena during intercourse – see section 3, under “How to personally check that Kyleena is correctly positioned”
• you experience sudden changes in your menstrual pattern. For example: your periods stop while using Kyleena, and then suddenly return.

These signs may indicate that Kyleena has been expelled – see section 4, under “If Kyleena is expelled”. They may also indicate perforation – see section 4, under “Perforation”.
If you notice any of these signs indicating incorrect positioning, contact your healthcare provider immediately. You should avoid sexual intercourse unless using a condom or diaphragm until your healthcare provider confirms that Kyleena is still correctly positioned.
Your partner may feel the Kyleena threads during sexual intercourse. This does not necessarily mean that Kyleena has moved out of position. However, if this causes discomfort for your partner, your healthcare provider can make adjustments to help.

Menstrual hygiene products
If you have periods, it is preferable to use external sanitary pads. If you use tampons or a menstrual cup, you must change them carefully to avoid accidentally pulling on the Kyleena threads. If you suspect that you have displaced Kyleena (see list above for possible signs), do not have sexual intercourse unless using a condom or diaphragm until you have seen your healthcare provider.

Breast cancer
Women who take oral contraceptives have a slightly increased risk of breast cancer. This risk returns to baseline age-appropriate levels within 10 years after stopping the pill.
Some scientific studies have suggested a slight increase in breast cancer risk with levonorgestrel-releasing intrauterine systems such as Kyleena, while other studies have not shown an increased risk. For any concerns, consult your doctor.

Mental health problems
Some women using hormonal contraceptives, including Kyleena, develop depression or low mood.
For more information, see section 4, under “Mental health problems”.

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

Other medicines and Kyleena
Inform your healthcare provider if you are taking, have recently taken, or might start taking any other medicines.

Pregnancy, breastfeeding and fertility
Pregnancy
Kyleena must not be inserted if you are pregnant.
If your periods stop during use of Kyleena
During use of Kyleena, some women may stop having periods. If your periods stop, this is likely due to Kyleena. More information is available in section 4, under “Irregular or infrequent bleeding”.
Have you missed your period for 6 weeks? Then you may take a pregnancy test. If the test shows you are not pregnant, there is no need to repeat the test.
If you experience symptoms of pregnancy
If you experience symptoms of pregnancy, such as missed periods, nausea, and tender breasts, you must:

1. take a pregnancy test
2. contact your healthcare provider for an examination.

If you become pregnant
If you become pregnant while using Kyleena, contact your healthcare provider immediately. They will remove Kyleena.
There is a risk of miscarriage when Kyleena is removed. However, if you continue the pregnancy with Kyleena still in place, you face a higher risk of:

• miscarriage
• premature delivery of the baby

Discuss with your healthcare provider the benefits and risks of continuing the pregnancy with Kyleena in place. Your healthcare provider will monitor you closely. Contact your healthcare provider immediately if you experience:

• abdominal cramps
• stomach pain
• fever

Kyleena contains a hormone called levonorgestrel. Ask your healthcare provider about the potential effects this hormone may have on the developing baby. Very few cases have been reported of levonorgestrel-releasing intrauterine devices affecting the genital development of female fetuses in utero.

Ectopic pregnancy
The chance of becoming pregnant while using Kyleena is very low. However, if you do become pregnant while using Kyleena, there is an increased risk that the fertilized egg will implant outside the uterus, such as in a fallopian tube or the abdominal cavity (ectopic pregnancy). This condition is serious and requires immediate medical intervention. After an ectopic pregnancy, it may be more difficult to become pregnant again. See section 4, under “Ectopic pregnancy”.

Breastfeeding
You may use Kyleena while breastfeeding. A small amount of hormone passes into breast milk. However, it is unlikely that Kyleena will affect the quantity or quality of breast milk, or the growth and development of the breastfed infant.

Fertility
If you wish to become pregnant, contact your healthcare provider to have Kyleena removed.
Kyleena does not affect fertility after removal.

Driving and using machines
Kyleena does not affect the ability to drive or operate machinery.

3. How to use Kyleena

Starting to use Kyleena

• Before Kyleena is inserted, it must be confirmed that you are not pregnant.
• Kyleena should be inserted within 7 days of the start of menstruation. When inserted within this time frame, it works immediately and will prevent pregnancy right away.
• If it is not possible to insert Kyleena within 7 days of the start of menstruation, or if your menstrual cycle is irregular, it may be inserted on any other day. In this case, you must not have had unprotected sexual intercourse since your last menstrual period and must have a negative pregnancy test before insertion. Additionally, Kyleena may not reliably prevent pregnancy immediately. Therefore, you must use a barrier contraceptive method (such as condoms) or abstain from vaginal intercourse during the first 7 days after insertion.
• Kyleena is not an emergency contraceptive, such as the "morning-after pill."

Starting to use Kyleena after childbirth

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

Starting to use Kyleena after an abortion

• Kyleena may be inserted immediately after an abortion if the pregnancy lasted less than 3 months, provided there are no genital infections. It will work immediately.

Replacing a used Kyleena with a new one

• Kyleena may be replaced with a new device at any time during the menstrual cycle. The new Kyleena will work immediately.

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

• Kyleena may be inserted immediately if it is reasonably certain that you are not pregnant.
• If more than 7 days have passed since the start of your menstrual period, you must abstain from vaginal intercourse or use additional contraceptive protection for the next 7 days.

What happens when Kyleena is inserted?

Examination before insertion

• Sometimes, your healthcare provider may wish to perform certain tests before inserting Kyleena, for example:
  • a cervical smear test (Pap smear)
  • a breast examination
  • if necessary, other tests, such as for sexually transmitted infections.

Insertion of Kyleena

• First, your healthcare provider will examine the size and exact position of your uterus (pelvic examination).
• Your healthcare provider will insert a speculum into the vagina and clean the cervix with an antiseptic solution. Sometimes, your healthcare provider may administer local anaesthesia to the cervix.
• Next, your healthcare provider will insert Kyleena into the uterus using a thin, flexible plastic tube (the insertion tube).
• Insertion of Kyleena may sometimes be uncomfortable. Some women may feel dizzy or faint. Pain or mild vaginal bleeding may also occur. This is not unusual.
• Once insertion is complete, your healthcare provider will give you a card: the patient reminder card. On this card, you can record the date of your next follow-up appointment for Kyleena. Bring this card with you to every appointment.

Follow-up checks after insertion

• Kyleena must be checked by a healthcare provider 4–6 weeks after insertion. Your healthcare provider will determine how often you need follow-up checks thereafter. You must have Kyleena checked at least once a year. Always bring your patient reminder card to each appointment.

How to personally check that Kyleena is correctly positioned

• You can check by gently inserting a finger into the vagina. In doing so, you should be able to feel the threads at the top of the vagina, near the cervix. The cervix is the entrance to the uterus.
  Note: Do not pull on the threads, as this may accidentally dislodge Kyleena.

• If you cannot feel the threads, you must have a healthcare provider check whether Kyleena is still in the correct position. You must not have sexual intercourse unless you use a condom or diaphragm until you have consulted your healthcare provider.

• If you or your partner can feel the lower plastic end of Kyleena – Kyleena is not in the correct position. Contact your healthcare provider immediately. You must not have sexual intercourse unless you use a condom or diaphragm until you have consulted your healthcare provider.

Removal of Kyleena

• Kyleena works for up to 5 years. It must be removed after 5 years, but may also be removed at any time before then. Your healthcare provider will remove it. After removal, you may become pregnant again.

• Removal of Kyleena may be slightly uncomfortable. Some women may feel dizzy or faint during or immediately after removal. You may also experience mild pain and vaginal bleeding. This is not unusual.

Continuing contraception after removal

• If you do not wish to become pregnant after Kyleena is removed, you should know the following:

  • It is preferable to have Kyleena removed within 7 days of the start of menstruation. If it is removed outside of menstruation, you must use a condom or diaphragm during sexual intercourse for 7 days prior to removal.
  • If you have irregular or absent periods, you must use a condom or diaphragm during sexual intercourse for 7 days before removal. Irregular periods mean that the number of days between menstrual cycles is not always the same.
  • A new Kyleena device may be inserted immediately after removal of the previous one; in this case, no additional contraceptive protection is needed. If you do not wish to continue with this method, consult your healthcare provider about other reliable contraceptive options.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Life-threatening side effects
There are some side effects that are life-threatening, meaning that if you experience any of them, you must contact a healthcare professional immediately:

• stomach pain, fever, unusual discharge or abnormal vaginal bleeding, or pain during sexual intercourse – you may have an infection of the uterus, fallopian tubes or ovaries; see below under “Pelvic infection”;
• severe pain similar to menstrual pain, more intense pain than expected, or very heavy vaginal bleeding after insertion. Or pain or bleeding that persists for more than a few weeks, sudden changes in menstrual patterns, pain during sexual intercourse, or inability to feel the Kyleena threads. These could be signs of perforation – see below under “Perforation”;
• your periods have stopped, but you then develop vaginal bleeding that does not stop, or severe lower abdominal pain that does not go away – these could be signs of an ectopic pregnancy – see below under “Ectopic pregnancy”;
• mood changes and symptoms of depression – see below under “Mental health problems”;
• allergic reaction, such as rash, hives, or swelling of the tongue, lips, face or throat. This type of reaction is very rare.

If you think any of the above conditions apply to you, seek immediate medical advice.

Other side effects
Below are other possible side effects that may occur. The most frequently occurring side effects are listed first, followed by less common ones.

Very common side effects: may affect more than 1 in 10 people

• headache
• abdominal pain or pelvic pain
• acne or oily skin
• changes in menstruation, for example: heavier or lighter bleeding than usual, bleeding or light spotting between periods, irregular or infrequent periods, or absence of periods. More information is available below under “Irregular or infrequent bleeding”
• small fluid-filled sac in the ovary (ovarian cyst). More information is available below under “Ovarian cyst”
• inflammation of the labia and vagina (vulvovaginitis)

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

• decreased sexual desire (reduced libido)
• migraine
• dizziness
• nausea
• hair loss
• painful periods
• tender or sore breasts
• accidental expulsion of Kyleena (complete or partial). More information is available below under “If Kyleena is expelled”
• vaginal discharge
• weight gain

Uncommon side effects: may affect up to 1 in 100 people

• increased body hair growth

Description of some possible side effects

Ectopic pregnancy
Signs of an ectopic pregnancy include:

• your periods have stopped, but you then develop vaginal bleeding that does not stop
• you have severe lower abdominal pain or persistent pain
• you have normal signs of pregnancy, such as nausea or tender breasts, but also vaginal bleeding and dizziness
• your pregnancy test is positive

If you experience any of these symptoms, you must contact a healthcare professional immediately.
The risk of becoming pregnant while using Kyleena is very low. However, if you do become pregnant while using Kyleena, there is an increased risk that the fertilized egg will implant outside the uterus, for example in one of the fallopian tubes or in the abdominal cavity (ectopic pregnancy). Approximately 2 out of 1,000 women using Kyleena for one year will develop an ectopic pregnancy. This type of pregnancy is serious and requires immediate medical treatment. You may need surgery.
Some women are at higher risk of ectopic pregnancy. These include women who:

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

Irregular or infrequent bleeding
Your periods are likely to change due to Kyleena. For example:

• you may have light bleeding when you are not having your period. This bleeding is called spotting;
• your periods may become less regular. In this case, the number of days between menstrual cycles is not always the same;
• your periods may become shorter or longer;
• you may lose more or less blood than usual during your periods;
• you may stop having periods altogether.

These changes often occur only during the first few months after insertion. For example:

• bleeding between periods or spotting is more common during the first 3–6 months;
• some women initially have heavier periods than usual.

You may gradually lose less blood each month and have shorter periods. Eventually, in some women, periods may stop completely.
If you no longer have periods, this is usually normal. Most of the time, it does not mean you are pregnant or in menopause. Here’s why: normally, the lining of the uterus thickens each month in preparation for pregnancy and sheds during menstruation. Kyleena reduces the thickening of the uterine lining, which may stop periods altogether. Your hormone levels generally remain normal.
If Kyleena is removed, periods usually return to normal. If not, contact your healthcare provider.

Pelvic infection
Kyleena is free from bacteria, viruses and fungi (sterile), as is the inserter. However, you may still develop a pelvic infection at the time of insertion or within the first 3 weeks after insertion. This may affect the lining of the uterus, the fallopian tubes or the ovaries. These events may affect up to 1 in 10 women.
You may experience:

• stomach pain
• fever
• unusual vaginal discharge
• pain during sexual intercourse

The risk of pelvic infection is higher if:

• you have a sexually transmitted infection
• you or your partner have multiple sexual partners
• you have previously had a pelvic infection

If you develop a pelvic infection, it is important to seek immediate medical attention. A pelvic infection may lead to:

• fertility problems later on – meaning it may be more difficult to become pregnant;
• an ectopic pregnancy if you become pregnant;
• a serious infection or blood poisoning (sepsis). This is very rare and usually occurs shortly after insertion of Kyleena. Blood poisoning refers to a severe illness caused by infection. If left untreated, sepsis can be fatal.

Kyleena must be removed if the pelvic infection:

• recurs several times;
• is very severe;
• does not resolve with treatment.

If Kyleena is expelled
Kyleena may shift or be expelled. This is due to contractions of the uterine muscles during menstruation. This may occur in up to 1 in 10 women, especially if:

• you are overweight at the time of Kyleena insertion;
• you previously had heavy periods.

If Kyleena moves, it may no longer work properly. You will be at higher risk of pregnancy. If Kyleena is expelled, it will no longer prevent pregnancy.
If Kyleena shifts or is expelled, you may experience pain or abnormal vaginal bleeding. It is also possible for Kyleena to be expelled without you noticing.
Kyleena usually reduces the amount of blood lost during periods. The longer you use it, the less blood you will lose during your periods. Therefore, if menstrual bleeding suddenly increases again, Kyleena may have been expelled. To check that it is still in place, and for information on what to do if you suspect Kyleena is no longer in position, see section 3 “How to check yourself that Kyleena is correctly positioned”.

Perforation
It is possible that Kyleena may be pushed into or through the wall of the uterus. This is called perforation. Perforation usually occurs during insertion of Kyleena. Perforation does not always cause pain, so you may not notice it until later. If Kyleena is no longer correctly positioned due to perforation, it will no longer be effective against pregnancy. A doctor must remove it as soon as possible. Sometimes surgery is required.
Perforation occurs in up to 1 in 1,000 women. Your risk of perforation is higher (up to 1 in 100) if:

• you are breastfeeding when Kyleena is inserted;
• you have given birth within the 9 months prior to Kyleena insertion.

You may have a perforation if:

• you have severe pain similar to menstrual pain, or more intense pain than expected;
• you have very heavy vaginal bleeding after insertion;
• you have pain or bleeding that persists for more than a few weeks;
• you have sudden changes in your menstrual pattern;
• you have pain during sexual intercourse;
• you can no longer feel the Kyleena threads.

If you think you may have a perforation, contact a healthcare professional immediately. Remember to inform them that you have Kyleena, especially if it is not the person who inserted it.

Ovarian cyst
Sometimes, when using Kyleena, a small fluid-filled sac may develop in one of the ovaries. This is called an ovarian cyst.
Signs of an ovarian cyst may include:

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

An ovarian cyst usually disappears on its own. However, it may require medical treatment. In rare cases, surgery may be needed. If you think you have an ovarian cyst, contact your healthcare provider.

Mental health problems
Some women using hormonal contraceptives, including Kyleena, may develop depression or depressed mood. Depression can be life-threatening and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact a healthcare professional as soon as possible. Depression and depressed mood may affect up to 1 in 100 users of Kyleena.

Reporting of side effects
If you experience any possible side effect, including those not listed in this leaflet, talk to your healthcare provider. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kyleena

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not open the blister (the plastic container in which Kyleena is packaged). Only a healthcare professional is
authorized to do so.
Do not use this medicine after the expiry date stated on the carton and on the blister after "Exp". The expiry date refers to the last day of that month.

6. Package contents and other information

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

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

Description of the appearance of Kyleena and the contents of the pack
Kyleena is a hormonal intrauterine device (intrauterine releasing system). It is T-shaped and white in colour.
On the vertical part there is a small reservoir containing the hormone levonorgestrel. Two blue threads are attached to the lower end of the device. These allow the healthcare provider to remove Kyleena. Additionally, there is a silver ring near the horizontal arms of Kyleena. This ring can be seen by the healthcare provider during ultrasound examination.
Pack sizes:

• 1x1 intrauterine releasing system.
• 5x1 intrauterine releasing system. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bayer S.p.A, Viale Certosa n.130, 20156 Milan, Italy
Manufacturer
Bayer Oy, Pansiontie 47, 20210 Turku, Finland
This medicinal product is authorised in the European Economic Area countries under the following
names:

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

Other sources of information
Detailed and up-to-date information about this medicinal product is available by scanning the QR code on the package leaflet, the outer carton, and the reminder card using a smartphone. The same information is also available at the following URL: www.pi.bayer.com/kyleena/it and on the website of AIFA (https://www.aifa.gov.it/home)
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The following information is intended exclusively for healthcare professionals

INSERTION INSTRUCTIONS
Kyleena 19.5 mg intrauterine delivery system
levonorgestrel
Insertion must be performed by a healthcare professional under aseptic conditions.
Kyleena is supplied in a sterile package with an integrated inserter that allows insertion with one hand. The package must not be opened until the time of insertion. Do not re-sterilize.
Kyleena is for single use only. Do not use if the blister is damaged or opened. Do not insert after the expiry date stated on the carton and blister after "Exp."
Any unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.
Kyleena is supplied with a patient reminder card in the outer packaging.
Complete the patient reminder card and give it to the patient after insertion.

Preparation for insertion

• Evaluate the patient to exclude contraindications to insertion of Kyleena (see section 4.3 and section 4.4 Medical examination/consultation in the Summary of Product Characteristics).
• Insert a speculum, visualize the cervix and carefully cleanse the cervix and vagina with an appropriate antiseptic solution.
• Use an assistant if necessary.
• Grasp the anterior lip of the cervix with a tenaculum forceps or other suitable forceps to stabilize the uterus. If the uterus is retroverted, grasping the posterior lip of the cervix may be appropriate. Apply gentle traction on the forceps to straighten the cervical canal. Throughout the entire insertion procedure, the forceps must remain in place and gentle counter-traction on the cervix must be maintained.
• Advance a uterine sound through the cervical canal to the uterine fundus to measure uterine depth, confirm uterine cavity orientation, and rule out intrauterine abnormalities (e.g., septum, submucosal fibroids) or a previously inserted intrauterine contraceptive device not yet removed. In case of difficulty, consider the possibility of cervical dilation. If cervical dilation is required, consider using analgesics and/or a paracervical block.

Insertion

1. First, fully open the sterile package (Figure 1). Work under aseptic conditions using sterile gloves.

Figure 1

Grip marking
Kyleena
Slider containing threads
Flange
Insertion tube
with plunger and
graduated scale
Figure 2

2. Push the slider forward, in the direction of the arrow, to its furthest position to load Kyleena into the insertion tube (Figure 2).

IMPORTANT! Do not pull the slider downward, as this will cause premature release of Kyleena. Once released, Kyleena cannot be reloaded.

3. While keeping the Figure 3 slider in the furthest position, set the upper edge of the flange at the measured uterine depth (Figure 3).

4. While keeping the Figure 4 slider in the furthest position, advance the inserter into the cervix until the flange is approximately 1.5–2.0 cm from the cervix (Figure 4).

IMPORTANT! Do not force the inserter. If necessary, dilate the cervical canal.

5. Holding the inserter steady, pull the slider downward to the mark to open the horizontal arms of Kyleena (Figure 5).
   Wait 5–10 seconds to allow the horizontal arms to fully deploy.

6. Gently advance the inserter toward the uterine fundus until the flange touches the cervix (Figure 6). Kyleena is now positioned at the fundus.

7. While keeping the inserter in place, release Kyleena by pulling the slider fully downward (Figure 7). While keeping the slider in the downward position, gently remove the inserter by pulling it out. Cut the threads, leaving approximately 2–3 cm protruding from the cervix.
   IMPORTANT! If incorrect placement is suspected, verify the position (e.g., by ultrasound). Remove the system if it is not correctly positioned within the uterine cavity. Once removed, the system must not be reinserted.

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

To remove Kyleena, gently pull the threads with forceps (Figure 8).
A new Kyleena system may be inserted immediately after removal.
After removal of Kyleena, the device must be examined to ensure it is intact and has been completely removed.

[QR code to Summary of Product Characteristics to be inserted at national level]
Summary of Product Characteristics for Kyleena available online at www.pi.bayer.com/kyleena/it