Important Facts About Kyleena® (levonorgestrel-releasing intrauterine system) 19.5 mg

Read this Patient Information carefully before you decide if Kyleena is right for you. This information does not take the place of talking with your gynecologist or other healthcare professional (HCP) who specializes in women’s health. If you have any questions about Kyleena, ask your HCP. You should also learn about other birth control methods to choose the one that is best for you.

Kyleena does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). INDICATION FOR KYLEENA

Kyleena is a hormone-releasing intrauterine device (IUD) that prevents pregnancy for up to 5 years.

Who might use Kyleena?

You might choose Kyleena if you:

• want long-term birth control that provides a low chance of getting pregnant (less than 1 in 100)

• want birth control that works continuously for up to 5 years

• want birth control that is reversible

• want a birth control method that you do not need to take daily

• are willing to use a birth control method that is placed in the uterus

• want birth control that does not contain estrogen

Do not use Kyleena if you:

• are or might be pregnant; Kyleena cannot be used as an emergency contraceptive

• have a serious pelvic infection called pelvic inflammatory disease (PID) or have had PID in the past unless you have had a normal pregnancy after the infection went away

• have an untreated genital infection now

• have had a serious pelvic infection in the past 3 months after a pregnancy

• can get infections easily. For example, if you:

- have multiple sexual partners or your partner has

multiple sexual partners

- have problems with your immune system

- use or abuse intravenous drugs

• have or suspect you might have cancer of the uterus or cervix

• have bleeding from the vagina that has not been explained

• have liver disease or a liver tumor

• have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past

• have an IUD in your uterus already

• have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors

• are allergic to these ingredients:

- do not use Kyleena if you’re allergic to levonorgestrel, silicone, polyethylene, silver, silica, barium sulfate, polypropylene, or copper phthalocyanine

Before having Kyleena placed, tell your HCP about all of your medical conditions including if you:

• have any of the conditions listed above

• have had a heart attack

• have had a stroke

• were born with heart disease or have problems with your heart valves

• have problems with blood clotting or take medicine to reduce clotting

• have high blood pressure

• recently had a baby or are breastfeeding

• have severe headaches or migraine headaches

• have AIDS, HIV, or any other STI

Tell your HCP about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Should I check that Kyleena is in place?

Yes, you should check that Kyleena is in proper position by feeling the removal threads. It is a good habit to do this 1 time a month. If you feel more than just the threads or if you cannot feel the threads, be sure to call your HCP and avoid intercourse or use non-hormonal back-up birth control, as Kyleena may not be in the right position and may not prevent pregnancy.

How soon after placement should I return to my HCP?

Call your HCP if you have any questions or concerns (see “After Kyleena has been placed, when should I call my HCP?”). Otherwise, you should return to your HCP for a follow-up visit 4 to 6 weeks after Kyleena is placed to make sure that Kyleena is in the right position.

Can I use tampons or menstrual cups with Kyleena?

Yes, tampons or menstrual cups may be used with Kyleena. Change tampons or menstrual cups with care to avoid pulling the threads of Kyleena. If you think you may have pulled Kyleena out of place, avoid intercourse or use back-up birth control.

What if I become pregnant while using Kyleena?

Call your HCP right away if you think you may be pregnant. If possible, also do a urine pregnancy test. If you get pregnant while using Kyleena, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy.

Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.

There are also risks if you get pregnant while using Kyleena and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an IUD. Because of this, your HCP may try to remove Kyleena, even though removing it may cause a miscarriage. If Kyleena cannot be removed, talk with your HCP about the benefits and risks of continuing the pregnancy and possible effects of the hormone on your unborn baby.

If you continue your pregnancy, see your HCP regularly. Call your HCP right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection.

How will Kyleena change my periods?

For the first 3 to 6 months, your period may become irregular and the number of bleeding days may increase. You may also have frequent spotting or light bleeding. Some women have heavy bleeding during this time. You may also have cramping during the first few weeks. After you have used Kyleena for a while, the number of bleeding and spotting days is likely to lessen. For some women, periods will stop altogether. When Kyleena is removed, your menstrual periods should return.

Is it safe to breastfeed while using Kyleena?

You may use Kyleena when you are breastfeeding. Kyleena is not likely to affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported. The risk of Kyleena going into the wall of the uterus (becoming embedded) or going through the wall of the uterus is increased if Kyleena is inserted while you are breastfeeding.

Will Kyleena interfere with sexual intercourse?

You and your partner should not feel Kyleena during intercourse. Kyleena is placed in the uterus, not in the vagina. Sometimes your partner may feel the threads. If this occurs, or if you or your partner experience pain during sex, talk with your HCP.

Can I have an MRI with Kyleena in place?

Kyleena can be safely scanned with MRI only under specific conditions. Before you have an MRI, tell your HCP that you have Kyleena, an IUD, in place.

What are the possible serious side effects of Kyleena?

• 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 HCP 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 PID. PID is usually sexually transmitted. 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 HCP 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 non-hormonal back-up birth control (such as condoms or spermicide) and call your HCP. The risk of expulsion is increased with insertion right after delivery or second-trimester abortion.

Common side effects of Kyleena include:

• Pain, bleeding or dizziness during and after placement. If these symptoms do not stop 30 minutes after placement, Kyleena may not have been placed correctly. Your HCP will examine you to see if Kyleena needs to be removed or replaced.

• Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3-6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may be irregular. Call your HCP if the bleeding remains heavier than usual or increases after it has been light for a while.

• Missed menstrual periods. About 12 out of 100 women stop having periods after 1 year of Kyleena use. If you have any concerns that you may be pregnant while using Kyleena, do a urine pregnancy test and call your HCP. If you do not have a period for 6 weeks during Kyleena use, call your HCP. When Kyleena is removed, your menstrual periods should return.

• Cysts on the ovary. About 22 out of 100 women using Kyleena develop a cyst on the ovary. These cysts usually disappear on their own in 2 to 3 months. However, cysts can cause pain and sometimes cysts will need surgery.

Other common side effects for Kyleena include:

• inflammation or infection of the outer part of your vagina (vulvovaginitis)

• abdomen or pelvic pain

• headache or migraine

• acne or greasy skin

• painful periods

• sore or painful breasts

These are not all of the possible side effects with Kyleena. For more information, ask your HCP.

Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Bayer Healthcare Pharmaceuticals at 1-888-842-2937.

After Kyleena has been placed, when should I call my HCP?

If Kyleena is accidentally removed and you had vaginal intercourse within the preceding week, you may be at risk of pregnancy, and you should talk to an HCP.

Call your HCP if you have any concerns about Kyleena. Be sure to call if you:

• think you are pregnant

• have pelvic pain, abdominal pain, or pain during sex

• have unusual vaginal discharge or genital sores

• have unexplained fever, flu-like symptoms or chills

• might be exposed to STIs

• are concerned that Kyleena may have been expelled (came out)

• cannot feel Kyleena's threads

• develop very severe or migraine headaches

• have yellowing of the skin or whites of the eyes. These may be signs of liver problems.

• have had a stroke or heart attack

• become HIV positive or your partner becomes HIV positive

• have severe vaginal bleeding or bleeding that lasts a long time or concerns you

To learn more, talk about Kyleena with your HCP and see the FDA-approved Full Prescribing Information found on www.kyleena.com, or call 1-866-647-3646.