Kyleena

Kyleena is a hormone-releasing system placed in the uterus to prevent pregnancy for up to 5 years. This hormone-releasing system is a type of intrauterine system also known as an intrauterine device (IUD) and releases a progestin hormone called levonorgestrel (LNG) that is often used in birth control pills.

Kyleena belongs to a group of drugs called progestins which change the lining of the uterus, thicken the cervical mucus to make it difficult for sperm to enter the uterus.

This medication comes in the form of a small, flexible, t-shaped plastic device that is inserted into the uterus by a healthcare provider. 

Common side effects of Kyleena include missed menstrual periods, changes in bleeding and cysts on the ovary. 

Kyleena is a hormone-releasing system placed in the uterus to prevent pregnancy for up to 5 years.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Kyleena can cause serious side effects. See Drug Precautions. 

Common side effects of Kyleena include:

• Pain, bleeding or dizziness. This may happen during and after placement of Kyleena. If these symptoms do not stop 30 minutes after Kyleena has been inserted, the IUD may not have been placed correctly. Your healthcare provider will examine you to see if the IUD needs to be removed or replaced.
• Expulsion. If the IUD comes out by itself, this is called expulsion. You may become pregnant if the IUD comes out. If you notice the IUD has come out, use a backup birth control method like condoms and call your healthcare provider.
• Missed menstrual periods. About 12 out of 100 women stop having periods after 1 year of when Kyleena was inserted. If you do not have a period for 6 weeks during Kyleena use, call your healthcare provider. When the IUD is removed, your menstrual periods will come back.
• Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may even become irregular. Call your healthcare provider if the bleeding remains heavier than usual or if the bleeding becomes heavy after it has been light for a while.
• Cyst on the ovary. About 22 out of 100 women using this hormone-releasing system develop a cyst on the ovary. These cysts usually disappear on their own in two to three months. However, cysts can cause pain and sometimes surgery is needed to treat cysts. 

Other common side effects include: 

• Inflammation or infection of the outer part of your vagina 
• Stomach or pelvic pain 
• Headache or migraine 
• Acne 
• Painful periods 
• Sore or painful breasts 

This is not a complete list of possible side effects with Kyleena. For more information, ask your healthcare provider. Tell your healthcare provider if you have any side effect that bothers you or does not go away. 

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Although no drug-drug interaction studies have been conducted with Kyleena, some medications, that affect the enzyme CYP3A4, may affect the levels of Kyleena. Since the device is placed in the uterus and releases hormones in the uterus, these interactions are unlikely. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Kyleena can cause serious side effects including: 

• Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you become pregnant while using Kyleena. 
• Pelvic inflammatory disease. Some intrauterine device (IUD) users get a serious pelvic infection called pelvic inflammatory disease (PID). PID is usually sexually transmitted. You have a higher chance of getting PID if you or your partner have 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. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death. Tell your healthcare provider right away if you have any of these signs of PID such as long-lasting or heavy bleeding, unusual vaginal discharge, low stomach area pain, sex that is painful, chills, or fever.
• Life-threatening infection. Life-threatening infection can occur within the first few days after the IUD is placed. Call your healthcare provider if you develop severe pain within a few hours after the IUD is placed.
• Perforation. The IUD may go through the wall of the uterus. This is called perforation. If your uterus is perforated, this medication may no longer prevent pregnancy. It may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have the IUD removed.

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

Although the risk of heart side effects increases in women taking estrogen-containing combined birth control and who smoke cigarettes, especially those who are >35 years, this risk relative to progestin-only contraceptives has not been established. Talk to your doctor about your risk. 

Do not use this medication if you:

• are allergic to Kyleena, silicone, polyethylene, silver, silica, barium sulfate, polypropylene, or copper phthalocyanine 
• might be pregnant
• have had a serious pelvic infection called pelvic inflammatory disease (PID) unless you have had a normal pregnancy after the infection went away
• have an untreated pelvic 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:
  • more than one sexual partner or your partner has more than one partner
  • problems with your immune system
  • inject illicit drugs into the vein
• 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 liver tumor
• have breast cancer now or in the past or suspect you have breast cancer
• have an intrauterine device in your uterus already
• have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Kyleena, there are no specific foods that you must exclude from your diet when receiving this medication.

Before having the intrauterine device (IUD) placed, tell your doctor if you:

• are allergic to Kyleena
• 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 if you are breastfeeding
• have severe migraine headaches

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Call your healthcare provider right away if you think you are pregnant. If you become pregnant while using this medication, 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 become pregnant while using this medication and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an intrauterine device (IUD). Because of this, your healthcare provider may try to remove the IUD, even though removing it may cause a miscarriage. If the IUD cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy.

If you continue your pregnancy, see your healthcare provider regularly. Contact your healthcare provider right away if you notice signs and symptoms of infection such as flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina.

It is not known if this hormone-releasing system can cause long-term effects on the fetus if it stays in place during a pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Kyleena has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Kyleena, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.

Kyleena will be inserted by a healthcare provider. The placement only takes a few minutes during an office visit.

When inserting Kyleena:

1) Your healthcare provider will examine your pelvis to find the exact position of your uterus.

2) Your healthcare provider will then clean your vagina and cervix with an antiseptic solution, and slide a thin plastic tube containing Kyleena into your uterus.

3) Your healthcare provider will then remove the plastic tube, and leave Kyleena in your uterus. Your healthcare provider will cut the threads to the right length. 

During and After Placement:

You may experience pain, bleeding or dizziness during and after placement of Kyleena. If these symptoms do not pass 30 minutes after placement of Kyleena, it may not have been placed correctly. Your healthcare provider will examine you to see if Kyleena needs to be removed or replaced.

After Placement:

It is recommended you check that Kyleena is in proper position by feeling the removal threads. It is recommended to check if Kyleena is in place after each menstrual period.

1) Wash your hands with soap and water.

2) Feel for the threads at the top of your vagina with your clean fingers. The threads are the only part of the IUD you should feel when it is in your uterus. Be careful not to pull on the threads.

• If you feel more than just the threads, the IUD is not in the right position and may not prevent pregnancy. Call your healthcare provider to resolve the issue. 
• If you cannot feel the threads at all, ask your healthcare provider to check the IUD is still in the right place. In either case, use a non-hormonal birth control method (such as condoms or spermicide) until otherwise advised by your healthcare provider.

Other important notes:

• Call your healthcare provider if you have any questions or concerns. Otherwise, you should return to your healthcare provider for a follow-up visit 4 to 6 weeks after Kyleena is inserted to make sure that it is in the right position.
• Tampons may be used with the IUD.
• Kyleena can be used whether or not you have given birth to a child.
• You and your partner should not feel Kyleena during intercourse.
• Although Kyleena is intended for use up to 5 years, If you want to stop using Kyleena, your healthcare provider can remove Kyleena at any time.

Call your healthcare provider if you have any concerns about this medication. Be sure to call if you:

• are or might be pregnant
• have pelvic pain, stomach pain, or pain during sex
• have unusual vaginal discharge or genital sores
• have signs of an infection such as unexplained fever, flu-like symptoms, and chills
• might be exposed to sexually transmitted infections (STIs)
• are concerned that Kyleena may have come out
• cannot feel Kyleena 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 a stroke or heart attack
• become HIV positive or your partner becomes HIV positive
• have severe vaginal bleeding or bleeding that is concerning

Kyleena contains 19.5 mg of levonorgestrel. 

Kyleena is intended for use up to 5 years and therefore must be removed or replaced after 5 years. 

Although it is intended for use up to 5 years, Kyleena can be removed at any time by a healthcare provider. 

Since Kyleena is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Call your healthcare provider if you have any questions or concerns. Otherwise, you should return to your healthcare provider for a follow-up visit 4 to 6 weeks after Kyleena is inserted to make sure that it is in the right position.