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Kyleena is an intrauterine device (IUD), a form of birth control, that is inserted into the uterus to prevent pregnancy for up to five years. Common side effects include headache, painful periods or cramping, or changes in menstrual bleeding. Serious side effects are rare but can include infections or uterus problems. 

Uses

What is Kyleena used for?

Kyleena (levonorgestrel) is an intrauterine device (IUD) that is commonly used to prevent pregnancy for up to five years.

Kyleena may also be used for other conditions as determined by your health care provider.

There are other levonorgestrel intrauterine devices (IUDs) available. See Liletta, Mirena, and Skyla for more information.

How does Kyleena work (mechanism of action)?

Kyleena works by slowly releasing a progestin hormone, called levonorgestrel, into the uterus. It may prevent pregnancy by thickening the mucus in your cervix to block sperm from reaching the uterus. It may also affect sperm so they cannot survive or function properly, and change the lining of your uterus to make it less likely for a pregnancy to happen.

How is Kyleena supplied (dosage forms)?

Brands and other names

  • Kyleena

Dosage forms and strengths

Kyleena is available as an intrauterine device (IUD) that is inserted by a health care provider.

How should I store Kyleena?

Kyleena is usually inserted by a health care provider during an office visit or in the hospital. You will not store it at home.

Side Effects

What are the most common side effects of Kyleena?

The most common side effects of Kyleena are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Inflammation or infection of the outer parts of the vagina (vaginitis)  
  • Ovarian cysts (see below)
  • Stomach or pelvic pain 
  • Headache or migraine
  • Acne or greasy skin
  • Painful periods or cramping
  • Sore or painful breasts
  • Changes in menstrual bleeding (see below) 

There may be other side effects of Kyleena that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Kyleena?

While less common, the most serious side effects of Kyleena are described below, along with what to do if they happen.

Severe Allergic Reactions. Kyleena may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Severe Infection. Kyleena can increase your risk of a severe infection or sepsis within the first few days after the device is inserted. Call your health care provider right away if you have severe pain or fever.  

Uterus Problems. Kyleena may go into the wall of the uterus (become embedded) or go through the wall of the uterus (perforation). This increases your risk of pregnancy. It also increases the risk of infection and damage to other organs. The risk of perforation is higher if Kyleena is inserted after you have recently given birth or if you are breastfeeding. Tell your health care provider right away if you cannot feel the threads of the device inside your vagina or if you have pain or bleeding that gets worse after Kyleena is inserted. 

Expulsion. Kyleena may come out of the uterus by itself, which is called expulsion. The risk of expulsion is higher if Kyleena is placed right after you deliver a baby or have a second-trimester abortion. If Kyleena comes out, you will be at higher risk of pregnancy. Tell your health care provider right away if you cannot feel the threads of Kyleena inside your vagina or if you have pain or bleeding that gets worse after Kyleena is inserted.

Ovarian Cysts. Kyleena may cause cysts to form on your ovaries. Some ovarian cysts are harmless and go away on their own, while others may grow and cause bloating, swelling, or pain in your lower belly. Get emergency help right away if you have any of the following symptoms that an ovarian cyst has burst.

  • Sharp, sudden pain in your lower belly or back
  • Abnormal spotting or bleeding
  • Pain with fever and throwing up
  • Dizziness, weakness, or feeling faint
  • Fast breathing (hyperventilation)

Changes in Menstrual Bleeding. Kyleena can cause your period to become irregular, longer, and heavier within the first three to six months after placement. It can also cause frequent spotting or light bleeding. Bleeding or spotting usually lessens after using Kyleena for a while. For some people, periods will stop. Call your health care provider right away if bleeding remains heavier than usual or if it increases after it has been light or absent for a while. 

Pelvic Inflammatory Disease. Kyleena can increase the risk of pelvic inflammatory disease (PID), which is an infection that can affect the uterus, ovaries, or fallopian tubes. Bacteria that cause pelvic inflammatory disease can get into your body when Kyleena is inserted. Call your health care provider right away if you have any of the following symptoms of PID.

  • Pain in your lower belly or pelvis
  • Heavy vaginal discharge that is discolored and has a bad smell
  • Heavy bleeding during your period or bleeding between periods
  • Pain or bleeding during sex
  • Chills or fever
  • Pain when your pee or problems peeing
  • Sores on your genitals

Pregnancy Problems. If you become pregnant while using Kyleena, you may be at higher risk of miscarriage, infection, and early labor or delivery. You may also be at higher risk of that pregnancy being outside the uterus (ectopic pregnancy). With ectopic pregnancy, as the fertilized egg grows, it can burst (rupture) and cause life-threatening bleeding and death. Call your health care provider right away if you think you might be pregnant or have any of the following symptoms. 

  • Pain in your lower stomach or vomiting
  • Sharp belly cramps 
  • Unusual vaginal bleeding or discharge
  • Pain on one side of your body
  • Dizziness or weakness
  • Pain in your shoulder, neck, or rectum
  • Fever, chills, or flu-like symptoms

Warnings & Precautions

Who should not use Kyleena?

Allergies to Ingredients. People who are allergic to any of the following should not use Kyleena.

  • Kyleena
  • Levonorgestrel
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Kyleena.

Pregnancy. Do not use Kyleena if you are pregnant or think you might be pregnant. If you become pregnant, contact your health care provider right away. See the Pregnancy section for more details

Uterus Problems. Kyleena should not be used if you have bleeding from the uterus for an unknown reason, or if you have problems that change the shape of your uterus, such as fibroids. Kyleena may not work as well if you have these conditions.

Pelvic or Genital Infections. Kyleena should not be used if you are at high risk of pelvic inflammatory disease (PID), which is an infection that can affect the uterus, ovaries, or fallopian tubes. It should also not be used if you have recently had an infection of the uterus after a pregnancy or abortion, or if you currently have an infection of the uterus, ovaries, fallopian tubes, cervix, or vagina. The infection should be treated before using Kyleena.

Cancer. Kyleena should not be used if you have or have had breast, uterine, or cervical cancer. Some cancers are sensitive to hormones and could get worse if you use Kyleena.

Liver Problems. Kyleena should not be used if you have liver disease or a liver tumor. Tell your health care provider if you have any liver problems.

Another Intrauterine Device (IUD). Kyleena should not be used if you already have an intrauterine device (IUD) inside your uterus. The other device must be removed before Kyleena can be placed.

What should I know about Kyleena before using it?

Kyleena is an intrauterine device (IUD) that is inserted into the uterus by your health care provider at a medical facility. It will be removed or replaced after five years, but it can be removed at any time.

Kyleena does not protect you from HIV, AIDS, or other sexually transmitted diseases (STDs). 

Depending on when Kyleena is inserted during your menstrual period, or if you are switching from another form of birth control, you may need to use backup birth control (such as condoms or spermicide) after Kyleena is placed. Ask your health care provider whether you need to use backup birth control and for how long. 

Tell your health care provider right away if you have intense pain, bleeding, or dizziness 30 minutes or more after Kyleena is inserted. It may need to be removed or replaced.

Check that Kyleena is in place by feeling the threads inside the vagina at least once a month. Talk with your health care provider if you have questions about how to do this. 

If you think Kyleena has fallen out of your uterus (expulsion) or is out of place, call your health care provider right away and use backup birth control (such as condoms or spermicide) until Kyleena can be replaced. 

Be extra careful when changing tampons or menstrual cups so that you do not accidentally pull the Kyleena threads. Call your health care provider right away if you think you have pulled Kyleena out of place. 

Make sure to keep all follow-up appointments with your health care provider. They will use these appointments to check that Kyleena is in the right position. 

You may need special X-rays or other methods to check whether Kyleena is in place, or to help find the device when it is time to take it out. Depending on the exact position of the device, removal may be difficult and may require surgery. Talk to your health care provider if you have questions.

Tell all your health care providers that you have Kyleena in place, especially if you need an MRI (magnetic resonance imaging). It may not be safe to have an MRI in some cases. 

What should I tell my health care provider before using Kyleena?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Kyleena is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

  • Heart problems, heart attack, or stroke
  • Problems with blood clotting 
  • High blood pressure (hypertension)
  • Recently had a baby 
  • Severe headaches or migraine 
  • HIV, AIDS, or another sexually transmitted disease (STD)
  • Multiple sexual partners or your partner has multiple sexual partners
  • Immune system problems
  • Substance use disorder (specifically injectable drugs)
  • Liver problems or yellowing of your skin or eyes (jaundice)
  • Cancer
  • Unexplained vaginal bleeding
  • Conditions that affect the shape of your uterus, such as fibroids

Other Medicines and Supplements. Kyleena may interact with other medicines and supplements. Before using Kyleena, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Do not use Kyleena during pregnancy. Using Kyleena while you are pregnant may cause complications during pregnancy. If you become pregnant or think you might be pregnant while using Kyleena, contact your health care provider right away.

Breastfeeding. Kyleena passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Kyleena while breastfeeding.

How can I get more information about Kyleena?

For more information about Kyleena, you can visit the drugmaker’s website at www.kyleena-us.com or call 844-695-9533.

Interactions

Does Kyleena interact with foods or drinks?

There are no known interactions between Kyleena and foods or drinks.

It is unknown if drinking alcohol will affect Kyleena.

Does Kyleena interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are taking a blood thinner, which is a medicine used to treat or prevent blood clots.

This may not be a complete list of medicines that can interact with Kyleena. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Kyleena?

If you or someone else has used too much Kyleena, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Kyleena?

Kyleena is inserted by a health care provider and left in place for up to five years. If it has been in place for too long or has come out of place, avoid sexual intercourse or use backup birth control (such as condoms or spermicide) and contact your health care provider right away.

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