Kyleena

Generic name: levonorgestrel intrauterine system (LEE voe nor JES trel IN tra UE ter ine SIS tem)
Brand name: Kyleena, Liletta, Mirena, Skyla
Drug class: Contraceptives, Progestins

Levonorgestrel is a female hormone that can cause changes in your cervix and uterus. Kyleena or intrauterine device (IUD) is placed in the uterus where it slowly releases the hormone.

Kyleena is used to prevent pregnancy for 3 to 6 years. Mirena is also used to treat heavy menstrual bleeding in women who choose to use an intrauterine form of birth control.

Levonorgestrel does not contain estrogen and should not be used as emergency birth control.

Kyleena may also be used for purposes not listed in this medication guide.

Warnings

Do not use during pregnancy. Tell your doctor right away if you become pregnant.

Before taking this medicine

An IUD can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about this risk.

Do not use during pregnancy. If left in place during pregnancy, this IUD could cause severe infection, miscarriage, premature birth, or death of the mother. The hormone in the IUD may also cause unwanted effects in a female newborn.

Tell your doctor right away if you become pregnant. If you continue the pregnancy, watch for signs such as fever, chills, cramps, vaginal bleeding or discharge.

You should not use this device if you are allergic to levonorgestrel, silicone, silica, silver, barium, iron oxide, or polyethylene, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;
• an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
• endometriosis or a serious pelvic infection following a pregnancy or abortion in the past 3 months;
• pelvic inflammatory disease (PID), unless you had a normal pregnancy after the infection was treated and cleared;
• uterine fibroid tumors or conditions that affect the shape of the uterus;
• past or present cancer of the breast, cervix, or uterus;
• liver disease or liver tumor (benign or malignant);
• a condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse;
• if you have another intrauterine device (IUD) in place;
• if you had an abortion or miscarriage in the past 6 weeks; or
• if you gave birth to a baby in the past 6 weeks.

Tell your doctor if you have ever had:

• high blood pressure, heart problems, a heart attack, or a stroke;
• bleeding problems;
• migraine headaches; or
• a vaginal infection, pelvic infection, or sexually transmitted disease.

Do not breastfeed until at least 6 weeks have passed since your baby was born. The risk of uterine complications from IUD insertion is greater while you are breastfeeding.

How is Kyleena used?

The levonorgestrel IUD is inserted through the vagina and placed into the uterus by a doctor.

You may feel pain or dizziness during insertion of the IUD, and you may have minor vaginal bleeding. Tell your doctor if these symptoms last longer than 30 minutes.

The IUD should not interfere with sexual intercourse, wearing a tampon or menstrual cup, or using other vaginal medications.

Your doctor should check the IUD after a few weeks to make sure it is still in place. You will also need annual pelvic exams and Pap smears.

You may have irregular periods for 3 to 6 months. Your flow may be lighter or heavier, and your periods may stop after several months. Tell your doctor if you do not have a period for 6 weeks or if you think you might be pregnant.

The IUD may come out by itself. After each menstrual period, make sure you can still feel the removal strings at the opening of your cervix.

Call your doctor at once if you cannot feel the strings, or if you think the IUD has slipped lower or has come out of your uterus, especially if you also have pain or bleeding. Use a non-hormone method of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy until your doctor is able to replace the IUD.

If you need to have an MRI (magnetic resonance imaging), tell your caregivers ahead of time that you have an IUD in place.

Your IUD may be removed at any time you decide to stop using birth control. Mirena or Liletta must be removed at the end of the 6-year wearing time. Kyleena must be removed after 5 years, and Skyla must be removed after 3 years. Your doctor can insert a new device if you wish to continue using this form of birth control. Only your doctor should remove the IUD. Do not attempt to remove the device yourself.

If you decide to use a different method of birth control, you may need to start using it a week before your IUD is removed.

What happens if I miss a dose?

Since the IUD continuously releases a low dose of levonorgestrel, missing a dose does not occur when using this form of levonorgestrel.

What happens if I overdose?

An overdose of levonorgestrel released from the intrauterine system is very unlikely to occur.

What should I avoid while using Kyleena?

Avoid having more than one sex partner. The IUD can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted disease. Kyleena will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to help protect yourself from these diseases.

Call your doctor if your sex partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

Kyleena side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy.

The IUD may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. Your doctor may need to surgically remove the device.

Call your doctor at once if you have:

• severe cramps or pelvic pain, pain during sexual intercourse;
• extreme dizziness or light-headed feeling;
• severe migraine headache;
• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
• pale skin, weakness, easy bruising or bleeding, fever, chills, or other signs of infection;
• jaundice (yellowing of the skin or eyes); or
• sudden numbness or weakness (especially on one side of the body), confusion, problems with vision, sensitivity to light.

Common side effects may include:

• pelvic pain, painful or irregular menstrual periods, changes in bleeding patterns or flow;
• vaginal swelling, itching or infection;
• temporary pain, bleeding, or dizziness during insertion of the IUD;
• ovarian cysts (pelvic pain that disappears within 3 months);
• stomach pain, nausea, vomiting, bloating;
• headache, migraine, depression, mood changes;
• back pain, breast tenderness or pain;
• weight gain, acne, oily skin, changes in hair growth, loss of interest in sex; or
• puffiness in your face, hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Kyleena?

Other drugs may affect levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.