The Skyla intrauterine device (IUD) contains levonorgestrel, a female hormone that can cause changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Skyla is a small, flexible plastic T-shaped device. This device is placed in the uterus where it slowly releases the hormone to prevent pregnancy for 3 years. (Other types of levonorgestrel intrauterine systems release different amounts of hormone and are used for different lengths of time.)

Skyla can be used whether you have had children or not. It should not be used during pregnancy.

Levonorgestrel is a progestin hormone and does not contain estrogen. The Skyla IUD releases levonorgestrel in the uterus, but only small amounts of the hormone reach the bloodstream. Skyla should not be used as emergency birth control.

You should not use the Skyla IUD if you have abnormal vaginal bleeding, a pelvic infection, certain other problems with your uterus or cervix, or if you have breast or uterine cancer, liver disease or liver tumor, or a weak immune system.

Do not use Skyla during pregnancy. Call your doctor if you think you might be pregnant.

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

Call your doctor at once if you have symptoms of a stroke or heart attack, such as sudden numbness or weakness, severe headache, or chest pain.

The Skyla 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.

Skyla 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 a Skyla IUD in place.

Your IUD may be removed at any time you decide to stop using birth control. 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.

Usual Adult Dose for Contraception:

Intrauterine Device (IUD) insertion should be performed by a trained healthcare provider thoroughly familiar with product; product manufacturer labeling should be consulted:

Insert 1 Skyla IUD (13.5mg) into uterus

Timing of insertion:
-For women who are not currently using hormonal or intrauterine contraception: Insertion may occur at any time the woman is not pregnant; if inserted after the first 7 days of menstrual cycle, an additional method of contraception should be used for 7 days after insertion
-Switching from an oral, transdermal, or vaginal hormonal contraceptive: Insertion may occur at any time; if inserted during the hormone phase, continue use for 7 days after insertion or until the end of the current treatment cycle
-Switching from an injectable progestin contraceptive: Insertion may occur at any time; if inserted more than 3 months after the last injection, an additional method of contraception should be used for 7 days after insertion
-Switching from a contraceptive implant or another IUD: Insertion should occur on the same day the implant or IUD is removed
-Inserting after abortion or miscarriage:
--First trimester: May insert IUD immediately after a first trimester abortion or miscarriage
--Second trimester: Insertion of IUD should be delayed a minimum of 4 weeks or until the uterus is fully involuted; if involution is delayed, insertion should be delayed until involution is complete; consider the possibility of ovulation and conception occurring prior to insertion and advise patient on need for an additional method of contraception for 7 days after insertion
-After childbirth: Insertion of IUD should be delayed a minimum of 4 weeks after delivery, or until the uterus is fully involuted; if involution is delayed, insertion should be delayed until involution is complete; consider the possibility of ovulation and conception occurring prior to insertion and advise patient on need for an additional method of contraception for 7 days after insertion

Replacement: A Skyla IUD should be replaced after 3 years. A new IUD may be inserted for continued use

Comments: The Skyla IUD may be removed at any time but must be removed by the end of the prescribed time; if continued use is desired, replace with a new IUD.

Uses: Prevention of pregnancy for up to 3 years.

Skyla 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, Skyla 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 Skyla 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.

To make sure Skyla is safe for you, tell your doctor if you have:

• 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.

You may use Skyla when you are breastfeeding. Levonorgestrel 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 uterine complications from IUD insertion is greater while you are breastfeeding.

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

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

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. Skyla will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom may 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.

Get emergency medical help if you have signs of an allergic reaction to Skyla: 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 Skyla 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.

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