Liletta

Liletta is a hormone-releasing system placed in the uterus to prevent pregnancy for up to 4 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 that is often used in birth control pills.

Liletta belongs to a group of drugs called progestins which change the lining of the uterus and 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 and is inserted by a healthcare professional.

Common side effects of Liletta include infections of the vagina and acne.

Liletta is a hormone-releasing system placed in the uterus to prevent pregnancy for up to 4 years.

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

• Actavis Pharma, Inc.

Liletta can cause serious side effects. See Drug Precautions. 

Common side effects of Liletta include:

• infections of the vagina (bacterial and yeast)
• acne
• nausea or vomiting
• stomach or pelvic pain
• weight increase
• mood changes such as depression 
• headache
• pain during sex
• breast pain
• vaginal discharge
• anxiety

This is not a complete list of Liletta side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effects that bother you or that do not go away. 

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

Although no drug-drug interaction studies have been conducted with Liletta, it is recommended you tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Liletta can cause the following serious side effects:

• Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you become pregnant while using Liletta. 
• Pregnancy risks. If you become pregnant while Liletta 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. 
• Pelvic inflammatory disease (PID) or endometritis. Some intrauterine device (IUD) users get a serious pelvic infection called pelvic inflammatory disease. PID and is endometritis are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner have sex with other partners. PID or endometritis 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 or endometritis may require surgery. Tell your healthcare provider right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low stomach area pain, painful sex, 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 or fever 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.
• Expulsion. Liletta may come out of your uterus. Continue to check if Liletta is in place. You may become pregnant if Liletta comes out. If you believe Liletta has come out, use another form of birth control and contact your healthcare provider. 
• Cysts on the ovary. Some women develop cysts while using Liletta. These typically disappear on their own. 
• Changes in bleeding. Especially during the first 3 to 6 months, you may notice bleeding and spotting between menstrual periods. In some cases, the bleeding is heavier than usual at first. However, the bleeding usually gets lighter (more than usual) and may even be irregular. Call your healthcare provider if the bleeding remains heavier than usual or increases after it has been light for a while.

Liletta 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 Liletta if you:

• are allergic to Liletta or silicone, polyethylene, or barium sulfate
• are or might be pregnant
• have a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis 
• have an untreated genital infection now
• have had an infection from an abortion within the last 3 months
• 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
  • use inject illicit drugs into the vein 
• have or suspect you might have cancer of the uterus or cervix
• have bleeding from the vagina that is caused by an unknown reason
• have liver disease or liver tumor
• have breast cancer now or in the past 
• 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 Liletta, there are no specific foods that you must exclude from your diet when receiving this medication.

Before having Liletta inserted, tell your doctor if you:

• are allergic to Liletta or to any of its ingredients
• 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 migraines or severe or frequent headaches  

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

Tell your doctor if you are pregnant or plan to become pregnant.

Tell all 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 stomach 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.

Liletta has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Liletta, 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.

Use Liletta exactly as prescribed by your doctor. 

Liletta can prevent pregnancy for up to 4 years.

• It can be removed at any time but must be removed by the end of the fourth year.
• Liletta can be replaced at the time of removal with a new Liletta if for continued contraception if desired.
• Liletta can be used whether or not you have given birth to a child.

Insertion:

First, your healthcare provider will examine your pelvis to find the exact position of your uterus. Your healthcare provider will then clean your vagina and cervix with an antiseptic solution, and slide a thin plastic tube containing Liletta into your uterus. Your healthcare provider will then remove the plastic tube, and leave the IUD in your uterus. Your healthcare provider will cut the threads to the right length. Placement takes only a few minutes during an office visit.

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

Periodic Checking:

You should check that Liletta is in proper position by feeling the removal threads. It is recommended you check that Liletta is in place after each menstrual period.

1) First, 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, then Liletta 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 that Liletta 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.

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 the IUD is placed to make sure that it is in the right position.

Other important notes:

• Tampons may be used with the IUD.
• Liletta can be used whether or not you have given birth to a child.
• You and your partner should not feel Liletta during intercourse.
• Although Liletta is intended for use up to 4 years, If you want to stop using Liletta, your healthcare provider can remove Liletta at any time.

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

• think you are pregnant
• have pelvic pain or pain during sex
• have unusual vaginal discharge or genital sores
• have signs of an infection such as unexplained fever, flu-like symptoms or chills
• might be exposed to sexually transmitted infections (STIs)
• are concerned that Liletta has come out
• cannot feel Liletta 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
• or your partner becomes HIV positive
• have severe vaginal bleeding or bleeding that lasts a long time

Liletta contains 52 mg of levonorgestrel.

Liletta remains in place to prevent pregnancy for up to 4 years. This is done because levonorgestrel is released at a certain rate per day. 

Although Liletta is intended for use up to 4 years, If you want to stop using Liletta, your healthcare provider can remove Liletta at any time.

Since Liletta 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 Liletta is placed to make sure that it is in the right position.