Skyla

Skyla is a prescription implantable intrauterine system (IUS) containing a hormone and is used to prevent pregnancy for up to 3 years at a time. Skyla belongs to a group of drugs called progestins which work to prevent pregnancy by altering the lining of the uterus and cervical mucus, which prevents sperm from entering the uterus.

This medication comes in a plastic device that is manually inserted into the uterus by a healthcare provider.

Common side effects of Skyla include vaginal irritation and/or inflammation, acne, and ovarian cysts.

Skyla is a prescription implantable intrauterine system (IUS) containing a hormone and is used to prevent pregnancy for up to 3 years at a time.

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

• Bayer Healthcare Pharmaceuticals Inc.

Serious side effects have been reported with Skyla. See the “Skyla Precautions” section.

Common side effects of Skyla include the following:

• vaginal pain and/or irritation
• acne
• ovarian cysts
• abdominal pain
• headache
• painful menstrual periods
• increased menstrual bleeding

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

Tell your doctor if you have any side effect that bothers you or that does 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.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medications that induce the enzyme CYP3A4 such as:

• Barbiturates
• Bosentan
• Carbamazepine
• Efavirenz
• Felbamate
• Griseofulvin
• Nevirapine
• Oxcarbazepine
• Phenytoin
• Rifabutin
• Rifampin
• St. John’s wort
• Topiramate

 This is not a complete list of Skyla drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Skyla including the following:

• Pelvic inflammatory disease (PID). Some intrauterine systems (IUS) users develop a serious pelvic infection called pelvic inflammatory disease (PID). PID is usually sexually transmitted. You have a higher risk of developing PID if you or your partner also has sex with other partners. PID can cause serious medical problems including infertility and ectopic pregnancy. PID is usually treated with antibiotics. Serious cases of PID may require surgery and 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 symptoms of PID:
  • long-lasting and/or heavy menstrual bleeding
  • unusual vaginal discharge
  • low abdominal (stomach area) pain
  • painful sex
  • chills
  • fever
• Embedment. The IUS may become attached to the uterine wall. This is called embedment. If embedment happens, this medication may no longer prevent pregnancy and you may need surgery to have it removed. Your physician will monitor placement of Skyla at regular intervals during your treatment.
• Pain, bleeding or dizziness during and after placement. If these symptoms do not stop 30 minutes after placement, the IUS may not have been placed correctly. Inform your healthcare provider and they will examine you to see if the IUS needs to be removed or replaced.
• Ectopic pregnancy. Approximately half of pregnancies that occur with Skyla in place are ectopic (outside the uterus). The incidence of ectopic pregnancy in clinical trials with Skyla, which excluded women with a history of ectopic pregnancy, was approximately 0.1% per year. The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use Skyla is unknown. Ectopic pregnancy may result in loss of fertility. Consult with your physician about your risk for ectopic pregnancy.
• Sepsis. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of the IUS. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Consult with your physician about your risk of developing sepsis before starting treatment with Skyla.
• Perforation. The IUS may pass through the uterus, this is called perforation. If your uterus is perforated, Skyla may no longer prevent pregnancy and 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 IUS removed.
• Breast cancer. Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use Skyla because some breast cancers are hormone-sensitive and can worsen if medications like Skyla are taken.
• Heart attacks and strokes. Cigarette smoking increases the risk of serious cardiovascular events like heart attacks and strokes. Risk also increases with age (over 35 years) and with the number of cigarettes smoked. Skyla should not be used by women who are over 35 years of age and smoke.

Do not use this medication if you:

• are allergic to Skyla or to any of its ingredients 
• are pregnant or suspect you might be pregnant
• have an untreated pelvic infection now
• have had a serious pelvic infection in the past 3 months
• are at high risk for developing infections; for example, if you:
  • have more than one sexual partner or your partner has more than one sexual partner
  • have immune system problems
  • abuse intravenous drugs
• 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 tumors
• 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
• are over 35 years of age and/or smoke

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 Skyla, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Skyla, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Skyla or to any of its ingredients 
• 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 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 tumors
• are pregnant or think you might be pregnant
• have breast cancer now or in the past or suspect you have breast cancer
• have had a serious pelvic infection in the past 3 months after a pregnancy
• 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
• are over 35 years of age and/or smoke
• develop very severe or migraine headaches
• have yellowing of the skin or whites of the eyes
• have a stroke or heart attack
• or your partner becomes HIV positive
• have severe vaginal bleeding or menstrual bleeding that lasts an unusually long time

• are at high risk for developing infections; for example, if you:
  • have more than one sexual partner or your partner has more than one sexual partner
  • have problems with your immune system
  • abuse intravenous drugs

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.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Skyla falls into category X. These medicines should never be used by pregnant women.

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

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

Take Skyla exactly as prescribed.

Skyla comes in a plastic intrauterine system (IUS) form that is manually inserted into the uterus by a healthcare provider.

Implantation process

1. First, 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 the intrauterine system (IUS) into your uterus.
3. Your healthcare provider will then remove the plastic tube, and leave the IUS in your uterus.
4. Your healthcare provider will cut the threads to the right length. Placement takes only a few minutes during an office visit.
5. You may experience pain, bleeding or dizziness during and after placement. If these symptoms do not pass 30 minutes after placement, the IUS may not have been placed correctly. Your healthcare provider will examine you to see if the IUS needs to be removed or replaced.

Monthly checks

After each menstrual period, you should check that the IUS is in proper position by feeling the removal threads. First, wash your hands with soap and water. Feel for the threads at the top of your vagina with your clean fingers. The threads are the only part of the IUS 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 IUS is not in the right position and may not prevent pregnancy. Call your healthcare provider to have it removed. If you cannot feel the threads at all, ask your healthcare provider to check the IUS 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.

The IUS may come out by itself. This is called expulsion. You may become pregnant if the IUS comes out. If you notice the IUS has come out, use a backup birth control method like condoms and call your healthcare provider.

Skyla does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

Tampons may be used with the IUS.

Use Skyla exactly as prescribed by your doctor. 

The recommended dose of Skyla for prevention of pregnancy for up to 3 years at a time is 6 mcg/day, which is released from the implanted Skyla IUS.

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