Skyla

Generic Name: levonorgestrel intrauterine system (LEE voe nor JES trel IN tra UE ter ine SIS tem)
Brand Names: Mirena, Skyla

What is Skyla?

Skyla 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 to 3 years.

Skyla can be used whether or not you have had a child.

Levonorgestrel is a progestin hormone and does not contain estrogen. The Skyla intrauterine device release levonorgestrel in the uterus, but only small amounts of the hormone reach the bloodstream.

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

Important information

Skyla should not be used during pregnancy.

You should not use this medicine if you have abnormal vaginal bleeding, uterine infection after a pregnancy, pelvic inflammatory disease (PID), uterine fibroid tumors, a vaginal or cervical infection, abnormal Pap smear, breast cancer, cervical or uterine cancer, liver disease, or liver tumor.

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

Skyla can be removed by your healthcare provider at any time.

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.

Before using Skyla

The Skyla device 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 your personal risk and about ways to help prevent a pelvic infection.

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;

  • an untreated or uncontrolled pelvic infection (vaginal, cervical uterine, or bladder);

  • a serious pelvic infection following a pregnancy or abortion within the past 3 months;

  • a history of pelvic inflammatory disease (PID), unless you have had a normal pregnancy after the infection was treated and cleared;

  • uterine fibroid tumors or other conditions that affect the shape of the uterus;

  • past or present breast cancer, known or suspected cervical or uterine cancer;

  • liver disease or liver tumor (benign or malignant);

  • a recent abnormal Pap smear that has not yet been diagnosed or treated;

  • a disease or condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse; or

  • if you have another intrauterine device (IUD) in place.

You may need special tests to safely use a Skyla if you have:

  • diabetes;

  • a bleeding or blood-clotting disorder;

  • migraine headaches;

  • a vaginal infection, pelvic infection, or sexually transmitted disease; or

  • high blood pressure, heart disease or a heart valve disorder.

Skyla should not be used during pregnancy. This device can cause severe infection, miscarriage, premature birth, or death of the mother if it is left in place during pregnancy. Tell your doctor right away if you become pregnant while using the intrauterine system. If you choose to continue a pregnancy that occurs while using Skyla, watch for signs of infection such as fever, chills, flu symptoms, cramps, vaginal bleeding or discharge.

If you have recently had a baby and are breast-feeding, wait until your baby is at least 6 weeks old before you start using the Skyla intrauterine device.

How is Skyla used?

Skyla is a T-shaped plastic device that is inserted through the vagina and placed into the uterus. The device is usually inserted within 7 days after the start of a menstrual period.

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 slim plastic tube containing Skyla into your uterus. Your healthcare provider will then remove the plastic tube, and leave Skyla in your uterus. Your healthcare provider will cut the threads to the right length. Placement takes only a few minutes.

You may feel pain or dizziness during insertion of the intrauterine device. You may also have minor vaginal bleeding. These symptoms should last only 30 minutes or less. Tell your doctor if you still have these symptoms longer than 30 minutes.

The Skyla device should not interfere with sexual intercourse, wearing tampons, or using other vaginal medications recommended by your doctor.

After each menstrual period you should check to make sure you can still feel the removal strings. Wash your hands with soap and water, and insert your clean fingers into the vagina. You should be able to feel the strings at the opening of your cervix. Call your doctor at once if you cannot feel the strings, or if you think the Skyla device has slipped lower in your uterus or out of your uterus. A sudden increase in menstrual flow may be a sign that the device has slipped out of place.

If you think the Skyla device is not properly in place, use a non-hormone method of birth control (condom, or diaphragm with spermicide) to prevent pregnancy until your doctor is able to replace the levonorgestrel device.

Your doctor will need to see you within a few weeks after insertion of the device to make sure it is still in place correctly. You will also need regular annual pelvic exams and Pap smears.

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

For the first 3 to 6 months, your period may become irregular and the number of bleeding days may increase. You may also have frequent spotting or light bleeding. Some women have heavy bleeding during this time. After you have used Skyla for a while, the number of bleeding and spotting days is likely to lessen. There is a small chance that your periods will stop altogether.

Your Skyla device may be removed at any time you decide to stop using birth control. The device must be removed after 3 years. Your doctor can insert a new device at that time if you wish to continue using this form of birth control. Only your doctor should remove the Skyla intrauterine device. Do not attempt to remove the device yourself.

Following removal of the Skyla device, you may become pregnant right away.

What happens if I miss a dose?

Since the intrauterine device 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?

Avoid having more than one sexual partner. Skyla 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 is the only way to help protect yourself from these diseases. Contact your doctor if your sexual partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

Skyla side effects

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

The Skyla device 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;

  • extreme dizziness or light-headed feeling;

  • 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;

  • pain during sexual intercourse;

  • sudden numbness or weakness (especially on one side of the body), sudden or severe headache, confusion, problems with vision, sensitivity to light;

  • jaundice (yellowing of the skin or eyes); or

  • signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common Skyla side effects may include:

  • vaginal itching, irregular menstrual periods, changes in bleeding patterns or flow;

  • mild stomach pain, nausea, bloating;

  • back pain, breast tenderness or pain;

  • weight gain, acne, changes in hair growth, mood changes, loss of interest in sex;

  • 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.

See also: Side effects (in more detail)

Skyla dosing information

Usual Adult Dose for Contraception:

Contraception:
Skyla: One 13.5 mg intrauterine system inserted during seven days of the menstrual cycle or immediately after a first trimester abortion. Postpone postpartum insertion and insertions following second trimester abortions a minimum of six weeks or until the uterus is fully involuted. One system is effective for 3 years.

Comments:
Back up contraception not needed when Skyla is inserted as directed.

What other drugs will affect Skyla?

Tell your doctor about all medicines you use, and those you start or stop using while your Skyla device is in place, especially:

  • bosentan, griseofulvin, insulin, St. John's wort, topiramate; or

  • a barbiturate--butabarbital, phenobarbital, secobarbital, and others; a blood thinner--warfarin, Coumadin; HIV/AIDS medication--efavirenz, nevirapine, ritonavir; seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; steroids--prednisone, fluticasone, mometasone, dexamethasone, and others; tuberculosis medication--rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about the Skyla.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Skyla only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 5.02. Revision Date: 2013-07-15, 1:50:09 PM.

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