Levonorgestrel-releasing intrauterine system

What is Levonorgestrel-releasing intrauterine system?

• Levonorgestrel-releasing intrauterine system (Skyla) is a progestin-containing intrauterine system (IUS) used for prevention of pregnancy for up to 3 years.

What are the uses of this medicine?

• Skyla is a hormone-releasing system placed in your uterus by your healthcare provider to prevent pregnancy for up to 3 years.
• Skyla is a small, flexible plastic T-shaped system that slowly releases a progestin hormone called levonorgestrel (LNG) that is often used in birth control pills.

How does this medicine work?

• Levonorgestrel acts by binding to the progesterone receptor in the nuclei of target cells, resulting in transcription activation and an alteration in protein synthesis.
• Subsequently, luteinizing hormone (LH) activity and ovulation are suppressed.
• Levonorgestrel may also exhibit antiproliferative activity in endometrial tissue.
• Studies of Skyla and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium.

Who Should Not Use this medicine ?

This medicine cannot be used in patients if:

• are or might be pregnant; Skyla cannot be used as an emergency contraceptive
• have a serious pelvic infection called pelvic inflammatory disease (PID) or have had PID in the past unless you have had a normal pregnancy after the infection went away
• have an untreated genital infection now
• have had a serious pelvic infection in the past 3 months after a pregnancy
• can get infections easily. For example, if you:
• have multiple sexual partners or your partner has multiple sexual partners
• have problems with your immune system
• use or 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 a liver tumor
• have breast cancer or any other cancer that is sensitive to progestin (a female hormone), 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
• are allergic to levonorgestrel, silicone, polyethylene, silver, silica, barium sulfate or iron oxide

What drug interactions can this medicine cause?

• No drug-drug interaction studies have been conducted with Skyla.
• The contraceptive effect of Skyla is mediated via the direct release of LNG into the uterine cavity and is unlikely to be affected by drug interactions via enzyme induction or inhibition.

Is this medicine FDA approved?

• Initial U.S. Approval: 2000

How should this medicine be used?

Recommended Dosage:

• Release rate of levonorgestrel (LNG) is 14 mcg/day after 24 days and declines to 5 mcg/day after 3 years; Skyla must be removed or replaced after 3 years.

Administration

• To be inserted by a trained healthcare provider using strict aseptic technique. Follow insertion instructions exactly as described.
• Patient should be re-examined and evaluated 4 to 6 weeks after insertion; then, yearly or more often if clinically indicated.
• 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 through the cervix 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.
• You may experience pain, bleeding or dizziness during and after placement. If your symptoms do not pass within 30 minutes after placement, Skyla may not have been placed correctly. Your healthcare provider will examine you to see if Skyla needs to be removed or replaced.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing dosage form:

• As One sterile intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 13.5 mg levonorgestrel packaged within a sterile inserter

This medicine is available in fallowing brand namesː

• Skyla

What side effects can this medication cause?

The most common side effects of this medicine include:

• Pain, bleeding or dizziness during and after placement
• Changes in bleeding
• Missed menstrual periods
• Cysts on the ovary
• abdominal or pelvic pain
• acne or greasy skin
• headache or migraine
• inflammation or infection of the outer part of your vagina (vulvovaginitis)
• painful periods

What special precautions should I follow?

• Remove Skyla if pregnancy occurs with Skyla in place. If a pregnancy occurs, there is increased risk of ectopic pregnancy including loss of fertility, pregnancy loss, septic abortion (including septicemia, shock and death), and premature labor and delivery.
• Group A streptococcal infection has been reported following insertion of LNG IUS; strict aseptic technique is essential during insertion.
• Before using Skyla, consider the risks of PID.
• Perforation (total or partial, including penetration/embedment of Skyla in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later. Uterine perforation may occur and may reduce contraceptive effectiveness or require surgery. Risk is increased if inserted in lactating women and may be increased if inserted in women with fixed retroverted uteri and postpartum.
• Partial or complete expulsion may occur, which can be unnoticed, leading to loss of contraceptive efficacy.
• Evaluate persistent enlarged ovarian follicles or ovarian cysts.
• Bleeding patterns become altered, may remain irregular and amenorrhea may ensue.
• Skyla can be safely scanned with MRI only under certain conditions.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• The use of Skyla is contraindicated in pregnancy or with a suspected pregnancy and Skyla may cause adverse pregnancy outcomes .
• If a woman becomes pregnant with Skyla in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery.

Can this medicine be used in children?

• Safety and efficacy of Skyla have been established in women of reproductive age.
• Use of this product before menarche is not indicated.

What are the active and inactive ingredients in this medicine?

• Active ingredient: levonorgestrel
• Inactive ingredients: silicone, polyethylene, silver, silica, barium sulfate, iron oxide

Who manufactures and distributes this medicine?

• Manufactured for: Bayer HealthCare Pharmaceuticals Inc.

Whippany

What should I know about storage and disposal of this medication?

• Skyla is supplied sterile.
• Skyla is sterilized with ethylene oxide.
• Do not resterilize.
• For single use only.
• Do not use if the inner package is damaged or open.
• Insert before the end of the month shown on the label.
• Store at 25°C (77°F); with excursions permitted between 15–30°C (59–86°F).

• Dailymed label info on Levonorgestrel-releasing intrauterine system
• FDA Levonorgestrel-releasing intrauterine system

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