Mirena

What is Mirena?

• Mirena (levonorgestrel intrauterine device) is a progestin-containing intrauterine system (IUS) used for prevention of pregnancy, and treatment of heavy menstrual bleeding.

Levonorgestrel

Levonorgestrel molecule ball

What are the uses of this medicine?

• MIRENA is a hormone-releasing system placed in your uterus by your healthcare provider to prevent pregnancy for up to 7 years.
• MIRENA can also be used to decrease menstrual blood loss for up to 5 years in women who have heavy menstrual flow and who also want to use a birth control method that is placed in the uterus to prevent pregnancy.

How does this medicine work?

• MIRENA may work in several ways including thickening cervical mucus, inhibiting sperm movement, reducing sperm survival, and thinning the lining of your uterus.
• It is not known exactly how these actions work together to prevent pregnancy.
• MIRENA can cause your menstrual bleeding to be less by thinning the lining of the uterus.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• are or might be pregnant; MIRENA 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, silica, barium sulfate or iron oxide

What drug interactions can this medicine cause?

• No drug-drug interaction studies have been conducted with Mirena.

Is this medicine FDA approved?

• Initial U.S. Approval: 2000

How should this medicine be used?

Recommended dosage:

• Initial release rate of levonorgestrel (LNG) is 20 mcg/day; this rate is reduced to about 10 mcg/day after 5 years and 8 mcg/day after 7 years.
• Patient should be re-examined and evaluated 4 to 6 weeks after insertion; then, yearly or more often if clinically indicated.

Administration:

• MIRENA is placed by your healthcare provider during an in-office visit or immediately after giving birth.
• 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 MIRENA through the cervix into your uterus.
• Your healthcare provider will then remove the plastic tube and leave MIRENA 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, MIRENA may not have been placed correctly.
• Your healthcare provider will examine you to see if MIRENA needs to be removed or replaced.

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

This medicine is available in fallowing doasage form:

• As One sterile intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 52 mg levonorgestrel packaged within a sterile inserter.

This medicine is available in fallowing brand namesː

• MIRENA

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

Other common side effects include:

• abdominal or pelvic pain
• inflammation or infection of the outer part of your vagina (vulvovaginitis)
• headache or migraine
• vaginal discharge

MIRENA can cause serious side effects including:

• Ectopic pregnancy and intrauterine pregnancy risks
• Life-threatening infection
• Pelvic inflammatory disease (PID)
• Perforation
• Expulsion

What special precautions should I follow?

• Remove Mirena if pregnancy occurs with Mirena in place. If 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.
• Evaluate women for ectopic pregnancy if they become pregnant with Mirena in place because the likelihood of a pregnancy being ectopic is increased with Mirena.
• Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of Mirena. Group A streptococcal infection has been reported following insertion of LNG IUS; strict aseptic technique is essential during insertion.
• Mirena is contraindicated in the presence of known or suspected PID or in women with a history of PID unless there has been a subsequent intrauterine pregnancy. Before using Mirena, consider the risks of PID.
• 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 or postpartum.
• Partial or complete expulsion of Mirena may occur resulting in the loss of efficacy.
• Ovarian cysts have been reported. Evaluate persistent enlarged ovarian follicles or ovarian cysts.
• Mirena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea.

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 Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes.

Can this medicine be used in children?

• Safety and efficacy of Mirena have been established in women of reproductive age.
• Efficacy is expected to be the same for postpubertal females under the age of 18 as for users 18 years and older.
• 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, silica, barium sulfate, iron oxide

Who manufactures and distributes this medicine?

Manufactured for:

• Bayer HealthCare Pharmaceuticals Inc.
• Whippany, NJ

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

• Store at 25°C (77°F); with excursions permitted between 15–30°C (59–86°F).

• Dailymed label info on Mirena
• FDA Mirena

Mirena Resources
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