MIRENA®

Mirena® (levonorgestrel-releasing intrauterine system) 52 mg is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. Mirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed.

Mirena is a progestin-containing intrauterine system (IUS) indicated for:

• Prevention of pregnancy for up to 8 years
• Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years.

Mirena (levonorgestrel-releasing intrauterine system) contains 52 mg of LNG, a progestin, and is intended to provide an initial release rate of LNG of approximately 21 mcg/day after 24 days.

1. Contraindications

   • Pregnancy or suspicion of pregnancy. Cannot be used for post-coital contraception (emergency contraception).
   • Congenital or acquired uterine anomaly if it distorts the uterine cavity.
   • Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy.
   • Postpartum endometritis or infected abortion in the past 3 months.
   • Known or suspected uterine or cervical malignancy.
   • Known or suspected breast cancer or other progestin-sensitive cancer.
   • Uterine bleeding of unknown etiology.
   • Untreated acute cervicitis or vaginitis or other lower genital tract infections.
   • Acute liver disease or liver tumor (benign or malignant).
   • Increased susceptibility to pelvic infection.
   • A previous intrauterine device (IUD) that has not been removed.
   • Hypersensitivity to any component of Mirena.

2. After-care

   • Common side effects of Mirena include:
     • Pain, bleeding or dizziness during and after placement. If these symptoms do not stop 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.
     • Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may be irregular. Call your healthcare provider if the bleeding remains heavier than usual or increases after it has been light for a while.
     • Missed menstrual periods. About 2 out of 10 women stop having periods after 1 year of MIRENA use. If you have any concerns that you may be pregnant while using MIRENA, do a urine pregnancy test and call your healthcare provider. If you do not have a period for 6 weeks during MIRENA use, call your healthcare provider. When MIRENA is removed, your menstrual periods should return.
     • Cysts on the ovary. Some women using MIRENA develop a painful cyst on the ovary. These cysts usually disappear on their own in 2 to 3 months. However, cysts can cause pain and sometimes cysts will need surgery.
   • 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.

These are not all of the possible side effects with MIRENA. For more information, ask your healthcare provider.