Important Safety Information About Skyla® (levonorgestrel-releasing intrauterine system) 13.5 mg and Mirena® (levonorgestrel-releasing intrauterine system) 52 mg

If you have a pelvic infection, get infections easily, or have certain cancers, don’t use Skyla or Mirena. Less than 1% of users get a serious pelvic infection called PID. If you have persistent pelvic or stomach pain or if Skyla or Mirena comes out, tell your doctor...
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Full prescribing information for Skyla and Mirena

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THE ACCESS AND RESOURCES IN CONTRACEPTIVE HEALTH (ARCH)

Patient Assistance Program provides Skyla and Mirena IUDs at no cost for eligible women*

*The Access and Resources in Contraceptive Health (ARCH) Patient Assistance Program provides Skyla and Mirena intrauterine devices (IUD) at no cost to women in the United States who do not have either private health insurance or Medicaid coverage for Skyla or Mirena, and who meet all other program eligibility requirements. Please note that while Bayer provides the Mirena IUD and Skyla IUD at no cost to patients, the insertion and removal of the Mirena IUD and Skyla IUD may incur a cost. Please speak with your provider for more information.

The Affordable Care Act requires most insurance plans to cover the cost of prescription birth control, so if you have private health insurance, you may be eligible to receive Skyla or Mirena at no cost, including your placement and removal appointments.1

If you are unsure of your health insurance status, check with your health insurance provider or your healthcare professional. To better understand eligibility for the ARCH program, please click here for details and learn how you can apply.

Indication for Skyla® (levonorgestrel-releasing intrauterine system) 13.5 mg

Skyla is a hormone-releasing intrauterine device (IUD) indicated for the prevention of pregnancy for up to 3 years.

Indications for Mirena® (levonorgestrel-releasing intrauterine system) 52 mg

Mirena is a hormone-releasing intrauterine device (IUD) placed in your uterus to prevent pregnancy for as long as you want to for up to 5 years. Mirena also treats heavy periods in women who choose intrauterine contraception. Mirena is recommended for women who have had a child.

IMPORTANT SAFETY INFORMATION ABOUT SKYLA AND MIRENA

If you have a pelvic infection, get infections easily, or have certain cancers, don’t use Skyla or Mirena. Less than 1% of users of Skyla or Mirena get a serious pelvic infection called PID.

If you have persistent pelvic or stomach pain or if Skyla or Mirena comes out, tell your doctor. If Skyla or Mirena comes out, use back-up birth control. Skyla or Mirena may attach to or go through the uterus and cause other problems.

Pregnancy while using Skyla or Mirena is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Ovarian cysts may occur with Skyla or Mirena but usually disappear.

Bleeding and spotting may increase in the first 3 to 6 months and remain irregular with Skyla or Mirena. Periods over time usually become shorter, lighter, or may stop.

Skyla and Mirena do not protect against HIV or STDs.

Only you and your healthcare provider can decide if Skyla or Mirena is right for you. Both Skyla and Mirena are available by prescription only.

For important risk and use information about Skyla, please see the full Prescribing Information.

For important risk and use information about Mirena, please see the full Prescribing Information.

Reference: 1. Affordable Care Act Implementation FAQs - set 12. Centers for Medicare and Medicaid services website. https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html. Accessed February 27, 2015.

ARCH Patient Assistance Program for Skyla® and Mirena®

PO Box 29061, Phoenix, AZ 85038 Phone: 1-877-393-9071 Fax: 1-877-229-1421

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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Site Last Modified: 09/2015