Important Safety Information About Kyleena, Mirena® and Skyla®

If you have a pelvic infection, get infections easily, or have certain cancers, don’t use Kyleena, Mirena and Skyla. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID). If you have persistent pelvic or stomach pain or if Kyleena, Mirena and Skyla comes out, tell your healthcare provider... continue reading below

CONTACT US

ARCH Patient Assistance Program for Kyleena, Mirena® or Skyla®

Please call the number below for questions related to the status of your submitted application or with any questions on how to complete the Application Form.

Phone: 1-877-393-9071

Completed Application Forms can be sent by Fax or Mail

Fax: 1-877-229-1421

Mail: ARCH Patient Assistance Program, PO Box 29061, Phoenix, AZ 85038

 



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

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 KYLEENA

Kyleena (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 5 years.

IMPORTANT SAFETY INFORMATION
  • If you have a pelvic infection, get infections easily, or have certain cancers, don't use Kyleena. Less than 1% of users get a serious pelvic infection called PID.
  • If you have persistent pelvic or stomach pain or if Kyleena comes out, tell your doctor. If Kyleena comes out, use back-up birth control. Kyleena may attach to or go through the uterus and cause other problems.
  • Pregnancy while using Kyleena is uncommon but can be life threatening and may result in loss of pregnancy or fertility.
  • Ovarian cysts may occur but usually disappear.
  • Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop.

Kyleena does not protect against HIV or STDs.

Only you and your healthcare provider can decide if Kyleena is right for you. Kyleena is available by prescription only.

For important risk and use information about Kyleena, please see the Full Prescribing Information.

INDICATIONS FOR MIRENA

Mirena® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy 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.


INDICATION FOR SKYLA

Skyla® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to three years.

MIRENA AND SKYLA IMPORTANT SAFETY INFORMATION
  • If you have a pelvic infection, get infections easily, or have certain cancers, don't use Mirena or Skyla. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID).
  • If you have persistent pelvic or stomach pain or if Mirena or Skyla comes out, tell your healthcare provider (HCP). If Mirena or Skyla comes out, use back-up birth control.
  • Mirena and Skyla may attach to or go through the uterus (perforation) and cause other problems. The risk of perforation is increased if Mirena or Skyla is inserted while you are breastfeeding. Talk to your HCP.
  • Pregnancy while using Mirena or Skyla is uncommon but can be life threatening and may result in loss of pregnancy or fertility.
  • Ovarian cysts may occur but usually disappear.
  • Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop.

Mirena and Skyla do not protect against HIV or STDs.

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

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

For important risk and use information about Skyla, 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 Kyleena, Mirena® or Skyla®

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.
Bayer, the Bayer cross, Mirena, and Skyla are registered trademarks of Bayer.
Kyleena is a trademark of Bayer.
ARCH is a service mark of Bayer.
All other trademarks are property of their respective owners.
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Site Last Modified: 02/2017