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 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 Kyleena, Mirena and Skyla comes out, tell your healthcare provider... continue reading below

APPLICATION PROCESS

Once the completed and signed Application Form has been submitted, including proof of income (either documentation or certification, as described under Proof of Income), the ARCH Program case coordinators will review the application and then notify both provider and patient of the outcome.

If the Application is approved, a unit will be shipped directly to the facility shipping address provided on the Application Form. If the Application is incomplete, the ARCH program case coordinators will attempt to contact the patient and provider to request the missing information. If the Application is denied, a reason will be provided. The patient may reapply if relevant circumstances change.

Please allow up to 5 business days to receive a response from the time the complete application is submitted. If you have not heard back within this time frame, please contact the ARCH Program at 1-877-393-9071.

These applications require the use of Adobe Reader. If you do not have Adobe Acrobat installed,
you may download the application for free here:
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*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.

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.

INDICATION FOR SKYLA

Skyla® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 3 years.


IMPORTANT SAFETY INFORMATION FOR KYLEENA, MIRENA AND SKYLA
  • If you have a pelvic infection, get infections easily, or have certain cancers, don't use Kyleena, 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 Kyleena, Mirena or Skyla comes out, tell your healthcare provider (HCP). If Kyleena, Mirena or Skyla comes out, use back-up birth control. Kyleena, Mirena or Skyla may attach to or go through the uterus and cause other problems.
  • Pregnancy while using Kyleena, 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.

Kyleena, Mirena and Skyla do not protect against HIV or STDs.

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

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

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, Kyleena, Mirena, and Skyla are registered trademarks of Bayer.
ARCH is a service mark of Bayer.
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Site Last Modified: 07/2017