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

PROOF OF INCOME

Proof of Annual Household Income Requirements

In addition to the Application Form, proof of annual household income is required. This can be provided either by sending an acceptable form of documentation to the ARCH Program, or by presenting an acceptable form of documentation to a health care provider or administrator who will certify that the patient’s income as reported on the ARCH Application Form is accurate.

Acceptable forms of documentation include (please provide one of the following):

  • Federal tax return for the prior tax year; or
  • Statement from the IRS stating that patient does not file a tax return; or
  • Household pay stubs representing 4 consecutive weeks of wages paid within the last 6 months; or
  • A letter of means of support (i.e. food stamps, housing assistance, or any other assistance received); or
  • A statement signed by the patient, stating that the patient has no source of income.

Instead of sending their documentation to the ARCH Program, patients may instead request a health care provider or administrator to certify their reported income is accurate, by providing the following information on the Application Form:

  • Signature, name and title of health care provider or health care administrator, [see ARCH Program Application Form, Proof of Income Certification section], certifying that the patient’s reported income is accurate, based on that person’s review of appropriate proof of income documentation as described above.

If you have questions about any of the above requirements, please contact one of the ARCH Program case coordinators at 1-877-393-9071.

*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