LETAIRIS Education and Access Program (LEAP)
Because of the risk of serious birth defects, LETAIRIS is only available through a restricted program called the LETAIRIS Education and Access Program (LEAP).
Gilead and the Food and Drug Administration (FDA) created LEAP to help you learn about the benefits and risks of using LETAIRIS, including the risk of serious birth defects, and to reduce the risk of becoming pregnant if you are on LETAIRIS.
Your doctor will enroll you in LEAP for you to receive LETAIRIS.
Requirements of LEAP
Your doctor will explain the benefits and risks of taking LETAIRIS, and the requirements of LEAP.
All patients must:
- Have a blood test for anemia (low red blood cell count) before starting LETAIRIS, one month after starting LETAIRIS, and as needed thereafter
Female patients who are able to become pregnant must:
- Have a negative pregnancy test before starting LETAIRIS
- Have a monthly pregnancy test while taking LETAIRIS
- Use two acceptable forms of birth control at the same time while taking LETAIRIS and for one month after stopping LETAIRIS
- Avoid unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Tell your doctor right away if you miss a menstrual period or think you may be pregnant
LabSync can help
Ask your doctor about a service called LabSync®, which can help you choose an insurance-approved laboratory facility for testing, schedule and remind you of your laboratory tests, assist in resolving any insurance issues related to your laboratory testing, and make sure your doctor automatically receives the results of your monthly tests. Click here to find out more about LabSync.
Receiving LETAIRIS after you enroll in LEAP
Because of the risk of birth defects, LETAIRIS is only available through a restricted program called the LETAIRIS Education and Access Program (LEAP). Your doctor must enroll you in LEAP for you to receive LETAIRIS.
LETAIRIS is mailed to your home by a Certified Specialty Pharmacy. Your doctor will help you choose a Certified Specialty Pharmacy.
Before sending you your monthly refill, a representative from the Certified Specialty Pharmacy will call you to make sure you have completed your monthly laboratory tests and to review important information about LETAIRIS.
IMPORTANT SAFETY INFORMATION
BOXED WARNING
Because of the risk of birth defects, LETAIRIS is available only through a restricted program called the LETAIRIS Education and Access Program (LEAP). To receive LETAIRIS, you must talk to your doctor, understand the benefits and risks of LETAIRIS, and agree to all of the instructions in the LEAP program.
Serious birth defects: LETAIRIS can cause serious birth defects if taken during pregnancy. Women must not be pregnant when they start taking LETAIRIS or become pregnant during treatment. Women who are able to get pregnant must have a negative pregnancy test before beginning treatment with LETAIRIS and each month during treatment. Your doctor will decide when to do the test, depending on your menstrual cycle. Women who are able to get pregnant must use two acceptable forms of birth control, during LETAIRIS treatment and for one month after stopping LETAIRIS. If you have had a tubal sterilization or have an IUD, these methods can be used alone and no other form of birth control is needed. Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about how to prevent pregnancy. Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may tell you to use emergency birth control. Tell your doctor right away if you miss a menstrual period or think you may be pregnant.
Please see patient Medication Guide and full prescribing information, including boxed WARNING.
