Getting started with LETAIRIS
If you and your doctor have decided that LETAIRIS is right for you, there are a few steps that you must take in order to receive your medication.
Step 1: Enroll in LEAP
Because of the risk of serious birth defects, LETAIRIS is only available through a restricted distribution 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.
Step 2: Required laboratory testing
Before you can receive your medication, you will need to have blood tests to check for signs of anemia (low red blood cell count). If you are a woman who is able to become pregnant, you will need to have a negative pregnancy test before starting the medication.
While you are taking LETAIRIS, you must have a monthly pregnancy test if you are a woman who is able to become pregnant.
Women who are able to become pregnant must also use two acceptable forms of birth control at the same time during LETAIRIS treatment and for one month after stopping LETAIRIS.
Step 3: Certified Specialty Pharmacy
Your Certified Specialty Pharmacy will ship LETAIRIS to you each month. Before sending 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 special restricted distribution 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. 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.
