If you are experiencing unwanted side effects, speak with your doctor right away. Your doctor may have a solution to help manage these side effects.
What to expect while taking LETAIRIS
LETAIRIS is not a cure for PAH.
It is important to remember that everyone responds differently to treatment. In clinical studies, people taking LETAIRIS for 12 weeks showed measurable improvements in the distance they could walk in 6 minutes compared with people taking a placebo. Your response may differ. Talk to your doctor about what you can expect.
Give LETAIRIS time to work so that you can experience its full benefit. Take every dose as directed and do not stop taking LETAIRIS unless you have been instructed to do so.
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.
