What is LETAIRIS?
LETAIRIS is a prescription medicine to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
LETAIRIS can improve your ability to exercise (as measured by how far you can walk in 6 minutes) and it can help slow down the worsening of your physical condition and symptoms. In LETAIRIS clinical studies, clinical worsening was defined as any of the following: a need to go to the hospital for worsening PAH symptoms, a need to take additional PAH treatments, discontinuation of treatment due to worsening PAH symptoms, lung transplantation or other surgical procedures to reduce pulmonary pressures, or death.
Who should not take LETAIRIS?
Do not take LETAIRIS if you are pregnant, plan to become pregnant, or become pregnant during treatment with LETAIRIS. LETAIRIS can cause serious birth defects if taken during pregnancy. Serious birth defects can happen early in pregnancy.
Tell your doctor about all your medical conditions and all the medicines you take, including prescription and non-prescription medicines, such as vitamins and supplements. LETAIRIS and other medicines may affect each other causing side effects. Do not start any new medicines until you check with your doctor.
Especially tell your doctor if you take the medicine cyclosporine (Gengraf®, Neoral®, Sandimmune®). Your doctor may need to change your dose of LETAIRIS. You should not take more than 5 mg of LETAIRIS each day if you also take cyclosporine.
LETAIRIS has not been studied in children.
You can learn more about PAH and LETAIRIS by choosing among the topics below:
- About PAH
- LETAIRIS and PAH
- How to take LETAIRIS
- Starting LETAIRIS
- What to expect
- Assistance programs
- Frequently asked questions
Read more about LETAIRIS
For additional information on LETAIRIS, download this brochure:
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.
