Letairis® (ambrisentan) is a prescription medicine to treat pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO Class II or III symptoms. PAH is high blood pressure in the arteries of the lungs. Letairis can improve your ability to exercise, and it can help slow down the worsening of your physical condition and symptoms.

When Letairis was studied, people who were 65 years and older improved less than younger people in how far they could walk in 6 minutes (this result varied from person to person). Swelling of the ankles and legs was also more common in older people.

Letairis Access

If you or your doctor has decided that Letairis pulmonary arterial hypertension (PAH) treatment is right for you, there are a few steps that you must take in order to receive your medication.

For all females

Because of the risk of serious birth defects, the FDA has required a special program called a Risk Evaluation and Mitigation Strategy (REMS) for Letairis. The purpose of the Letairis REMS Program is to make sure the benefits of Letairis outweigh the risks. All females must enroll in the Letairis REMS Program to receive Letairis.

To receive Letairis:

1) You must talk with your doctor to ensure the benefits outweigh the risks of Letairis

2) You must agree to all of the requirements of the Letairis REMS Program

3) Your doctor will enroll you in the Letairis REMS Program

4) Your prescription will be mailed to you from a Certified Pharmacy

For females who are able to get pregnant

You are considered to be a female who can get pregnant if you have entered puberty, have a uterus, and have not passed through menopause.

To receive Letairis, the Letairis REMS Program will require that you must:

  • Have a monthly pregnancy test and use of appropriate birth control while taking Letairis, and for 1 month after stopping Letairis.
  • Have a negative pregnancy test before you start taking Letairis and before you receive your refills. Your doctor will order the pregnancy test for you. Your Certified Pharmacy will call you and ask if you have taken this test before shipping your refill.
  • Be sure you take your monthly pregnancy test as ordered by your doctor. You may not receive your Letairis refill on time if you do not take your monthly pregnancy test.

Do not have unprotected sex. Use appropriate birth control during your Letairis treatment and for 1 month after stopping your Letairis treatment because the medicine may still be in your body.

Talk to your doctor or pharmacist right away if you have unprotected sex, if you think your birth control has failed, or if you think you may be pregnant. Your doctor may tell you to use emergency birth control. Do not wait until your next appointment to tell your doctor if you miss your menstrual period or if you think you may be pregnant.

For males

Males are not required to participate in the REMS Program in order to receive Letairis. Your prescription will be mailed to you from a Certified Pharmacy.

Gilead has a program called LEAP (Letairis Education and Access Program) available to both male and female patients to assist with the access and financial support services it offers. See the Letairis Support section of this site for more information.