LETAIRIS can improve your ability to exercise
In clinical studies, ability to exercise was measured by the 6-minute walk test (6MWT), in which study participants were asked to walk as far as they could on a flat surface for 6 minutes. Study participants were instructed to take either LETAIRIS or a placebo in addition to whatever medications they were already taking. These medications could have included anticoagulants (blood thinners), diuretics (to reduce fluid buildup), calcium channel blockers (for blood pressure), or digoxin (for heart failure), but not drugs used specifically to treat PAH. At 12 weeks, people with PAH who took either 5 mg or 10 mg of LETAIRIS experienced significantly greater improvements in how far they could walk on the 6MWT than those taking a placebo.
In one study, people with PAH who took LETAIRIS for 12 weeks were able to walk up to an average of 59 m (194 feet) farther on the 6MWT than people who took a placebo.
LETAIRIS can help slow down the worsening of your physical condition and symptoms
The worsening of PAH was defined as a need to go to the hospital for worsening PAH symptoms, a need to take additional PAH treatment, discontinuation of treatment due to worsening PAH symptoms, lung transplantation or other surgical procedures to reduce pulmonary pressures, or death.
In clinical studies, people with PAH who took LETAIRIS found that LETAIRIS helped to slow down the worsening of their physical condition and symptoms compared with people who took placebo.
- In one study, 3% of people taking LETAIRIS had PAH that worsened during
12 weeks of treatment, compared with 10% of those taking a placebo - In another study, 6% of people taking LETAIRIS had PAH that worsened during
12 weeks of treatment, compared with 22% of those taking a placebo
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.
