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Brand Names: Letairis

Generic Name: ambrisentan (Pronunciation: am bri SEN tan)

• What is ambrisentan (Letairis)?
• What are the possible side effects of ambrisentan (Letairis)?
• What is the most important information I should know about ambrisentan (Letairis)?
• What should I discuss with my healthcare provider before taking ambrisentan (Letairis)?
• How should I take ambrisentan (Letairis)?
• What happens if I miss a dose (Letairis)?
• What happens if I overdose (Letairis)?
• What should I avoid while using ambrisentan (Letairis)?
• What other drugs will affect ambrisentan (Letairis)?
• Where can I get more information?

What is ambrisentan (Letairis)?

Ambrisentan prevents thickening of the blood vessels, especially those in the lungs and heart. Ambrisentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Ambrisentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Ambrisentan may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ambrisentan (Letairis)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling short of breath;
• fast or pounding heartbeats;
• swelling of the feet, ankles, or legs;
• nausea, stomach pain, loss of appetite, low fever, itching;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• headache;
• stomach pain, constipation;
• stuffy nose, sinus pain, sore throat; or
• warmth, redness, or tingly feeling under your skin.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ambrisentan (Letairis)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you miss a menstrual period during treatment with ambrisentan. Use two reliable forms of birth control together while you are taking the medication and for at least 1 month after your treatment ends.

You will probably be required to take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

Ambrisentan can cause severe liver problems. Symptoms include nausea, stomach pain, itching, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking ambrisentan, and again each month during your treatment.

Do not stop taking ambrisentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Ambrisentan is available only under a special program called LEAP (Letairis Education and Access Program). You must be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing as required by the program. Read all program brochures and agreements carefully.