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What should I discuss with my healthcare provider before taking ambrisentan (Letairis)?

Your should not use this medication if you are allergic to ambrisentan, if you have moderate or severe liver disease, or if you are pregnant.

To make sure you can safely take ambrisentan, tell your doctor if you have any of these other conditions:

• anemia (low red blood cell counts);
• a history of liver problems; or
• if you are pregnant or plan to become pregnant while taking ambrisentan.

If you are a woman of child-bearing potential, you will need to have a negative pregnancy test before you start treatment with ambrisentan. You will also be re-tested each month during your treatment.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use ambrisentan if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

You will be required to use two forms of birth control to prevent pregnancy during your treatment, and for at least 1 month after your treatment ends. If you have had a tubal ligation or are using a copper IUD (intrauterine device), you will not need to use a second form of birth control.

Recommended combinations of birth control forms include:

• 1 hormone form (birth control pill, skin patch, implant, vaginal ring, or injection) plus 1 barrier form (condom, diaphragm with spermicide, or cervical cap with spermicide).
• a condom and a female barrier form together (diaphragm with spermicide, or cervical cap with spermicide).
• a partner's vasectomy plus 1 hormone form or 1 barrier form.

Talk with your doctor about the use of emergency contraception if you have unprotected sex or if you believe your form of contraception has failed.

It is not known whether ambrisentan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using ambrisentan.

Ambrisentan may lower a man's sperm count and could affect fertility (your ability to have children).

How should I take ambrisentan (Letairis)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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.

Before you start treatment with ambrisentan, your doctor may perform blood tests to make sure it is safe for you to take this medication. Your blood will need to be tested often during treatment. Visit your doctor regularly.

Ambrisentan can be taken with or without food.

Do not crush, chew, or split the tablet. Swallow the pill whole.

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.

Store at room temperature away from moisture and heat. Keep this medicine in its original container.

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