ambrisentan

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

What is ambrisentan?

Ambrisentan lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Ambrisentan is used to treat pulmonary arterial hypertension (PAH) in adults. It improves your ability to exercise and prevents your condition from getting worse. Ambrisentan is sometimes used with a medicine called tadalafil (Adcirca).

For women, ambrisentan is available only from a certified pharmacy under a special program. You must be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing.

Ambrisentan may also be used for purposes not listed in this medication guide.

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

You will need to have a negative pregnancy test before starting this treatment. You will be re-tested every month during your treatment, and 1 month after your last dose.

Even if you are not planning a pregnancy, you are considered able to become pregnant if:

• you have entered puberty (even if you have not yet started having periods);
• you have never had a hysterectomy or had your ovaries removed; or
• you have not gone through menopause (you have never gone 12 months in a row without a menstrual period).

While taking ambrisentan and for at least 30 days after your last dose, you must use a highly effective form of birth control or two methods together.

Recommended forms of birth control forms include:

• a tubal ligation, or a copper IUD (intrauterine device) or progesterone implant;
• one 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); or
• a partner's vasectomy plus 1 hormone form or 1 barrier form.

Ambrisentan comes with patient instructions about acceptable forms of birth control to use while taking this medicine. Follow these directions carefully. Ask your doctor about emergency contraception if you have unprotected sex or if you believe your contraception has failed.

Tell your doctor if you have ever had:

• liver disease; or
• anemia (low red blood cell counts).

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

How should I take ambrisentan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

You will need frequent medical tests.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while using ambrisentan?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of ambrisentan?

• severe shortness of breath, wheezing, cough with foamy mucus, chest pain;
• swelling, tiredness, rapid weight gain;
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• liver problems --loss of appetite, stomach pain (upper right side), nausea, vomiting, fever, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• swelling in your hands, legs, ankles, or feet;
• stuffy nose, sinus pain; or
• hot flashes, redness in your face.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ambrisentan?

Tell your doctor about all your other medicines, especially:

• cyclosporine.

This list is not complete. Other drugs may affect ambrisentan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about ambrisentan.