Ambrisentan (By mouth)

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using cyclosporine (Gengraf®, Neoral®, Sandimmune®) or rifampin (Rifadin®, Rimactane®).

Warnings While Using This Medicine

• Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant while you are using this medicine (even if the medicine is temporarily stopped), and for at least one month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. If a woman has had a tubal ligation, she does not need to use a second form of birth control. If you think you have become pregnant while using this medicine, tell your doctor right away.
• If you are a woman who can get pregnant, you must have a negative pregnancy test before you will be allowed to take this medicine. You will also be required to have a pregnancy test every month during your treatment. If you miss a period while you are using this medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have liver disease, heart failure, anemia (low red blood cells), or edema (swelling in the hands, lower legs, or feet).
• Stop using this medicine and call your doctor right away if you start to have nausea, vomiting, fever, dark-colored urine or pale stools, a loss of appetite, pain in your upper stomach, or yellow eyes or skin. These could be signs of liver injury.
• This medicine may cause fluid retention (edema) in some patients. Check with your doctor right away if you are gaining weight rapidly; have swelling in your hands, ankles, feet, or all over the body; or if you have trouble with breathing while you are using this medicine.
• This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• A lung condition called pulmonary edema may occur with this medicine. Stop using this medicine and check with your doctor right away if you have chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; or shortness of breath.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Fast, pounding heartbeat.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Rapid weight gain.
• Shortness of breath.
• Swelling in your hands, ankles, or feet.
• Unusual weakness.
• Warmth or redness in your face, neck, arms, or upper chest.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Constipation.
• Headache, runny or stuffy nose.
• Sore throat.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. If you take more medicine than you are supposed to, call your doctor right away.
• You may take this medicine with or without food.
• Swallow the tablet whole. Do not crush, break, or chew it.
• It is very important that you understand the rules of the LEAP® program. This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Introduction

Ambrisentan (am-bri-SEN-tan)

Treats a lung condition called pulmonary hypertension (high blood pressure in the arteries of the lungs).

Brand Name(s)

Letairis