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• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.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 use cyclosporine (Gengraf®, Neoral®, Sandimmune®).

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.You must use 2 forms of effective birth control to avoid pregnancy while you use this medicine and for at least 1 month after you stop taking the medicine.
• You must have a negative pregnancy test before you take this medicine. You will also be required to have a pregnancy test every month during your treatment. Tell your doctor right away if you miss a period while you are using this medicine.
• Make sure your doctor knows if you are breastfeeding or if you have liver disease, heart failure, anemia, edema, or lung problems.
• Call your doctor right away if you start to have nausea, 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 have a rapid weight gain, swelling, or trouble with breathing while you are using this medicine.
• Check with your doctor right away if you have chest pain, trouble breathing, blue lips and fingernails, pale skin, or increased sweating. These could be symptoms of a lung condition called pulmonary edema, which may occur with 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 you use this medicine.
• 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 or chest pain
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Rapid weight gain
• Swelling in your hands, legs, ankles, or feet
• Unusual tiredness or weakness
• Trouble breathing
• Yellow skin or eyes

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

• Headache
• Stuffy or runny nose

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.Call your doctor right away if you take more medicine than you are supposed to.
• Swallow the tablet whole. Do not crush, break, or chew it.
• It is very important that you understand the rules of the LEAP® program before you take this medicine.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 pulmonary hypertension.

Brand Name(s)

Letairis