Ambrisentan (By mouth)
Treats pulmonary hypertension.
LetairisThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:Do not use this medicine if you have had an allergic reaction to ambrisentan, or if you are pregnant or breastfeeding. Do not use this medicine if you have idiopathic pulmonary fibrosis (IPF).
How to Use This Medicine:
- 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.
- Take this medicine at the same time each day.
- 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.
- This medicine is available only under a restricted distribution program called the LETAIRIS Education and Access Program (LEAP).
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.
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- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.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 have liver disease, anemia, edema, heart failure, or lung problems.
- Check with your doctor right away if you have dark urine or pale stools, upper stomach pain, nausea, loss of appetite, or yellow eyes or skin. These could be symptoms of a serious liver problem.
- 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 breathing.
- 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.
- This medicine may decrease the amount of sperm made and affect a man's ability to father a child. Talk with your doctor before you use this medicine if you plan to have children.
- 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
- Chest pain, trouble breathing
- Dark urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
- Fast, pounding heartbeat
- Rapid weight gain, swelling in your hands, legs, ankles, or feet
- Unusual tiredness or weakness
If you notice these less serious side effects, talk with your doctor:
- Stuffy 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
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