Friday, September 30, 2016

Letairis


Pronunciation: AM-bri-SEN-tan
Generic Name: Ambrisentan
Brand Name: Letairis

Letairis may cause serious birth defects if you take it while you are pregnant. Women who are pregnant should not take Letairis. You must have a negative pregnancy test before you start to take Letairis, and monthly while you take it. You must also use 2 effective forms of birth control while you take Letairis and for 1 month after you stop taking it. Talk with your doctor about the use of effective birth control while you use Letairis.


Letairis is only available through a special program called Letairis Education and Access Program (LEAP). Talk to your doctor to be sure you are enrolled in this program and that you meet all of its requirements.





Letairis is used for:

Treating high blood pressure in the lungs (pulmonary arterial hypertension [PAH]) in certain patients.


Letairis is an endothelin receptor antagonist. It works by blocking a certain substance in the lungs.


Do NOT use Letairis if:


  • you are allergic to any ingredient in Letairis

  • you are pregnant or may become pregnant

  • you have moderate to severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.



Before using Letairis:


Some medical conditions may interact with Letairis. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of liver problems, heart problems (eg, heart failure), or blood problems (eg, anemia)

  • if you have fluid retention (eg, unusual swelling of the arms, hands, legs, or feet)

  • if you have had abnormal liver function tests while taking another endothelin receptor antagonist (eg, bosentan)

Some MEDICINES MAY INTERACT with Letairis. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Cyclosporine because it may increase the risk of Letairis's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Letairis may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Letairis:


Use Letairis as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Letairis comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Letairis refilled.

  • Take Letairis by mouth with or without food.

  • Swallow Letairis whole. Do not break, crush, or chew before swallowing.

  • Take Letairis on a regular schedule to get the most benefit from it. Taking Letairis at the same times each day will help you to remember to take it.

  • Continue to take Letairis even if you feel well. Do not miss any doses.

  • If you miss a dose of Letairis, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Letairis.



Important safety information:


  • Do NOT take more than the recommended dose without checking with your doctor.

  • Do not stop taking Letairis unless your doctor tells you to.

  • Serious liver problems have been reported with other medicines that are similar to Letairis (eg, bosentan). Contact your doctor right away if you develop symptoms of liver problems, such as nausea, vomiting, loss of appetite, fever, stomach pain, yellowing of the skin or eyes, dark urine, pale stools, itching, or unusual tiredness or achiness. Discuss any questions or concerns with your doctor.

  • Some men taking another medicine similar to Letairis (bosentan) have experienced a decrease in sperm count. A low sperm count may decrease the ability to father a child. It is not known if Letairis may cause the same effect on sperm count. Discuss any questions or concerns with your doctor.

  • Women who are able to become pregnant must have a negative pregnancy test before they start to take Letairis, and monthly while they are taking it. Talk with your doctor for more information.

  • Women who are able to become pregnant must use 2 effective forms of birth control while they take Letairis and for at least 1 month after they stop taking it. Talk with your doctor about the use of effective birth control while you use Letairis. Tell your doctor right away if you miss a menstrual period or think you may be pregnant.

  • Lab tests, including liver function and complete blood cell counts, may be performed while you use Letairis. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Letairis with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the arms, hands, legs, or feet.

  • Letairis should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not take Letairis if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Letairis is found in breast milk. Do not breast-feed while taking Letairis.


Possible side effects of Letairis:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; flushing; headache; nose or throat irritation; stomach pain; stuffy nose.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); irregular heartbeat; shortness of breath; sudden weight gain; swelling (eg, of the arms, legs, hands, feet); unusual tiredness or weakness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Letairis side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; light-headedness; severe dizziness.


Proper storage of Letairis:

Store Letairis between 59 and 86 degrees F (15 and 30 degrees C) in the original package. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Letairis out of the reach of children and away from pets.


General information:


  • If you have any questions about Letairis, please talk with your doctor, pharmacist, or other health care provider.

  • Letairis is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Letairis. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Letairis resources


  • Letairis Side Effects (in more detail)
  • Letairis Use in Pregnancy & Breastfeeding
  • Letairis Drug Interactions
  • Letairis Support Group
  • 2 Reviews for Letairis - Add your own review/rating


  • Letairis Prescribing Information (FDA)

  • Letairis Consumer Overview

  • Letairis Monograph (AHFS DI)

  • Letairis Advanced Consumer (Micromedex) - Includes Dosage Information

  • Ambrisentan Professional Patient Advice (Wolters Kluwer)



Compare Letairis with other medications


  • Pulmonary Arterial Hypertension

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