Letairis

Pronunciation

Generic Name: ambrisentan (AM-bri-SEN-tan)
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, monthly while you take it, and for 1 month after you stop taking 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.

For female patients, Letairis is only available through a special program called Letairis Risk Evaluation and Mitigation Strategy Program (REMS). 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, which helps to decrease blood pressure in the lungs.

Do NOT use Letairis if:

  • you are allergic to any ingredient in Letairis
  • you are pregnant, may become pregnant, or plan to become pregnant
  • you have moderate to severe liver problems
  • you have a certain type of lung problem called idiopathic pulmonary fibrosis

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

Slideshow: Flashback: FDA Drug Approvals 2013

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 able to become pregnant
  • 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 failure, or anemia
  • if you have fluid retention (eg, unusual swelling of the arms, hands, legs, or feet) or a certain lung problem (pulmonary veno-occlusive disease)
  • if you have had abnormal liver function tests while taking another endothelin receptor antagonist (eg, bosentan)
  • if you drink alcohol or take medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver

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, split, 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, monthly while they are taking it, and for 1 month after they stop 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. Talk with your doctor right away if you miss a menstrual period, have unprotected sex, think your birth control has failed, or think you may be pregnant.
  • Tell your doctor or dentist that you take Letairis before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver function, hemoglobin levels, and hematocrit levels, 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:

Flushing; nose or throat irritation; 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); new or worsening shortness of breath; new or worsening swelling of the hands, legs, ankles, and feet; sudden or unusual weight gain; 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.

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.

Proper storage of Letairis:

Store Letairis between 68 and 77 degrees F (20 and 25 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 should not be used to decide whether or not to take Letairis or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Letairis. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Letairis. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Letairis.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web3)