Letairis Warnings and Precautions

If you have kidney disease or are breastfeeding, tell your healthcare provider before undergoing treatment with Letairis. This drug may not be suitable for everyone, so before starting treatment, be sure you understand the drug's safety precautions and warnings. Letairis should be avoided by women who are pregnant and people with idiopathic pulmonary fibrosis or certain allergies.


What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Letairis® (ambrisentan) if you have:
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings for Letairis

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • Because Letairis increases the risk for birth defects, it is only available through a restricted program that helps ensure the medicine is used safely. You, your healthcare provider, and the pharmacy that sends you the medicine must be enrolled in this program. Your healthcare provider will describe the risks and benefits of Letairis treatment with you and enroll you in the program, as long as you agree to follow the instructions for using Letairis. You will need to be re-enrolled each year of your treatment.
  • This medicine can cause swelling of the hands, legs, ankles, and feet. This is known medically as peripheral edema. In some cases, the edema may be severe enough to require medical treatment or even a hospital stay. Let your healthcare provider know if you experience any swelling of your body or develop sudden, unexplained weight gain. Your healthcare provider will evaluate you to determine whether Letairis or something else is the cause.
  • Some people who are diagnosed with pulmonary arterial hypertension may have pulmonary veno-occlusive disease, a rare form of high blood pressure in the lungs. Let your healthcare provider know if you develop signs of pulmonary veno-occlusive disease, such as a cough, shortness of breath, or fatigue. Letairis should not be used in people with this condition.
  • If you are a male, you should know that Letairis may decrease your sperm count, which could affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.
  • Letairis may cause anemia (low levels of red blood cells), which can occur as early as the first few weeks of treatment and can become severe enough to require a blood transfusion. Your healthcare provider will order blood tests to check for anemia before you start Letairis and periodically during treatment.  
  • Medications like Letairis have been reported to cause liver problems. Let your healthcare provider know if you develop any signs of liver problems during Letairis treatment, such as:
    • Nausea and vomiting
    • Fever
    • Upper-right abdominal (stomach) pain
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Constant fatigue or tiredness
    • Dark urine
    • Itching
    • Loss of appetite.
  • Letairis is a pregnancy Category X medication, which means it is not safe for use in women who are pregnant (see Letairis and Pregnancy).
  • It is unknown if Letairis passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the medication (see Letairis and Breastfeeding).

Letairis Medication Information

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