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Precautions and Warnings With Ambrisentan

Before starting ambrisentan, it's a good idea to become familiar with the drug's warnings and precautions. For example, this medication carries warnings about possible dangers for women who are pregnant or breastfeeding, potential liver problems, and risks for those who have scarring of the lungs or certain other medical issues. Also, ambrisentan may not be safe to use in combination with certain other medications.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking ambrisentan (Letairis®) 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 Ambrisentan Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • Because ambrisentan 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 ambrisentan treatment with you and enroll you in the program, as long as you agree to follow the instructions for using ambrisentan. 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 ambrisentan 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. Ambrisentan should not be used in people with this condition.
  • If you are a male, you should know that ambrisentan 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.
  • Ambrisentan 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 ambrisentan and periodically during treatment.  
  • Medications like ambrisentan have been reported to cause liver problems. Let your healthcare provider know if you develop any signs of liver problems during ambrisentan 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.
  • Ambrisentan 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 ambrisentan 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).

Ambrisentan Drug Information

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