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U.S. Department of Health and Human Services

Safety

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Letairis (ambrisentan) 5 mg and 10 mg tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

 

Summary View

 

WARNINGS AND PRECAUTIONS

Hematological Changes (reworded)
  • Measure hemoglobin prior to initiation of Letairis, at one month, and periodically thereafter. Initiation of Letairis therapy is not recommended for patients with clinically significant anemia. If a clinically significant decrease in hemoglobin is observed and other causes have been excluded, consider discontinuing Letairis

ADVERSE REACTIONS

Most common placebo-adjusted adverse reactions are...nasopharyngitis

Clinical Trials Experience (sentence added)
  • See Boxed Warning for discussion of potential liver injury and Warnings and Precautions (5.2) for discussion of hematological changes.
Postmarketing Experience
  • The following adverse reactions were identified during postapproval use of Letairis: Fluid retention, heart failure (associated with fluid retention), hypersensitivity (e.g., angioedema, rash), and anemia.

DRUG INTERACTIONS

  • No clinically significant interactions of Letairis with warfarin, sildenafil, tadalafil, omeprazole (CYP2C19 inhibitor), ketoconazole (strong CYP3A inhibitor), digoxin, ethinyl estradiol, or norethisterone have been observed.
In vitro studies, In vivo studies and Unknown sections added

USE IN SPECIFIC POPULATIONS

Hepatic Impairment
  • There is no information on the use of Letairis in patients with mild pre-existing impaired liver function; however, exposure to ambrisentan may be increased in these patients.

MEDICATION GUIDE

Serious side effects of Letairis include
  • abdominal (stomach area) pain (reworded)
The most common side effects of Letairis are
  • Allergic reactions (rash, swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing) have been reported infrequently