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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
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
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.
- 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.
- 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
- 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.
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