These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS.
Letairis (ambrisentan) tablets, for oral use
Initial U.S. Approval: 2007
WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning.
-
Do not administer Letairis to a pregnant female because it may cause fetal harm (4.1, 5.1, 8.1).
-
Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception (2.2, 8.6).
-
For all female patients, Letairis is available only through a restricted program called the Letairis Risk eva luation and Mitigation Strategy (REMS) (5.2).
RECENT MAJOR CHANGES
-
Indications and Usage (1)
-
Dosage and Administration (2.1)
-
Warnings and Precautions (5.3)
|
-
-
10/2015
-
-
10/2015
-
-
10/2015
|
INDICATIONS AND USAGE
Letairis is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
-
To improve exercise ability and delay clinical worsening.
-
In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
Studies establishing effectiveness included trials predominantly in patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%) (1).
DOSAGE AND ADMINISTRATION
-
Initiate treatment at 5 mg once daily (2.1).
-
May be started with tadalafil (2.1).
-
Titrate at 4-week intervals as needed and tolerated (2.1).
-
Do not split, crush, or chew tablets (2.1).
DOSAGE FORMS AND STRENGTHS
Tablet: 5 mg and 10 mg (3)
CONTRAINDICATIONS
-
Pregnancy (4.1)
-
Idiopathic Pulmonary Fibrosis (4.2)
WARNINGS AND PRECAUTIONS
-
Fluid retention may require intervention (5.3).
-
If patients develop acute pulmonary edema during initiation of therapy with Letairis, consider underlying pulmonary veno-occlusive disease and discontinue treatment if necessary (5.4).
-
Decreases in sperm count have been observed in patients taking endothelin receptor antagonists (5.5).
-
Decreases in hemoglobin have been observed within the first few weeks; measure hemoglobin at initiation, at 1 month, and periodically thereafter (5.6).
ADVERSE REACTIONS
-
Most common adverse reactions (>3% compared to placebo) are peripheral edema, nasal congestion, sinusitis, and flushing (6.1).
-
When used in combination with tadalafil, most common adverse reactions (>5% compared with either monotherapy) are peripheral edema, headache, nasal congestion, cough, anemia, dyspepsia, and bronchitis (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at (1-800-445-3235, Option 3) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Cyclosporine increases ambrisentan exposure; limit ambrisentan dose to 5 mg once daily (7).
USE IN SPECIFIC POPULATIONS
-
Breastfeeding: Choose Letairis or breastfeeding (8.3).
-
Not recommended in patients with moderate or severe hepatic impairment (8.8).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 10/2015
