HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciAmb safely and effectively. See full prescribing information for LuciAmb.

INDICATIONS AND USAGE

LuciAmb 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%) .

DOSAGE AND ADMINISTRATION

· Initiate treatment at 5 mg once daily .

· May be started with tadalafil .

· Titrate at 4-week intervals as needed and tolerated .

· Do not split, crush, or chew tablets .

DOSAGE FORMS AND STRENGTHS

Tablets: 5 mg×30 tablets

CONTRAINDICATIONS

· Pregnancy

· Idiopathic Pulmonary Fibrosis

WARNINGS AND PRECAUTIONS

· Fluid retention may require intervention .

· If patients develop acute pulmonary edema during initiation of therapy with LuciAmb, consider underlying pulmonary veno occlusive disease and discontinue treatment if necessary .

· Decreases in sperm count have been observed in patients taking endothelin receptor antagonists.

· Decreases in hemoglobin have been observed within the first few weeks; measure hemoglobin at initiation, at 1 month, and periodically thereafter.

ADVERSE REACTIONS

· Most common adverse reactions (>3% compared to placebo) are peripheral edema, nasal congestion, sinusitis, and flushing.

· 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.

DRUG INTERACTIONS

Cyclosporine increases ambrisentan exposure; limit ambrisentan dose to 5 mg once daily.

USE IN SPECIFIC POPULATIONS

· Breastfeeding: Choose LuciAmb or breastfeeding.

· Not recommended in patients with moderate or severe hepatic impairment.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.