Ambrisentan

Indications and Usage

LuciAmb is 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 risks of disease progression and hospitalization, and to improve exercise ability.

Efficacy was established in patients predominantly with WHO Functional Class II–III symptoms, including:
• Idiopathic or heritable PAH (60%)
• PAH associated with connective tissue diseases (34%)

Dosage and Administration

• Initiate at 5 mg once daily.
• May be started concurrently with tadalafil.
• Titrate every 4 weeks 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

• Monitor for fluid retention; may require intervention.
• If acute pulmonary edema occurs, evaluate for pulmonary veno-occlusive disease and discontinue if needed.
• Possible decrease in sperm count.
• Decreases in hemoglobin may occur—monitor at initiation, after 1 month, and periodically thereafter.

Adverse Reactions

Common (≥3% vs. placebo): Peripheral edema, nasal congestion, sinusitis, flushing

Combination with tadalafil (≥5%): Peripheral edema, headache, nasal congestion, cough, anemia, dyspepsia, bronchitis

Drug Interactions

Cyclosporine increases ambrisentan exposure. Limit LuciAmb dose to 5 mg once daily when co-administered.

Use in Specific Populations

• Breastfeeding: Discontinue LuciAmb or breastfeeding—do not use both.
• Hepatic Impairment: Not recommended in moderate or severe cases.

Storage

• Store at 20°C to 25°C (68°F to 77°F)
• Excursions permitted between 15°C and 30°C (59°F to 86°F)
• Protect from moisture
• Follow USP Controlled Room Temperature standards