HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciMaci is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH .

DOSAGE AND ADMINISTRATION

•  10 mg once daily. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended.

DOSAGE FORMS AND STRENGTHS

Tablets: 10 mg×30 tablets

CONTRAINDICATIONS

• Pregnancy

• Hypersensitivity

WARNINGS AND PRECAUTIONS

• ERAs cause hepatotoxicity and liver failure. Obtain baseline liver enzymes and monitor as clinically indicated.

• Fluid retention may require intervention.

• Decreases in hemoglobin .

• Pulmonary edema in patients with pulmonary veno-occlusive disease. If confirmed, discontinue treatment .

• Decreases in sperm count have been observed in patients taking ERAs.

ADVERSE REACTIONS

Most common adverse reactions (more frequent than placebo by ≥3%) are anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.

DRUG INTERACTIONS

•Strong CYP3A4 inducers (rifampin) reduce exposure to macitentan: avoid  co-administration with LuciMaci.

• Strong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan: avoid co-administration with LuciMaci .

• Moderate dual CYP3A4 and CYP2C9 inhibitors (fluconazole, amiodarone) or use of combined CYP3A4 and CYP2C9 inhibitors may increase exposure to macitentan: avoid co-administration with LuciMaci .

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

Storage

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