HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciPirfe is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

DOSAGE AND ADMINISTRATION

• Take with food.

• Recommended dosage: 801 mg three times daily (2403 mg/day).

• Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows:

 Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions.

• Prior to treatment, conduct liver function tests.

DOSAGE FORMS AND STRENGTHS

Capsules: 200 mg×120 capsules

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

• Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with LuciPirfe including cases of druginduced liver injury. In the postmarketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required.

• Photosensitivity and rash: Photosensitivity and rash have been noted with LuciPirfe. Avoid exposure to sunlight and sunlamps. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required.

• Severe Cutaneous Adverse Reactions (SCAR): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reactions with eosinophilia and systemic symptoms (DRESS) have been reported in association with the use of LuciPirfe in the postmarketing setting. Interrupt LuciPirfe in case of signs or symptoms of SCAR. Permanently discontinue LuciPirfe if a SCAR is confirmed.

• Gastrointestinal disorders: Nausea, vomiting, diarrhea, dyspepsia, gastroesophageal reflux disease, and abdominal pain have occurred with LuciPirfe. Temporary dosage reductions or discontinuations may be required.

ADVERSE REACTIONS

The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, dyspepsia, dizziness, vomiting, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.

DRUG INTERACTIONS

Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g.,fluvoxamine) increase systemic exposure of LuciPirfe and may alter the adverse reaction profile of LuciPirfe. Discontinue fluvoxamine prior to administration of LuciPirfe or reduce to 267 mg three times a day . Consider dosage reduction with use of ciprofloxacin.

USE IN SPECIFIC POPULATIONS

• Hepatic Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of LuciPirfe as needed. LuciPirfe is not recommended for use in patients with severe hepatic impairment.

• Renal Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of LuciPirfe as needed. LuciPirfe is not recommended for use in patients with end stage renal disease on dialysis.

• Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of LuciPirfe.

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.