HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciElafib is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Limitations of Use:

Use of LuciElafib is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

DOSAGE AND ADMINISTRATION

• Before treatment, evaluate for muscle pain or myopathy, and/or verify that females of reproductive potential are not pregnant.

• The recommended dosage is 80 mg orally once daily with or without Food.

DOSAGE FORMS AND STRENGTHS

Tablets: 80 mg×30 tablets

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

• Myalgia, Myopathy, and Rhabdomyolysis: Assess for muscle pain and myopathy prior to LuciElafib initiation. Consider periodic assessment (clinical exam, CPK measurement). Interrupt LuciElafib if there is new onset or worsening of muscle injury, or muscle pain.

• Fractures: The risk of fracture should be considered in the care of patients treated with LuciElafib. Apply current standards of care for assessing and maintaining bone health.

• Adverse Effects on Fetal and Newborn Development: May cause fetal harm. Verify that a female of reproductive potential is not pregnant prior to initiating LuciElafib. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

• Drug-Induced Liver Injury: Obtain clinical and laboratory assessments at treatment initiation and monitor thereafter according to routine patient management. Interrupt the treatment if liver tests worsen, or patients develop signs and symptoms consistent with clinical hepatitis. Consider permanent discontinuation if liver tests worsen after restarting LuciElafib.

• Hypersensitivity Reactions: If severe hypersensitivity reactions occur, permanently discontinue LuciElafib. If a mild or moderate hypersensitivity reaction occurs, interrupt LuciElafib and treat promptly. Monitor until signs and symptoms resolve.

• Biliary Obstruction: Avoid use in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LuciElafib and treat as clinically indicated.

ADVERSE REACTIONS

Most common adverse reactions with LuciElafib (reported in ≥ 5% and higher compared to placebo) are weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash.

DRUG INTERACTIONS

• Hormonal Contraceptives: Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives and for at least 3 weeks after last dose.

• HMG-CoA Reductase Inhibitors: Monitor for signs and symptoms of muscle injury.

• Rifampin:Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LuciElafib treatment.

• Bile Acid Sequestrants: Administer at least 4 hours before or 4 hours after taking a bile acid binding sequestrant, or at as great an interval as possible.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed during treatment and for 3 weeks after last dose.

• Hepatic Impairment: Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuation if patient progresses to moderate or severe hepatic impairment (Child-Pugh B or C).

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.