Elafibrano tablets 80mg/tablet, 30 tablets/box

Medication Safety Tips

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Contraindications

Warnings and Precautions
• Myalgia, myopathy and rhabdomyolysis: Evaluate muscle pain and myopathy before starting LuciElafib. Consider periodic assessments (clinical examinations, creatine kinase (CPK) measurements). In case of new or worsening muscle damage or muscle pain, treatment with LuciElafib should be interrupted.
• Fracture: Fracture risk should be considered in the care of patients treated with LuciElafib. Apply current standards of care to assess and maintain bone health.
• Adverse effects on fetal and neonatal development: May cause damage to the fetus. Confirmed absence of pregnancy in women of childbearing age prior to initiation of LuciElafib. Women of childbearing age are informed of the potential risks of the drug to the fetus and are advised to take effective contraception.
• Drug-induced liver injury: Clinical and laboratory evaluations at the beginning of treatment and follow-up monitoring according to routine patient management. Treatment should be interrupted if liver function test results worsen, or if the patient develops signs and symptoms consistent with clinical hepatitis. If liver function test results worsen after restarting LuciElafib, consider permanent discontinuation.
• Allergic reactions: permanently discontinue LuciElafib in the event of a severe allergic reaction. In case of mild or moderate anaphylaxis, interrupt LuciElafib and treat immediately. Continue to monitor until symptoms and signs disappear.
• Biliary Obstruction: Avoid use in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LuciElafib and treat as clinically indicated.

Medication risks

Adverse Reactions
The most common adverse effects of LuciElafib (reported incidence ≥ 5% and higher than placebo) are weight gain, diarrhea, abdominal pain, nausea, vomiting, joint pain, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash.