Livmarli

Obtain baseline liver tests (eg, ALT, AST, total/direct bilirubin, INR) and monitor frequently for the first 6 to 8 months during therapy and as clinically indicated; consider dose reduction or interruption if abnormalities or signs of clinical hepatitis occur in the absence of other causes. Discontinue permanently if persistent or recurrent liver test abnormalities, signs and symptoms consistent with clinical hepatitis upon rechallenge, or a hepatic decompensation event occur. Decompensated cirrhosis: monitor frequently in compensated cirrhosis and discontinue if hepatic decompensation occurs. Monitor for dehydration if diarrhea occurs and treat promptly. Consider dose reduction or interruption if persistent diarrhea, abdominal pain, or diarrhea accompanied with signs/symptoms occur; restart and adjust dose appropriately when resolves. Consider discontinuing if diarrhea or abdominal pain persists and no alternate etiology is identified, or if diarrhea or abdominal pain recur upon rechallenge. Obtain serum fat-soluble vitamin (FSV) levels at baseline and monitor during therapy; consider discontinuing if FSV deficiency persists or worsens despite supplementation. Consider interrupting if bone fracture or bleeding occurs and supplement with FSV; restart once FSV deficiency is corrected and maintained. Elderly (≥65yrs), ALGS or PFIC with clinically significant portal hypertension or with decompensated cirrhosis: not established. Pregnancy. Nursing mothers.