LIVMARLI Rx

Obtain baseline liver tests (eg, ALT, AST, total/direct bilirubin, INR) and monitor during therapy; consider dose reduction or interruption if abnormalities occur in the absence of other causes. Consider discontinuing if persistent or recurrent liver test abnormalities occur. ALGS with cirrhosis: monitor for liver elevations, liver-related adverse reactions; permanently discontinue if progresses to portal hypertension or a hepatic decompensation event (eg, variceal hemorrhage, ascites, hepatic encephalopathy). Consider dose reduction or interruption if GI reactions occur (diarrhea, abdominal pain, vomiting) and no alternate etiology is identified. Monitor for dehydration if diarrhea or vomiting occur. Consider dose interruption if persistent diarrhea or diarrhea accompanied with signs/symptoms occur; restart and adjust dose appropriately when resolves. Obtain serum fat-soluble vitamin (FSV) levels at baseline and monitor during therapy; consider discontinuing if FSV deficiency persists or worsens despite supplementation. Elderly (≥65yrs), ALGS with clinically significant portal hypertension or with decompensated cirrhosis: not established. Pregnancy. Nursing mothers.