Summary

• Terlipressin may cause serious or fatal respiratory failure in patients with type 1 hepatorenal syndrome (type 1 HRS) at a frequency higher than previously known. 
• Terlipressin may increase the risk of sepsis/septic shock in patients with type 1 HRS. 
• Avoid terlipressin in patients with advanced renal dysfunction (baseline serum creatinine [sCr] ≥ 442µmol/l (5.0 mg/dl)), due to reduced efficacy, increased mortality and increased risk of adverse events observed in these patients, unless the benefit is judged to outweigh the risks.
• Avoid terlipressin in patients with Acute-on-Chronic Liver Failure (ACLF) grade 3 and/or Model for End-stage Liver Disease (MELD) score ≥39, due to reduced efficacy, increased mortality, and increased risk of respiratory failure observed in these patients, unless the benefit is judged to outweigh the risks.
• Stabilise patients with new onset of breathing difficulties or worsening of existing respiratory disease prior to administering the first dose of terlipressin. These patients should be closely monitored during treatment. If patients develop respiratory symptoms, dose reduction of human albumin should be considered, if used. If symptoms are severe or do not resolve, terlipressin should be discontinued.
• Closely monitor patients for signs and symptoms of infection.
• Terlipressin can be administered as a continuous intravenous (IV) infusion. Administration of terlipressin as continuous IV infusion may be associated with lower rates of severe adverse events than with administration by IV bolus.