Most common adverse reactions (reported by ≥4% of patients treated with TERLIVAZ)1
- The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea1
aIschemia-related events include preferred terms: skin discoloration, cyanosis, ischemia, and intestinal ischemia.1
Respiratory failure rates in CONFIRM stratified by ACLF grade
aSerious respiratory failure events were reported as respiratory failure and acute respiratory failure by investigators.3
bBased on CLIF-SOFA scoring system.4
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
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TERLIVAZ® may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ.
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Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
INDICATION
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
LIMITATION OF USE
Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.
Contraindications
TERLIVAZ is contraindicated:
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In patients experiencing hypoxia or worsening respiratory symptoms.
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In patients with ongoing coronary, peripheral, or mesenteric ischemia.
Warnings and Precautions
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Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms.
Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.
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Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
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Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions.
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Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.
Adverse Reactions
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The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
Please see full Prescribing Information, including BOXED WARNING.
References: 1. TERLIVAZ® (terlipressin). Prescribing Information. Bridgewater, NJ: Mallinckrodt Hospital Products Inc. 2. Center for Drug Evaluation and Research. Application number: 022231Orig1s000. Accessed January 20, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022231Orig1s000IntegratedR.pdf 3. Data on File – Ref-05035. Keenova Therapeutics. 4. Moreau R, Jalan R, Ginés P, et al. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology. 2013;144(7):1426-1437. doi:10.1053/j.gastro.2013.02.042 5. Malek R, Soufi S. Pulmonary edema. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2025. Accessed January 20, 2026. https://www.ncbi.nlm.nih.gov/books/NBK557611/ 6. Arroyo V, Fernandez J. Pathophysiological basis of albumin use in cirrhosis. Ann Hepatol. 2011;10(suppl 1):S6-S14. 7. Bihari S, Wiersema UF, Perry R, et al. Efficacy and safety of 20% albumin fluid loading in healthy subjects: a comparison of four resuscitation fluids. J Appl Physiol. 2019;126(6):1646-1660. doi:10.1152/japplphysiol.01058.2018 8. Allegretti AS, Subramanian RM, Francoz C, Olson JC, Cárdenas A. Respiratory events with terlipressin and albumin in hepatorenal syndrome: a review and clinical guidance. Liver Int. 2022;42(10):2124-2130. doi:10.1111/liv.15367 9. Israelsen M, Dahl EK, Madsen BS, et al. Dobutamine reverses the cardio-suppressive effects of terlipressin without improving renal function in cirrhosis and ascites. Am J Physiol Gastrointest Liver Physiol. 2020;318(2):313-321. doi:10.1152/ajpgi.00328.2019 10. Karvellas CJ, Gustot T, Fernandez J. Management of the acute on chronic liver failure in the intensive care unit. Liver Int. Published online June 27, 2023. doi:10.1111/liv.15659 11. Nadim MK, Garcia-Tsao G. Acute kidney injury in patients with cirrhosis. N Engl J Med. 2023;388(8):733-745. doi:10.1056/nejmra2215289 12. China L, Freemantle N, Forrest E, et al. A randomized trial of albumin infusions in hospitalized patients with cirrhosis. N Engl J Med. 2021;384(9):808-817. doi:10.1056/NEJMoa2022166