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HRS patients are faced with poor outcomes1-3

Hepatorenal syndrome (HRS) with rapid reduction in kidney function is an acute condition that occurs in patients with decompensated cirrhosis and ascites.4

Without treatment1,2

Median Survival Time Icon

≤2 weeks


Mortality Icon



within 3 months

With treatment3,a,b

In-Hospital Mortality Rate Icon



30-Day Readmission Rate Icon



41% of which were unplanned

Mean Length of Stay Icon

30.5 days


aPatient identification based on ICD coding, which does not differentiate types of HRS.

bReason for discharge varied among patients and was not necessarily indicative of patient outcomes.

There is an unmet need for treating HRS with rapid reduction in kidney function1,4-9

Historical Treatment Options
Midodrine and OctreotideNorepinephrine
FDA Approved to Treat HRS With Rapid Reduction in Kidney FunctionNo1No1
AASLD HRS Guidance Recommendation/Preference3rd preference42nd preference4
FDA-Established Efficacy for Treating HRSNo1,4No1,5
FDA-Established Safety for Treating HRSNo1No1
Typical Treatment SettingMedical Floor6ICU5
Need for Dedicated Central LineNo7,8Yes5
Need for Cardiac MonitoringcNo7,8Yes9
Mechanism of Action

Midodrine: α-agonist that acts as a peripheral vasoconstrictor7

Octreotide: somatostatin analog that reduced splanchnic blood flow8

Mixed α- and β-adrenergic receptor agonist that acts as a peripheral vasoconstrictor in the setting of HRS9

AASLD, American Association for the Study of Liver Diseases; ICU, intensive care unit.

cWhile the Prescribing Information for midodrine and octreotide does not require cardiac monitoring, HCPs should exercise their own medical judgment when making patient-specific treatment decisions.

Recent diagnostic criteria allow for earlier diagnosis and intervention, which may lead to better outcomes10,11

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TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

  • Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.



  • 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.
  • 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%.


TERLIVAZ is contraindicated:

  • In patients experiencing hypoxia or worsening respiratory symptoms.
  • In patients with ongoing coronary, peripheral, or mesenteric ischemia.

Warnings and Precautions

  • 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.

  • 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.

  • 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.

  • 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

  • The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.

Please see full Prescribing Information, including Boxed Warning.


  1. Boyer T, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design. Open Access J Clin Trials. 2012;4:39-49.
  2. Flamm SL, Brown K, Wadei HM, et al. The current management of hepatorenal syndrome—acute kidney injury in the United States and the potential of terlipressin. Liver Transpl. 2021;27:1191-1202.
  3. Jamil K, Huang X, Lovelace B, et al. The burden of illness of hepatorenal syndrome (HRS) in the United States: a retrospective analysis of electronic health records. J Med Econ. 2019;22:421-429.
  4. Biggins SW, Angeli P, Garcia-Tsao G, et al. Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: 2021 practice guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021;74:1014-1048.
  5. European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69:406-460. Published correction appears in J Hepatol. 2018;69:1207.
  6. Tariq R, Singal AK. Management of hepatorenal syndrome: a review. J Clin Transl Hepatol. 2020;8:192-199.
  7. Midodrine hydrochloride. Prescribing Information. Morgantown, WV: Mylan Pharmaceuticals, Inc.; 2020.
  8. Sandostatin® (octreotide acetate). Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2021.
  9. LEVOPHED® (norepinephrine bitartrate). Prescribing Information. Lake Forest, IL: Hospira, Inc.; 2020.
  10. Wong F, Pappas S, Vargas HE, et al. The diagnosis of hepatorenal syndrome: how much does use of the 2015 revised consensus recommendations affect earlier treatment and serum creatinine at treatment start? (Poster SAT-141) J Hepatol. 2019;70:e692-e693.
  11. Sanyal A, Boyer TD, Frederick RT, et al. Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the OT-0401 and REVERSE randomized clinical studies. Aliment Pharmacol Ther. 2017;45:1390-1402.