TERLIVAZ:
THE FRONT LINE OF HRS REVERSAL

The first and only FDA-approved therapy to improve kidney function in adults with HRS with rapid reduction in kidney function.1

Address the urgency

Historically, patients with HRS-AKI have faced poor outcomes, with or without treatment.2,3

Start with the preferred vasoconstrictor4,5

Find out more about how terlipressin and other therapies are used to treat HRS-AKI.

Use on the floor or in the ICU based on patient needs

TERLIVAZ was more commonly used on the floor in the CONFIRM trial and was associated with a reduced ICU length of stay.6,a

HRS-AKI, hepatorenal syndrome–acute kidney injury; ICU, intensive care unit.

aPatient health outcomes were independent of these metrics, and results may have varied.

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IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE

  • 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%.

INDICATION AND LIMITATION OF USE

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.

Contraindications

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.

References: 1. TERLIVAZ® (terlipressin). Prescribing Information. Bridgewater, NJ: Mallinckrodt Hospital Products Inc. 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(8):1191-1202. doi:10.1002/lt.26072 3. Jamil K, Huang X, Lovelace B, Pham AT, Lodaya K, Wan G. The burden of illness of hepatorenal syndrome (HRS) in the United States: a retrospective analysis of electronic health records. J Med Econ. 2019;22(5):421-429. doi:10.1080/13696998.2019.1580201 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(2):1014-1048. doi:10.1002/hep.31884 5. Bajaj JS, O’Leary JG, Lai JC, et al. Acute-on-chronic liver failure clinical guidelines. Am J Gastroenterol. 2022;117(2):225-252. doi:10.14309/ajg.0000000000001595 6. Karvellas CJ, Subramanian R, Olson JC, Jamil K. Role of terlipressin in patients with hepatorenal syndrome-acute kidney injury admitted to the ICU: a substudy of the CONFIRM trial. Crit Care Explor. 2023;5(4):e0890. doi:10.1097/CCE.0000000000000890

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