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Please see FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING

THESE HIGHLY RESPECTED SOCIETIES' GUIDELINES/GUIDANCES ARE INTERNATIONALLY RECOGNIZED

AASLD Guidance and ACG Guidelines Regarding Terlipressin1,2,a

AASLD GUIDANCE 20211*

“The treatment of choice for HRS-AKIb is vasoconstrictor drugs in combination with albumin. The preferred drug is terlipressin.”

ACG GUIDELINES 20222

“In hospitalized patients with cirrhosis and HRSb without high grade of ACLF or disease, we suggest terlipressin (moderate quality, conditional recommendationc) or norepinephrine (low quality, conditional recommendationc) to improve renal function.”

AASLD, American Association for the Study of Liver Diseases; ACG, American College of Gastroenterology; ACLF, acute-on-chronic liver failure; AKI, acute kidney injury; HRS, hepatorenal syndrome.

aTERLIVAZ (terlipressin) was not evaluated in comparison to other treatments in a head-to-head clinical study.

bDefinition of kidney injury for HRS-AKI: increase in SCr of ≥0.3 mg/dL within 48 hours or percent increase in SCr that is ≥50% of what was known or presumed to have occurred within the prior 7 days.

cIn the ACG guidelines, a strength of recommendation is given as either strong (recommendations) or conditional (suggestions).

*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. Biggins SW, Angeli P, Garcia-Tsao G, Ginès P, Ling SC, Nadim MK, Wong F, Kim WR. Copyright © 2021 American Association for the Study of Liver Diseases.
Reproduced with permission of John Wiley & Sons, Inc.

CONFIRM was the largest HRS trial to date

SEE THE STUDY DESIGN

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.

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%.

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. 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.
  2. Bajaj JS, O'Leary JG, Lai JC, et al. Acute-on-chronic liver failure clinical guidelines. Am J Gastroenterol. 2022;117:225-252.