For US healthcare professionals only.
Please see full Prescribing Information, including Boxed Warning.
CONTACT A REP

Efficacy

The NEJM-published CONFIRM trial was the largest HRS trial globally to date1

The multicenter, 2:1 randomized, placebo-controlled, double-blind, phase 3 trial evaluated the safety and efficacy of TERLIVAZ + albumin in 300 adults with HRS with rapid reduction in kidney function.2,3

Explore Trial Design

Find out how TERLIVAZ lowered SCr to help reverse HRS

CONFIRM not only evaluated improvement in SCr, but it also included a multicomponent primary end point. That end point required the treatment-related improvement in renal function be durable enough to have a significant impact on patient morbidity and short-term mortality.1

REVIEW THE RESULTS

A greater reduction in SCr was shown by end of treatment with TERLIVAZ®

Post hoc analysis of change from baseline SCr in overall population

  • The reduction from baseline to end of treatment in SCr was significantly larger in the TERLIVAZ group vs the placebo group4

  • Meanb treatment difference between the groups with interaction was -0.7 mg/dL (0.10), P<.0014,c

Additionally, a significantly higher percentage of patients treated with TERLIVAZ had >30% improvement in SCr from baseline to day 14 (P<.001).4

ITT, intent-to-treat; LS, least squares; SCr, serum creatinine; SE, standard error.

a“Overall population” refers to the ITT population, which comprised all patients who underwent randomization.3 N values denote the number of subjects at that timepoint and with a baseline measure.4

bLS mean.

cBased on repeated-measures analysis of covariance with factors of “treatment,” “qualifying SCr,” “prior large volume paracentesis within 14 days of randomization,” and “day,” and the “treatment-by-day” interaction.4

Discover the impact of TERLIVAZ on RRT independence over time

TERLIVAZ was shown to improve kidney function, helping more patients avoid RRT than those treated with placebo.4

REVIEW THE RESULTS

Comparison of liver transplant rates between overall and subpopulation

Comparison of liver transplant rates between overall population and subpopulation

LT, liver transplant; MELD, Model for End-Stage Liver Disease.

aPlacebo group not shown.

Subpopulation analysis parameters

Overall population3,4

  • SCr ≤7 mg/dL
  • ACLF grade 0-3
  • MELD ≤40

Subpopulation4

  • SCr <5 mg/dL
  • ACLF grade 0-2
  • MELD <35
    (if transplant-listed)

For more information about the parameters, review the .

POST HOC ANALYSIS OF PRESPECIFIED END POINTS

More patients treated with TERLIVAZ® were RRT free before and after liver transplanta

Data showing TERLIVAZ was associated with a lower incidence of RRT before and after liver transplant

ITT, intent-to-treat; RRT, renal replacement therapy.

aThese post hoc analyses were done to show RRT incidence in patients in the ITT population who received a liver transplant. RRT incidence was assessed pretransplant and at 90 days posttransplant. The analyses were retrospective and based on a much smaller population than the full randomized population in the CONFIRM trial.4

See the impact on HRS reversal when initiating treatment at lower SCr levels

A pooled analysis supports that treating earlier with TERLIVAZ has a positive impact on HRS reversal, RRT independence, and liver transplantation rates.5

REVIEW THE RESULTS
+

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. Jamil K, Pappas SC, Wong F, Sanyal AJ. Verified hepatorenal syndrome reversal as a robust multi-component primary end point: the CONFIRM study trial design. Open Access J Clin Trials. 2019;11:67-73. doi:10.2147/OAJCT.S224974 2. TERLIVAZ® (terlipressin). Prescribing Information. Bridgewater, NJ: Mallinckrodt Hospital Products Inc. 3. Wong F, Pappas SC, Curry MP, et al. Terlipressin plus albumin for the treatment of type 1 hepatorenal syndrome. N Engl J Med. 2021;384(9):818-828. doi:10.1056/NEJMoa2008290 4. Data on File – Ref-05035. Mallinckrodt Pharmaceuticals. 5. Curry MP, Vargas HE, Befeler AS, Pyrsopoulos NT, Patwardhan VR, Jamil K. Early treatment with terlipressin in patients with hepatorenal syndrome yields improved clinical outcomes in North American studies. Hepatol Commun. 2023;7(1):e1307. doi:10.1097/01.HC9.0000897228.91307.0c 6. Data on File – Ref-05858. Mallinckrodt Pharmaceuticals. 7. Sanyal AJ, Boyer T, Garcia-Tsao G, et al. A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome. Gastroenterology. 2008;134(5):1360-1368. doi:10.1053/j.gastro.2008.02.014 8. Sanyal AJ, 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(11):1390-1402. doi:10.1111/apt.14052 9. Boyer TD, Sanyal AJ, Wong F, et al. Terlipressin plus albumin is more effective than albumin alone in improving renal function in patients with cirrhosis and hepatorenal syndrome type 1. Gastroenterology. 2016;150(7):1579-1589. doi:10.1053/j.gastro.2016.02.026

WELCOME TO TERLIVAZ.COM

This website is intended for US healthcare professionals only.

Continue to website

Leave website

DISCLAIMER

You are now leaving TERLIVAZ.com and entering a third-party site.

CONTINUE

DISCLAIMER

You are now leaving TERLIVAZ.com and entering another Mallinckrodt-hosted website.

CONTINUE

DISCLAIMER

To play our diagnostic challenge game, you will leave TERLIVAZ.com and enter a third-party website.

CONTINUE