– Findings from two clinical studies in adults with HRS involving rapid reduction in kidney function1 provide insight into the use of terlipressin among patients with comorbidities and varying baseline characteristics2,3 –
TERLIVAZ (terlipressin) for injection is a synthetic vasopressin analogue indicated to improve kidney function in adults with HRS with rapid reduction in kidney function.1 Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.1
Please see Important Safety Information, including Boxed Warning, below.
TERLIVAZ is the first and only FDA-approved product indicated for the treatment of adults with HRS involving rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.4 Terlipressin is recommended by the American Association for the Study of Liver Diseases (AASLD) guidance5 and the American College of Gastroenterology (ACG) guidelines.6
The findings from the pooled analysis of the Phase III REVERSE and CONFIRM studies, presented by
Renal failure requiring hemodialysis post-liver transplant is a major risk factor for death in liver transplant recipients.7 Patients who require post-transplant dialysis also have significantly worse graft survival compared with those without post-transplant dialysis.8
"We are excited to share findings from our latest clinical research that not only support the use of terlipressin to improve kidney function for appropriate patients with HRS involving rapid reduction in kidney function,1,3 but also aim to generate increased awareness and understanding among healthcare professionals of the treatment considerations and goals for HRS patients with burdensome comorbidities, like systemic inflammatory response syndrome,2" said
Liver transplantation is the only definitive treatment for patients with HRS with rapid reduction in kidney function,1 yet the majority of HRS patients still face access challenges.9 In light of these ongoing challenges, improving transplant outcomes – and conducting research that provides insight into the clinical management of these critically ill patients – is essential to addressing the scarcity of available liver transplants and other prominent unmet needs.7
These studies were sponsored by Mallinckrodt Pharmaceuticals:
Find more information on the
About Hepatorenal Syndrome (HRS)
Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.4 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.4 HRS involving rapid reduction in kidney function1 is estimated to affect between 30,000 and 40,000 Americans annually.10,11 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.12
INDICATION AND LIMITATION OF USE
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
TERLIVAZ is contraindicated:
Warnings and Precautions
Please click here to see full Prescribing Information, including Boxed Warning.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to TERLIVAZ and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the
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©2023 Mallinckrodt. US-2300270 6/23
1 TERLIVAZ® (terlipressin) for injection. [Prescribing Information].
2 Said, A, et al. Terlipressin Improves Clinical Outcomes in Patients with Hepatorenal Syndrome Type 1 and Systemic Inflammatory Response Syndrome: A Pooled Analysis of the Phase III REVERSE and CONFIRM Studies. Abstract to be presented at
3 Gordon, F. et al. Liver transplant rates and clinical outcomes in patients with hepatorenal syndrome type 1 and ACLF grade 0−2 and serum creatinine (SCr) <5 mg/dL at baseline. Abstract to be presented at
4 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed April 27, 2023.
5 Biggins SW, Angeli P,
6 Bajaj JS, O'Leary JG, Lai JC, et al. Acute-on-chronic liver failure clinical guidelines. Am J Gastroenterol. 2022;1-28.
7 Zand MS, et al. High mortality in orthotopic liver transplant recipients who require hemodialysis. Clin Transpl. 2011;25(2):213-21.
8 Nagai S, et al. Incidence and outcomes of immediate post-operative dialysis in liver transplantation. Am J Transpl. 2017;17:774.
9 Kwong AJ, Kim WR,
10 C Pant, B S Jani, M Desai, A Deshpande,
11 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed April 27, 2023.
12 Flamm SL, Brown K, Wadei HM., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
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