– Five scientific abstracts spanning clinical and health economic outcomes research will be presented at the ACG Scientific Meeting, showcasing the breadth of Mallinckrodt's commitment to HRS patients with rapid reduction in kidney function1 –
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
The findings from one of the abstracts, presented by Dr.
"We look forward to sharing a range of new data, among those an ACG Award-Winning abstract that has received Presidential Poster recognition, highlighting the importance of additional treatment options for patients with HRS, like terlipressin. These findings not only have important implications for morbidity and mortality, but also help to shine a light on the persistent clinical and economic burden HRS patients in the
These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
Abstract D0501: Clinical and Economic Burden of Patients With HRS-AKI Treated With Current Standard of Care: Retrospective Analysis of Real World Data4
Oral Abstract 22: Terlipressin Treatment of Patients With Hepatorenal Syndrome Type 1 Decreased the Need for Renal Replacement Therapy in Transplant Recipients: A 12-Month Follow-Up of the CONFIRM Study5
Abstract D0499: Treatment Response to Terlipressin Plus Albumin Varies by Precipitating Factor in Patients with Hepatorenal Syndrome Type 13
Abstract D0474: Impact of Terlipressin on Serum Sodium Levels in Patients With Hepatorenal Syndrome Type 1 (HRS-1): CONFIRM Study6
Abstract D0505: Increasing Burden of Hepatorenal Syndrome and Acute Kidney Injury Among Hospitalized Patients With Chronic Liver Disease is Associated With High In-Hospital Mortality and Increased Healthcare Resource Utilization7
Find more information on the
Terlipressin is one of the most studied pharmacological agents in HRS with more than 70 published manuscripts and presented abstracts on clinical data to date.8 It has been approved outside 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.2 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.2 HRS involving rapid reduction in kidney function is estimated to affect between 30,000 and 40,000 Americans annually.11,12 If left untreated, HRS with rapid reduction in kidney function has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.13
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
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.
Please click here to see full Prescribing Information, including Boxed Warning.
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to TERLIVAZ, including 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 SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Senior Vice President,
Global Corporate Controller & Chief Investor Relations Officer
Vice President, Investor Relations
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.
©2022 Mallinckrodt. US-2201018 10/22
1 Terlivaz® (terlipressin) for injection [prescribing information]. Mallinckrodt Pharmaceuticals.
2 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed October 13, 2022.
3 RT Frederick. Treatment Response to Terlipressin Plus Albumin Varies by Precipitating Factor in Patients With Hepatorenal Syndrome Type 1. Presented at
4 X Huang. Clinical and Economic Burden of Patients With HRS-AKI Treated With Current Standard of Care: Retrospective Analysis of Real World Data. Presented at
5 KR Reddy. Terlipressin Treatment of Patients With Hepatorenal Syndrome Type 1 Decreased the Need for Renal Replacement Therapy in Transplant Recipients: A 12-Month Follow-Up of the CONFIRM Study. Presented at
6 N Pyrsopoulos. Impact of Terlipressin on Serum Sodium Levels in Patients with Hepatorenal Syndrome Type 1 (HRS-1): CONFIRM Study. Presented at
7 RJ Wong. Increasing Burden of Hepatorenal Syndrome and Acute Kidney Injury Among Hospitalized Patients With Chronic Liver Disease Is Associated With High In-Hospital Mortality and Increased Healthcare Resource Utilization. Presented at
8 Data on File – Ref-05488. Mallinckrodt Pharmaceuticals.
9 Data on File – Ref-05482. Mallinckrodt Pharmaceuticals.
10 FDA Cardiovascular and Renal Drugs Advisory Committee. Mallinckrodt Pharmaceuticals Terlipressin Advisory Committee Briefing Document NDA #022231.
11 C Pant, B S Jani, M Desai, A Deshpande,
12 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed October 13, 2022.
13 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
View original content to download multimedia:https://www.prnewswire.com/news-releases/mallinckrodt-to-present-data-on-terlivaz-terlipressin-for-injection-in-adult-patients-with-hepatorenal-syndrome-hrs-at-the-american-college-of-gastroenterology-acg-annual-scientific-meeting-301656655.html