– Findings from a retrospective investigation suggest that patients with baseline acute-on-chronic liver nonaccomplishment (ACLF) people ≤2 treated with TERLIVAZ® positive albumin had a higher incidence of HRS reversal than those treated with placebo positive albumin1 –
, /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a planetary specialty pharmaceutical company, contiguous announced the presumption of results from a retrospective investigation of 3 North American-centric, Phase III, randomized, placebo-controlled studies comparing the incidence of hepatorenal syndrome (HRS) reversal with baseline acute-on-chronic liver nonaccomplishment (ACLF) people successful adults with accelerated simplification successful kidney function2 treated with TERLIVAZ® positive albumin versus those treated with placebo positive albumin. Investigators volition contiguous the findings during an oral presumption astatine the SCCM 2023 Critical Care Congress connected January 22, taking spot successful San Francisco, CA from January 21-24.
TERLIVAZ is the archetypal and lone FDA-approved merchandise indicated for the attraction of adults with HRS involving accelerated simplification successful kidney function,2 an acute and life-threatening information requiring hospitalization.3 Terlipressin is recommended by the American Association for the Study of Liver Diseases (AASLD) guidance4 and the American College of Gastroenterology (ACG) guidelines.5
Please spot Limitation of Use and Important Safety Information, including Boxed Warning, below.
The retrospective investigation utilized pooled information from the OT-0401, REVERSE, and CONFIRM Phase III studies to comparison the incidence of HRS reversal by baseline ACLF people successful patients treated with terlipressin positive albumin versus placebo positive albumin for up to 14 days. Severity of ACLF was graded according to the fig of organ failures (ACLF people 0-1, people 2, and people 3). The incidence of HRS reversal was defined arsenic astatine slightest 1 serum creatinine worth of ≤1.5 mg/dL portion connected treatment.1
"We're excited to stock these information that not lone supply invaluable penetration into the relation betwixt baseline diligent ACLF people and attraction effect with TERLIVAZ, but besides reenforce the value of aboriginal attraction involution to assistance amended outcomes for patients with HRS with accelerated simplification successful kidney function,1,2" said Khurram Jamil, Vice President, Hepatology, Clinical Development & Critical Care. "In airy of the caller FDA support of TERLIVAZ arsenic the archetypal and lone attraction to amended kidney relation successful adults with HRS with accelerated simplification successful kidney function,2 we stay committed to addressing the unmet needs of critically sick diligent populations."
In the pooled investigation colonisation (n=607), 278 patients had ACLF people 0-1 (terlipressin: n=164; placebo: n=114), 208 patients had ACLF people 2 (terlipressin: n=116; placebo: n=92), and 121 patients had ACLF people 3 (terlipressin: n=72; placebo: n=49). The incidence of HRS reversal successful terlipressin-treated patients decreased with expanding ACLF people (ACLF people 0-1: 43% (n=71/164); ACLF people 2: 28% (n=32/116); ACLF people 3: 19% (n=14/72)), whereas HRS reversal was akin crossed ACLF grades successful placebo-treated patients (ACLF people 0-1: 18% (n=21/114); ACLF people 2: 15% (n=14/92); ACLF people 3: 14% (n=7/49)).1
Additionally, a higher percent of terlipressin-treated patients with ACLF people 0-1 oregon people 2 achieved HRS reversal compared with those successful the respective placebo-treated groups (ACLF people 0-1: terlipressin 43% (n=71/164) vs placebo 18% (n=21/114); ACLF people 2: terlipressin 28% (n=32/116) vs placebo 15% (n=14/92)) (p<0.0001 and p=0.02, respectively). No differences successful the incidence of HRS reversal were observed betwixt terlipressin- (19%; n=14/72) and placebo- (14%; n=7/49) treated patients with ACLF people 3 (p=0.46).1
This survey was sponsored by Mallinckrodt Pharmaceuticals:
Baseline ACLF Grade and Treatment Response to Terlipressin successful Patients with Hepatorenal Syndrome1
- Presenter: Ram Subramanian
- Presentation Date: January 22; 2:30PM PT
- Location: Exhibit Hall RST 8, Moscone Center South
Find much accusation connected the Society of Critical Care Medicine's (SCCM) 2023 Critical Care Congress Meeting website.
About Hepatorenal Syndrome (HRS)
Hepatorenal syndrome (HRS) involving accelerated simplification successful kidney function2 is an acute and life-threatening information that occurs successful radical with precocious liver disease.3 HRS is classified into 2 chiseled types – a rapidly progressive benignant that leads to acute renal nonaccomplishment wherever patients are typically hospitalized for their attraction and a much chronic benignant that progresses implicit weeks to months.3 HRS involving accelerated simplification successful kidney function2 is estimated to impact betwixt 30,000 and 40,000 Americans annually.6,7 If near untreated, HRS with accelerated simplification successful kidney relation has a median endurance clip of astir 2 weeks and greater than 80 percent mortality wrong 3 months.8
INDICATION AND LIMITATION OF USE
TERLIVAZ is indicated to amended kidney relation successful adults with hepatorenal syndrome with accelerated simplification successful kidney function.
- Patients with a serum creatinine >5 mg/dL are improbable to acquisition benefit.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
- TERLIVAZ whitethorn origin superior oregon fatal respiratory failure. Patients with measurement overload oregon with acute-on-chronic liver nonaccomplishment (ACLF) Grade 3 are astatine accrued risk. Assess oxygenation saturation (e.g., SpO2) earlier initiating TERLIVAZ.
- Do not initiate TERLIVAZ successful patients experiencing hypoxia (e.g., SpO2 <90%) until oxygenation levels improve. Monitor patients for hypoxia utilizing continuous pulse oximetry during attraction and discontinue TERLIVAZ if SpO2 decreases beneath 90%.
Contraindications
TERLIVAZ is contraindicated:
- In patients experiencing hypoxia oregon worsening respiratory symptoms.
- In patients with ongoing coronary, peripheral, oregon mesenteric ischemia.
Warnings and Precautions
- Serious oregon Fatal Respiratory Failure: Obtain baseline oxygen saturation and bash not initiate TERLIVAZ successful hypoxic patients. Monitor patients for changes successful respiratory presumption utilizing continuous pulse oximetry and regular objective assessments. Discontinue TERLIVAZ successful patients experiencing hypoxia oregon accrued respiratory symptoms.
Manage intravascular measurement overload by reducing oregon discontinuing the medication of albumin and/or different fluids and done judicious usage of diuretics. Temporarily interrupt, reduce, oregon discontinue TERLIVAZ attraction until diligent measurement presumption improves. Avoid usage successful patients with ACLF Grade 3 due to the fact that they are astatine important hazard for respiratory failure.
- Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) whitethorn marque a diligent ineligible for liver transplantation, if listed. For patients with precocious prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ whitethorn not outweigh its risks.
- Ischemic Events: TERLIVAZ whitethorn origin cardiac, cerebrovascular, peripheral, oregon mesenteric ischemia. Avoid usage of TERLIVAZ successful patients with a past of terrible cardiovascular conditions oregon cerebrovascular oregon ischemic disease. Discontinue TERLIVAZ successful patients who acquisition signs oregon symptoms suggestive of ischemic adverse reactions.
- Embryo-Fetal Toxicity: TERLIVAZ whitethorn origin fetal harm erstwhile administered to a large woman. If TERLIVAZ is utilized during pregnancy, the diligent should beryllium informed of the imaginable hazard to the fetus.
Adverse Reactions
- The astir communal adverse reactions (≥10%) see abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
Please click here to spot afloat Prescribing Information, including Boxed Warning.
ABOUT MALLINCKRODT
Mallinckrodt is simply a planetary concern consisting of aggregate wholly owned subsidiaries that develop, manufacture, marketplace and administer specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of absorption see autoimmune and uncommon diseases successful specialty areas similar neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory captious attraction therapies; analgesics; cultured tegument substitutes and gastrointestinal products. Its Specialty Generics reportable conception includes specialty generic drugs and progressive pharmaceutical ingredients. To larn much astir Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website arsenic a transmission of organisation of important institution information, specified arsenic property releases, capitalist presentations and different fiscal information. It besides uses its website to expedite nationalist entree to time-critical accusation regarding the institution successful beforehand of oregon successful lieu of distributing a property merchandise oregon a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the aforesaid information. Therefore, investors should look to the Investor Relations leafage of the website for important and time-critical information. Visitors to the website tin besides registry to person automatic email and different notifications alerting them erstwhile caller accusation is made disposable connected the Investor Relations leafage of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This merchandise includes forward-looking statements, including with respect to TERLIVAZ, its imaginable interaction connected patients. The statements are based connected assumptions astir galore important factors, including the following, which could origin existent results to disagree materially from those successful the forward-looking statements: restitution of regulatory and different requirements; actions of regulatory bodies and different governmental authorities; changes successful laws and regulations; issues with merchandise quality, manufacturing oregon supply, oregon diligent information issues; and different risks identified and described successful much item successful the "Risk Factors" conception of Mallinckrodt's Annual Report connected Form 10-K for the fiscal twelvemonth ended December 31, 2021, arsenic updated by Mallinckrodt's Quarterly Reports connected Form 10-Q for the quarterly periods ended April 1, July 1 and September 30, 2022 and different filings with the SEC, each of which are disposable connected its website. The forward-looking statements made herein talk lone arsenic of the day hereof and Mallinckrodt does not presume immoderate work to update oregon revise immoderate forward-looking statement, whether arsenic a effect of caller information, aboriginal events and developments oregon otherwise, but arsenic required by law.
CONTACT
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Mallinckrodt, the "M" marque people and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company oregon their respective owners.
©2023 Mallinckrodt. US-2201162 1/23
References
1 Subramanian R. Baseline ACLF Grade and Treatment Response to Terlipressin successful Patients with Hepatorenal Syndrome. Abstract. Presented astatine the Society of Critical Care Medicine (SCCM) 2023 Critical Care Congress. January 2023.
2 TERLIVAZ® (terlipressin) for injection [Prescribing Information]. Mallinckrodt Hospital Products Inc.
3 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed December 2, 2022.
4 Biggins SW, Angeli P, Garcia-Tsao G, et al. Diagnosis, evaluation, and absorption of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: 2021 signifier 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 nonaccomplishment objective guidelines. Am J Gastroenterol. 2022;1-28.
6 C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan Taylor, R Gilroy, M OIyaee. Heptorenal syndrome successful hospitalized patients with chronic liver disease: results from the Nationwide Inpatient Sample 2002-2012. J of Investig Med. 2016; 64:33-38.
7 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed December 2, 2022.
8 Flamm SL, Brown K, Wadei HM., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury successful the United States and the Potential of Terlipressin. Liver Transpl. 2021;27:1191-1202. https://doi.org/10.1002/lt.26072.
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