Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that two scientific abstracts on the clinical and health economic outcomes of treatment with TERLIVAZ^® (terlipressin) for adult patients with hepatorenal syndrome (HRS) will be presented at the National Kidney Foundation (NKF) 2023 Spring Clinical Meeting (SCM) in Austin, TX taking place April 11 – 15, 2023.

TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function,^[1] an acute and life-threatening condition requiring hospitalization.^[2]

Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.

The findings from one of the abstracts, presented by Xingyue Huang, PhD, Senior Director, HEOR, Critical Care at Mallinckrodt, provide insight into the treatment cost per response in patients with hepatorenal syndrome treated with TERLIVAZ plus albumin versus other unapproved treatments from a U.S. hospital perspective.^[3] Furthermore, findings from a pooled analysis of three Phase III terlipressin trials, presented by Muhammad A Mujtaba, MD, University of Texas Medical Branch, Galveston TX, offer perspective into the clinical impact of serum creatinine reduction from treatment initiation with TERLIVAZ through end of treatment on outcomes for adults with hepatorenal syndrome.^[4]

Additional information on these studies and the full list of Mallinckrodt’s presentations can be found below.

“We look forward to sharing our new data highlighting our commitment to continued clinical investigation with treatment options for patients with HRS, like TERLIVAZ, as well as addressing the real-world impact that HRS and current treatment plans impart upon patients and healthcare systems from a cost and outcomes perspective,^[3,4]” said Khurram Jamil, Vice President, Hepatology, Clinical Development & Critical Care. “These findings not only have important implications for how the medical community defines and achieves treatment goals, but also help to raise awareness, and ultimately drive action, for the persistent clinical and economic burden HRS patients in the U.S. face.”

These studies are sponsored by Mallinckrodt Pharmaceuticals and include:

Poster #10: Treatment-Related Cost Analysis for Adults with Hepatorenal Syndrome with Rapid Reduction in Kidney Function^[3]

• Presenter: Xingyue Huang, PhD, Senior Director, HEOR, Critical Care at Mallinckrodt
• Presentation Date: Wednesday, April 12, 2023; 6:00 – 7:30PM CDT
• Location: Exhibit Hall 4, Austin Convention Center

Poster #20: A Reduction in Serum Creatinine of at Least 30% Leads to Meaningful Clinical Outcomes in Patients with Hepatorenal Syndrome Type 1: A Pooled Analysis of 3 Phase III Studies^[4]

• Presenter: Muhammad Ahmad Mujtaba, MD, University of Texas Medical Branch
• Presentation Date: Wednesday, April 12, 2023; 6:00 – 7:30PM CDT
• Location: Exhibit Hall 4, Austin Convention Center

Find more information on the National Kidney Foundation (NKF) 2023 Spring Clinical Meeting (SCM) website.

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 click here to see full Prescribing Information, including Boxed Warning.