- Two poster presentations of Mallinckrodt's research for adults with HRS with rapid reduction in kidney function1 provide further insight into treatment with TERLIVAZ for appropriate patients -
DUBLIN, May 18, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of two posters on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at the 2024 Digestive Disease Week® (DDW) taking place in Washington, DC from May 18-21, 2024.
The posters feature a post-hoc analysis of data from the pivotal Phase III CONFIRM trial, analyzing the impact of dose interruptions on treatment response to TERLIVAZ in patients with hepatorenal syndrome-acute kidney injury (HRS-AKI),2 and a pooled analysis of three Phase III clinical studies assessing the impact of TERLIVAZ treatment on patients with HRS and a baseline serum creatinine (SCr) <5mg/dL.3
TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.4 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually and rates of hospitalizations are increasing.5
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
"We're excited to present our research at DDW. It represents our ongoing commitment to add to the depth and breadth of data on TERLIVAZ and its important role in the treatment of adult patients with HRS with rapid reduction in kidney function,"1 said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer. "Collectively, these data support our understanding of those who are most likely to benefit from TERLIVAZ showing the potential impact of use in the real-world, including when the dosing schedule is interrupted."
Abstract #4025396: Treatment Response to Terlipressin is Unaffected by Dose Interruptions in Patients with Hepatorenal Syndrome-Acute Kidney Injury2
- Presenter: Khalid Mumtaz, MD, The Ohio State University Wexner Medical Center, Columbus, OH
- Session Type: Poster Presentation
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Session Date and Time: Saturday, May 18, 2024; 12:30 - 1:30 p.m. EDT
This analysis evaluated the effect of dose interruption on the incidence of HRS reversal for patients with HRS-AKI.2 The recommended dose regimen includes administering TERLIVAZ 0.85 mg (1 vial) intravenously every six hours on days one to three.1 On day four, assess SCr versus baseline and if SCr has decreased by at least 30% from baseline continue TERLIVAZ 0.85 mg (1 vial) intravenously every six hours.1 Patients included in the analysis experienced a dose interruption due to adverse events or any other reason.2 After a dose interruption, treatment could be restarted at a reduced dose of 0.5 mg or 1 mg every 6-12 hours.2 The safety and efficacy of this particular use has not been evaluated by FDA.
Abstract #4034883: Terlipressin Treatment Benefits Those Patients with Baseline Serum Creatinine <5 mg/dl: The North American Experience3
- Presenter: Prasun K. Jalal, MD, Baylor College of Medicine, Houston, TX
- Session Type: Poster Presentation
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Session Date and Time: Saturday, May 18, 2024; 12:30 - 1:30 p.m. EDT
This analysis included pooled data from three Phase III, placebo-controlled studies of TERLIVAZ in 608 patients with HRS with rapid reduction in kidney function.1,3 Patients were dosed with 1 mg terlipressin acetate (equivalent to 0.85 mg terlipressin base) every six hours for =14 days.3 Data was assessed by SCr subgroup (baseline SCr <5 mg/dL or =5 mg/dL) for the outcomes of HRS reversal (defined as>/= 1 SCr of 3
These analyses were sponsored by Mallinckrodt Pharmaceuticals.
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.
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 more than 42,000 Americans annually and rates of HRS hospitalizations are increasing.5 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of less than two weeks and greater than 80 percent mortality within three months.6
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©2024 Mallinckrodt. US-2400300 05/24
References
1 TERLIVAZ® (terlipressin) for Injection. Prescribing Information. Mallinckrodt Hospital Products Inc. 2023.
https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed January 2024.
https://doi.org/10.1002/lt.26072.
SOURCE Mallinckrodt plc
