Mallinckrodt plc announced the presentation of a poster on TERLIVAZ®? (terlipressin) injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function at Kidney Week 2024, the annual meeting of the American Society of Nephrology (ASN) taking place in San Diego from October 23 to 27 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid decline in kidney function, an acute, life-threatening condition requiring hospitalization.
HRS with rapid reduction in kidney function is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the US population, making it a very rare condition; and hospitalization rates are increasing. The poster presentation highlights a pooled analysis of data from the phase 3 placebo-controlled CONFIRM and REVERSE trials of TERLIVAZ.5 The analysis examined rates of reversal of hepatorenal syndrome-acute kidney injury (HRS-AKI), renal replacement (RRT) and liver transplantation (LT) among a subpopulation of patients listed for LT at baseline who met FDA label guidelines for treatment with TERLIVAZ (SCr. The rate of RRT in TERLIVAZ and placebo groups was 28% and 46% at day 30; 32% and 54% at day 60; and 36% and 54% at day 90, respectively.
The LT rate was similar in the TERLIV AZ and placebo groups at all time points evaluated: 53% and 51% by Day 30; 66% and 57% by Day 60; and 66% and 63% for Day 90, respectively; Limitations of this study include, but are not limited to, small sample sizes, variables in the methodology, and potential errors and omissions within the data sets. TERLIVAZ is indicated to improve renal function in adult patients with hepatorenal syndrome with rapid reduction in renal function. Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.
IMPORTANT SAFETY INFORMATION: Warning: SEVERE OR FATAL RESPIRATORY FAILURE: TERLIVAZ can cause severe or fatal respiratory failure. Patients with volume overload or grade 3 acute-chronic liver failure (ALF) are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating treatment with TERLIVAZ.
Do not start TERLIVAZ in patients experiencing hypoxia (e.g. Spo2 HRS) which involves a 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 rapid, life-threatening condition that occurs in people with advanced liver disease.2 HRS is classified into two distinct types – a rapid, life-threatening condition.
