The FDA has approved a new drug called Terlivaz (terlipressin) for adults with hepatorenal syndrome (HRS) who have a rapid decline in kidney function. HRS is a serious complication of cirrhosis, a type of liver disease. This is the first FDA-approved therapy specifically for HRS. The approval was based on a study where 29% of patients taking Terlivaz showed improved kidney function compared to 16% on placebo. The drug is given through a vein (intravenously). It works by narrowing blood vessels to increase blood flow to the kidneys. However, patients with very high creatinine levels (above 5 mg/dL) are unlikely to benefit. Doctors will monitor oxygen levels and check for signs of liver failure before starting treatment. While this approval is a step forward, it is important to remember that Terlivaz treats a complication of liver disease, not the liver disease itself. If you or a loved one has cirrhosis and kidney problems, talk to your doctor about whether this new option might be appropriate. Your healthcare team can help you understand the risks and benefits based on your specific situation.
FDA approved Terlivaz (terlipressin) for Hepatorenal Syndrome with Rapid Kidney Function DeclineFDA approved new drug Terlivaz for kidney failure in liver disease patients.
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The FDA has approved Terlivaz (terlipressin) for improving kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. This is the first FDA-approved therapy specifically for HRS, a serious complication of cirrhosis. The approval was supported by the CONFIRM trial, a multicenter, double-blind, placebo-controlled study. In the trial, 29.1% of patients receiving Terlivaz achieved verified HRS reversal compared to 15.8% with placebo (p=0.012). The label notes that patients with serum creatinine >5 mg/dL are unlikely to benefit. Terlivaz is a vasopressin receptor agonist administered intravenously. Clinicians should monitor oxygen saturation and assess for acute-on-chronic liver failure grade before initiating therapy.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Terlivaz is a vasopressin receptor agonist. It improves kidney function in hepatorenal syndrome by causing splanchnic vasoconstriction, which reduces portal pressure and increases renal blood flow.
Terlivaz is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Limitation of Use: Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.
Prior to initial dosing, assess patients for ACLF Grade 3 and obtain baseline oxygenation. Monitor oxygen saturation with pulse oximetry. Recommended dosage: Days 1-3: 0.85 mg IV every 6 hours. Day 4: Assess SCr vs baseline. If SCr decreased ≥30%, continue 0.85 mg every 6 hours. If decreased <30%, may increase to 1.7 mg every 6 hours. If SCr at or above baseline, discontinue. Continue until 24 hours after two consecutive SCr ≤1.5 mg/dL at least 2 hours apart or max 14 days. Reconstitute each vial with 5 mL 0.9% Sodium Chloride Injection. Administer as slow IV bolus over 2 minutes. Flush line after administration. Store reconstituted solution at 2-8°C for up to 48 hours; do not freeze.
The CONFIRM trial (NCT02770716) was a multicenter, double-blind, randomized, placebo-controlled study. 300 patients with cirrhosis, ascites, and HRS-1 (SCr ≥2.25 mg/dL) were randomized 2:1 to Terlivaz (n=199) or placebo (n=101). Median age 55 years, 60% male, 90% White. Baseline mean SCr 3.5 mg/dL, mean MELD 33. Primary endpoint: Verified HRS Reversal (two consecutive SCr ≤1.5 mg/dL at least 2 hours apart while on treatment by Day 14 or discharge, alive and without renal replacement therapy for ≥10 days after reversal). Results: 29.1% Terlivaz vs 15.8% placebo (p=0.012).
Contraindicated in patients with hypoxia. Do not use in patients experiencing hypoxia until resolved. Assess ACLF Grade and volume status before initiating. Monitor oxygen saturation continuously during treatment.
Terlivaz is the first FDA-approved therapy for hepatorenal syndrome with rapid reduction in kidney function. It should be used in appropriate candidates with SCr ≤5 mg/dL. The label does not provide comparative efficacy data against other vasopressors or liver transplant.
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