The FDA announced on Sept. 14 the approval of terlipressin injection (Terlivaz) to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. This is the first FDA-approved medication for the condition.
Effectiveness, assessed by the percentage of patients who had kidney function improvement, was shown in a double-blind, placebo-controlled study. Among those who received the drug, 29% had kidney function improvement compared to 16% of those in the placebo group.
Patients with serum creatinine levels of 5 mg/dL or greater should not take the drug because they are unlikely to benefit. The drug increases the risk of serious or fatal respiratory failure, and those with low blood oxygen levels should not start the medication, the FDA said. During treatment, patients should be monitored for breathing problems with a pulse oximeter.
The most common side effects include abdominal pain, nausea, diarrhea, respiratory failure, and dyspnea. Side effects may prevent patients from receiving a liver transplant. The drug can also cause fetal harm and ischemic events that may require pausing or stopping treatment.