Authors

  1. Aschenbrenner, Diane S. MS, RN

Abstract

* Terlipressin (Terlivaz) has been approved as the first drug to treat hepatorenal syndrome.

 

* The drug may cause serious or fatal respiratory failure. Nurses should confirm that patients have an oxygen saturation level by pulse oximetry of at least 90% in order to start therapy.

 

 

Article Content

The Food and Drug Administration has approved terlipressin (Terlivaz) as the first drug to treat hepatorenal syndrome, the end stage of deteriorating kidney function brought about by increasingly severe hepatic injury. With this syndrome, liver failure reduces blood flow to the kidneys. The loss of kidney function can come on suddenly even when there has been no previous kidney disease. A liver transplant is usually required.

 

Terlipressin is a vasopressin receptor agonist selective for vasopressin V1 receptors. It also acts as a prodrug for lysine vasopressin. Terlipressin is believed to increase renal blood flow by reducing portal hypertension and blood circulation in portal vessels. It also induces a decrease in heart rate and an increase in diastolic, systolic, and mean arterial pressure. These changes are evident within five minutes of dosing and last at least six hours. Terlipressin is given via intravenous infusion.

 

Terlipressin's efficacy was assessed in a multicenter, double-blind, 2:1 randomized, placebo-controlled study of 300 patients. To be included in the primary efficacy end point analysis, patients had to be alive and without intervening renal replacement therapy (dialysis, for example) at least 10 days after achieving verified hepatorenal syndrome reversal, defined as two consecutive serum creatinine values less than or equal to 1.5 mg/dL obtained at least two hours apart by day 14 of treatment or discharge. A greater proportion of patients receiving terlipressin achieved a verified hepatorenal syndrome reversal compared with those receiving placebo (29.1% versus 15.8%).

 

Terlipressin carries a boxed warning that it may cause serious or fatal respiratory failure. Other warnings include the risk of ischemic events from its vasoconstrictive effect. These adverse effects may make a patient ineligible for a liver transplant. The most common adverse effects include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. The drug is also known to produce embryo-fetal toxicity.

 

Nurses should confirm that patients have adequate oxygenation, with an oxygen saturation level by pulse oximetry (SpO2) of at least 90%, prior to administering terlipressin because of the risk of the drug causing respiratory failure. Patients with volume overload or the presence of acute on chronic liver failure with three or more organs failing are at higher risk for respiratory failure. Terlipressin should be discontinued if the SpO2 level drops below the 90% threshold. Other regular clinical assessment of respiratory function should also be performed. Nurses should also monitor the patient for intravascular volume overload and provide treatment if it develops.

 

Nurses must assess for ongoing coronary, peripheral, or mesenteric ischemia prior to starting terlipressin, as these conditions are contraindications for its use. Patients with serum creatinine levels equal to or greater than 5 mg/dL should not be given terlipressin, as they are not likely to benefit from the treatment.

 

For complete prescribing information for terlipressin, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022231s000lbl.pdf.