IN CONFIRM TRIAL
TERLIVAZ® was used on the floor and associated with a reduced ICU LOS1,2,a
TERLIVAZ can be used on the floor3:
- The full prescribing information does not include a requirement for cardiac monitoringb
- TERLIVAZ can be administered through a peripheral IV line; a dedicated central line is not required
Patient Treatment Location1,c
POST HOC ANALYSIS
In those admitted to the ICU, terlipressin was associated with a 50% reduction in the ICU LOS2,d:
ICU, intensive care unit; IV, intravenous; LOS, length of stay.
aPatient health outcomes were independent of these metrics, and results may have varied.
bYou are advised to use your own medical judgment in making patient-specific treatment decisions.
cThe proportion of patients treated in the ICU was balanced between TERLIVAZ and placebo arms.
dThis post hoc analysis was done to show ICU length of stay in the ITT population that was admitted to the ICU. The analysis was retrospective and based on a much smaller population than the full randomized population in the CONFIRM trial.
Proper patient management is importantLEARN ABOUT CLINICAL MANAGEMENT WITH TERLIVAZ
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%.
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.
- The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
- Data on File. Ref-05035. Mallinckrodt Pharmaceuticals.
- Data on File. Ref-05871. Mallinckrodt Pharmaceuticals.
- TERLIVAZ® (terlipressin). Prescribing Information. Bridgewater, NJ: Mallinckrodt Hospital Products Inc.