Suggested clinical management of patients receiving TERLIVAZ®1*
Prior to initiation1
- Diagnose HRS with rapid reduction in kidney function
- Assess ACLF grade, baseline SpO2, and volume status
- Acquire baseline SCr
- Implement continuous pulse oximetry
- Assess response at Day 4 using SCr
- Adjust dose based on Prescribing Information
- Manage intravascular volume overload by reducing or discontinuing administration of albumin and/or other fluids and judiciously use diuretics. Temporarily interrupt, reduce, or discontinue terlipressin treatment until patient volume status improves
- No response at Day 4
- Hypoxia detected (SpO2 <90%)
- Achieve 2 consecutive SCr values of ≤1.5 mg/dL at least 2 hours apart
- Complete 14 days of treatment
ACLF, acute-on-chronic liver failure; HRS, hepatorenal syndrome; SCr, serum creatinine; SpO2, oxygen saturation.
*Terlipressin was used in combination with albumin for plasma volume expansion in the CONFIRM trial as clinically indicated.
†This metric is independent of patient health outcomes, which varied among subjects.
TERLIVAZ patients spent 50% less time in the ICU as compared to placebo2†LEARN MORE ABOUT HOSPITAL OUTCOMES
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.
Please see full Prescribing Information, including Boxed Warning.
- TERLIVAZ® (terlipressin). Prescribing Information. Bedminster, NJ: Mallinckrodt Hospital Products Inc.
- Data on File. Ref-05871. Mallinckrodt Pharmaceuticals.