TERLIVAZ dosing algorithm1
aDo not use TERLIVAZ in patients experiencing hypoxia (eg, SpO2 <90%) until hypoxia resolves.1
bOne vial of TERLIVAZ is equivalent to 0.85 mg of terlipressin or 1 mg of terlipressin acetate.1
cBaseline SCr is the last available SCr before initiating treatment.1
Stock 20 vials of TERLIVAZ per patient to enable treatment through day 43
Reconstitution1
- Reconstitute with 5 mL 0.9% sodium chloride injection
- Reconstituted solution does not need to be protected from light
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Considerations to manage the risk of respiratory failure
Monitor all patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments.1
In the phase 3 pivotal trial, when respiratory failure occurred with TERLIVAZ, it generally did not occur immediately following drug initiation.3 The median onset was 5 days, the mean onset was 7.5 days, and the range was 1 to 67 days.3
See how to use TERLIVAZ
Learn more about practical considerations for treating appropriate patients with TERLIVAZ
ACLF, acute-on-chronic liver failure; HRS, hepatorenal syndrome; IV, intravenous; SCr, serum creatinine; SpO2, oxygen saturation.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
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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.
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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%.
INDICATION AND LIMITATION OF USE
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
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Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.
CONTRAINDICATIONS
TERLIVAZ is contraindicated:
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In patients experiencing hypoxia or worsening respiratory symptoms.
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In patients with ongoing coronary, peripheral, or mesenteric ischemia.
Warnings and Precautions
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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.
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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.
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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.
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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.
Adverse Reactions
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The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
Please see full Prescribing Information, including Boxed Warning.
References: 1. TERLIVAZ® (terlipressin). Prescribing Information. Bridgewater, NJ: Mallinckrodt Hospital Products Inc. 2. Biggins SW, Angeli P, Garcia-Tsao G, et al. Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: 2021 practice guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021;74(2):1014-1048. doi:10.1002/hep.31884 3. Data on File – Ref-05035. Mallinckrodt Pharmaceuticals.