TERLIVAZ® was associated with an improvement in mean length of ICU stay, RRT incidence, and discharge timing metrics1-4,a
of patients were treated on the floor,
avoiding ICU admission. Of those admitted to ICU,
TERLIVAZ patients spent 50% less time in the ICU1
Mean ICU length of stay2
TERLIVAZ = 6.4 days
Placebo = 13.2 days
This post hoc analysis was done to show ICU length of stay in the ITT population that was admitted to the ICU.c
TERLIVAZ was associated
with less RRT at
Day 14 and Day 303,c
Day 14: 44% less RRT with
Day 30: 39% less RRT with
This post hoc analysis was done to show RRT incidence in patients in the ITT population who were alive through Day 90.c
increase in the number of
patients discharged by Day 144,d
Discharge by Day 14*
TERLIVAZ = 39.2%
Placebo = 27.7%
*Reason for discharge varied among patients and was not necessarily indicative of patient outcomes.
aPatient health outcomes were independent of these metrics, and results may have varied.
bPlease note, this is an approximate value—the exact value was 84.4% on the floor.
cThe analysis was retrospective and based on a much smaller population than the full randomized population in the CONFIRM trial.
dCONFIRM ITT population.
ICU, intensive care unit; ITT, intent-to-treat; RRT, renal replacement therapy.
TERLIVAZ recommended dosing and management regimenLEARN MORE ABOUT DOSING & ADMINISTRATION
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.
- Data on File. Ref-05035. Mallinckrodt Pharmaceuticals.
- Data on File. Ref-05871. Mallinckrodt Pharmaceuticals.
- Data on File. Ref-05872. Mallinckrodt Pharmaceuticals.
- Data on File. Ref-05873. Mallinckrodt Pharmaceuticals.