Clinical Experience

In Confirm

TERLIVAZ administration was more common on the floor^a

Patient treatment location^1,2,b

84.4% of patients were treated on the floor compared to 15.6% in the ICU

Patients treated with TERLIVAZ

Were treated for a mean duration of 6.2 days³
- 8% of patients received treatment for >12 days³
Received a mean total number of 20.3 doses³
- 28.6% of patients received a dose increase³

Administration considerations

The full Prescribing Information does not include a requirement for cardiac monitoring^4,c
TERLIVAZ can be administered through a peripheral IV line; a dedicated central line is not required⁴

^aPatient health outcomes were independent of these metrics, and results may have varied.

^bThe proportion of patients treated in the ICU was balanced between TERLIVAZ and placebo arms.¹

^cYou are advised to use your own medical judgment in making patient-specific treatment decisions.

In Confirm

When administered in the ICU, TERLIVAZ use was associated with a reduced length of stay^a

Patients treated with TERLIVAZ in the ICU had a significantly greater improvement in renal function at EOT compared with placebo¹:

Mean^b change in SCr^c: -0.7 vs +0.2 mg/dL; P=.001¹

Chart showing TERLIVAZ was linked to a 50% reduction in ICU LOS

^aPatient health outcomes were independent of these metrics, and results may have varied.

^bLS mean.

^cBased on repeated-measures analysis of covariance with factors of “study,” “treatment,” and “day.” Significance was maintained when also accounting for the interaction between treatment and day of patient admission to the ICU.¹

^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.¹

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%.

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.

CONTRAINDICATIONS

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.

Adverse Reactions

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. Karvellas CJ, Subramanian R, Olson JC, Jamil K. Role of terlipressin in patients with hepatorenal syndrome-acute kidney injury admitted to the ICU: a substudy of the CONFIRM trial. Crit Care Explor. 2023;5(4):e0890. doi:10.1097/CCE.0000000000000890 2. Huang X, Bindra J, Chopra I, Niewoehner J, Wan GJ. Treatment-related cost analysis of terlipressin for adults with hepatorenal syndrome with rapid reduction in kidney function. Adv Ther. 2023;40(12):5432-5446. doi:10.1007/s12325-023-02674-z 3. Data on File – Ref-05035. Mallinckrodt Pharmaceuticals. 4. TERLIVAZ® (terlipressin). Prescribing Information. Bridgewater, NJ: Mallinckrodt Hospital Products Inc.

TERLIVAZ administration was more common on the floora

When administered in the ICU, TERLIVAZ use was associated with a reduced length of staya