Table 3.
Terlipressin US Package Insert Recommendations46
Prescribing parameter | Description |
---|---|
Boxed warning |
Warning: serious or fatal respiratory failure. Terlipressin may cause serious or fatal respiratory failure. Patients with volume overload or with ACLF grade 3a are at increased risk. Assess oxygen saturation (eg, Spo2) before initiating terlipressin. Do not initiate terlipressin in patients experiencing hypoxia (eg, Spo2 of <90%) until oxygenation improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue terlipressin if Spo2 decreases below 90%. |
Indications | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function |
Contraindications | In patients experiencing hypoxia or worsening respiratory symptoms and in patients with ongoing coronary, peripheral, or mesenteric ischemia |
Warnings and precautions | Serious or fatal respiratory failure. Monitor patients for changes in respiratory status using pulse oximetry and regular clinical assessments. Actively manage intravascular volume overload and adjust terlipressin therapy as appropriate. |
Ineligibility for liver transplantation. Terlipressin-related adverse reactions may make a patient ineligible for liver transplantation, if listed. | |
Ischemic events. Terlipressin is a vasoconstrictor and can cause ischemic events (cardiac, peripheral, or mesenteric) that may require dose interruption or discontinuation. | |
Embryo-fetal toxicity. Terlipressin may cause fetal harm when used during pregnancy. Advise females of reproductive potential of the potential hazard to the fetus. | |
Adverse reactions | The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. |
Abbreviation: ACLF, acute-on-chronic liver failure.
aFor more information on acute-on-chronic liver failure and access to an online calculator, see reference 47.