Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia.For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks. Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients.In patients with ongoing coronary, peripheral, or mesenteric ischemia.In patients experiencing hypoxia or worsening respiratory symptoms.Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90%. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 Assess oxygenation saturation (e.g., SpO 2) before initiating TERLIVAZ. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. TERLIVAZ may cause serious or fatal respiratory failure.WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE 2 Furthermore, the results of the retrospective analysis of the Phase III CONFIRM trial, presented by Fredric Gordon, Tufts Medical Center, Boston, Mass., offer perspective into terlipressin's therapeutic potential to reduce renal replacement therapy (RRT) requirements post-liver transplant in HRS-1 patients with acute-on-chronic liver failure (ACLF) grade 0-2 and serum creatinine (SCr) levels 5 mg/dL are unlikely to experience benefit. The findings from the pooled analysis of the Phase III REVERSE and CONFIRM studies, presented by Adnan Said, University of Wisconsin Hospital and Clinics, Madison, Wis., provide insight into clinical outcomes following terlipressin therapy compared with placebo in patients with HRS type 1 (HRS-1) and systemic inflammatory response syndrome (SIRS).
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