Serious or fatal respiratory failure
TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with ACLF Grade 3 are at increased risk.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
During treatment, monitor patient oxygen saturation using continuous pulse oximetry.
PATIENT CARE PLAN
TERLIVAZ is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms.
TERLIVAZ is contraindicated in patients with ongoing coronary, peripheral or mesenteric ischemia.
Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ.
Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 <90>
Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and judicious use of diuretics.
Patient Counseling Information
Inform female patients of reproductive potential that TERLIVAZ may cause fetal harm and to inform their prescriber of a known or suspected pregnancy