테를리프레신아세트산염

is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Limitation of Use Patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit. TERLIVAZ is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. ( 1 ) Limitation of Use Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit. ( 1 )

is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms. TERLIVAZ is contraindicated in patients with ongoing coronary, peripheral, or mesenteric ischemia. TERLIVAZ is contraindicated: In patients experiencing hypoxia or worsening respiratory symptoms. ( 4 ) In patients with ongoing coronary, peripheral, or mesenteric ischemia. ( 4 )

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 TERLIVAZ therapy as appropriate. ( 5.1 ) Ineligibility for Liver Transplant : TERLIVAZ-related adverse reactions may make a patient ineligible for liver transplantation, if listed. ( 5.2 ) Ischemic Events : TERLIVAZ is a vasoconstrictor and can cause ischemic events (cardiac, peripheral, or mesenteric) that may require dose interruption or discontinuation. ( 5.3 ) Embryo-Fetal Toxicity : TERLIVAZ may cause fetal harm when used during pregnancy. Advise females of reproductive potential of the potential hazard to the fetus. ( 5.4 , 8.1 ) 5.1 Serious or Fatal Respiratory Failure In the primary clinical trial [see Clinical Studies (14) ] , serious or fatal respiratory failure occurred in 14% of patients treated with TERLIVAZ compared to 5% of patients on placebo. Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients [see Contraindications (4) ] . 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. Patients with fluid overload may be at increased risk of respiratory failure. Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and judicious …

8.1 Pregnancy Risk Summary Based on findings from the published literature and on its mechanism of action, TERLIVAZ may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . In small, published studies, administration of a single intravenous dose of terlipressin to pregnant women during the first trimester induced uterine contractions and endometrial ischemia. The limited published data are not sufficient to determine a drug-associated risk for major birth defects or miscarriage . If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the …