Finished product reference

Terlipressin Acetate

Injection, Solution · Parenteral · 200 µg/1mL · 5 mL

List code
53221
Pharmacologic class
Vasopressin Receptor Agonist
Boxed warning

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., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve.

What it is and how it works

Mechanism of Action Terlipressin is a synthetic vasopressin analogue with twice the selectivity for vasopressin V 1 receptors versus V 2 receptors. Terlipressin acts as both a prodrug for lysine-vasopressin, as well as having pharmacologic activity on its own. Terlipressin is thought to increase renal blood flow in patients with hepatorenal syndrome by reducing portal hypertension and blood circulation in portal vessels and increasing effective arterial volume and mean arterial pressure (MAP).

Mechanism class: Vasopressin Receptor Agonists

Indications

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. Limitation of Use Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.

Dosage and administration (summary)

Prior to initial dosing, assess patients for ACLF Grade 3 and obtain patient baseline oxygenation level. Monitor patient oxygen saturation with pulse oximetry. Recommended Dosage Regimen: Days 1 to 3 administer TERLIVAZ 0.85 mg (1 vial) intravenously every 6 hours. Day 4: Assess serum creatinine (SCr) versus baseline. If SCr has decreased by at least 30% from baseline, continue TERLIVAZ 0.85 mg (1 vial) intravenously every 6 hours. If SCr has decreased by less than 30% from baseline, dose may be increased to TERLIVAZ 1.7 mg (2 vials) intravenously every 6 hours. If SCr is at or above baseline value, discontinue TERLIVAZ.

Contraindications

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. 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 TERLIVAZ therapy as appropriate. Ineligibility for Liver Transplant : TERLIVAZ-related adverse reactions may make a patient ineligible for liver transplantation, if listed. Ischemic Events : TERLIVAZ is a vasoconstrictor and can cause ischemic events (cardiac, peripheral, or mesenteric) that may require dose interruption or discontinuation.

Pregnancy

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 . In small, published studies, administration of a single intravenous dose of terlipressin to pregnant women during the first trimester induced uterine contractions and endometria…

Storage and supply

Store TERLIVAZ vials in the carton under refrigerated conditions at 2°C to 8°C (36°F to 46°F). Store in the original carton to protect from light prior to reconstitution.

Source: Terlipressin (Terlivaz) — US FDA prescribing information, 2026-06-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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