Miscellaneous urogenital disorders:

Indications for: TERLIVAZ

To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

Limitations of Use:

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

Adult Dosage:

Give by slow IV bolus inj over 2mins. Initially 0.85mg (1 vial) every 6hrs on Days 1 to 3. On Day 4: if SCr decreased by ≥30% from baseline, continue 0.85mg (1 vial) every 6hrs; if decreased by <30% from baseline, increase to 1.7mg (2 vials) every 6hrs. For both, continue until 24hrs after patient achieves a second consecutive SCr value of ≤1.5mg/dL at least 2hrs apart or for a max of 14 days. If SCr is at or above baseline value, discontinue therapy.

Children Dosage:

Not established.

TERLIVAZ Contraindications:

Patients experiencing hypoxia or worsening respiratory symptoms. Patients with ongoing coronary, peripheral, or mesenteric ischemia.

Boxed Warning:

Serious or fatal respiratory failure.

TERLIVAZ Warnings/Precautions:

Risk of serious respiratory failure (may be fatal). Obtain baseline oxygen saturation; do not initiate in hypoxic patients. Assess Acute-on-Chronic Liver Failure (ACLF), volume status, and last available serum creatinine (SCr) prior to initiation. Monitor for changes in respiratory status; discontinue if hypoxia or increased respiratory symptoms occur. Increased risk of respiratory failure in those with fluid overload. Manage volume overload by reducing or discontinuing albumin and/or other fluids and use of diuretics. Temporarily interrupt, reduce, or discontinue therapy until volume status improves. Patients with ACLF Grade 3, a history of severe cardiovascular conditions, cerebrovascular and ischemic disease: avoid. Discontinue if signs/symptoms of ischemic adverse reactions occur. Ineligibility for liver transplantation possible due to terlipressin-related adverse reactions. Embryo-fetal toxicity. Pregnancy. Nursing mothers.

TERLIVAZ Classification:

Vasopressin (synthetic).

Adverse Reactions:

Abdominal pain, nausea, respiratory failure, diarrhea, dyspnea; ischemic events.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1