Terlivaz

TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

• Prior to initial dosing, assess patients for ACLF Grade 3 and obtain patient baseline oxygenation level. Monitor patient oxygen saturation with pulse oximetry. (
  2.1 Important Considerations Prior to Initiating and During Therapy

  Obtain baseline oxygen saturation (SpO₂) prior to administering the first dose of TERLIVAZ. During treatment, monitor patient oxygen saturation using continuous pulse oximetry. Do not use TERLIVAZ treatment in patients experiencing hypoxia until hypoxia resolves

  [see Contraindications (4),

  and

  Warnings and Precautions (5.1)]

  .

  Assess Acute-on-Chronic Liver Failure (ACLF) Grade and volume status before initiating TERLIVAZ

  [see Warnings and Precautions (5.1)

  and

  References (15)].
  )
• Recommended Dosage Regimen: (
  2.2 Recommended Dosage

  Record last available serum creatinine (SCr) value prior to initiating treatment (baseline SCr). The recommended starting dosage is TERLIVAZ 0.85 mg every 6 hours by slow intravenous bolus injection (over 2 minutes) on Days 1 through 3. Adjust the dose on Day 4 based on changes from baseline SCr using the dosing chart (Figure 1).

  Figure 1: Dosing Chart

  

  ^aBaseline SCr is the last available serum creatinine before initiating treatment.

  Figure 1

  )
  • 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.
  • Continue TERLIVAZ until 24 hours after two consecutive SCr ≤1.5 mg/dL values at least 2 hours apart or a maximum of 14 days.
  See full prescribing information for instructions on preparation and administration (
  2.3 Preparation and Administration

  Reconstitute each vial with 5 mL of 0.9% Sodium Chloride Injection to prepare a 0.85 mg/5 mL solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Administer TERLIVAZ through a peripheral or central line. A dedicated central line is not required. Flush the line after TERLIVAZ administration.

  If not administered immediately, store TERLIVAZ at 2°C to 8°C (36°F to 46°F) for up to 48 hours. Do not freeze. The reconstituted solution does not need protection from light.
  ). Flush IV line after administration.

For injection: TERLIVAZ 0.85 mg is a white to off-white lyophilized powder in a single-dose vial for reconstitution.

Based on findings from the published literature and on its mechanism of action, TERLIVAZ may cause fetal harm when administered to a pregnant woman

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.