Usual Adult Dose for Hepatorenal Syndrome

Initial dose:
Day 1 to 3:
0.85 mg IV bolus injection every 6 hours over a period of two minutes

Day 4:

• If serum creatinine (SCr) has decreased by 30% or more from baseline:

0.85 mg IV bolus injection every 6 hours over a period of two minutes

• If SCr has decreased by less than 30% from baseline:

1.7 mg IV bolus injection every 6 hours over a period of two minutes

Duration of therapy: Until 24h after patient achieves a second consecutive SCr value of less than or equal to 1.5 mg/dL at least 2 hours apart or for a maximum of 14 days

Comments:

• Monitor oxygen saturation using continuous pulse oximetry.
• Obtain baseline oxygen saturation prior to starting therapy.
• Record the serum creatinine (baseline SCr) value prior to starting treatment.
• Assess serum creatinine (SCr) versus baseline prior to starting day 4 treatment.
• If SCr is at or above the baseline value after the third day of treatment, stop therapy with this drug.

Use: To improve kidney function in adults with hepatorenal syndrome

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

No adjustment recommended.

Precautions

US BOXED WARNING:
SERIOUS OR FATAL RESPIRATORY FAILURE

• Serious or fatal respiratory failure may occur with the use of this drug.
• Patients with volume overload or acute-on-chronic liver failure (ACLF) grade 3 are more likely to have respiratory failure.

Recommendation

• Assess oxygenation saturation (e.g., SpO2) prior to starting treatment with this drug.
• Do not administer this drug to hypoxic patients (e.g., SpO2 less than 90%) until their oxygen levels improve.
• Monitor for hypoxia using continuous pulse oximetry during treatment and stop therapy with this drug if SpO2 decreases below 90%.

CONTRAINDICATIONS:

• Coronary, peripheral or mesenteric ischemia.
• Hypoxia or worsening respiratory symptoms.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer this drug through a peripheral or central line.
• Determine acute or chronic liver failure (ACLF) grade and volume status before beginning treatment with this drug.
• Treatment with this drug is not recommended in patients experiencing hypoxia until the hypoxia resolves.
• Visually inspect the drug solution for the presence of particulate matter and discoloration prior to administration.

Storage requirements:

• Refrigerate unopened vial at 2C to 8C (36F to 46F) in original carton to protect from light.
• Store reconstituted solution at 2C to 8 C (36F to 46 F) to use within 48 hours, if not used at once.
• Do not freeze.

Reconstitution technique:

• Reconstitute each vial with 5 mL of 0.9% Sodium Chloride Injection to prepare a 0.85 mg/5 mL solution.

General:

• In the event of an overdose, monitor vital signs, electrolytes, and potential ischemic events and administer symptomatic treatment.
• Patients with serum creatinine levels greater than 5 mg/dL are unlikely to benefit from this drug.
• Baseline SCr is the last available serum creatinine before starting treatment.

Monitoring:
Respiratory: Respiratory status (Oxygen saturation, Hypoxia)
Renal: Serum Creatinine
Metabolism: Hyponatremia, hypokalemia, hypomagnesemia, electrolyte disturbances

Patient advice:

• Notify your health care provider of a known or suspected pregnancy.
• This drug has the potential to cause fetal harm.