TERLIPRESSIN INJ,PWDR

Clinical Criteria Summary

Improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
Limitation of Use: Patients with a serum creatinine (SCr) > 5 mg/dL are unlikely to experience benefit.

Assess oxygen saturation (SpO2), Acute-on-Chronic Liver Failure (ACLF) Grade, and volume status prior to initiating therapy.
Record the last available SCr value prior to initiating treatment.
Preferred patient profile for benefit: Patients who do NOT have an ACLF Grade of 3, do NOT have an SCr ≥ 5 mg/dL, and are NOT listed for liver transplant with a MELD score ≥ 35.

Initial Dose (Days 1–3): 0.85 mg every 6 hours by slow intravenous bolus injection (over 2 minutes).
Day 4 Dose Adjustment: Assess SCr vs baseline.
If SCr decreased by ≥ 30% from baseline: Continue 0.85 mg every 6 hours.
If SCr decreased by < 30% from baseline: Increase to 1.7 mg every 6 hours.
If SCr is at or above baseline value: Discontinue terlipressin.
Duration: Continue until 24 hours after achieving a second consecutive SCr value of ≤ 1.5 mg/dL (at least 2 hours apart) or for a maximum of 14 days.
Administration route: Can be administered through a peripheral or central line; a dedicated central line is not required.

Boxed Warning: Serious or fatal respiratory failure. Patients with ACLF Grade 3 (or volume overload) are at increased risk.
Warning/Precaution: Benefit-risk profile may not be favorable in patients at high priority for liver transplant, such as those with MELD scores ≥ 35.
Mitigation Strategy: Exclude patients meeting any of the following criteria: ACLF Grade 3, SCr ≥ 5 mg/dL, or listed for liver transplant with a MELD score ≥ 35.

Contraindications: Hypoxia or worsening respiratory symptoms; ongoing coronary, peripheral, or mesenteric ischemia.
Additional Warnings/Precautions: Terlipressin-related adverse reactions may make a patient ineligible for liver transplantation if patient is listed for liver transplant. Embryofetal toxicity and ischemic events are also noted.

Hospitalized inpatient status required
Documented initial nonresponse to volume expansion (e.g., albumin)
Documented diagnosis of hepatorenal syndrome with acute kidney injury made by a VA expert in GI/hepatology, nephrology, intensive care, or liver transplant surgery

Acute-on-chronic liver failure grade 3 (any 3 of: bilirubin > 12 mg/dL, SCr ≥ 3.5 or renal replacement, encephalopathy grade 3–4, INR ≥ 2.5, vasopressor for MAP < 70 mm Hg; or PaO2/FiO2 ratio ≤ 200, SpO2/FiO2 ratio ≤ 214 or intubated)
SCr > 5 mg/dL
Listed for liver transplant with MELD ≥ 35
Hypoxia (e.g., SpO2 < 90%) or worsening respiratory symptoms (use permitted once oxygenation improves)
Ongoing signs or symptoms of coronary, peripheral, or mesenteric ischemia
History of severe cardiovascular conditions, cerebrovascular and ischemic disease

Diagnosis may be a potential or working diagnosis of HRS-AKI; clinical latitude is allowed
Albumin volume challenge recommended for diagnostic workup to distinguish volume-responsive from volume-unresponsive acute renal failure/AKI
Typical presentation includes ascites, hyponatremia, and low mean arterial pressure (MAP < 70)
Use for uncertain diagnosis or as a "therapeutic trial" is not recommended

Orders must be processed as urgent requests and dispensed within 3 hours
Inpatient administration required; outpatient use adjudicated case-by-case (e.g., bridge to liver transplant)
May be administered via peripheral line in non-ICU settings
Concomitant albumin is NOT a requirement for use
If concomitant albumin is used, doses preferably should not exceed 50 g/d

Hold albumin if evidence of volume overload, hypoxemia, or serum albumin levels >3.5 g/dL
Terlipressin should be discontinued if no response by Day 4 (defined as SCr at or above baseline value)
Maximum therapy duration is 14 days