METHOD OF TREATING PATIENTS WITH HEPATORENAL SYNDROME TYPE 1
The principles and embodiments of the present disclosure relate to methods for using terlipressin to treat a patient having impaired renal function associated with liver disease. A method of treating an adult patient with type 1 hepatorenal syndrome (HRS-1) may include administering a dose of terlipressin to the patient if the patient has a baseline model end stage liver disease (MELD) score<35, the patient has a serum creatinine (SCr)<5 mg/dl, the patient has an ACLF Grade<3, or a combination thereof and/or monitoring the patient's oxygenation level (SpO 2 ) before and during treatment with the terlipressin.
1 . A method of treating an adult patient aged 18 years or older with hepatorenal syndrome comprising:
obtaining a baseline oxygenation level (SpO 2 ) from the patient via pulse oximetry;
administering a dose of a composition comprising terlipressin to the patient by intravenous (IV) injection if the patient's SpO 2 at baseline is greater than 90%;
monitoring the patient's SpO 2 during administration of the composition at least 3 times a day; and
discontinuing administration or reducing the dose of the composition if the patient's SpO 2 during treatment is less than 90%.
2 . The method of claim 1 , wherein the patient's SpO 2 is monitored continuously during administration of the terlipressin.
3 . The method of claim 1 , further comprising determining the patient's acute-on-chronic liver failure (ACLF) Grade, wherein the composition is administered to the patient if the ACLF Grade is <3.
4 . The method of claim 3 , further comprising acquiring a baseline model end stage liver disease (MELD) score of the patient, wherein the composition is administered to the patient if the baseline MELD score is <35.
5 . The method of claim 1 , further comprising acquiring a baseline SCr level in the patient, wherein the composition is administered to the patient if the baseline SCr level is <5 mg/dl.
6 . The method of claim 5 , wherein the dose is not administered if the baseline SCr level is ≥5 mg/dl.
7 . The method of claim 5 , further comprising:
measuring the SCr level in the patient during administration of the composition; and
continuing administration of the composition if the patient experiences greater than 20% improvement in serum creatinine.
8 . The method of claim 7 , wherein the administration is continued if the patient experiences greater than 30% improvement in serum creatinine.
9 . The method of claim 8 , further comprising continuing administration until 24 hours after two consecutive SCr levels of 1.5 mg/dL at least 2 hours apart for a maximum of 14 days.
10 . The method of claim 8 , further comprising increasing the dose of the composition if the SCr level has decreased by less than 30% after 3 days of administration.
11 . The method of claim 8 , further comprising discontinuing administration if the SCr level is at or above the baseline SCr level after 3 days of administration.
12 . The method of claim 1 , wherein the patient is only treated if the patient belongs to a patient population that has median waiting time from listing to transplant of 5.6 months or greater.
13 . The method of claim 1 , wherein the patient is excluded from treatment if the patient belongs to a patient population that has median waiting time from listing to transplant of 0.23 months or less.
14 . The method of claim 1 , wherein the composition is administered every 6 hours by IV bolus injection over 2 minutes.