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 ) via pulse oximetry;
administering a dose of terlipressin to the adult patient aged 18 years or older by intravenous (IV) injection if the patient: (a) is not experiencing hypoxia; and, (b) has a ACLF Grade <3; and
monitoring the patient's SpO 2 during treatment with the terlipressin.
2 . The method of claim 1 , wherein the administering a dose of terlipressin is every 6 hours.
3 . The method of claim 1 , wherein the monitoring of patient's SpO 2 comprises continuous pulse oximetry.
4 . The method of claim 1 , wherein the adult patient has a serum creatinine (SCr) ≥2.25 mg/dL.
5 . The method of claim 1 , wherein the adult patient has a serum creatinine (SCr) doubling to at least 2.25 mg/dL within 14 days.
6 . The method of claim 1 , wherein the adult patient aged 18 years or older patient's oxygen saturation is monitored for hypoxia.
7 . The method of claim 1 , further comprising discontinuing administration or reducing the dose of terlipressin if hypoxia is detected.
8 . The method of claim 1 , wherein the patient's SpO 2 is monitored at least 3 times a day during administration of terlipressin.
9 . The method of claim 1 , wherein the dose of terlipressin is not administered if the patient's SpO 2 at baseline is less than 90% and/or the patient's FiO 2 is greater than 0.36.
10 . The method of claim 1 , wherein the administration of terlipressin is discontinued if the patient's SpO 2 during treatment is less than 90% and/or the patient's FiO 2 is greater than 0.36.
11 . A method of treating an adult patient aged 18 years or older with hepatorenal syndrome comprising:
obtaining a baseline oxygenation level (SpO 2 ) via pulse oximetry;
administering a dose of terlipressin to the adult patient aged 18 years or older by intravenous (IV) injection if (a) the patient has a ACLF Grade <3); and (b) the patient does not have SpO 2 is less than 90%; and
monitoring the patient's SpO 2 with continuous pulse oximetry during treatment with the terlipressin.
12 . The method of claim 11 , wherein administering is every 6 hours.
13 . The method of claim 11 , wherein the adult patient has a serum creatinine (SCr) ≥2.25 mg/dL.
14 . The method of claim 11 , wherein the adult patient has a serum creatinine (SCr) doubling to at least 2.25 mg/dl within 14 days.
15 . A method of treating an adult patient aged 18 years or older with hepatorenal syndrome comprising:
obtaining a baseline oxygenation level (SpO 2 ) via pulse oximetry;
measuring a baseline serum creatinine (SCr) level in the patient;
administering a dose of terlipressin to the adult patient aged 18 years or older by intravenous (IV) injection if the patient: (a) is not experiencing hypoxia; and, (b) the baseline SCr level <5 mg/dl; and
monitoring the patient's SpO 2 during treatment with the terlipressin.
16 . The method of claim 15 , wherein the administering a dose of terlipressin is every 6 hours.
17 . The method of claim 15 , wherein the monitoring of patient's SpO 2 comprises continuous pulse oximetry.
18 . The method of claim 15 , wherein the adult patient aged 18 years or older patient's oxygen saturation is monitored for hypoxia.
19 . The method of claim 15 , further comprising discontinuing administration or reducing the dose of terlipressin if hypoxia is detected.
20 . The method of claim 15 , wherein the patient's SpO 2 is monitored at least 3 times a day during administration of terlipressin.
21 . The method of claim 15 , wherein the dose of terlipressin is not administered if the patient's SpO 2 at baseline is less than 90% and/or the patient's FiO 2 is greater than 0.36.
22 . The method of claim 15 , wherein the administration of terlipressin is discontinued if the patient's SpO 2 during treatment is less than 90% and/or the patient's FiO 2 is greater than 0.36.