Methods of treating disease with Terlipressin
Provided are methods of treating a disease with arginine vasopressin or an analogue thereof that reduce the risk of hyponatremia. Specifically, the invention relates to the novel observation that subjects receiving co-administration of terlipressin and gabapentin or pregabalin have a high incidence of severe hyponatremia. The methods of the invention include either excluding subjects receiving gabapentin, gabapentin analogues, gabapentinoids, and other drugs known to cause hyponatremia from treatment with arginine vasopressin or analogues thereof; or reducing the subject's dose of gabapentin, gabapentin analogues, gabapentinoids, and other drugs known to cause hyponatremia prior to administration with arginine vasopressin or analogues thereof; or discontinuing administration of gabapentin, gabapentin analogues, gabapentinoids, and other drugs known to cause hyponatremia during the course of administration of arginine vasopressin or analogues thereof or reducing the dose of the arginine vasopressin or analogues thereof.
1 . A method of administering terlipressin or a salt thereof to a subject receiving one or more drugs selected from the group consisting of gabapentin, gabapentin analogues, and gabapentinoids, the method comprising—reducing the subject's dose of the one or more drugs and
administering the terlipressin or a salt thereof to the subject.
2 . The method of claim 1 , wherein the one or more drugs is selected from gabapentin or pregabalin.
3 . The method of claim 1 , wherein administering the terlipressin or a salt thereof comprises continuous infusion, IV injection bolus, IV injection slow bolus, subcutaneous administration by injection or intranasal delivery.
4 . The method of claim 1 , wherein the one or more drugs is gabapentin.
5 . The method of claim 1 , wherein the one or more drugs is pregabalin.
6 . The method of claim 1 , wherein administering the terlipressin or a salt thereof comprises continuous infusion.
7 . The method of claim 1 , wherein the subject has ascites.
8 . The method of claim 1 , wherein administering the terlipressin or a salt thereof to the subject occurs only once the subject's dose of the one or more drugs has been reduced.
9 . The method of claim 1 , wherein reducing the subject's dose of the one or more drugs comprises weaning the subject off the one or more drugs.
10 . The method of claim 1 , wherein reducing the subject's dose of the one or more drugs comprises stopping the administration of the one or more drugs.
11 . The method of claim 1 , wherein the terlipressin or a salt thereof is in the form of terlipressin acetate.
12 . The method of claim 1 , wherein the terlipressin or a salt thereof is administered in an outpatient setting.
13 . The method of claim 1 , wherein the terlipressin or a salt thereof is administered at a dose of about 2 mg/day to about 4 mg/day.
14 . The method of claim 1 , wherein the terlipressin or a salt thereof is administered at a dose of 1 to 2 mg every 4 to 6 hours for up to 14 days.
15 . The method of claim 1 , further comprising reducing the subject's risk of hyponatremia.
16 . The method of claim 15 , wherein the subject has hyponatremia if the subject has a serum sodium level<125 mmol/L.
17 . The method of claim 15 , wherein the subject has hyponatremia if the subject has a serum sodium level decrease of at least 10 mmol/L.
18 . The method of claim 1 , wherein the one or more drugs is used for managing neuropathic pain.
19 . The method of claim 1 , wherein the subject has cirrhosis.