Claims for Patent: 10,183,006

Summary for Patent: 10,183,006

Title:	Methods of therapeutic monitoring of nitrogen scavenging drugs
Abstract:	The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
Inventor(s):	Scharschmidt; Bruce (San Francisco, CA), Mokhtarani; Masoud (Walnut Creek, CA)
Assignee:	Horizon Therapeutics, LLC (Lake Forest, IL)
Application Number:	15/980,376
Patent Claims:	1. A method of treating a urea cycle disorder (UCD) in a subject in need thereof who has hepatic impairment wherein the hepatic impairment is of class B or C according to the Child-Pugh Score, the method comprising: administering a nitrogen scavenging agent to the subject at a dosage of 5 g/m.sup.2/day, wherein the nitrogen scavenging agent is glyceryl tri-[4-phenylbutyrate]. 2. The method of claim 1, further comprising administering an increased dosage of the nitrogen scavenging agent to the subject wherein the increased dosage is calculated based on a target nitrogen output. 3. The method of claim 1, further comprising administering an increased dosage of the nitrogen scavenging agent to the subject wherein the increased dosage is calculated based on urinary PAGN level. 4. The method of claim 1, further comprising administering an increased dosage of the nitrogen scavenging agent to the subject wherein the increased dosage is calculated based on the subject's urinary PAGN level in combination with the subject's ammonia level. 5. The method of claim 1, further comprising administering an increased dosage of the nitrogen scavenging agent to the subject wherein the increased dosage is calculated based on the ratio of the concentration of urinary PAGN to urinary creatinine. 6. The method of claim 1, further comprising administering an increased dosage of the nitrogen scavenging agent to the subject, if the subject's fasting blood ammonia level is greater than half the upper limit of normal for the laboratory which performed the fasting blood ammonia level measurement. 7. The method of claim 1, wherein the nitrogen scavenging agent is administered orally.