Methods of therapeutic monitoring of nitrogen scavenging drugs
AssigneeHyperion Therapeutics, Inc.
InventorsBruce Scharschmidt, Masoud Mokhtarani
Life of this patent
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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.
Claims11
A method for adjusting the dosage of glyceryl tri-[4-phenylbutyrate] in a subject being treated for a urea cycle disorder who has previously been administered an initial dosage of glyceryl tri-[4-phenylbutyrate], the method comprising:
- (a) measuring a fasting plasma ammonia level for the subject;
- (b) comparing the fasting plasma ammonia level to the upper limit of normal for plasma ammonia level;
- and
- (c) administering an adjusted dosage of glyceryl tri-[4-phenylbutyrate], wherein the adjusted dosage is greater than the initial dosage if the fasting plasma ammonia level is greater than half the upper limit of normal for plasma ammonia level.
A method of treating a subject with a urea cycle disorder who has previously been administered an initial dosage of glyceryl tri-[4-phenylbutyrate], the method comprising:
- (a) measuring a fasting plasma ammonia level for the subject;
- (b) comparing the fasting plasma ammonia level to the upper limit of normal for plasma ammonia level;
- and
- (c) administering an adjusted dosage of glyceryl tri-[4-phenylbutyrate] that is greater than the initial dosage if the fasting plasma ammonia level is greater than half the upper limit of normal for plasma ammonia level.
A method of administering glyceryl tri-[4-phenylbutyrate] to a subject having a urea cycle disorder, the method comprising:
- (a) measuring a first fasting plasma ammonia level for the subject;
- (b) comparing the first fasting plasma ammonia level to the upper limit of normal for plasma ammonia level;
- and
- (c) administering an initial dosage of glyceryl tri-[4-phenylbutyrate] to the subject if the fasting plasma ammonia level is greater than half the upper limit of normal for plasma ammonia level.
Dependencies are inferred from the claim text.