Methods of administering anti-fibrotic therapy
The present disclosure relates to methods of administering Compound I for treating fibrotic disorders, inflammatory disorders or autoimmune disorders.
1. A method for providing oral Compound I therapy to a subject:
comprising providing a therapeutically effective amount of Compound I to the subject; and
advising the subject not to take a gastric acid reducing agent concomitantly with Compound I.
2. The method of claim 1 , wherein the gastric acid reducing agent is selected from a proton pump inhibitor (PPI), a histamine 2 receptor antagonist (H2RA), or an antacid, or combinations thereof.
3. The method of claim 2 , wherein the gastric acid reducing agent is a PPI.
4. The method of claim 3 , wherein the PPI is rabeprazole.
5. The method of claim 1 , further comprising advising the subject not to take the gastric acid reducing agent prior to or subsequent to taking the Compound I.
6. The method of claim 1 , further comprising advising the subject to take the Compound I with food.
7. The method of claim 1 , wherein the subject has an intra-gastric pH equal to or less than 4.
8. The method of claim 7 , wherein the subject has an intra-gastric pH less than 3.
9. The method of claim 1 , wherein the subject is in need of a gastric acid reducing agent.
10. The method of claim 1 , comprising providing a Compound I to the subject at a dosage in a range of 1 mg to 5000 mg per day.
11. A method for providing oral Compound I therapy to a subject:
comprising administering a therapeutically effective amount of Compound I to the subject and avoiding concomitant administration of a gastric acid reducing agent.
12. The method of claim 11 , wherein the gastric acid reducing agent is selected from a proton pump inhibitor (PPI), a histamine 2 receptor antagonist (H2RA), or an antacid, or combinations thereof.
13. The method of claim 12 , wherein the gastric acid reducing agent is a PPI.
14. The method of claim 13 , wherein the PPI is rabeprazole.
15. The method of claim 11 , comprising administering the Compound I with food.
16. The method of claim 11 , wherein the subject has an intra-gastric pH equal to or less than 4.
17. The method of claim 16 , wherein the subject has an intra-gastric pH less than 3.
18. The method of claim 11 , wherein the subject is in need of a gastric acid reducing agent.
19. The method of claim 11 , comprising providing a Compound I to the subject at a dosage in a range of 1 mg to 5000 mg per day.
20. A method for providing Compound I therapy to a subject in need thereof and in need of a gastric acid reducing agent:
comprising administering Compound I to the subject at a dosage of:
(i) 200 mg BID;
(ii) 525 mg QD; or
(iii) 275 mg BID; and
avoiding co-administration of a gastric acid reducing agent selected from a proton pump inhibitor (PPI), a histamine 2 receptor antagonist (H2RA), an antacid, or combinations thereof.