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 of providing Compound I therapy to a subject in need thereof:
comprising:
evaluating the renal function of the subject; and then
administering a therapeutically effective amount of Compound I to the subject.
2. The method of claim 1 , wherein evaluating the renal function of the subject comprises determining the subject's creatinine clearance rate.
3. The method of claim 2 , wherein the subject has a creatinine clearance of ≥90 mL/min.
4. The method of claim 2 , wherein the subject has a creatinine clearance of 60-89 mL/min.
5. The method of claim 2 , wherein the subject has a creatinine clearance of 30-59 mL/min and <50 mL/min.
6. The method of claim 2 , wherein the subject has a creatinine clearance of 15-29 mL/min.
7. The method of claim 1 , wherein the subject does not have end stage renal disease requiring dialysis.
8. The method of claim 1 , further comprising monitoring changes in the subject's serum creatinine (Scr) level after said administering of Compound I.
9. The method of claim 8 , further comprising adjusting the amount of Compound I or discontinuing Compound I therapy after monitoring changes in the subject's Scr level.
10. The method of claim 8 , further comprising advising the subject to discontinue Compound I therapy when the subject's Scr level is 1.5 times baseline or higher, or shows a ≥0.3 mg/dL (≥26.5 μmol/L) increase.
11. The method of claim 1 , wherein the subject is suffering from a fibrotic disorder.
12. The method of claim 11 , wherein the subject is suffering from idiopathic pulmonary fibrosis (IPF).