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Claims for Patent: 8,609,701

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Claims for Patent: 8,609,701

Title:Pirfenidone treatment for patients with atypical liver function
Abstract: Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
Inventor(s): Bradford; Williamson Ziegler (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee: Intermune, Inc. (Brisbane, CA)
Application Number:13/128,569
Patent Claims: 1. A method of treating a patient in need of pirfenidone and suffering from a Grade 2 abnormality in a liver function biomarker selected from the group consisting of alanine transaminase (ALT) and aspartate transaminase (AST) and wherein the abnormality occurs after a first pirfenidone administration, comprising providing to said patient a second administration of pirfenidone, comprising (a) administering to said patient at doses of at least 1600 mg/day or 1602 mg/day.

2. The method of claim 1 comprising (a) administering to said patient pirfenidone at doses of 2400 mg/day or 2403 mg/day.

3. The method of claim 2 wherein the second administration of pirfenidone further comprises, prior to step (a), administering to said patient pirfenidone at doses lower than 2400 mg/day.

4. The method of claim 1 further comprising, prior to step (a), discontinuing the first administration pirfenidone for about one week, or until biomarkers of liver function are within normal limits.

5. The method of claim 2 wherein the second administration further comprises, prior to step (a), administering about 1600 mg/day or 1602 mg/day pirfenidone for about one week, or until biomarkers of liver function are within normal limits.

6. The method of claim 2 wherein the second administration further comprises, prior to step (a), administering about 800 mg/day or 801 mg/day pirfenidone for about one week, or until biomarkers of liver function are within normal limits, followed by administering about 1600 mg/day or 1602 mg/day pirfenidone for about one week, or until biomarkers of liver function are within normal limits.

7. The method of claim 2 further comprising, prior to step (a), discontinuing the first administration of pirfenidone for about one week, or until biomarkers of liver function are within normal limits.

8. The method of claim 1, wherein the pirfenidone is administered three times per day with food.

9. The method of claim 1 further comprising the step of measuring one or more of AST and ALT.

10. The method according to claim 1, wherein the second administration of pirfenidone further comprises, prior to step (a), administering to said patient pirfenidone at doses lower than 1600 mg/day.

11. The method according to claim 10, wherein the second administration of pirfenidone further comprises, prior to step (a), discontinuation of pirfenidone administration to the patient for about one week or until biomarkers of liver function are within normal limits.

12. The method according to claim 1, wherein the second administration of pirfenidone further comprises, prior to step (a), about 800 mg/day or 801 mg/day to the patient for about one week, or until biomarkers of liver function are within normal limits.

13. The method according to claim 10, wherein the pirfenidone is administered three times per day with food.

14. The method according to claim 10 further comprising measuring one or more of ALT and AST during administration of pirfenidone.

15. The method of claim 2 wherein the second administration further comprises, prior to step (a), administering about 800 mg/day or 801 mg/day pirfenidone for about one week, or until biomarkers of liver function are within normal limits, followed by administering about 1600 mg/day or 1602 mg/day pirfenidone for about one week, or until biomarkers of liver function are within normal limits.

16. The method of claim 1, wherein step (a) comprises administering to said patient pirfenidone at a dose of about 1800 mg/day.

17. The method of claim 1, wherein the patient suffers from fibrosis.

18. The method of claim 1, wherein the patient suffers from a condition selected from the group consisting of renal fibrosis, vascular fibrosis and scleroderma.

19. The method of claim 1, wherein the patient suffers from idiopathic pulmonary fibrosis.
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