Claims for Patent: 8,592,462

Summary for Patent: 8,592,462

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:	13/312,746
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,592,462
Patent Claims:	1. A method of administering pirfenidone to treat a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited an increase of about 2.5-fold to about 5-fold, compared to the upper limit of normal, in one or both of alanine transaminase and aspartate transaminase after a first pirfenidone administration, comprising providing to said patient a second administration of pirfenidone, comprising (a) administering to said patient pirfenidone at a dose of at least 1600 mg/day. 2. The method of 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 for about a week, or until biomarkers of liver function are within normal limits. 3. The method of claim 1, wherein step (a) comprises administering to said patient pirfenidone at a dose of about 2400 mg/day or 2403 mg/day. 4. The method of claim 3 wherein the second administration of pirfenidone further comprises, prior to step (a), administering to said patient pirfenidone at doses lower than 2400 mg/day. 5. The method of claim 1, wherein step (a) comprises administering to said patient pirfenidone at a dose of about 1800 mg/day. 6. The method of claim 5 wherein the second administration of pirfenidone further comprises, prior to step (a), administering to said patient pirfenidone at doses of 1600 mg/day or lower for about a week, or until biomarkers of liver function are within normal limits. 7. The method of claim 5 further comprising, prior to step (a), discontinuing the first administration of pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 8. The method of claim 1 further comprising, prior to step (a), discontinuing the first administration of pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 9. The method of claim 1 wherein the second administration of pirfenidone further comprises, prior to step (a), administering about 800 mg/day or 801 mg/day pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 10. The method of claim 3 wherein the second administration of pirfenidone further comprises, prior to step (a), administering about 1600 mg/day or 1602 mg/day pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 11. The method of claim 1, wherein the pirfenidone is administered three times per day with food. 12. The method of claim 3 further comprising, prior to step (a), discontinuing the first administration of pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 13. The method of claim 3 wherein the second administration of pirfenidone further comprises, prior to step (a), administering about 800 mg/day or 801 mg/day pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 14. The method of claim 13 wherein the second administration of pirfenidone further comprises, prior to step (a), administering about 1600 mg/day or 1602 mg/day pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 15. The method of claim 3, wherein the pirfenidone is administered three times per day with food. 16. A method of administering pirfenidone to treat a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited an increase of about 2.5-fold to about 5-fold, compared to the upper limit of normal, in one or more biomarkers of liver function after a first pirfenidone administration, comprising providing to said patient a second administration of pirfenidone, comprising (a) administering to said patient pirfenidone at a dose of at least 1600 mg/day. 17. The method of claim 16 wherein the second administration of pirfenidone further comprises, prior to step (a), administering to said patient pirfenidone at doses lower than 1600 mg/day for about a week, or until biomarkers of liver function are within normal limits. 18. The method of claim 16 further comprising, prior to step (a), discontinuing the first administration of pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 19. The method of claim 16, wherein the pirfenidone is administered three times per day with food. 20. The method of claim 16, wherein step (a) comprises administering to said patient pirfenidone at a dose of about 1800 mg/day. 21. A method of administering pirfenidone to treat a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited a Grade 2 abnormality in one or more biomarkers of liver function after a first pirfenidone administration, comprising providing to said patient a second administration of pirfenidone, comprising (a) administering to said patient pirfenidone at a dose of at least 1600 mg/day. 22. The method of claim 21 wherein the second administration of pirfenidone further comprises, prior to step (a), administering to said patient pirfenidone at doses lower than 1600 mg/day for about a week, or until biomarkers of liver function are within normal limits. 23. The method of claim 21 further comprising, prior to step (a), discontinuing the first administration of pirfenidone for about a week, or until biomarkers of liver function are within normal limits. 24. The method of claim 21, wherein the pirfenidone is administered three times per day with food. 25. The method of claim 21, wherein step (a) comprises administering to said patient pirfenidone at a dose of about 1800 mg/day. 26. A method of administering pirfenidone to treat a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited a Grade 2 abnormality in one or both of alanine transaminase and aspartate transaminase after a first pirfenidone administration, comprising providing to said patient a second administration of pirfenidone, comprising (a) administering to said patient pirfenidone at a dose of at least 1600 mg/day. 27. The method of claim 26 wherein the second administration of pirfenidone further comprises, prior to step (a), administering to said patient pirfenidone at doses lower than 1600 mg/day for about a week, or until biomarkers of liver function are within normal limits. 28. The method of claim 26 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. 29. The method of claim 26, wherein the pirfenidone is administered three times per day with food. 30. The method of claim 26, wherein step (a) comprises administering to said patient pirfenidone at a dose of about 1800 mg/day.