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Claims for Patent: 7,566,729

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Claims for Patent: 7,566,729

Title:Modifying 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.
Inventor(s): Bradford; Williamson Ziegler (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee: Intermune, Inc. (Brisbane, CA)
Application Number:12/428,393
Patent Claims: 1. 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 pirfenidone administration, comprising (a) administering to said patient pirfenidone at doses lower than 2400 mg/day for a time period, followed by (b) administering to said patient pirfenidone at doses of 2400 mg/day or 2403 mg/day.

2. The method of claim 1 wherein prior to step (a) pirfenidone is discontinued until biomarkers of liver function are within normal limits.

3. The method of claim 1 wherein step (a) comprises administering about 1600 mg/day or 1602 mg/day pirfenidone for about one week, or until biomarkers of liver function are within normal limits.

4. The method of claim 1 wherein step (a) comprises 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.

5. The method of claim 1 wherein step (a) comprises discontinuing pirfenidone for about one week, or until biomarkers of liver function are within normal limits, followed by administering about 800 mg/day or 801 mg/day pirfenidone for about one week, followed by administering about 1600 mg/day or 1602 mg/day pirfenidone for about one week.

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

7. The method of claim 1, wherein said one or more biomarkers of liver function is selected from the group consisting of alanine transaminase, aspartate transaminase, bilirubin, and alkaline phosphatase.

8. The method of claim 1 further comprising the step of measuring one or more biomarkers of liver function during step (a).

9. The method of claim 1, wherein said one or more biomarkers of liver function comprise alanine transaminase and aspartate transaminase.
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