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Claims for Patent: 8,648,098

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Claims for Patent: 8,648,098

Title:Pirfenidone therapy and inducers of cytochrome P450
Abstract: The present invention relates to methods involving avoiding adverse drug interactions with pirfenidone and CYP inducers, such as smoking.
Inventor(s): Bradford; Williamson Ziegler (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee: Intermune, Inc. (Brisbane, CA)
Application Number:13/326,971
Patent Claims: 1. A method of increasing the effectiveness of pirfenidone therapy by avoiding decreased exposure to pirfenidone, in a patient in need of pirfenidone therapy who is a smoker, comprising discontinuing smoking to decrease levels of cytochrome P450 1A2 (CYP1A2) induction and then administering a therapeutically effective amount of pirfenidone.

2. The method of claim 1, further comprising advising the patient that smoking causes a 50% decrease in pirfenidone exposure compared to patients that do not smoke.

3. The method of claim 1, wherein the patient has idiopathic pulmonary fibrosis.

4. The method of claim 1, wherein the therapeutically effective amount of pirfenidone is 2403 mg per day.

5. The method of claim 1, comprising avoiding smoking during pirfenidone therapy to avoid reduced exposure to pirfenidone.

6. The method of claim 5, wherein the patient has idiopathic pulmonary fibrosis.

7. The method of claim 5, wherein the therapeutically effective amount of pirfenidone is 2403 mg per day.

8. The method of claim 5, further comprising advising the patient that smoking causes a 50% decrease in pirfenidone exposure compared to patients that do not smoke.

9. A method of increasing the effectiveness of pirfenidone therapy by avoiding decreased exposure to pirfenidone, in a patient in need of pirfenidone therapy that is receiving a strong CYP1A2 inducer, comprising discontinuing the strong CYP1A2 inducer to decrease the levels of CYP1A2 induction, and then administering a therapeutically effective amount of pirfenidone.

10. The method of claim 9 wherein the patient has idiopathic pulmonary fibrosis.

11. The method of claim 9 wherein the therapeutically effective amount of pirfenidone is 2403 mg per day.

12. The method of claim 10 wherein the therapeutically effective amount of pirfenidone is 2403 mg per day.

13. The method of claim 9, wherein the CYP1A2 inducer is discontinued within at least three weeks prior to pirfenidone administration.

14. The method of claim 1, wherein the smoker discontinues smoking within at least three weeks prior to pirfenidone administration.

15. The method of claim 3, wherein the therapeutically effective amount of pirfenidone is 2403 mg per day.
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