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Claims for Patent: 7,816,383

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Claims for Patent: 7,816,383

Title:Methods of administering pirfenidone therapy
Abstract: The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
Inventor(s): Bradford; Williamson Ziegler (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee: Intermune, Inc. (Brisbane, CA)
Application Number:12/684,879
Patent Claims: 1. A method of administering pirfenidone therapy to a patient in need thereof, comprising administering to the patient a therapeutically effective amount of pirfenidone, and avoiding co-administration of fluvoxamine, wherein said patient is also in need of fluvoxamine therapy.

2. The method of claim 1 wherein the patient has idiopathic pulmonary fibrosis (IPF).

3. The method of claim 1 wherein the therapeutically effective amount of pirfenidone is a daily dosage of 2400 mg or 2403 mg per day.

4. The method of claim 1 wherein 800 or 801 mg of pirfenidone is administered to the patient three times per day, with food.

5. A method of administering pirfenidone therapy to a patient in need thereof, comprising first discontinuing administration of fluvoxamine to avoid an adverse drug interaction with pirfenidone, and then administering to the patient a therapeutically effective amount of pirfenidone.

6. The method of claim 5 wherein the patient has idiopathic pulmonary fibrosis (IPF).

7. The method of claim 5 wherein the therapeutically effective amount of pirfenidone is a daily dosage of 2400 mg or 2403 mg per day.

8. The method of claim 5 wherein 800 or 801 mg of pirfenidone is administered to the patient three times per day, with food.

9. The method of claim 5 wherein the fluvoxamine is discontinued within 1 month prior to starting pirfenidone therapy.

10. The method of claim 5 wherein the fluvoxamine is discontinued within 2 weeks prior to starting pirfenidone therapy.

11. A method of administering pirfenidone therapy to a patient with IPF, wherein said patient is also in need of fluvoxamine therapy, comprising administering to the patient a daily dosage of 2400 mg or 2403 mg pirfenidone per day while avoiding fluvoxamine co-administration, and any one or more of the following: (a) advising the patient that fluvoxamine should be avoided or discontinued, (b) advising the patient that co-administration of pirfenidone with drugs that are moderate to strong inhibitors of both CYP1A2 and another CYP enzyme selected from the group consisting of CYP2C9, CYP2C19 and CYP3A4 can alter the therapeutic effect or adverse reaction profile of pirfenidone, (c) advising the patient that co-administration of pirfenidone with fluvoxamine can alter the therapeutic effect or adverse reaction profile of pirfenidone, (d) advising the patient that use of pirfenidone in patients being treated with fluvoxamine is contraindicated, (e) advising the patient that co-administration of pirfenidone and fluvoxamine resulted in a 6-fold increase in exposure to pirfenidone, or (f) advising the patient that strong CYP1A2 inhibitors should be used with caution in patients receiving pirfenidone due to the potential for reduced pirfenidone clearance.

12. The method of claim 11 wherein the patient is advised that fluvoxamine should be avoided or discontinued.

13. The method of claim 11 wherein the patient is advised that co-administration of pirfenidone with drugs that are moderate to strong inhibitors of both CYP1A2 and another CYP enzyme selected from the group consisting of CYP2C9, CYP2C19 and CYP3A4 can alter the therapeutic effect or adverse reaction profile of pirfenidone.

14. The method of claim 11 wherein the patient is advised that co-administration of pirfenidone with fluvoxamine can alter the therapeutic effect or adverse reaction profile of pirfenidone.

15. The method of claim 11 wherein the patient is advised that use of pirfenidone in patients being treated with fluvoxamine is contraindicated.

16. The method of claim 11 wherein the patient is advised that co-administration of pirfenidone and fluvoxamine resulted in a 6-fold increase in exposure to pirfenidone.

17. The method of claim 16 further comprising advising the patient that co-administration of pirfenidone and fluvoxamine resulted in a 2-fold increase in average peak serum concentration of pirfenidone (Cmax).

18. The method of claim 11 wherein the patient is advised that strong CYP1A2 inhibitors should be used with caution in patients receiving pirfenidone due to the potential for reduced pirfenidone clearance.

19. The method of claim 18 further comprising avoiding administering a strong CYP1A2 inhibitor.

20. The method of claim 18 further comprising discontinuing administration of a strong CYP1A2 inhibitor.
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