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Claims for Patent: 8,318,780

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Claims for Patent: 8,318,780

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:13/224,589
Patent Claims: 1. A method of administering pirfenidone to a patient in need thereof comprising administering to the patient a therapeutically effective amount of pirfenidone, and avoiding concomitant use of a cytochrome P450 1A2 (CYP1A2) inhibitor that is a moderate to strong inhibitor of both (i) CYP1A2 and (ii) another CYP enzyme selected from the group consisting of CYP2C9, CYP2C19 and CYP2D6, wherein the patient is also in need of said CYP1A2 inhibitor.

2. The method of claim 1 wherein the avoiding of the CYP1A2 inhibitor is to avoid an adverse drug interaction with pirfenidone.

3. The method of claim 1 wherein the patient is in need of an anti-fibrotic agent.

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

5. The method of claim 1 wherein the pirfenidone is administered at a total daily dosage of about 1600 mg.

6. The method of claim 3 wherein the pirfenidone is administered at a total daily dosage of about 1600 mg.

7. The method of claim 5 wherein the pirfenidone is administered three times per day.

8. The method of claim 1 wherein the pirfenidone is administered at a total daily dosage of about 2400 mg per day.

9. The method of claim 1 wherein the pirfenidone is administered at a total daily dosage of 2403 mg per day.

10. The method of claim 9 wherein the pirfenidone is administered three times per day.

11. A method of administering pirfenidone to a patient in need thereof, wherein said patient is in need of therapy with CYP1A2 inhibitor that is a moderate to strong inhibitor of both (i) CYP1A2 and (ii) another CYP enzyme selected from the group consisting of CYP2C9, CYP2C19 and CYP2D6, comprising: (a) discontinuing said CYP1A2 inhibitor and (b) administering to the patient a therapeutically effective amount of pirfenidone.

12. The method of claim 11 wherein the patient has discontinued administration of the CYP1A2 inhibitor within 1 month prior to the start of pirfenidone therapy.

13. The method of claim 11 wherein the patient has discontinued administration of the CYP1A2 inhibitor within 2 weeks prior to the start of pirfenidone therapy.

14. The method of claim 11 wherein the discontinuing of the CYP1A2 inhibitor is to avoid an adverse drug interaction with pirfenidone.

15. The method of claim 11 wherein the patient is in need of an anti-fibrotic agent.

16. The method of claim 11 wherein the patient has idiopathic pulmonary fibrosis (IPF).

17. The method of claim 11 wherein the pirfenidone is administered at a total daily dosage of about 1600 mg.

18. The method of claim 11 wherein the pirfenidone is administered at a total daily dosage of about 2400 mg per day.

19. The method of claim 11 wherein the pirfenidone is administered at a total daily dosage of 2403 mg per day.

20. The method of claim 17 wherein the pirfenidone is administered three times per day.

21. The method of claim 19 wherein the pirfenidone is administered three times per day.

22. The method of claim 16 wherein the pirfenidone is administered at a total daily dosage of about 1600 mg.

23. The method of claim 16 wherein the pirfenidone is administered at a total daily dosage of 2403 mg per day.

24. A method of administering pirfenidone comprising administering to a patient with IPF pirfenidone at a total daily dose of 2403 mg per day, administered three times per day, and avoiding or discontinuing concomitant use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both (i) CYP1A2 and (ii) another CYP enzyme selected from the group consisting of CYP2C9, CYP2C19 and CYP2D6, wherein the patient is also in need of said CYP1A2 inhibitor.
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