METHOD OF PROVIDING PIRFENIDONE THERAPY TO A PATIENT

• US 20080194644A1
• Filed: 12/18/2007
• Published: 08/14/2008
• Est. Priority Date: 12/18/2006
• Status: Active Grant

• Current Assignee: Intermune Incorporated (Roche Holding AG)
• Original Assignee: Intermune Incorporated (Roche Holding AG)
• Inventors: Bradford, Williamson Z.
• Granted Patent: US 7,767,700 B2
• Time in Patent Office: Days
• US Class Current: 514/345
• CPC Class Codes: A61J 1/03 for pills or tablets containers for pills or tablets with special dispensing means therefor B65D83/04
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 2205/50 using icons or symbolic figures, e.g. by a graphical representation symbolising the type of pathology or the organ by an image
• CPC Class Codes: A61K 31/4412 having oxo groups directly attached to the heterocyclic ring
• CPC Class Codes: A61K 31/4418 having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.

Claims

1-21. -21. (canceled)

22. A starter pack comprising:

a first set of compartments each having a first dosage amount of pirfenidone according to a first daily or first sub-daily periodic dosage of pirfenidone; and

at least one additional set of compartments each having a dosage amount of pirfenidone that is higher than the first dosage amount of pirfenidone and is according to a higher daily or higher sub-daily periodic dosage of pirfenidone.

23. The starter pack according to claim 22, wherein the starter pack comprises a row for each Day that the first daily periodic dosage is to be taken and for each Day that the higher daily periodic dosage is to be taken and separate columns for each of the first sub-daily periodic dosage to be taken and for each of the higher sub-daily periodic dosage to be taken, and wherein the first set of compartments are arranged within the rows and columns, and wherein the at least one additional set of compartments is arranged within the rows and columns.

24. The starter pack according to claim 23, wherein the first set of compartments and the at least one additional set of compartments each comprise three columns for each Day pirfenidone is to be taken.

25. The starter pack according to claim 24, wherein the starter pack comprises separate rows for Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14.

26. The starter pack according to claim 25, wherein the first set of compartments are for administering the first dosage amount of pirfenidone for Days 1, 2, 3, 4, 5, 6, and 7, and wherein each compartment in the first set of compartments contains one pill of 267-mg pirfenidone.

27. The starter pack according to claim 25, wherein the at least one additional set of compartments comprises a second set of compartments for administering a second dosage amount of pirfenidone higher than the first dosage amount and for Days 8, 9, 10, 11, 12, 13, and 14, and wherein each compartment in the second set of compartments contains two pills of 267-mg pirfenidone.

28. The starter pack according to claim 27, wherein the starter pack comprises separate rows for Days 15, 16, 17, 18, 19, 20, and 21.

29. The starter pack according to claim 28, wherein the at least one additional set of compartments comprises a third set of compartments for administering a third dosage amount of pirfenidone higher than the second dosage amount and for Days 15, 16, 17, 18, 19, 20, and 21, and wherein each compartment in the third set of compartments contains three pills of 267-mg pirfenidone.

30. The starter pack according to claim 22, further comprising a first panel having the first set of compartments and an additional panel for each of the at least one additional set of compartments, each of the first and additional panels containing an equal number of compartments

31. The starter pack according to claim 22, wherein the compartments are blisters.

32. The starter pack according to claim 22, wherein the starter pack comprises at least two panels and at least one fold separating the two panels, and wherein a first panel comprises dosage amount for a first period of time and wherein a second panel comprises dosage amounts for a second period of time.

33. The starter pack of claim 22, further comprising a casing for holding several containers each container comprising a panel bearing one of the first set of compartments or one of the at least one additional set of compartments.

53. The starter pack of claim 30, wherein each of the first panel and the additional panel for each of the at least one additional set of compartments comprise a circular form with compartments extending in a radial pattern from a center.

54. The starter pack of claim 53, wherein each radius of the circular form designates its own day for treatment with pirfenidone.

55. The starter pack of claim 53, wherein each radius of the circular form of the first panel contains the first dosage amount and wherein each radius of the circular form of the additional panel contains the corresponding dosage amount that is higher than the first dosage amount.

35-39. -39. (canceled)

40. A starter pack comprising:

a first panel having a plurality of compartments each providing a first daily dosage of pirfenidone for a patient in a first amount for the duration of a first period of time;

a second panel having a plurality of compartments each providing a second daily dosage of pirfenidone for the patient in a second amount for a second period of time; and

a third panel having a plurality of compartments each providing a third daily dosage of pirfenidone for the patient in a third amount for a third period of time, wherein the first and second periods of time each total at least about 7 days.

41. The starter pack according to claim 40, wherein the first daily dosage is in the range of about 700 mg/day to about 900 mg/day.

42. The starter pack according to claim 40, wherein the second daily dosage is in the range of about 1,500 mg/day to about 1,700 mg/day.

43. The starter pack according to claim 40, wherein the third daily dosage is in the range of about 2,300 mg/day to about 2,400 mg/day.

44. The starter pack according to claim 40, wherein the first period of time is in the range of about 3 days to about 10 days.

45. The starter pack according to claim 40, wherein the second period of time is in the range of about 3 days to about 10 days.

46. The starter pack according to claim 40, wherein the third period of time is more than one day.

47. The starter pack of claim 40, wherein the first panel, second panel and third panel are formed in a unitary structure having folds between adjacent ones of the first, second and third panel.

48. The starter pack of claim 47, wherein in a completely folded position, none of the compartments of the first, second, and third panels are exposed for dosing.

49. The starter pack of claim 48, wherein in a first unfolded position, the compartments of only one of the first, second, and third panels are exposed for dosing.

50. The starter pack of claim 49, wherein in the first unfolded position, the first panel is exposed for dosing.

51. The starter pack of claim 49, wherein each of the first, second and third panels each comprise indicia information for instructing a patient on dosing.

52. The starter pack of claim 51, further comprising a separate panel containing printed instructions.