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Claims for Patent: 7,696,236

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Claims for Patent: 7,696,236

Title:Method of providing pirfenidone therapy to a patient
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.
Inventor(s): Bradford; Williamson Z. (Ross, CA)
Assignee: InterMune, Inc. (Brisbane, CA)
Application Number:12/427,532
Patent Claims: 1. A method of providing pirfenidone therapy to a patient for the treatment of idiopathic pulmonary fibrosis in an initial dose escalation regimen, comprising: providing pirfenidone to a patient at a first oral daily dosage of 801 mg as one capsule comprising 267-mg of pirfenidone three times a day for days one to seven of the dose escalation regimen; providing a second oral daily dosage of 1602 mg as two capsules comprising 267-mg of pirfenidone three times a day for days eight to fourteen of the dose escalation regimen; providing a third oral daily dosage of 2403 mg as three capsules comprising 267-mg of pirfenidone three times a day for at least day fifteen of the dose escalation regimen; and instructing said patient to take said dosages with food, wherein the patient is provided pirfenidone for the treatment of idiopathic pulmonary fibrosis.

2. The method of claim 1 wherein the initial dose escalation regimen reduces the incidence of photosensitivity reaction adverse events.

3. The method of claim 2, wherein the incidence of photosensitivity reaction adverse events is about 12%.

4. A method of reducing the incidence of photosensitivity reaction adverse events in a patient receiving pirfenidone therapy for the treatment of idiopathic pulmonary fibrosis, comprising use of an initial dose escalation regimen comprising the steps of: providing pirfenidone to the patient at a first oral daily dosage of 801 mg as one capsule comprising 267-mg of pirfenidone three times a day for days one to seven of the dose escalation regimen; providing a second oral daily dosage of 1602 mg as two capsules comprising 267-mg of pirfenidone three times a day for days eight to fourteen of the dose escalation regimen; providing a third oral daily dosage of 2403 mg as three capsules comprising 267-mg of pirfenidone three times a day for at least day fifteen of the dose escalation regimen; and instructing said patient to take said dosages with food.

5. The method of claim 4, wherein the incidence of photosensitivity reaction adverse events is about 12%.

6. In a method of treating a patient with pirfenidone for idiopathic pulmonary fibrosis, the improvement comprising: reducing the incidence of photosensitivity reaction adverse events in the patient receiving pirfenidone therapy by use of an initial dose escalation regimen comprising providing pirfenidone to a patient at a first oral daily dosage of 801 mg as one capsule comprising 267-mg of pirfenidone three times a day for days one to seven of the dose escalation regimen; providing a second oral daily dosage of 1602 mg as two capsules comprising 267-mg of pirfenidone three times a day for days eight to fourteen of the dose escalation regimen; providing a third oral daily dosage of 2403 mg as three capsules comprising 267-mg of pirfenidone three times a day for at least day fifteen of the dose escalation regimen; and instructing said patient to take said dosages with food.

7. The method of claim 6, comprising reducing the incidence of photosensitivity reaction adverse events to about 12%.
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