Pirfenidone

Adults: Pirfenidone is taken by mouth with food. Adults: When treatment begins, the dose is increased gradually over 14 days until it reaches the recommended daily dose of nine 267 mg tablets or three 801 mg tablets per day, as follows. On days 1 to 7, one 267 mg tablet is taken three times a day (801 mg per day). On days 8 to 14, two 267 mg tablets are taken three times a day (1602 mg per day). From day 15 onward, three 267 mg tablets or one 801 mg tablet are taken three times a day (2403 mg per day). The recommended daily dose of Pirfenidone for patients with IPF is three 267 mg tablets or one 801 mg tablet three times a day with food, giving a total of 2403 mg per day. Doses above 2403 mg per day are not recommended for any patient. Patients who miss 14 or more consecutive days of Pirfenidone treatment should restart therapy by repeating the initial 2-week step-up schedule up to the recommended daily dose. If treatment is interrupted for fewer than 14 consecutive days, the previous recommended daily dose can be resumed without stepping up again. Dose adjustments and other points for safe use: Gastrointestinal events: Patients who cannot tolerate therapy because of gastrointestinal side effects should be reminded to take the medicine with food. If symptoms persist, Pirfenidone may be reduced to 1 to 2 tablets (267 mg to 534 mg) 2 to 3 times a day with food, and then increased again to the recommended daily dose as tolerated. If symptoms continue, patients may be told to stop treatment for 1 to 2 weeks so that the symptoms can settle. Photosensitivity reaction or rash: Patients who develop a mild to moderate photosensitivity reaction or rash should be reminded to apply a sunblock every day and to avoid sun exposure. The dose of Pirfenidone may be reduced to three 267 mg tablets per day (one 267 mg tablet three times a day). If the rash is still present after 7 days, Pirfenidone should be stopped for 15 days and then increased again to the recommended daily dose in the same way as during the initial step-up period. Patients who develop a severe photosensitivity reaction or rash should be told to stop taking the medicine and to seek medical advice. Once the rash has cleared, Pirfenidone may be restarted and increased again up to the recommended daily dose at the physician's discretion. Hepatic function: If there is a significant rise in alanine and/or aspartate aminotransferases (ALT/AST), with or without a rise in bilirubin, the dose of Pirfenidone should be adjusted or treatment stopped according to the guidelines.