Market Authorisation Date: 11 January, 2017

Treatment: Method of administering pirfenidone capsules to treat a fibrotic condition; Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen; Dose escalation over 14 days for treatment of idiopathic pulmonary fibrosis; Pirfenidone dose escalation regimen for treatment of ipf as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen; Method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis; Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by 801 mg/day, dose, then 1602 mg/day in treatment of ipf; Full daily dosing following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of ipf; Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering full daily dose in treatment of ipf; Dosing 1602 mg/day pirfenidone following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of ipf; Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits followed by administering 1602 mg/day in treatment of ipf; Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering 801 mg/day followed by administering 1602 mg/day in treatment of ipf; Continued dosing or dosage modification following elvated liver enzymes in use of pirfenidone; Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within limits, then sub-2400mg/day dose, then full daily dose in treatment of ipf; Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-2400mg/day dose then full daily dose in treatment of ipf; Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-2400 mg/day dose then full day daily dose in treatment of ipf; Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, then sub-2400mg/day dose, then full daily dose in treatment of ipf; Continued dosing or dosage modification following elevated liver enzymes in treatment of idiopathic pulmonary fibrosis; Method for administering pirfenidone to avoid reduced efficacy by avoiding smoking or by avoiding another strong cyp1a2 inducer; Discontinuing smoking to avoid reduced pirfenidone efficacy and then administering pirfenidone; Discontinuing administration of a strong cyp1a2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone; Administering pirfenidone while avoiding co-administration of a strong cyp1a2 inhibitor to avoid drug interactions with pirfenidone; Discontinuing administration of a strong cyp1a2 inhibitor to avoid drug interactions with pirfenidone and then administering pirfenidone; Discontinuing administration of fluvoxamine to avoid drug interactions with pirfenidone and then administering pirfenidone; Administering pirfenidone while avoiding co-administration of fluvoxamine to avoid drug interactions with pirfenidone; Administering pirfenidone while avoiding concomitant use of a cyp1a2 inhibitor that is a moderate to strong inhibitor of both cyp1a2 and another cyp enzyme selected from cyp2c9, cyp2c19, and cyp2d6; Discontinuing use of a cyp1a2 inhibitor that is a moderate to strong inhibitor of both cyp1a2 and another cyp enzyme selected from cyp2c9, cyp2c19, and cyp2d6 and then administering pirfenidone; Method for administering pirfenidone to avoid reduced efficacy by discontinuing smoking or by discontinuing or avoiding another strong cyp1a2 inducer; Method for administering pirfenidone to reduce drug interactions with fluvoxamine; Dosage modification in treatment with pirfenidone to reduce drug interactions with ciprofloxacin

Dosage: TABLET;ORAL