Applies to the following strength(s): 267 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Idiopathic Pulmonary Fibrosis
-Days 1 to 7: 267 mg (one capsule) orally three times a day
-Days 8 to 14: 534 mg (two capsules) orally three times a day
Maintenance/Maximum dose (Day 15 onward): 801 mg (three capsules) orally three times a day
-Take with food to reduce nausea and dizziness.
-Doses should be taken at the same time each day.
Use: Idiopathic pulmonary fibrosis (IPF)
Renal Dose Adjustments
-Mild to severe renal impairment (CrCl 80 mL/min or less): Use with caution
-End-stage renal disease requiring dialysis: Not recommended
Liver Dose Adjustments
-Mild to moderate liver impairment (Child-Pugh A and B): Use with caution
-Severe liver impairment (Child-Pugh C): Not recommended
If hepatotoxicity develops during treatment:
-ALT and/or AST greater than 3 but less than or equal to 5 times the upper limit of normal (ULN) without symptoms or hyperbilirubinemia: Maintain or reduce full daily dose as clinically appropriate, or interrupt therapy with subsequent re-titration to the full dose as tolerated after discontinuing confounding medications and excluding other causes.
-ALT and/or AST greater than 3 but less than or equal to 5 X ULN accompanied by symptoms or hyperbilirubinemia: Permanently discontinue treatment and do not re-challenge patient with this drug.
-ALT and/or AST greater than 5 X ULN: Permanently discontinue treatment and do not re-challenge patient with this drug.
-Treatment interruption 14 days or more: Re-initiate therapy by undergoing the initial 2-week titration regimen up to the full maintenance dose of 801 mg (three capsules) orally three times a day.
-Treatment interruption less than 14 days: Resume daily dose prior to interruption.
-Significant adverse reactions (i.e. GI, photosensitivity reaction or rash): Consider temporary dose reductions or treatment interruptions to allow for resolution of symptoms.
-Concomitant use of strong CYP450 1A2 inhibitors: Reduce dose to 267 mg (one capsule) orally three times a day.
-Concomitant use of ciprofloxacin 250 mg or 500 mg once daily: Close monitoring recommended.
-Concomitant use of ciprofloxacin 750 mg twice daily: Reduce dose to 534 mg (2 capsules) orally three times a day.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
-Dosages above 2403 mg per day (9 capsules) are not recommended.
-Conduct liver function tests (ALT, AST, and bilirubin) prior to treatment initiation, at monthly intervals for the first 6 months, and then every 3 months thereafter.
-Closely monitor patients with aminotransferase elevations more than 3 times the upper limit of normal (ULN) after starting treatment.
-Monitor closely for signs of toxicity and adverse reactions, especially in hepatically impaired patients concomitantly taking a CYP450 1A2 inhibitor.
-Avoid grapefruit, grapefruit juice, and smoking as they may affect how well this drug works.
-This drug can make your skin sensitive to light from the sun, sunlamps, and tanning beds. Avoid sun exposure, use sunblock (SPF 50 or higher) every day, and wear a hat and clothes that cover your skin when you're exposed to sunlight.
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