Usual Adult Dose for Idiopathic Pulmonary Fibrosis

Initial dose:

• 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

• Take with food to reduce nausea and dizziness.
• Doses should be taken at the same time each day.

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

• 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.

Dose Adjustments

• 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.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Not recommended

Other Comments

Administration advice:

• 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.

Frequently asked questions

• Can Ofev and Esbriet be given together?