Pirfenidone interactions

Food & lifestyle

• grapefruit juice

  Moderate

  Absorption

  Food significantly slows the rate but only modestly reduces the extent of absorption of pirfenidone. In healthy, older adult volunteers aged 50 to 66 years, administration of a single 801 mg oral dose of pirfenidone in the fed state resulted in an approximately 50% reduction in peak plasma concentration (Cmax) and a 15% to 20% reduction in systemic exposure (AUC) compared to administration in the fasted state. Median time to reach peak concentration (Tmax) increased from 0.5 hours to 3 hours with food. Less nausea and dizziness were observed in fed subjects compared to fasted subjects.

  What to do: Pirfenidone should be administered with food to reduce the likelihood of dizziness and gastrointestinal side effects such as nausea, diarrhea, dyspepsia, and vomiting. Patients who experience intolerance to therapy due to these adverse events should be reminded to take pirfenidone with food. If symptoms do not improve, or they worsen in severity, a dosage reduction or discontinuation of therapy may be warranted. Patients should be advised to avoid consumption of grapefruit and grapefruit juice during treatment with pirfenidone. Cigarette smoking should also be avoided during therapy to prevent reduced exposure to pirfenidone.

  2 sources

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Esbriet (pirfenidone)." Intermune Inc (2013):

Conditions

Conditions in which Pirfenidone needs care, as documented in this source.

• Hepatic Insufficiency

  Moderate

  Increases in ALT and AST (>3 x ULN) with or without concomitant elevations in bilirubin, have been reported in patients treated with pirfenidone. These findings were reversible with dose modification or treatment discontinuation. Conduct liver tests prior to therapy initiation in all patients, then monthly for the first 6 months and every 3 months thereafter. Dose modification or interruption may be necessary for liver enzyme elevations. Pirfenidone should be used with caution in patients with mild to moderate hepatic impairment, monitoring adverse reactions. The safety and efficacy of pirfenidone has not been studied in patients with severe hepatic impairment, and is not recommended for use in these patients.

  1 source

  1. "Product Information. Esbriet (pirfenidone)." Intermune Inc (2013):

• Kidney Diseases

  Moderate

  Pirfenidone should be used with caution in patients with mild, moderate, or severe renal impairment, monitoring for adverse reactions and considering dosage modifications or discontinuation as needed. The safety and efficacy of pirfenidone has not been studied in patients with end-stage renal disease requiring dialysis, so its use is not recommended in these patients.

  1 source

  1. "Product Information. Esbriet (pirfenidone)." Intermune Inc (2013):