Esbriet Dosage

Generic name: PIRFENIDONE 267mg
Dosage form: capsule, tablet
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Drugs.com. Last updated on Mar 8, 2023.

Testing Prior to ESBRIET Administration

Conduct liver function tests prior to initiating treatment with ESBRIET [see Warnings and Precautions (5.1)].

Recommended Dosage

The recommended daily maintenance dosage of ESBRIET is 801 mg three times daily for a total of 2403 mg/day. Doses should be taken with food at the same time each day.

Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows:

Table 1. Dosage Titration for ESBRIET in Patients with IPF
Treatment days	Dosage
Days 1 through 7	267 mg three times daily (801 mg/day)
Days 8 through 14	534 mg three times daily (1602 mg/day)
Days 15 onward	801 mg three times daily (2403 mg/day)

Dosages above 2403 mg/day are not recommended for any patient. Patients should not take 2 doses at the same time to make up for a missed dose. Patients should not take more than 3 doses per day.

Dosage Modifications due to Adverse Reactions

Patients who miss 14 or more days of ESBRIET should re-initiate treatment by undergoing the initial 2-week titration regimen up to the full maintenance dosage [see Dosage and Administration (2.2)]. For treatment interruption of less than 14 days, the dosage prior to the interruption can be resumed.

If patients experience significant adverse reactions (i.e., gastrointestinal, photosensitivity reaction or rash, severe cutaneous adverse reactions (SCAR)), consider temporary dosage reductions or interruptions of ESBRIET to allow for resolution of symptoms. If a SCAR is confirmed, permanently discontinue ESBRIET [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)].

Dosage Modification due to Elevated Liver Enzymes

Dosage modifications or interruptions may also be necessary when liver enzyme and bilirubin elevations are exhibited. For liver enzyme elevations, modify the dosage as follows:

If a patient exhibits >3 but ≤5 × the upper limit of normal (ULN) ALT and/or AST without symptoms or hyperbilirubinemia after starting ESBRIET therapy:

Discontinue confounding medications, exclude other causes, and monitor the patient closely.
Repeat liver chemistry tests as clinically indicated.
The full daily dosage may be maintained, if clinically appropriate, or reduced or interrupted (e.g., until liver chemistry tests are within normal limits) with subsequent re-titration to the full dosage as tolerated.

If a patient exhibits >3 but ≤5 × ULN ALT and/or AST accompanied by symptoms or hyperbilirubinemia: