Esbriet

Esbriet Dosage/Direction for Use

pirfenidone

Manufacturer:

Roche

Marketer:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Testing Prior to ESBRIET Administration: Conduct liver function tests prior to initiating treatment with ESBRIET (see Precautions).
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: (See Table 4.)

Click on icon to see table/diagram/image

Dosages above 2403 mg/day are not recommended for any patient (see Overdosage).
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 & Administration). For treatment interruption of less than 14 days, the dosage prior to the interruption can be resumed.
Gastrointestinal events: In patients who experience intolerance to therapy due to gastrointestinal side effects, patients should be reminded to take the medicinal product with food. If symptoms persist, the dose of Esbriet may be reduced to 267 mg - 534 mg two to three times a day with food with re-escalation to the recommended daily dose as tolerated. If symptoms continue, patients may be instructed to interrupt treatment for one to two weeks to allow symptoms to resolve.
Photosensitivity reaction or rash: Patients who experience a mild to moderate photosensitivity reaction or rash should be reminded to use a sunblock daily and to avoid exposure to the sun (see Photosensitivity Reaction or Rash under Precautions). The dose of Esbriet may be reduced to 801 mg each day (267 mg, three times daily). If the rash persists after 7 days, Esbriet should be discontinued for 15 days, with re-escalation to the recommended daily dose in the same manner as the dose escalation period. Patients who experience severe photosensitivity reaction or rash should be instructed to interrupt the dose and to seek medical advice (see Photosensitivity Reaction or Rash under Precautions). Once the rash has resolved, Esbriet may be re-introduced and re-escalated up to the recommended daily dose at the discretion of the physician.
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: Permanently discontinue ESBRIET.
Do not rechallenge patient with ESBRIET.
If a patient exhibits >5 × ULN ALT and/or AST: Permanently discontinue ESBRIET.
Do not rechallenge patient with ESBRIET.
Dosage Modification due to Drug Interactions: Strong CYP1A2 Inhibitors (e.g. fluvoxamine, enoxacin): Reduce ESBRIET to 267 mg three times a day (801 mg/day).
Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin): With use of ciprofloxacin at a dosage of 750 mg twice daily, reduce ESBRIET to 534 mg three times a day (1602 mg/day).
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