Esbriet

Esbriet Manufacturers

• Intermune, Inc.
  

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  Esbriet | Intermune, Inc.

  

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  2.1 Testing Prior to ESBRIET Administration

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

  2.2 Recommended Dosage

  The recommended daily maintenance dosage of ESBRIET is 801 mg (three 267 mg capsules) three times a day with food for a total of 2403 mg/day. Doses should be taken at the same time each day.

  Upon initiation of treatment, titrate to the full dosage of nine capsules per 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  1 capsule three times a day with food  Days 8 through 14  2 capsules three times a day with food  Days 15 onward  3 capsules three times a day with food

  Dosages above 2403 mg/day (9 capsules per day) are not recommended for any patient.

  2.3 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), consider temporary dosage reductions or interruptions of ESBRIET to allow for resolution of symptoms [see Warnings and Precautions (5.1, 5.2, 5.3)].

  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. 2.4 Dosage Modification due to Drug Interactions

  Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin)
  Reduce ESBRIET to one capsule three times a day.

  Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin)
  With use of ciprofloxacin at a dosage of 750 mg twice daily, reduce ESBRIET to two capsules three times a day.

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• Genentech, Inc.
  

  ×

  Esbriet | Genentech, Inc.

  

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  2.1 Testing Prior to ESBRIET Administration

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

  2.2 Recommended Dosage

  The recommended daily maintenance dosage of ESBRIET is 801 mg (three 267 mg capsules) three times a day with food for a total of 2403 mg/day. Doses should be taken at the same time each day.

  Upon initiation of treatment, titrate to the full dosage of nine capsules per 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  1 capsule three times a day with food  Days 8 through 14  2 capsules three times a day with food  Days 15 onward  3 capsules three times a day with food

  Dosages above 2403 mg/day (9 capsules per day) are not recommended for any patient.

  2.3 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), consider temporary dosage reductions or interruptions of ESBRIET to allow for resolution of symptoms [see Warnings and Precautions (5.1, 5.2, 5.3)].

  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. 2.4 Dosage Modification due to Drug Interactions

  Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin)
  Reduce ESBRIET to one capsule three times a day.

  Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin)
  With use of ciprofloxacin at a dosage of 750 mg twice daily, reduce ESBRIET to two capsules three times a day.

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