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Prescribing Information

Esbriet (pirfenidone) preserves more lung function for patients with IPF 2,14

Esbriet had a significant impact on lung function vs placebo

ASCEND: Lung function preserved from baseline at 52 weeks with Esbriet vs placebo (P<0.001)*

Ascend stable lung function chart

*Rank ANCOVA with lowest rank imputation for missing data due to death. Patients who died were counted in the ≥10% decline category.  1,2

No decline or an increase in lung function is defined as a ≥0% decline in %FVC from baseline at 52 weeks 2

Disease progression as measured by FVC decline was considered a high-value, patient-important outcome [ATS/ERS/JRS/ALAT Clinical Practice Guideline] 16

ASCEND: Significant difference in reducing risk of lung function decline for Esbriet vs placebo at 52 weeks (P=0.001) 2,14

Ascend worsening lung function chart

Meaningful decline in lung function is defined as a ≥10% decline in %FVC at 52 weeks 

According to ATS guidelines, ≥10% FVC decline is an established measure of IPF disease progression and may be predictive of mortality 9

CAPACITY 004: Significant difference in reducing risk of lung function decline as measured by %FVC for Esbriet vs placebo at 72 weeks (P=0.001) 1,15,†

Capacity 004 worsening lung function chart

† P  value is from Cochran-Mantel-Haenszel (CMH) row mean scores test.

In CAPACITY 004, patients on Esbriet also maintained significantly more lung function vs placebo, as measured by mean change in FVC (157 mL), P=0.004

In CAPACITY 006, from baseline to 72 weeks, no statistically significant difference vs placebo was observed in change in %FVC or decline in FVC volume 15

 

 

Esbriet delays disease progression 1,2,14

Esbriet delayed progression of IPF vs placebo through a sustained impact on reducing lung function decline

ASCEND: Mean change from baseline in FVC vs placebo at 52 weeks

Ascend FVC change from baseline curve

Adapted from N Engl J Med, King TE Jr, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis, 370(22):2083-2092. Copyright © 2014 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

‡ P  value is from rank ANCOVA on the % change in FVC volume.

 

Impact of Esbriet on FVC volume was assessed at week 13, week 26, and week 39, with the primary endpoint at week 52 1,2

Patients taking Esbriet maintained almost double (1.8x) the amount of lung function as patients on placebo at 52 weeks 1

In CAPACITY 006, from baseline to 72 weeks, no statistically significant difference vs placebo was observed in decline in FVC volume. 1,2

 

Change in FVC over time is a widely accepted assessment of disease progression in IPF, with even small declines believed to be clinically important 17,18

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Indication

Esbriet® (pirfenidone) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Important Safety Information

Elevated liver enzymes and drug-induced liver injury (DILI): DILI has been observed with Esbriet. In the postmarketing period, non-serious and serious cases of DILI, including severe liver injury with fatal outcome, have been reported. Patients treated with Esbriet had a higher incidence of ALT and/or AST elevations of ≥3x ULN (3.7%) compared with placebo patients (0.8%). Increases in ALT and AST ≥3x ULN were reversible with dose modification or treatment discontinuation.

Conduct liver function tests (ALT, AST, and bilirubin) prior to the initiation of therapy with Esbriet, monthly for the first 6 months, every 3 months thereafter, and as clinically indicated. Measure liver function promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Dosage modification or interruption may be necessary for liver enzyme elevations.

Photosensitivity reaction or rash: Patients treated with Esbriet had a higher incidence of photosensitivity reactions (9%) vs placebo (1%). Patients should avoid or minimize exposure to sunlight and sunlamps, regularly use sunscreen (SPF 50 or higher), wear clothing that protects against sun exposure, and avoid concomitant medications that cause photosensitivity. Dosage reduction or discontinuation may be necessary.

Gastrointestinal (GI) disorders: Patients treated with Esbriet had a higher incidence of nausea, diarrhea, dyspepsia, vomiting, gastroesophageal reflux disease (GERD), and abdominal pain. GI events required dose reduction or interruption in 18.5% of 2403 mg/day Esbriet-treated patients, compared with 5.8% of placebo patients; 2.2% of 2403 mg/day Esbriet-treated patients discontinued treatment due to a GI event, vs 1.0% of placebo patients. The most common (>2%) GI events leading to dosage reduction or interruption were nausea, diarrhea, vomiting, and dyspepsia. Dosage modification may be necessary.

Adverse reactions: The most common adverse reactions (≥10%) were nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, dyspepsia, dizziness, vomiting, GERD, sinusitis, insomnia, weight decreased, and arthralgia.

Drug Interactions:

CYP1A2 inhibitors: Concomitant use of Esbriet and strong CYP1A2 inhibitors (e.g., fluvoxamine) is not recommended, as CYP1A2 inhibitors increase systemic exposure of Esbriet. If discontinuation of the CYP1A2 inhibitor prior to starting Esbriet is not possible, dosage reduction of Esbriet is recommended. Monitor for adverse reactions and consider discontinuation of Esbriet.

Concomitant use of ciprofloxacin (a moderate CYP1A2 inhibitor) at the dosage of 750 mg BID and Esbriet are not recommended. If this dose of ciprofloxacin cannot be avoided, dosage reductions of Esbriet are recommended, and patients should be monitored.

Moderate or strong inhibitors of both CYP1A2 and other CYP isoenzymes involved in the metabolism of Esbriet should be avoided during treatment.

CYP1A2 inducers: Concomitant use of Esbriet and strong CYP1A2 inducers should be avoided, as CYP1A2 inducers may decrease the exposure and efficacy of Esbriet.

Specific Populations:

Mild to moderate hepatic impairment: Esbriet should be used with caution in patients with Child Pugh Class A and B. Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed.

Severe hepatic impairment: Esbriet is not recommended for patients with Child Pugh Class C. Esbriet has not been studied in this patient population.

Mild (CLcr 50–80 mL/min), moderate (CLcr 30–50 mL/min), or severe (CLcr<30 mL/min) renal impairment: Esbriet should be used with caution. Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed.

End-stage renal disease requiring dialysis: Esbriet is not recommended. Esbriet has not been studied in this patient population.

Smokers: Smoking causes decreased exposure to Esbriet which may affect efficacy. Instruct patients to stop smoking prior to treatment and to avoid smoking when on Esbriet.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.

    • Data on file. Genentech, Inc. 2022.

      Data on file. Genentech, Inc. 2022.

    • Esbriet Prescribing Information. Genentech, Inc. February 2022.

      Esbriet Prescribing Information. Genentech, Inc. February 2022.

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