Esbriet had a significant impact on
lung function vs placebo in patients with idiopathic pulmonary fibrosis1,2
2.3× more patients on Esbriet maintained
their baseline lung
function at 52 weeks
as measured by %FVC
vs placebo in
ASCEND1,2 (23% vs 10% of patients; 13% absolute difference; P<0.001)
Esbriet demonstrated
a significant effect on
lung function for up to
72 weeks in
CAPACITY 0043,4
In CAPACITY 006, no
statistically significant difference vs placebo
in change in %FVC or decline in FVC volume from baseline to 72 weeks was observed1,4 %FVC=percent predicted
forced vital capacity;
FVC=forced vital capacity.

WE WON'T
BACK DOWN
FROM IPF

Help preserve more
lung function. Reduce lung function
decline.1,2,4 Learn more »

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Indication

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

Select Important Safety Information

Elevated liver enzymes: Patients treated with Esbriet had a higher incidence of ALT and/or AST elevations of ≥3× ULN (3.7%) compared with placebo patients (0.8%). In some cases, these have been associated with concomitant elevations in bilirubin. No Esbriet-related cases of liver transplant or death due to liver failure have been reported. However, combined elevations of transaminases and bilirubin without evidence of obstruction is considered an important predictor of severe liver injury that could lead to death or the need for a transplant.

Measure ALT, AST, and bilirubin levels prior to initiating Esbriet, then monthly for the first 6 months, and every 3 months thereafter. Dosage modifications or interruption may be necessary.

Photosensitivity reaction or rash: Patients treated with Esbriet had a higher incidence of photosensitivity reactions (9%) compared with placebo patients (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, compared with 1.0% of placebo patients. The most common (>2%) GI events leading to dosage reduction or interruption were nausea, diarrhea, vomiting, and dyspepsia. Dosage modifications may be necessary.

Adverse reactions: The most common adverse reactions (≥10%) were nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, 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 reductions of Esbriet are 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 using 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.

Study design: The safety and efficacy of Esbriet were evaluated in 1247 patients with IPF in three phase 3, randomized, double-blind, placebo-controlled, multicenter trials.1 In ASCEND, 555 patients with IPF were randomized to receive Esbriet 2403 mg/day (n=278) or placebo (n=277) for 52 weeks. Eligible patients had percent predicted forced vital capacity (%FVC) from 50% to 90% and percent predicted diffusing capacity of lung for carbon monoxide (%DLco) from 30% to 90%. The primary endpoint was change in %FVC from baseline at week 52.2 In CAPACITY 004, 348 patients with IPF were randomized to receive Esbriet 2403 mg/day (n=174) or placebo (n=174) for 72 weeks. Eligible patients had %FVC ≥50% and %DLco ≥35%. The primary endpoint was change in %FVC from baseline at week 72.4 In CAPACITY 006, 344 patients with IPF were randomized to receive Esbriet 2403 mg/day (n=171) or placebo (n=173) for 72 weeks. Eligible patients had %FVC ≥50% and %DLco ≥35%. The primary endpoint was change in %FVC from baseline at week 72.4 Adult patients were enrolled who had a clinical and radiographic diagnosis of IPF (with or without accompanying surgical biopsy), without evidence or suspicion of an alternative diagnosis for interstitial lung disease.1 Study drug was administered with food in 3 equally divided doses and gradually increased to full dose over 2 weeks.2,4


References: 1. Esbriet Prescribing Information. Genentech, Inc. January 2017. 2. King TE Jr, Bradford WZ, Castro-Bernardini S, et al; for the ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis [published correction appears in N Engl J Med. 2014;371(12):1172]. N Engl J Med. 2014;370(22):2083–2092. 3. Data on file. Genentech, Inc. 2016. 4. Noble PW, Albera C, Bradford WZ, et al; for the CAPACITY Study Group. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011;377(9779):1760–
1769.


ESB/031116/0037(4) 12/18
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