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Trial Information

Esbriet® (pirfenidone) was rigorously analyzed in three Phase 3 trials2

The efficacy and safety of Esbriet was evaluated in 1247 patients with IPF in three phase 3, randomized, double-blind, placebo-controlled, multicenter trials2

Trial design flowchart

%FVC=percent predicted forced vital capacity; %DLco=percent predicted diffusing capacity of lung for carbon monoxide.

  • 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 disease2
  • Study drug was administered with food in 3 equally divided doses and gradually increased to full dose over 2 weeks14,15

Esbriet was studied across a range of patients with IPF

Clinical trials included patients with IPF with a range of clinical characteristics, select comorbidities, and concomitant medications1

Baseline Characteristics ASCEND
[N=555]		 CAPACITY 004
[N=348]		 CAPACITY 006
[N=344]		 All Trials
[N=1247]
Clinical Characteristics        

Mean %FVC

 68% 75% 74% 72%

Mean %DLCO

 44% 46% 48% 46%
% predicted FVC at baseline [% of patients]        

>80%

 18.2% 32.8% 29.3% 25.3%

≥65%-80%

 38.9% 41.6% 41% 40.3%

≥50%-<65%

 42.9% 25.6% 29.7% 34.4%
Patient demographics        

Mean age [range, 40-80 years]

 68 years 66 years 67 years 67 years

Male

 78% 71% 72% 74% 

Caucasian

 91% 97% 99% 95%

Current smoker

 0% 5% 2% 2%

Former smoker

 64% 64% 62% 63%
Select comorbidities*        

Hypertension

 49% 50% 56% 52%

GERD

 49% 45% 49% 48%

Cough

 39% 28% 15% 29%

Hypercholesterolemia

 21% 24% 27% 23%

Hyperlipidemia

 28% 15% 22% 23%

Osteoarthritis

 21% 21% 22% 21%

Diabetes

 21% 19% 20% 20%

Depression

 16% 16% 21% 17%

Coronary artery disease

 16% 13% 18% 16%
Concomitant medications†        

Renin-angiotensin inhibitors

 36% 36% 46% 39%

Beta blockers

 22% 24% 30% 25%

Calcium channel blockers

 19% 15% 17% 18%

Antiacid therapies

 69% 68% 68% 68%

Lipid-modifying agents

 63% 55% 61% 60%

Analgesics

 54% 50% 56% 53%

Antidiabetic agents

 21% 20% 22% 21%

Psychoanaleptics

 24% 23% 28% 25%

Antithrombotic agents

 53% 52% 59% 54%

*Prevalence of comorbidities occurred in ≥15% of enrolled patients across all trials (N=1247).
†Medications listed are commonly administered for select comorbidities.

Clinical Results

Learn how the efficacy and safety of Esbriet was evaluated.

See clinical results
NEXT: Esbriet side effects

Important Safety Information and Indication

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.

Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with the use of Esbriet in the post-marketing setting. If signs or symptoms of SCAR occur, interrupt Esbriet treatment until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, permanently discontinue Esbriet.

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.

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      Data on file. Genentech, Inc. 2022.

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      Esbriet Prescribing Information. Genentech, Inc. February 2023.

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