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For Patients and Caregivers

Esbriet® (pirfenidone) Treats Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis (IPF) is a relentlessly progressive disease

Of idiopathic interstitial lung diseases, IPF has the worst prognosis3

  • IPF is marked by progressive and irreversible respiratory decline4
  • While IPF is progressive, there is no way to predict how quickly a patient will progress4
  • Patients hospitalized as a result of a chronic condition often do not return to prehospitalization levels of functionality, with many experiencing continued functional decline5*

*The ATS/ERS/JRS/ALAT evidence-based guidelines for the diagnosis and management of IPF defines IPF as a chronic, progressive lung disease.

ATS=American Thoracic Society; ERS=European Respiratory Society; JRS=Japanese Respiratory Society; ALAT=Latin American Thoracic Association.

PROGRESSION IS UNPREDICTABLE AND CAN OCCUR AT ANY POINT6

IPF progression chart

Adapted from Ley et al (2011).
†Mixed decline refers to periods of relative stability with periods of acute worsening and rapid decline.

 

The unpredictability of disease progression is a critical concern because once lost, lung function cannot be restored4

Perception of stability may be misleading in IPF;
Symptoms alone are not an accurate way to measure disease stability7

  • Lung damage is present before patients experience progression of their symptoms7
  • Underlying disease progression may continue despite the stable appearance of symptoms7
  • As fibrosis spreads, lung function becomes more compromised7
  • Patients with IPF are commonly hospitalized, with the majority of hospitalizations being respiratory-related8

Regularly monitoring the clinical course of IPF in patients is necessary even when symptoms appear stable9

Comorbidities are commonly associated with IPF

PREVALENCE OF SELECT COMORBIDITIES IN A GENERAL IPF PATIENT POPULATION (N=4716)10‡§

 

Select comorbidities graph

Adapted from BMC Pulm Med. Mortimer K, Hartmann N, Chan C, Norman H, Wallace L, Enger C. 2019;19(1):11.

Optum Research Database–Medicare Advantage Population. Cohort Entry: January 1, 2008-September 30, 2014.

COPD=chronic obstructive pulmonary disease; GERD=gastroesophageal reflux disease; ICD-9=International Classification of Diseases, Ninth Revision.

‡Non-interventional cohort study from a Medicare Advantage and Part D plan of medical and pharmacy claims data (ICD-9 code) for patients newly diagnosed with IPF with ≥1 additional medical claim and ≥65 years of age (N=4716).

§Comorbidities of interest were defined using validated algorithms (when available) or with clinical input and searches of medical claims coding systems. Coverage was for at least 12 months.

||Mean follow-up time: 0.8 years. Follow-up time for each cohort member extended from the day after the index date until the earliest of disenrollment from the health plan, death, occurrence of baseline exclusion criterion during follow-up, or the end of the study period. For each outcome, patients were censored for any second occurrences of that outcome, but remained eligible for a different outcome.

 

Comorbidities are common in patients with IPF and may be an important consideration when developing a treatment plan as they may continue to develop.11

How Esbriet May Help Slow IPF

Esbriet preserves more lung function for patients with IPF and delays disease progression.

Learn more
NEXT: Differential diagnosis

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.

      Data on file. Genentech, Inc. 2022.

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      Esbriet Prescribing Information. Genentech, Inc. February 2023.

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