Esbriet

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 7/6/2022
Esbriet Side Effects Center

What Is Esbriet?

Esbriet (pirfenidone) is an anti-inflammatory drug used to treat idiopathic pulmonary fibrosis (IPF).

What Are Side Effects of Esbriet?

Common side effects of Esbriet include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

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. Esbriet may interact with enoxacin, ciprofloxacin, and fluvoxamine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Esbriet. It is unknown if this drug will harm a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Esbriet (pirfenidone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

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Esbriet Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe ongoing stomach pain, vomiting, diarrhea;
  • burning or pain in your esophagus or throat; or
  • liver problems--stomach pain (upper right side), easy bruising or bleeding, feeling tired, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, loss of appetite;
  • stomach pain, heartburn, upset stomach;
  • diarrhea;
  • headache, dizziness, tired feeling;
  • weight loss;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • joint pain; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Esbriet (Pirfenidone Capsules)

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Esbriet Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Liver Enzyme Elevations and Drug-Induced Liver Injury [see WARNINGS AND PRECAUTIONS]
  • Photosensitivity Reaction or Rash [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Disorders [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of pirfenidone has been evaluated in more than 1400 subjects with over 170 subjects exposed to pirfenidone for more than 5 years in clinical trials.

ESBRIET was studied in 3 randomized, double-blind, placebo-controlled trials (Studies 1, 2, and 3) in which a total of 623 patients received 2403 mg/day of ESBRIET and 624 patients received placebo. Subjects ages ranged from 40 to 80 years (mean age of 67 years). Most patients were male (74%) and Caucasian (95%). The mean duration of exposure to ESBRIET was 62 weeks (range: 2 to 118 weeks) in these 3 trials.

At the recommended dosage of 2403 mg/day, 14.6% of patients on ESBRIET compared to 9.6% on placebo permanently discontinued treatment because of an adverse event. The most common (>1%) adverse reactions leading to discontinuation were rash and nausea. The most common (>3%) adverse reactions leading to dosage reduction or interruption were rash, nausea, diarrhea, and photosensitivity reaction.

The most common adverse reactions with an incidence of ≥10% and more frequent in the ESBRIET than placebo treatment group are listed in Table 2.

Table 2: Adverse Reactions Occurring in ≥10% of ESBRIET-Treated Patients and More Commonly Than Placebo in Studies 1, 2, and 3

Adverse Reaction % of Patients (0 to 118 Weeks)
ESBRIET 2403 mg/day
(N = 623)
Placebo
(N = 624)
Nausea 36% 16%
Rash 30% 10%
Abdominal Pain* 24% 15%
Upper Respiratory Tract Infection 27% 25%
Diarrhea 26% 20%
Fatigue 26% 19%
Headache 22% 19%
Dyspepsia 19% 7%
Dizziness 18% 11%
Vomiting 13% 6%
Anorexia 13% 5%
Gastro-esophageal Reflux Disease 11% 7%
Sinusitis 11% 10%
Insomnia 10% 7%
Weight Decreased 10% 5%
Arthralgia 10% 7%
*Includes abdominal pain, upper abdominal pain, abdominal distension, and stomach discomfort.

Adverse reactions occurring in ≥5 to <10% of ESBRIET-treated patients and more commonly than placebo are photosensitivity reaction (9% vs. 1%), decreased appetite (8% vs. 3%), pruritus (8% vs. 5%), asthenia (6% vs. 4%), dysgeusia (6% vs. 2%), and non-cardiac chest pain (5% vs. 4%).

Postmarketing Experience

In addition to adverse reactions identified from clinical trials the following adverse reactions have been identified during post-approval use of pirfenidone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Blood And Lymphatic System Disorders

Agranulocytosis

Immune System Disorders

Angioedema

Hepatobiliary Disorders

Drug-induced liver injury [see WARNINGS AND PRECAUTIONS]

DRUG INTERACTIONS

CYP1A2 Inhibitors

Pirfenidone is metabolized primarily (70 to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1.

Strong CYP1A2 Inhibitors

The concomitant administration of ESBRIET and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to ESBRIET [see CLINICAL PHARMACOLOGY]. Use of fluvoxamine or other strong CYP1A2 inhibitors should be discontinued prior to administration of ESBRIET and avoided during ESBRIET treatment. In the event that fluvoxamine or other strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended. Monitor for adverse reactions and consider discontinuation of ESBRIET as needed [see DOSAGE AND ADMINISTRATION].

Moderate CYP1A2 Inhibitors

Concomitant administration of ESBRIET and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to ESBRIET [see CLINICAL PHARMACOLOGY]. If ciprofloxacin at the dosage of 750 mg twice daily cannot be avoided, dosage reductions are recommended [see DOSAGE AND ADMINISTRATION]. Monitor patients closely when ciprofloxacin is used at a dosage of 250 mg or 500 mg once daily.

Concomitant CYP1A2 And Other CYP Inhibitors

Agents or combinations of agents that are moderate or strong inhibitors of both CYP1A2 and one or more other CYP isoenzymes involved in the mettabolism of ESBRIET (i.e., CYP2C9, 2C19, 2D6, and 2E1) should be discontinued prior to and avoided during ESBRIET treatment.

CYP1A2 Inducers

The concomitant use of ESBRIET and a CYP1A2 inducer may decrease the exposure of ESBRIET and this may lead to loss of efficacy. Therefore, discontinue use of strong CYP1A2 inducers prior to ESBRIET treatment and avoid the concomitant use of ESBRIET and a strong CYP1A2 inducer [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Esbriet (Pirfenidone Capsules)

© Esbriet Patient Information is supplied by Cerner Multum, Inc. and Esbriet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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