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Esbriet® (pirfenidone) Side Effects

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Side effects
Potential serious side effects
Common side effects

Managing side effects

Some patients may experience side effects when taking Esbriet

Some patients may experience side effects when taking Esbriet. Make sure to discuss any potential side effects they may have so you can help manage them.

Inform your patients that some side effects may decrease

In clinical studies of Esbriet, some side effects occurred soon after starting treatment and/or decreased over time:

  • Sensitivity to sunlight. The majority of these reactions in clinical studies happened in the first 6 months of treatment. 9% of patients treated with Esbriet experienced sun sensitivity (vs 1% not taking Esbriet)
  • Stomach problems. These were most often experienced early in the course of treatment—mostly in the first 3 months—and decreased over time. 2.2% of patients had to stop taking Esbriet because of stomach problems (vs 1% not taking Esbriet)

Potential serious side effects

Patients should contact you immediately if they experience any of these serious side effects:

  • Liver problems
    • skin or the white part of the eyes turns yellow
    • have dark or brown (tea-colored) urine
    • pain in the upper right side of the stomach area
    • bleed or bruise more easily than normal
    • feel tired

Blood tests can determine how their liver is working during treatment with Esbriet.

  • Sensitivity to sunlight and skin rash
    Esbriet can cause skin to sunburn more easily
  • Severe cutaneous adverse reactions (SCAR)
    Esbriet can cause severe skin reaction such as skin blisters, rash, sores in the mouth, hives or other severe skin symptoms
  • Stomach problems
    Esbriet may cause nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain

Common side effects

In clinical studies, side effects that occurred in 10% or more of people treated with Esbriet included:

  • Nausea
  • Rash
  • Stomach pain
  • Upper respiratory tract infection
  • Diarrhea
  • Fatigue
  • Headache
  • Indigestion
  • Dizziness
  • Vomiting
  • Decreased or loss of appetite
  • Gastroesophageal reflux disease (GERD)
  • Sinusitis
  • Sleeplessness
  • Weight loss
  • Joint pain

Tell your patients to inform you immediately if they have any side effects while taking Esbriet.

Clinical Results

Learn how the efficacy and safety of Esbriet was evaluated.

Learn more
NEXT: Adverse reaction management

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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