Esbriet (pirfenidone) for idiopathic pulmonary fibrosis
Fact-checked by What is Esbriet for idiopathic pulmonary fibrosis?
Esbriet (pirfenidone) is an approved oral medication that’s used to slow the decline of lung function in people with idiopathic pulmonary fibrosis (IPF).
In IPF, progressive scarring (fibrosis) and inflammation develop in the lungs without a clear underlying cause, leading to declines in lung function over time.
Esbriet is an antifibrotic IPF treatment, meaning it helps slow the formation of scar tissue in the lungs. Although it is not clear exactly how Esbriet works to achieve this, research suggests it reduces the activity of a protein called transforming growth factor-beta, which in turn decreases the production of fibrosis-promoting proteins. It may also have immunosuppressive effects that help ease lung inflammation.
Legacy Pharma currently markets the brand-name medication in the U.S., where generic versions are also available.
Therapy snapshot
| Brand name | Esbriet |
| Chemical name | Pirfenidone |
| Usage | Used to treat idiopathic pulmonary fibrosis |
| Administration | Oral tablets or capsules |
Who can take Esbriet?
Esbriet is approved in the U.S. for the treatment of IPF, although the therapy’s safety and effectiveness in children have not been established. There are no contraindications, or reasons not to take Esbriet, although it is not generally recommended for people with severe kidney or liver disease.
The medication is also approved for adults with IPF in the European Union and Canada.
How is Esbriet administered?
Esbriet is available as oral tablets or capsules, with a recommended daily dose of 2,403 mg, split into three smaller doses of 801 mg each and taken with food. When starting treatment, people typically begin at a lower Esbriet dosage and work up to the recommended dosage over two weeks.
Doctors may prescribe a lower dose for people who experience significant side effects or are taking certain other medications that could affect the body’s exposure to Esbriet.
Esbriet in clinical trials
The approval of Esbriet for IPF was supported by data from three Phase 3 clinical trials involving more than 1,300 adults with IPF between the ages 40 to 80. These studies evaluated the effects of Esbriet on lung function with forced vital capacity (FVC), which measures the amount of air someone can forcefully expel after inhaling deeply.
- ASCEND (NCT01366209) showed that significantly more people treated with Esbriet than a placebo had no decline in FVC over a year (22.7% vs. 9.7%), and significantly fewer of them had an FVC decline of at least 10% or died (16.5% vs. 31.8%).
- CAPACITY-004 (NCT00287716) showed that FVC declined significantly less with Esbriet at its now-approved dose than with a placebo over about 1.5 years (8% vs. 12.4%)
- CAPACITY-006 (NCT00287729) showed that although Esbriet did not significantly slow FVC declines compared with a placebo, people who received Esbriet consistently had greater preservation of lung function until 48 weeks (about 11 months) into the study.
Esbriet side effects
The most common side effects of Esbriet include:
- nausea
- rash
- abdominal pain
- upper respiratory tract infection
- diarrhea
- fatigue
- headache
- decreased appetite
- indigestion
- dizziness
- vomiting
- gastroesophageal reflux disease, which causes stomach acid to flow back into the esophagus
- sinus inflammation
- difficulty falling or staying asleep
- weight loss
- joint pain
If gastrointestinal side effects such as nausea and vomiting are disruptive or intolerable, the dose of Esbriet may need to be reduced or treatment temporarily paused.
Esbriet also comes with warnings for less common, but potentially serious side effects, including:
- elevated liver enzymes or liver injury, which can be serious
- sensitivity to light (photosensitivity), including rashes or other reactions
- severe or life-threatening skin reactions
If certain complications occur, a doctor may recommend reducing the dose of Esbriet, temporarily pausing treatment, or discontinuing it altogether, depending on the severity.
Liver function will be tested before treatment is initiated, and periodically thereafter. Esbriet liver monitoring should occur monthly for the first six months of treatment and every three months thereafter.
To manage Esbriet photosensitivity, patients are advised to avoid direct sunlight, use sunscreen, and wear protective clothing when outdoors.
Esbriet may interact with other medications, so patients should inform their care providers about any other medications they are taking. Smoking may also reduce the body’s exposure to the active ingredient in Esbriet, potentially affecting its efficacy.
Pulmonary Fibrosis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
