Esbriet (Pirfenidone) - Oral

Warning:

The Food and Drug Administration (FDA) hasn't assigned any black box warnings to Esbriet.

What Is Esbriet?

Esbriet (pirfenidone) is a prescription medication option used to treat idiopathic pulmonary fibrosis (IPF). Esbriet is in a medication class called pyridones. It's also known as an antifibrotic medication. It's unclear how Esbriet exactly works, but it's thought to work by lessening lung swelling and preventing fibrosis (thickening or scarring of the lungs). In general, Esbriet may help your lungs work better. The medication may also prevent worsening lung symptoms and improve your life expectancy.

Esbriet is available in tablet and capsule dosage forms.

Drug Facts

Generic Name: Pirfenidone

Brand Name(s): Esbriet

Drug Availability: Prescription

Therapeutic Classification: Pyridone or antifibrotic

Available Generically: Tablets are available as generic

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Pirfenidone

Dosage Form(s): Tablets and capsules

What Is Esbriet Used For?

Esbriet is a medication option used to treat idiopathic pulmonary fibrosis (IPF). IPF is a condition of the lungs, which become increasingly thick, scarred, and thick over time. If you have IPF, you may experience symptoms of breathing difficulties and a dry cough that doesn't go away.

The cause of IPF is unknown, but people with IPF tend to start having symptoms as adults between the ages of 19 to 65. This condition affects 3,000 to 30,000 people in the United States (U.S.).

Esbriet (Pirfenidone) Drug Information - A person with their lungs showing

Verywell / Zoe Hansen

How to Take Esbriet

Take Esbriet by mouth three times daily with food.

Storage

When you receive Esbriet from the pharmacy, store the medication at room temperature, around 77 degrees Fahrenheit (F)—with a short-term safety storage range between 59 degrees to 86 degrees F.

To be safe, you may also place Esbriet in a locked cabinet or closet to keep your medication out of the reach of children and pets.

If you plan to travel with Esbriet, get familiar with your final destination's regulations. Checking with the U.S. embassy or consulate might be a helpful resource. In general, however, make sure to copy your Esbriet prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, ask your pharmacist or healthcare provider.

You can also ask your pharmacist or healthcare provider about the best ways to dispose of your medications. The FDA's website is a potentially helpful resource for knowing where and how to discard all unused and expired drugs. You can also find disposal boxes in your area.

How Long Does Esbriet Take to Work?

You may notice an improvement in your lung function within one year of taking Esbriet.

Off-Label Uses

Esbriet doesn't currently have any off-label uses.

What Are the Side Effects of Esbriet?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects with Esbriet may include:

Severe Side Effects

Get medical help right away if you develop any of the following serious side effects:

  • Severe allergic reaction: If you have a severe allergic reaction to Esbriet, symptoms may include itchiness, rash, and breathing difficulties.
  • Digestive system-related effects: Digestive system-related effects (e.g., stomach pain, heartburn) are common. These effects, however, might become severe and excessive.
  • Light sensitivity: Esbriet can make you more sensitive to the sun. So, find ways (e.g., sunblock) to protect your skin and prevent developing a rash. Also, avoid sunlamps.
  • Liver injury: Esbriet raises your risk of liver injury. If you're experiencing worsening liver function, symptoms may include right-sided stomach pain, dark-colored urine, and yellowing of the eyes or skin.

Call 911 if your symptoms feel life-threatening.

Long-Term Side Effects

Esbriet's long-term side effects are similar to its common and severe side effects. Many of Esbriet's common side effects, however, tend to go away after six months of treatment.

Report Side Effects

Esbriet may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Esbriet Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (capsules or tablets):
    • For idiopathic pulmonary fibrosis:
      • Adults—On Days 1 to 7, 267 milligrams (mg) 3 times a day. On Days 8 to 14, 534 mg 3 times a day. On Day 15 and each day after, 801 mg 3 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2403 mg per day.
      • Children—Use and dose must be determined by your doctor.

Modifications

The following modifications (changes) should be kept in mind when using Esbriet:

Severe allergic reaction: Avoid using Esbriet if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: In rat and rabbit animal studies, Esbriet negatively affected the fetus. We don't know enough about the safety and effects of Esbriet in pregnant humans and their unborn fetuses. Discuss with your healthcare provider if you plan to become pregnant or are pregnant. Your healthcare provider will help you weigh the benefits and risks of taking Esbriet during your pregnancy.

Breastfeeding: In animal studies, Esbriet was present in rat breastmilk. We don't know enough about the effects and safety of Esbriet in human breastmilk and on nursing babies. Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider will help you weigh the benefits and harms of taking Esbriet while nursing. They can also discuss the different ways available to feed your baby.

Adults over 65: There were no effectiveness or safety differences between older and younger adults.

Children: There is little safety and effectiveness information about Esbriet in children.

Kidney problems: Individuals with kidney problems may not be able to clear medication from their bodies as easily. This means the medicine stays in the body longer and can have increased side effects. Your healthcare provider may adjust your Esbriet dosage if you have kidney impairment. If you're on dialysis, Esbriet isn't recommended.

Liver problems: If you have mild to moderate liver impairment, your healthcare provider may adjust your Esbriet dosage. If you have severe liver impairment, Esbriet isn't recommended for you.

Digestive system-related effects: Your healthcare provider may adjust your Esbriet dosage based on the severity of the medication's digestive system-related side effects.

Light sensitivity: Your healthcare provider may adjust your Esbriet dosage depending on the severity of your side effects, such as light sensitivity and rash.

People who smoke: Smoking can lower Esbriet's effectiveness. Try to stop smoking before starting Esbriet, and avoid smoking while taking Esbriet. Your healthcare provider can help you with this goal.

Missed Dose

If you accidentally forgot your Esbriet dose, take it as soon as you remember. If it's already close to your next scheduled dose, then skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose. Also, don't take Esbriet more than three times per day.

Try to find ways that work for you to help yourself remember to keep your appointments and take your medication routinely. If you miss too many doses, Esbriet might be less effective at treating your condition.

If you didn't take Esbriet for 14 or more days, contact your healthcare provider before taking the medication again. You may need to restart Esbriet at a lower dose and slowly increase the dosage.

Overdose: What Happens If I Take Too Much Esbriet?

There is limited information available about Esbriet overdose. Healthy study participants, however, were able to tolerate high doses of up to 1,335 milligrams (mg) three times daily.

If you think that you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

What Happens If I Overdose on Esbriet?

If you think you or someone else may have overdosed on Esbriet, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Esbriet, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make your skin more sensitive to sunlight. Use sunscreen or sunblock lotions with a sun protection factor (SPF) 50 or higher on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

Check with your doctor right away if you have diarrhea, nausea, vomiting, heartburn, stomach pain or upset while using this medicine.

Stop smoking before treatment with Esbriet® and avoid smoking while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Esbriet?

Before taking Esbriet, talk with your healthcare provider if any of the following applies to you:

  • Severe allergic reaction: If you have a severe allergic reaction to Esbriet or its components (ingredients), this medication isn't a viable option for you.
  • Pregnancy: There is limited information about the effects and safety of Esbriet on the unborn fetus. Reach out to your healthcare provider to discuss the benefits and risks of taking Esbriet during your pregnancy.
  • Breastfeeding: There is no information about the effects and safety of Esbriet on nursing babies. Talk with your healthcare provider about the benefits and harms of taking Esbriet while breastfeeding.
  • Children: There is little effectiveness and safety data about Esbriet in children.
  • Adults over 65: Older and younger adults didn't respond differently to Esbriet.
  • Dialysis: Esbriet hasn't been studied in people on dialysis. Therefore, Esbriet isn't recommended if you're receiving dialysis treatments.
  • Severe liver impairment: Esbriet hasn't been studied in people with severe liver impairment. As a result, Esbriet isn't recommended for people with this condition.

What Other Medications Interact With Esbriet?

Esbriet is broken down in the body by multiple cytochrome P450 (CYP450) proteins—especially CYP1A2—located in the liver.

So, if possible, avoid medications that moderately or strongly affect how CYP1A2 works. Avoid medicines that also moderately or strongly block the effectiveness of CYP1A2 and other CYP450 proteins.

The following are some examples of these medications that might interact with Esbriet.

  • Ciprofloxacin: Ciprofloxacin is a fluoroquinolone antibiotic. It's considered a moderate CYP1A2 inhibitor. So, it prevents CYP1A2 from working as well. As a result, there might be a build-up of ciprofloxacin in the body and more side effects.
  • Fluvoxamine: Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) typically used for obsessive-compulsive disorder (OCD). Fluvoxamine is a potent (strong) CYP1A2 inhibitor. It also inhibits other CYP450 proteins.
  • Rifampin: Rifampin is usually used in combination with other medications for tuberculosis (TB). Rifampin is a moderate CYP1A2 inducer. So, it encourages CYP1A2 to break down Esbriet quickly. With less amounts of Esbriet in the body, the medication is also less effective.

If avoiding these medications isn't possible, your healthcare provider will adjust your dosages and closely monitor your side effects. Talk with your pharmacist or healthcare provider for more detailed information about medication interactions with Esbriet.

And be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter, nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

Esbriet is the only pyridone used to treat idiopathic pulmonary fibrosis (IPF). Esbriet is also considered an antifibrotic (a drug that reduces fibrosis). So, a similar medication would be Ofev (nintedanib), another antifibrotic.

It's unknown how Esbriet exactly works. Esbriet, however, is thought to work by lessening lung swelling and preventing fibrosis (thickening or scarring of the lungs). Ofev, on the other hand, is a tyrosine kinase inhibitor (TKI). So, Ofev works by blocking tyrosine kinase proteins that play a role in fibrosis.

Both medications are effective for IPF—with Ofev possibly having better outcomes. Ofev, however, might also be linked to more side effects. More comparison studies are likely needed.

Ofev is also a specialty medication that doesn't have a generic version yet. Esbriet, on the other hand, is available as a generic pirfenidone tablet, which isn't a specialty medication. So, Esbriet might be less costly when compared to Ofev.

Healthcare providers will typically choose one—but not both—of these medications for IPF. They will consider factors such as costs, medication side effects, and preferences to select one of these antifibrotics.

Frequently Asked Questions

  • Where is Esbriet available?

    Esbriet is available with a prescription from your healthcare provider. Your local retail pharmacy will likely carry it. If necessary, your pharmacy staff can try to order this medication for you.

  • How much does Esbriet cost?

    Esbriet is available as generic pirfenidone tablets. This may help you save some money.

    If cost is a concern, the Esbriet brand-name manufacturer (Genentech) does offer financial assistance. For questions, consider visiting Genentech's website or call 1-844-693-7274.

    Other potentially helpful resources may also include RxAssist, NeedyMeds, Simplefill, BenefitsCheckUp, Medicare Rights Center, State Pharmaceutical Assistance Programs (SPAPs), or Rx Outreach.

  • How long do I need to take Esbriet?

    Idiopathic pulmonary fibrosis (IPF) is a chronic (long-term) lung condition that worsens over time. Therefore, your healthcare provider may recommend that you take Esbriet as a chronic medication.

    Esbriet may help your lungs work better and prevent worsening symptoms. This medication may also improve your life expectancy.

  • Can I chew or crush Esbriet tablets?

    There are no studies to show that chewing or crushing Esbriet won't affect the medication's effectiveness.

How Can I Stay Healthy While Taking Esbriet?

If you're taking Esbriet, chances are idiopathic pulmonary fibrosis (IPF) has been negatively affecting your quality of life. You may have tried different approaches or treatments. While living with IPF does have its challenges, there are ways to help improve your quality of life. Refer below for some general tips to support your health:

  • Take IPF-related medications as recommended by your healthcare provider.
  • Participate in pulmonary (lung) rehabilitation programs.
  • Keep up with your medical and lab appointments.
  • Notify your healthcare provider of any worsening symptoms, such as breathing troubles.
  • Avoid triggers (e.g., high altitudes, bad air-quality days) that can cause a flare-up.
  • Quit smoking.
  • Maintain a healthy weight with regular physical activity. Moderate exercise (e.g., walking, using a stationary bike) can help you maintain your lung function. It can also help with stress management. If necessary, talk with your healthcare provider about using oxygen when you exercise.
  • Consider a healthy diet with multiple smaller meals that might minimize the sensation of a full stomach and help you breathe easier.
  • Consider support groups or work with a mental health professional to help you find coping strategies that help you notice and possibly change how you think, feel, react, or respond to living with IPF.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

17 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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By Ross Phan, PharmD, BCACP, BCGP, BCPS
Ross is a writer for Verywell with years of experience practicing pharmacy in various settings. She is also a board-certified clinical pharmacist and the founder of Off Script Consults.