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Pirfenidone

Generic Name: pirfenidone (pir-FEN-i-done)
Brand Name: Esbriet

Pirfenidone is used for:

Treating idiopathic pulmonary fibrosis (IPF).

Pirfenidone is an antifibrotic agent. Exactly how it works to treat IPF is not known.

Do NOT use pirfenidone if:

  • you are allergic to any ingredient in pirfenidone
  • you have severe liver problems or are on dialysis
  • you are taking any medicines that may increase the risk of sunburn. There are many medicines that can do this. Ask your doctor pharmacist if you are not sure

Contact your doctor or health care provider right away if any of these apply to you.

Before using pirfenidone:

Some medical conditions may interact with pirfenidone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems
  • if you smoke

Some MEDICINES MAY INTERACT with pirfenidone. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Ciprofloxacin, enoxacin, or fluvoxamine because they may increase the risk of pirfenidone's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if pirfenidone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use pirfenidone:

Use pirfenidone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with pirfenidone. Talk to your pharmacist if you have questions about this information.
  • Take pirfenidone by mouth with food.
  • Pirfenidone works best if it is taken at the same time each day.
  • If you miss a dose of pirfenidone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
  • If you miss 14 or more days of pirfenidone, call your doctor to find out what to do.

Ask your health care provider any questions you may have about how to use pirfenidone.

Important safety information:

  • Tell your doctor or dentist that you take pirfenidone before you receive any medical or dental care, emergency care, or surgery.
  • Do NOT take more than the recommended dose, change your dose, or stop taking pirfenidone without checking with your doctor.
  • Stop smoking before starting pirfenidone and avoid smoking while taking it. Smoking may decrease pirfenidone's effectiveness. Discuss any questions or concerns with your doctor.
  • If you have diarrhea, heartburn, nausea, stomach pain, vomiting, or loss of appetite, talk with your doctor. There may be ways to lower these side effects.
  • Pirfenidone may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to pirfenidone. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Lab tests may be performed while you take pirfenidone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using pirfenidone while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking pirfenidone.

Possible side effects of pirfenidone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; heartburn; joint pain; loss of appetite; nausea; stomach pain; taste changes; tiredness; trouble sleeping; upset stomach; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); chest pain; severe or persistent diarrhea, nausea, stomach pain or upset, or vomiting; sunburn; symptoms of liver problems (eg, bleeding or bruising more easily than normal, dark urine, pale stools, persistent loss of appetite, severe stomach pain, unusual tiredness, yellowing of the eyes or skin).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of pirfenidone:

Store pirfenidone at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep pirfenidone out of the reach of children and away from pets.

General information:

  • If you have any questions about pirfenidone, please talk with your doctor, pharmacist, or other health care provider.
  • Pirfenidone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pirfenidone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pirfenidone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pirfenidone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using pirfenidone.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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