Pirfenidone

Pirfenidone is a prescription medication used to treat a lung disease called idiopathic pulmonary fibrosis (IPF).

Pirfenidone belongs to a group of drugs called immunosuppressants. These work by suppressing the body’s immune system to help stop inflammation and fibrosis.

This medication comes in capsules form and is taken typically 3 times a day, with food.

Common side effects of pirfenidone include rash, nausea, fatigue, and diarrhea.

Pirfenidone is a prescription medication used to treat idiopathic pulmonary fibrosis (IPF).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Pirfenidone may be found in some form under the following brand names:

• Esbriet

Serious side effects have been reported with pirfenidone. See the “Pirfenidone Precautions” section.

Common side effects of pirfenidone include the following:

• nausea
• rash
• abdominal pain
• upper respiratory tract infection
• diarrhea
• fatigue
• headache
• dyspepsia
• dizziness
• vomiting
• decreased/loss of appetite
• gastroesophageal reflux disease
• sinusitis
• insomnia
• decreased weight
• joint pain

This is not a complete list of pirfenidone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin)
• ciprofloxacin 

This is not a complete list of pirfenidone drug interactions. Ask your doctor or pharmacist for more information.

Pirfenidone may cause serious side effects, including:

• liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, or feeling tired.
  Your doctor will do blood tests to check how your liver is working during your treatment with pirfenidone.
• sensitivity to sunlight (photosensitivity) and rash. 
• stomach problems. pirfenidone may cause stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Tell your doctor right away if your stomach problems get worse or do not go away. Your doctor may need to change your dose of pirfenidone.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pirfenidone, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take pirfenidone, tell your doctor if you:

• have liver problems
• have kidney problems
• are a smoker
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if pirfenidone will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if pirfenidone passes into your breast milk. You and your doctor should decide if you will take pirfenidone or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pirfenidone falls into category C. There are no well-done studies that have been done in humans with pirfenidone. In animal studies, pregnant animals were given this medication, and the babies did not show impaired fertility or harm to the fetus related to this medication.

It is not known if pirfenidone crosses into human milk. In rat studies, pirfenidone or its metabolites were excreted in milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using pirfenidone.

Take pirfenidone exactly as your doctor tells you to take it.

• Your doctor may change your dosage of pirfenidone as needed.
• Take pirfenidone with food. This may help to decrease nausea and dizziness.
• If you miss a dose of pirfenidone take your next dose as soon as you remember.
• Do not take 2 doses at the same time to make up for your missed dose.
• Do not more than 3 doses each day.
• Your doctor should do certain blood tests before you start taking pirfenidone.

What you should avoid while taking pirfenidone:

• Avoid sunlight. pirfenidone can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen (SPF50) and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn.
• Avoid smoking. Smoking may affect how well pirfenidone works.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dosage is gradually increased over 2 weeks to 801 mg (3 capsules) by mouth three times daily.

• Take 1 pirfenidone capsule 3 times each day for days 1 through 7.
• Take 2 pirfenidone capsules 3 times each day for days 8 through 14.
• Take 3 pirfenidone capsules 3 times each day on day 15 and each day after.

If you take too much pirfenidone, call your doctor or go to the nearest hospital emergency room right away.

• Store pirfenidone at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep in a tightly closed container.
• Safely throw away any pirfenidone that is out of date or no longer needed.
• Keep pirfenidone and all medicines out of reach of children.