Pirfenidone

Pirfenidone comes as a capsule to take by mouth. It is usually taken with food three times a day. Take pirfenidone capsules at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pirfenidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will start you on a low dose of pirfenidone and gradually increase your dose over a 2-week period.

Your doctor may need to decrease your dose or stop treatment if you experience certain severe side effects. Be sure to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

>10%

Nausea (36%)

Rash (30%)

Upper respiratory tract infection (27%)

Diarrhea (26%)

Abdominal pain (24%)

Headache (22%)

Dyspepsia (19%)

Dizziness (18%)

Vomiting (13%)

GERD (11%)

Sinusitis (11%)

1-10%

Insomnia (10%)

Weight decreased (10%)

Arthralgia (10%)

Photosensitivity (9%)

Decreased appetite (8%)

Pruritus (8%)

Asthenia (6%)

Dysgeusia (6%)

Noncardiac chest pain (5%)

AST/ALT ≥3 x ULN (3.7%)

<1%

AST/ALT ≥10 x ULN (0.3%)

Postmarketing Reports

Blood and lymphatic system disorders: Agranulocytosis

Immune system disorders: Angioedema

Hepatobiliary disorders: Bilirubin increased in combination with increases of ALT and AST

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.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using pirfenidone.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take pirfenidone with food at the same time each day.

Pirfenidone is usually taken 3 times per day. Your dose needs will change over the first 15 days of your treatment.

• For the first week, you will take only 1 capsule or tablet at a time.

• During the second week, you will take 2 capsules or tablets at a time.

• From the third week on, you will take 3 capsules or tablets at a time.

If you use the 801-milligram tablet from the third week on you will take only 1 tablet at a time, 3 times per day.

You should not take more than 3 doses per day.

You must follow this first-2-week "dose escalation" schedule when you start taking pirfenidone, or if you start taking the medicine again after not taking it for 14 days or longer. Follow your doctor's dosing instructions very carefully.

If you do stop taking pirfenidone for any reason, talk with your doctor before restarting the medicine.

You may need frequent medical tests to be sure pirfenidone is not causing harmful effects on your liver. Your next few doses may be delayed or reduced based on the results of these tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Pirfenidone is used to treat idiopathic pulmonary fibrosis.

pirfenidone is available only with your doctor's prescription.

• It is used to treat idiopathic pulmonary fibrosis.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take pirfenidone with food.
• Take this medicine at the same time of day.
• To gain the most benefit, do not miss doses.
• Keep taking pirfenidone as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, with food.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you miss 14 or more days of taking this medicine, call your doctor before you start taking it again.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Chest pain or pressure.
• Very loose stools (diarrhea).
• Very upset stomach or throwing up.
• Very bad belly pain.
• Sunburn.
• Any unexplained bruising or bleeding.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about pirfenidone, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using pirfenidone.

Review Date: October 4, 2017

• Esbriet

Idiopathic pulmonary fibrosis: Treatment of idiopathic pulmonary fibrosis (IPF)

Refer to adult dosing.

Commonly reported side effects of pirfenidone include: abdominal distention, abdominal pain, diarrhea, dizziness, dyspepsia, fatigue, gastroesophageal reflux disease, nausea, skin rash, upper abdominal pain, vomiting, weight loss, and anorexia. Other side effects include: pruritus, skin photosensitivity, and decreased appetite. See below for a comprehensive list of adverse effects.

Initial dose:
-Days 1 to 7: 267 mg (one capsule) orally three times a day
-Days 8 to 14: 534 mg (two capsules) orally three times a day
Maintenance/Maximum dose (Day 15 onward): 801 mg (three capsules) orally three times a day

Comments:
-Take with food to reduce nausea and dizziness.
-Doses should be taken at the same time each day.

Use: Idiopathic pulmonary fibrosis (IPF)

-Mild to moderate liver impairment (Child-Pugh A and B): Use with caution
-Severe liver impairment (Child-Pugh C): Not recommended

If hepatotoxicity develops during treatment:
-ALT and/or AST greater than 3 but less than or equal to 5 times the upper limit of normal (ULN) without symptoms or hyperbilirubinemia: Maintain or reduce full daily dose as clinically appropriate, or interrupt therapy with subsequent re-titration to the full dose as tolerated after discontinuing confounding medications and excluding other causes.
-ALT and/or AST greater than 3 but less than or equal to 5 X ULN accompanied by symptoms or hyperbilirubinemia: Permanently discontinue treatment and do not re-challenge patient with this drug.
-ALT and/or AST greater than 5 X ULN: Permanently discontinue treatment and do not re-challenge patient with this drug.