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

Pirfenidone may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You will need frequent blood tests to check your liver function and your next dose may be delayed based on the results.

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. Follow your doctor's dosing instructions very carefully.

You should not take more than 3 doses per day.

If you stop using this medicine, do not start it again without your doctor's advice.

Store tightly closed at room temperature, away from moisture and heat.

Usual Adult Dose for Idiopathic Pulmonary Fibrosis:

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)

Tell your doctor if you have or have ever had:

• if you smoke; or

• liver or kidney disease.

It is not known if pirfenidone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using pirfenidone.

Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not use the medication if the seal over the opening of the bottle from the manufacturer is broken or missing when you first receive it.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Pirfenidone could make you sunburn more easily. Avoid sunlight, tanning beds and other medications that can make your skin sensitive to sunlight. Wear protective clothing and use sunscreen (SPF 50 or higher) when you are outdoors.

Avoid smoking while taking pirfenidone. Smoking could make pirfenidone less effective.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Pirfenidone may cause serious side effects. Call your doctor at once if you have:

• new or worsening problems in your stomach or esophagus such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach or esophagus pain;

• skin rash on your face or arms that worsen in sunlight; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of pirfenidone may include:

• nausea, vomiting, loss of appetite;

• stomach pain, heartburn, upset stomach;

• diarrhea;

• headache, dizziness, tired feeling;

• weight loss;

• joint pain;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect pirfenidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pirfenidone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.