pirfenidone

What is the most important information I should know about pirfenidone?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is pirfenidone?

Pirfenidone is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). IPF causes scar tissue to form deep within your lungs. The scar tissue thickens and becomes stiff or thick over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.

The cause of IPF is often unknown, but this condition is a progressive disease that can be fatal. Pirfenidone is not a cure for IPF, but this medicine may slow the progress of this disease.

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

What should I discuss with my healthcare provider before taking pirfenidone?

To make sure pirfenidone is safe for you, tell your doctor if you have:

• liver disease;
• kidney disease; or
• if you smoke.

How should I take 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.

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 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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while taking pirfenidone?

Tell your doctor if you are also using antibiotic medicine, which can also make you more sensitive to sunlight.

What are the possible side effects of pirfenidone?

• severe ongoing stomach pain, vomiting, diarrhea;
• burning or pain in your esophagus or throat; or
• liver problems --stomach pain (upper right side), easy bruising or bleeding, feeling tired, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, vomiting, loss of appetite;
• stomach pain, heartburn, upset stomach;
• diarrhea;
• headache, dizziness, tired feeling;
• weight loss;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• joint pain; 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.

What other drugs will affect pirfenidone?

Other drugs may interact with pirfenidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about pirfenidone.