Pirfenidone, Oral

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KEY POINTS

• This medicine is taken by mouth to treat idiopathic pulmonary fibrosis. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: pyridone

Generic and brand names: pirfenidone, oral; Esbriet

What is this medicine used for?

This medicine is taken by mouth to treat idiopathic pulmonary fibrosis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver or kidney disease

Tell your provider if you smoke. Smoking affects the way this medicine works. You should not smoke while taking this medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with food. Take it at the same time each day.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. Do not take more than 3 doses each day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Do not smoke while taking this medicine. Talk with your healthcare provider if you need help quitting.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Shortness of breath; severe diarrhea, nausea, or vomiting; severe stomach pain; yellowing of the skin or eyes; dark urine; unusual bruising or bleeding; light-colored bowel movements; chest pain.

Other: Mild stomach pain; mild nausea, vomiting, or diarrhea; heartburn; headache; dizziness; decreased appetite; weight loss; mild rash; tiredness; trouble sleeping; joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as ciprofloxacin (Cipro), isoniazid, ofloxacin, and rifampin (Rifadin)
• Antidepressants such as citalopram (Celexa), fluvoxamine (Luvox), and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), luliconazole (Luzu), miconazole (Monistat, Oravig), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Cancer medicines such as abiraterone (Zytiga), imatinib (Gleevec), and vemurafenib (Zelboraf)
• Gemfibrozil (Lopid)
• Heart medicines such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), mexiletine, nicardipine (Cardene), propafenone (Rythmol), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as delavirdine (Rescriptor), efavirenz (Sustiva), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and tipranavir (Aptivus)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), lansoprazole (Prevacid), and omeprazole (Prilosec)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Teriflunomide (Aubagio)
• Warfarin (Coumadin)
• Zileuton (Zyflo)

The effects of this medicine may be decreased if you smoke. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.