Esbriet

For the first 7 days of treatment, the dose of Esbriet (Pirfenidone) is 267 mg taken 3 times a day. For the next 7 days (day 8 to day 14), increase the dose to 534 mg taken 3 times a day. From day 15 onwards, increase the dose to 801 mg taken 3 times per day. Esbriet (Pirfenidone) should be taken with food, or during or after a meal to reduce side effects such as stomach problems and dizziness. Swallow each capsule whole with water. Your doctor may adjust your dose depending on how you tolerate Esbriet (Pirfenidone).

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Esbriet (Pirfenidone) exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with the next dose in your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. If you miss taking Esbriet (Pirfenidone) for 14 days in a row or more, contact your doctor, as you will need to restart treatment with increasing doses.

Store Esbriet (Pirfenidone) at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Capsule

Each hard gelatin two-piece capsule, with a white opaque body and white opaque cap imprinted with "PFD 267 mg" in brown ink and containing a white-to-pale-yellow powder, contains 267 mg of Esbriet (Pirfenidone). Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone; capsule: gelatin and titanium dioxide; imprinting ink: brown S-1-16530 or 03A2 inks containing: ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, and shellac.

Tablet

267 mg
Each yellow, oval, biconvex, film-coated tablet, debossed with "PFD", contains 267 mg of Esbriet (Pirfenidone). Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, iron oxide, macrogol (polyethylene glycol), magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, and titanium dioxide.

801 mg
Each brown, oval, biconvex, film-coated tablet, debossed with "PFD", contains 801 mg of Esbriet (Pirfenidone). Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, iron oxide, macrogol (polyethylene glycol), magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, and titanium dioxide.

Do not take Esbriet (Pirfenidone) if you:

• are allergic to Esbriet (Pirfenidone) or any ingredients of the medication
• have a history of angioedema after taking Esbriet (Pirfenidone)
• are taking the medication Fluvoxamine
• have severe kidney problems or are on dialysis
• have severe liver problems

There may be an interaction between Esbriet (Pirfenidone) and any of the following:

• Abiraterone
• Amiodarone
• birth control pills
• Bupropion
• cannabis
• Carbamazepine
• Cinacalcet
• Cyproterone
• Deferasirox
• Duloxetine
• Esomeprazole
• fluconazole
• Fluoxetine
• fluvoxamine
• grapefruit juice
• Leflunomide
• methoxsalen
• Mexiletine
• Moclobemide
• Omeprazole
• Paroxetine
• Phenytoin
• Porfimer
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifampin
• terbinafine
• Teriflunomide
• tobacco (smoked)
• Voriconazole

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Esbriet (Pirfenidone). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Esbriet (Pirfenidone).

HEALTH CANADA ADVISORY

September 14, 2020

Health Canada has issued new information concerning the use of Esbriet (Pirfenidone). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Fatigue and dizziness: Esbriet (Pirfenidone) can cause fatigue and dizziness. Do not drive or operate machinery until you know that Esbriet (Pirfenidone) does not affect your ability to perform these activities safely. To reduce dizziness, take Esbriet (Pirfenidone) with food.

Kidney function: If you have Kidney Disease, discuss with your doctor how Esbriet (Pirfenidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Esbriet (Pirfenidone), and whether any special monitoring is needed. If you have severely reduced kidney function or are receiving dialysis treatment, you should not take Esbriet (Pirfenidone).

Liver function: Liver disease or reduced liver function may cause Esbriet (Pirfenidone) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Esbriet (Pirfenidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Esbriet (Pirfenidone), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Esbriet (Pirfenidone).

If you experience symptoms of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, itching) while taking Esbriet (Pirfenidone), contact your doctor.

If you have severe liver disease, you should not take Esbriet (Pirfenidone).

Sun sensitivity: Esbriet (Pirfenidone) may increase the sensitivity of your skin to the sun. Avoid exposure to direct and indirect sunlight (including sunlamps and window light), use an effective sunblock daily (at least SPF 50 for UVA and UVB), and wear clothing that protects you from the sun (e.g., hat, long-sleeves) while taking Esbriet (Pirfenidone). If you get a skin reaction (e.g., rash, sunburn, blistering, peeling) from the sun, contact your doctor.

Weight loss: Esbriet (Pirfenidone) may cause loss of appetite and weight loss. Your doctor will monitor your weight while you are taking Esbriet (Pirfenidone).

Pregnancy: Esbriet (Pirfenidone) should not be used during pregnancy. If you become pregnant while taking Esbriet (Pirfenidone), contact your doctor immediately.

Breast-feeding: It is not known if Esbriet (Pirfenidone) passes into breast milk. If you are a breast-feeding mother and are taking Esbriet (Pirfenidone), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Esbriet (Pirfenidone) have not been established for anyone under the age of 18.