Esbriet (Pirfenidone)

Side Effects

• Tiredness, lack of energy, loss of appetite, weight loss, or changes in taste may occur. Dizziness, nausea, upset stomach, vomiting, diarrhea, or heartburn may also occur but taking pirfenidone with food may lessen these side effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
• Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
• Pirfenidone may rarely cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.
• A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
• This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

• Before taking pirfenidone tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
• Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease (such as dialysis).
• This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.
• This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.
• Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
• During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
• It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

• Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
• Other medications can affect the removal of pirfenidone from your body, which may affect how pirfenidone works. Examples include rifamycins (such as rifampin), drugs used to treat seizures (such as phenytoin), among others.
• Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

Missed Dose

• If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.
• If you miss 14 days or more of treatment in a row, you may have to restart treatment with a lower dose. Ask your doctor for more details.

Storage

• Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist for directions on proper disposal.

References:

https://reference.medscape.com/drug/esbriet-pirfenidone-999972

https://www.esbriet.com

https://www.esbriet.com/about-esbriet/how-esbriet-may-help.html

https://www.webmd.com/drugs/2/drug-165325/esbriet-oral/details

https://www.ema.europa.eu/en/medicines/human/EPAR/esbriet

https://pulmonaryfibrosisnews.com/2017/04/07/review-says-pulmonary-fibrosis-therapy-esbriet-can-prolong-life/