Patient Medication Information: uses, side effects, how to take - Auro-Pirfenidone
Serious Warnings and Precautions
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What is Auro-Pirfenidone used for?
- Auro-Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.
How does Auro-Pirfenidone work?
How Auro-Pirfenidone works is not yet fully understood. It may reduce inflammation and fibrosis in your lungs. It may slow down worsening of your IPF.
What are the ingredients in Auro-Pirfenidone?
Medicinal ingredients: pirfenidone
Non-medicinal ingredients:
Croscarmellose sodium, Hypromellose, Lactose monohydrate, Silica, Colloidal Anhydrous and Sodium Stearyl Fumarate.
Ferric Oxide (NFDC red iron oxide 3017) is only used for 801 mg tablet.
Ferric Oxide (NFDC Yellow Iron Oxide 2190) is only used for 267 mg tablet.
Auro-Pirfenidone comes in the following dosage forms:
267 mg (yellow), 801 mg (pink) film-coated tablets
Do not use Auro-Pirfenidone if:
- you are allergic to pirfenidone or any of the other ingredients in this medicine.
you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue which may be associated with difficulty
- you have severe or end-stage liver disease.
- you have severe or end-stage kidney disease or you require dialysis.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-Pirfenidone. Talk about any health conditions or problems you may have, including if you:
- Have liver or kidney problems or disease.
Are pregnant or planning to become pregnant. It is not known whether taking Auro-Pirfenidone may be harmful to an unborn baby.
- Are breastfeeding or planning to do so. It is not known if Auro-Pirfenidone passes into breast milk.
Other warnings you should know about:
Driving and using machines: Before you perform tasks which may require you to be alert and coordinated, wait until you know how you will respond to Auro-Pirfenidone. Dizziness and tiredness can occur when you take Auro-Pirfenidone. Taking Auro-Pirfenidone with food may decrease dizziness. Be careful when driving or using machines.
Increased sensitivity to sunlight: You may become more sensitive to sunlight when taking Auro-Pirfenidone. You should:
- Avoid other medicines which may make you more sensitive to sunlight. Ask your pharmacist if you are not sure.
- Avoid or minimize exposure to direct or indirect sunlight, including through windows and from sunlamps.
- Wear an effective sunblock daily (at least SPF 50, against UVA and UVB).
- Wear clothing that protects against sun exposure such as a wide-brimmed hat and long sleeves.
- Seek shade.
Auro-Pirfenidone can cause weight loss. Your healthcare professional will monitor your weight while you are taking this medicine.
Do not drink grapefruit juice during the time that you are taking Auro-Pirfenidone. Grapefruit juice may prevent Auro-Pirfenidone from working properly.
Do not smoke before and during treatment with Auro-Pirfenidone. Cigarette smoking may reduce the effect of Auro-Pirfenidone.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
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The following may also interact with Auro-Pirfenidone:
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How to take Auro-Pirfenidone:
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- Swallow the /tablets:
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Usual dose:
Auro-Pirfenidone is usually prescribed in increasing doses as follows:
- If taking tablets:
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Pink tablet three times a day with food (a total of 2403 mg a day).
Your healthcare professional may reduce your dose if you have:
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If your stomach problems do not get better, your healthcare professional may stop treatment with Auro-Pirfenidone.
If you have not taken Auro-Pirfenidone for 14 days or more in a row:
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Overdose:
| If you think you, or a person you are caring for, have taken too much Auro-Pirfenidone, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If a dose is missed, the next dose should be taken as originally planned. Double doses should not be taken to make up for forgotten doses.
What are possible side effects from using Auro-Pirfenidone?
These are not all the possible side effects you may have when taking Auro-Pirfenidone. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
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Auro-Pirfenidone may cause liver problems and other abnormal blood test results. You will need blood tests to check your blood levels and to make sure that your liver is working properly. Blood tests should be done before you start taking Auro-Pirfenidone, at monthly intervals for the first 6 months and then every three months while you are taking this medicine. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
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Only if severe | In all cases | ||
| VERY COMMON | |||
Increased Sensitivity to Sunlight: skin reaction/rash to sunlight, blistering and/or marked peeling of the skin | ✓ | ||
| Diarrhea | ✓ | ||
| Fatigue | ✓ | ||
Persistent Stomach Problems: such as nausea, vomiting | ✓ | ||
| COMMON | |||
| Dizziness | ✓ | ||
| UNCOMMON | |||
| Liver Problems (abnormal blood test results related to your liver): yellow skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
Angioedema: swelling of the face, lips and/or tongue, difficulty breathing or wheezing | ✓ | ||
| RARE | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Chest pain (angina), slow, fast or irregular heart beats | ✓ | ||
| Severe cutaneous adverse reactions (severe skin reactions): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands; fever, severe rash, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, urinate less often, less urine. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
- Store tablets at room temperature (15 - 30°C).
- Keep out of reach and sight of children.
If you want more information about Auro-Pirfenidone:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.