Patient Medication Information: uses, side effects, how to take - Auro-Febuxostat
What the medication is used for:
Auro-Febuxostat is used to lower uric acid levels in adult patients with gout. It is used when allopurinol has not worked well enough or when allopurinol is not right for you.
What it does:
Auro-Febuxostat contains febuxostat which is a xanthine oxidase (XO) inhibitor. Auro-Febuxostat works to lower the uric acid in the blood by selectively inhibiting XO involved in uric acid formation. The normal uric acid level should be lower than 360 µmol/L (6.0 mg/dL).
When it should not be used:
Do not take Auro-Febuxostat if you are allergic to febuxostat or any other ingredients in Auro-Febuxostat.
Do not take Auro-Febuxostat if you take:
- azathioprine
- mercaptopurine
What the medicinal ingredient is:
Febuxostat (as febuxostat hemihydrate)
What the important nonmedicinal ingredients are:
Lactose monohydrate, Cellulose Microcrystalline, Croscarmellose sodium, Hydroxypropyl cellulose, Silica colloidal anhydrous, Magnesium stearate, Opadry II complete film coating system 85F510039 Green.
Opadry II complete film coating system 85F510039 Green contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine AL 3% - 5%, Macrogol, Talc and Titanium Dioxide.
What dosage forms it comes in:
Tablets. Each tablet contains 80 mg febuxostat (as febuxostat hemihydrate).
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- A higher number of deaths was seen in a study of gout patients with heart problems who were treated with febuxostat. This was compared to patients treated with allopurinol.
- Your doctor will consider the side effects and benefits
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Auro-Febuxostat treatment should only be started when the acute attack of gout has subsided.
Whenever you start medicines that can lower uric acid levels, like Auro-Febuxostat, gout may flare up. This is due to the body’s efforts to get rid of uric acid crystals from the joints. However over time, reducing your uric acid level can decrease your gout flares. Your healthcare professional may add other medicines to help prevent or manage flares while taking Auro-Febuxostat.
Heart attacks, strokes and heart-related deaths have been reported. You should not use Auro-Febuxostat if you have heart problems, such as heart failure or have had a stroke or heart attack.
Mild increases in liver function tests were reported in some patients taking febuxostat. Your healthcare professional may do blood tests to check your liver function.
Some serious skin and allergic reactions such as rash, skin reddening, pain, swelling or blistering of lips, eyes or mouth, skin peeling and flu-like symptoms have been reported in patients taking febuxostat. If you get these symptoms, your doctor may stop your treatment until your skin condition improves. Patients who had previous reactions to allopurinol are at greater risk for these skin conditions.
BEFORE you use Auro-Febuxostat talk to your doctor or pharmacist if you:
- have taken allopurinol. Tell your doctor what happened to you while you were taking it.
- have a history of liver or kidney problems.
- have heart disease, heart problems or had a stroke.
are pregnant, breastfeeding or plan to become pregnant, or plan to breast-feed. It is not known if Auro-Febuxostat will harm your unborn baby. It is also unknown if Auro-Febuxostat passes into your breast milk.
Have ones of the following hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
This is because Auro-Febuxostat contains lactose.
It is not known if Auro-Febuxostat is safe and effective in children under 18 years of age.
INTERACTIONS WITH THIS MEDICATION
Do not take Auro-Febuxostat if you take:
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Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Auro-Febuxostat may affect the way other medicines work, and other medicines may affect how Auro-Febuxostat works.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
PROPER USE OF THIS MEDICATION
Usual adult dose:
The recommended dose of Auro-Febuxostat is one 80 mg tablet once daily.
- Take Auro-Febuxostat exactly as your healthcare provider tells you to take it.
Auro-Febuxostat can be taken with or without food.
- Auro-Febuxostat can be taken with antacids.
- It is important not to stop taking your Auro-Febuxostat without first consulting with your healthcare provider even if you have a flare.
- Your healthcare provider may do certain tests while you take Auro-Febuxostat.
Overdose:
| If you think you, or a person you are caring for, have taken too much Auro-Febuxostat, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose: If you miss a dose of Auro-Febuxostat, take your Auro-Febuxostat as soon as you remember. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects of Auro-Febuxostat include:
- liver problems
- diarrhea
- rash
- nausea
- dizziness
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| Uncommon | Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
Serious Skin Reaction (Stevens- Johnson Syndrome, Toxic Epidermal Necrolysis, DRESS [drug rash with eosinophilia and systemic symptoms]): any combination of red itchy rash with blisters and peeling of the skin and /or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have less or dark urine, yellow skin or eyes. | √ | |||
| Stroke: loss of feeling or movement on one side of the body, slurring of speech, sudden blurry vision, or severe headache. | √ | |||
| Heart problems: chest pain, shortness of breath, dizziness, fainting or feeling light-headed, rapid or irregular heartbeat. | √ | |||
This is not a complete list of side effects. For any unexpected effects while taking Auro-Febuxostat, contact your doctor or pharmacist. HOW TO STORE IT
HOW TO STORE IT
Store between 15°C - 30°C. Protect from light.
Keep Auro-Febuxostat and all medicines out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
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. |
MORE INFORMATION
If you want more information about Auro-Febuxostat:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer 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 http://www.auropharma.ca, or by calling 1- 855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Last Prepared: December 1, 2022