Patient Medication Information: uses, side effects, how to take - Mar-Febuxostat
What the medication is used for:
MAR-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:
MAR-FEBUXOSTAT contains febuxostat which is a xanthine oxidase (XO) inhibitor. MAR-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 MAR-FEBUXOSTAT if you are allergic to febuxostat or any other ingredients in MAR-FEBUXOSTAT.
Do not take MAR-FEBUXOSTAT if you take:
- azathioprine
- mercaptopurine
What the medicinal ingredient is:
Febuxostat as (febuxostat hemihydrate).
What the important nonmedicinal ingredients are:
Lactose monohydrate, microcrystalline cellulose, Pregelatinized starch, sodium croscarmellose, colloidal silicon dioxide and magnesium stearate. MAR-FEBUXOSTAT tablets are coated with Opadry II green (which contains polyvinyl alcohol, talc, PEG 4000, titanium dioxide, FD&C Yellow No.5 tartrazine aluminium lake, FD&C Blue No.1, and FD&C Blue No.2).
What dosage forms it comes in:
Tablets. Each tablet contains 80 mg febuxostat as (febuxostat hemihydrate).
WARNINGS AND PRECAUTIONS
MAR-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 MAR-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 MAR-FEBUXOSTAT.
Heart attacks, strokes and heart- related deaths have been reported. You should not use MAR-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 MAR-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 MAR-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 MAR-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 MAR-FEBUXOSTAT will harm your unborn baby. It is also unknown if MAR-FEBUXOSTAT passes into your breast milk.
Have ones of the following hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
This is because MAR-FEBUXOSTAT contains lactose.
It is not known if MAR-FEBUXOSTAT is safe and effective in children under 18 years of age.
INTERACTIONS WITH THIS MEDICATION
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. MAR-FEBUXOSTAT may affect the way other medicines work, and other medicines may affect how MAR-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.
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 of MAR-FEBUXOSTAT before and during your treatment. MAR-FEBUXOSTAT should only be used when allopurinol has not worked well enough or when allopurinol is not right for you.
Do not take MAR-FEBUXOSTAT if you take:
- azathioprine
- mercaptopurine
PROPER USE OF THIS MEDICATION
Usual adult dose:
The recommended dose of MAR-FEBUXOSTAT is one 80 mg
tablet once daily.
- Take MAR-FEBUXOSTAT exactly as your healthcare provider tells you to take it.
MAR-FEBUXOSTAT can be taken with or without food.
- MAR-FEBUXOSTAT can be taken with antacids.
- It is important not to stop taking your MAR-FEBUXOSTAT without first consulting with your healthcare provider even if you have a flare.
- Your healthcare provider may do certain tests while you take MAR-FEBUXOSTAT.
Overdose:
Missed Dose: If you miss a dose of MAR-FEBUXOSTAT, take your MAR-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 MAR-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 doctor or pharmacist | 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 | ||
| √ | ||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| 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 heart beat. | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking MAR-FEBUXOSTAT, contact your doctor or pharmacist.
HOW TO STORE IT
If you think you have taken too much MAR-FEBUXOSTAT, contact your healthcare professional (e.g. doctor), hospital emergency department or the regional Poison Control Centre, immediately even if there are no symptoms.
MAR-FEBUXOSTAT should be protected from light.
Store MAR-FEBUXOSTAT between 15°C - 30°C.
Keep MAR-FEBUXOSTAT and all medicines out of the reach of children.
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. |
MORE INFORMATION
For more information, please contact your healthcare professionals or pharmacist first, or Marcan Pharmaceuticals Inc. at: 1-855-627-2261 or visit the website at www.marcanpharma.com
The information in this document is current as of the last revision date shown below. For the most current information please visit our website or contact us directly.
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Date of Revision: January 22, 2020