Patient Medication Information: uses, side effects, how to take - Albrioza
What is ALBRIOZA used for?
Please see the boxed text below:
For the following indication, ALBRIOZA has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.
Health Canada is unable to confirm whether ALBRIOZA helps with survival or slowing down the disease. For more information, talk to your healthcare professional. |
|---|
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada
How does ALBRIOZA work?
The exact way ALBRIOZA works is unknown. It appears that ALBRIOZA slows the loss of physical function due to progression of ALS.
What are the ingredients in ALBRIOZA?
Medicinal ingredients: sodium phenylbutyrate and ursodoxicoltaurine
Serious Warnings and Precautions
ALBRIOZA is only available through the Patient Support Program to patients currently receiving treatment with ALBRIOZA. ALBRIOZA will be withdrawn from the Canadian market no later than December 31, 2024. For more information on the Patient Support Program, contact Amylyx’ patient support program at 1-877-710-0711 or support@amylyxcareteam.ca.
Non-medicinal ingredients: Flavor masking and mixed berry flavoring, hydrated dextrates, maltodextrin, silicon dioxide, sodium phosphate dibasic anhydrous, sodium stearyl fumarate, sorbitol, sucralose.
ALBRIOZA comes in the following dosage forms:
Powder for suspension: each ALBRIOZA sachet contains 3 g sodium phenylbutyrate and 1 g ursodoxicoltaurine.
Do not use ALBRIOZA if:
- You are allergic to sodium phenylbutyrate, ursodoxicoltaurine, bile salts, or any of the ingredients in ALBRIOZA.
- You are pregnant, think you may be pregnant, or plan to become pregnant.
- You are breast-feeding or plan to breast-feed.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ALBRIOZA. Talk about any health conditions or problems you may have, including if you:
- Have any allergies
- Have any kidney problems
- Have any liver problems
- Have cancer
- Have digestive problems or problems with your pancreas
- Have heart problems or congestive heart failure
- Have any condition associated with salt and fluid retention because each sachet contains approximately 400 mg of sodium
- Have a condition called glucose-galactose malabsorption
Other warnings you should know about:
Pregnancy: ALBRIOZA should not be used during pregnancy. If you are a female of childbearing potential, you must use an effective method of birth control while taking ALBRIOZA. Wait at least 30 days after stopping treatment with ALBRIOZA before trying to conceive.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ALBRIOZA:
- Aluminum-based antacids: take antacids at least 2 hours before or 2 hours after taking ALBRIOZA
- Cholesterol lowering agents that bind to bile, such as colestipol, cholestyramine, colesevelam
- Some medicines that treat infections, such as cyclosporine, rifampicin, penicillin
- Probenecid, used to prevent gout
- Valproate, used in the treatment of epilepsy and bipolar disorder
- Lithium, used in the treatment of bipolar disorder
- Topiramate, used to treat epilepsy and migraines
- Some anti-cancer drugs known as histone deacetylase (HDAC) inhibitors, such as romidepsin, vorinostat
- Some drugs that are used to treat inflammation and pain, such as diclofenac, ketoprofen
- Methotrexate, used to treat cancer
- Warfarin, used to prevent blood clots (a blood thinner)
- Alfentanil, used for anesthesia during surgery
- Some medicines for heart problems, such as mexiletine, quinidine, digoxin
- Antiviral medicines, including some used to treat human immunodeficiency virus (HIV), such as tenofovir
How to take ALBRIOZA:
Take ALBRIOZA before a meal
- Empty the full contents of 1 sachet into a cup (250 mL or 8 oz.) of room temperature water and stir vigorously. Drink it, or take it via feeding tube, within 1 hour of preparation
To reduce the bitter aftertaste, you can:
- Use mint-flavored mouth strips or mouth spray immediately before or after taking ALBRIOZA
- Eat a snack or meal, eat honey, or drink milk after taking ALBRIOZA
- Avoid drinking fruit juice at the same time as ALBRIOZA
Usual dose:
Take 1 sachet once a day for the first 3 weeks of treatment. After 3 weeks, the dose is usually increased to 1 sachet in the morning and 1 sachet at night. Take ALBRIOZA exactly as your healthcare professional has told you to.
Overdose:
| If you think you, or a person you are caring for, have taken too much ALBRIOZA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you forget to take one or more doses, skip the missed dose(s) and take your next dose at the normal time and in the normal amount. Do not take more than what is prescribed.
What are possible side effects from using ALBRIOZA?
These are not all the possible side effects you may have when taking ALBRIOZA. If you experience any side effects not listed here, tell your healthcare professional.
- diarrhea
- nausea
- vomiting
- decreased appetite
- weight loss
- stomach pain or discomfort
- flatulence
- fatigue
- dizziness
- drowsiness
- altered sense of taste
- abnormal skin odour
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive), thoughts of death or suicide | X | ||
| Diverticulitis (inflammation in your intestines): left lower stomach pain, fever, nausea, diarrhea, or constipation | X | ||
| Heart problems: irregular or very rapid heart rhythm, fast heartbeat, dizziness, light-headedness | X | ||
| Leukopenia (decreased white blood cells): infections, fatigue, fever, aches, pains and flu-like symptoms | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| Nephrolithiasis (kidney stones): pain in the lower abdomen, pain between the ribs and hip on one side that spreads across the abdomen, back pain, nausea, vomiting, sweating, blood or a stone in the urine | ||
| X | ||
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. |
Storage:
Store ALBRIOZA between 20 - 25°C and protect from moisture.
Keep out of reach and sight of children.
If you want more information about ALBRIOZA:
- 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); or by calling 1-833-606-2574.