Apo-Brivaracetam: Uses, Side Effects and Dosage

What is APO-BRIVARACETAM used for?

APO-BRIVARACETAM is used in adults, adolescents and children ≥4 years of age with epilepsy to treat partial-onset seizures when taken together with other anti-seizure medicines.

How does APO-BRIVARACETAM work?

APO-BRIVARACETAM works in the brain to block the spread of seizure activity. The precise way that APO-BRIVARACETAM works to treat partial-onset seizures is unknown.

What are the ingredients in APO-BRIVARACETAM?

Medicinal ingredients: brivaracetam

Non-medicinal ingredients: croscarmellose sodium, ferric oxide red (50 mg, 75 mg), ferric oxide yellow (25 mg, 50 mg, 75 mg, 100 mg), iron oxide black (25 mg, 75 mg, 100 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

APO-BRIVARACETAM comes in the following dosage forms:

Tablets: 10 mg, 25 mg, 50 mg, 75 mg and 100 mg

Do not use APO-BRIVARACETAM if:

• you are allergic to brivaracetam or any of the other ingredients of this medicine (listed in section What are the ingredients in APO-BRIVARACETAM?)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-BRIVARACETAM. Talk about any health conditions or problems you may have, including if you:

• have ever had a rash or unusual reaction while taking APO-BRIVARACETAM or any other anti-epileptic drug
• have or have had depression, mood problems or suicidal thoughts or behaviour
• have liver problems. Your healthcare professional may need to adjust the dose.
• have kidney problems
• are allergic to lactose. APO-BRIVARACETAM tablets contain lactose.

• are pregnant or planning to become pregnant. You must only take APO-BRIVARACETAM during pregnancy if your healthcare professional tells you to.

• If you become pregnant while you are taking APO-BRIVARACETAM, ask your healthcare professional about joining the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of anti-epileptic medicine during pregnancy. You can enroll in this registry by calling (888) 233-2334 (toll free). Information on the registry can also be found at: http://www.aedpregnancyregistry.org/;
• are breastfeeding or planning to breastfeed. APO-BRIVARACETAM passes into breast milk. You and your healthcare professional should decide whether you should take APO-BRIVARACETAM or breastfeed, but not both.

Other warnings you should know about:

• New or Worsened Emotional Problems: A small number of people being treated with anti- epileptic medicines such as APO-BRIVARACETAM have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, talk to your healthcare professional immediately.
• Serious Skin Reactions: Serious allergic skin reactions can be caused by anti-epileptic medicines. Get immediate medical help if you develop a rash together with a fever at any point during treatment. This includes skin peeling, itching, redness, and blisters of the lips, eyes, mouth, nasal passages or genitals along with other symptoms such as sore throat, swollen glands, joint pain or any problems related to the liver, kidneys, heart, lungs or other organs.

• Driving and Using Machines: APO-BRIVARACETAM may make you feel dizzy, drowsy and affect your coordination. Do not drive, operate machinery, or engage in other hazardous activities until you know how APO-BRIVARACETAM affects you.

• Serious Allergic Reaction: Taking APO-BRIVARACETAM may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. These allergic reactions can be life-threatening and can cause death. Get immediate medical help if you have: fever, severe rash, hives, swollen lymph glands, swelling of your face, flu-like feeling, yellow skin or eyes, shortness of breath, swelling of the legs, dry cough, chest pain or discomfort, urinating less often, less urine or dark urine.

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 APO-BRIVARACETAM:

• Rifampin, an antibiotic used to treat infections
• Other anti-epileptic medicines including carbamazepine, phenytoin and phenobarbital
• Alcohol. You should not drink alcohol while you are taking APO-BRIVARACETAM. APO-BRIVARACETAM can make the effects of alcohol worse.

How to take APO-BRIVARACETAM:

• Always take APO-BRIVARACETAM exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Do not stop taking APO-BRIVARACETAM without talking to your healthcare professional. Stopping APO-BRIVARACETAM suddenly can cause serious problems, including seizures that will not stop. Your healthcare professional will decide how long you should take APO-BRIVARACETAM.

• Swallow APO-BRIVARACETAM tablets whole with a glass of water. Do not crush or chew the tablets. APO-BRIVARACETAM tablets can be taken with or without food.

Usual dose:

Usual dose for adults, and adolescents and children (aged 4 years and older) weighing 50 kg or more:

• The recommended starting dose for adults is 50 mg twice a day (100 mg/day).
• The recommended starting dose for adolescents and children weighing 50 kg or more is 25 mg twice a day (50 mg/day).
• The dose may be adjusted to between 25 mg twice a day (50 mg/day) and 100 mg twice a day (200 mg/day), to be taken once in the morning and once in the evening at about the same time each day.
• The maximum dose is 100 mg twice a day (200 mg/day).

Usual dose for children and adolescents (aged 4 years and older) weighing less than 50 kg:

• Your healthcare professional will decide on the right dose for your child, depending on their weight.

Overdose:

You may experience dizziness and sleepiness.

If you think you, or a person you are caring for, have taken too much APO-BRIVARACETAM, 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, take it as soon as you remember. Take your next dose at the time you would normally take it. If you are not sure what to do, ask your healthcare professional.

What are possible side effects from using APO-BRIVARACETAM?

These are not all the possible side effects you may have when taking APO-BRIVARACETAM. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Sleepiness/drowsiness
• Feeling tired/fatigue
• Headache
• Dizziness
• Poor coordination
• Nausea, vomiting
• Irritability

Serious side effects and what to do about them

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:

• 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
• Calling toll-free at 1-866-234-2345.

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 APO-BRIVARACETAM at room temperature, 15°C to 30°C.

Keep out of reach and sight of children.

If you want more information about APO-BRIVARACETAM:

• 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 (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: December 19, 2025