Brivlera

The usual starting dose of Brivlera (Brivaracetam) for adults is 50 mg taken by mouth, 2 times a day. Depending on how well it works and how you react to it, your doctor may gradually increase the dose to a maximum of 100 mg taken 2 times a day.

The dose of Brivlera (Brivaracetam) for children and adolescents is based on the child's weight, and will be calculated by your doctor. The medication is taken by mouth and divided into two doses, spaced approximately 12 hours apart.

Brivlera (Brivaracetam) may be taken with or without food.

The tablets should be swallowed whole with liquid. Do not chew or crush them. If you are using the liquid, use an oral syringe to measure each dose, as it gives a more accurate measurement than household teaspoons.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Brivlera (Brivaracetam) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Brivlera (Brivaracetam) at room temperature, protect it from light and moisture, and keep it out of the reach of children. Store the liquid in its original container. Any oral liquid left 5 months after opening the bottle should be safely disposed of and a fresh supply started.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause drowsiness or dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may affect your mood; it can affect your balance; it can cause dizziness. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Tablets

10 mg
Each white-to-off-white, round, film-coated tablet debossed with "u10" on one side contains 10 mg of Brivlera (Brivaracetam). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, polyvinyl alcohol, talc, Polyethylene Glycol 3350, and titanium dioxide.

25 mg
Each grey, oval, film-coated tablet, debossed with "u25" on one side contains 25 mg of Brivlera (Brivaracetam). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, and black iron oxide.

50 mg
Each yellow, oval, film-coated tablet, debossed with "u50" on one side contains 50 mg of Brivlera (Brivaracetam). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, and red iron oxide.

75 mg
Each purple, oval, film-coated tablet debossed with "u75" on one side contains 75 mg of Brivlera (Brivaracetam). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, and black iron oxide.

100 mg
Each green-grey, oval, film-coated tablet debossed with "u100" on one side contains 100 mg of Brivlera (Brivaracetam). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, and black iron oxide.

Oral Solution
Each 1 mL of slightly viscous, clear, colorless-to-yellowish, raspberry-flavoured liquid contains 10 mg of Brivlera (Brivaracetam). Nonmedicinal ingredients: sodium citrate anhydrous citric acid, methylparaben, carboxymethylcellulose sodium, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water.

Injection
Each 1 mL of clear, colorless, sterile solution contains 10 mg of Brivlera (Brivaracetam). Nonmedicinal ingredients: sodium acetate (trihydrate), glacial acetic acid, sodium chloride, and water for injection.

Do not take Brivlera (Brivaracetam) if you are allergic to Brivlera (Brivaracetam) or any ingredients of the medication.

There may be an interaction between Brivlera (Brivaracetam) and any of the following:

• alcohol
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• azelastine
• barbiturates (e.g., butalbital, pentobarbital, Phenobarbital)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• brimonidine
• Buprenorphine
• Butorphanol
• Buspirone
• cannabis
• chloral hydrate
• Clonidine
• Dabrafenib
• efavirenz
• Entacapone
• Enzalutamide
• Flibanserin
• fluconazole
• Guanfacine
• lumacaftor and Ivacaftor
• Mefloquine
• Methadone
• Metoclopramide
• Mirtazapine
• Moclobemide
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Orlistat
• Pramipexole
• rifampin
• Ropinirole
• Rotigotine
• scopolamine
• other seizure medications (e.g., Carbamazepine, Clobazam, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline)
• sodium oxybate
• Stiripentol
• Tapentadol
• thalidomide
• tolcapone
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Clomipramine, Desipramine, Imipramine)
• Voriconazole
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Brivlera (Brivaracetam). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Brivlera (Brivaracetam).

Behaviour changes: Behaviour changes may occur with many medications used to treat seizures. Some people have reported changes in behaviour associated with taking Brivlera (Brivaracetam). There have been occasional reports of aggressive behaviour or hostility, anxiousness, disorientation, or decreased memory. These behaviour changes appear to be more common for children taking Brivlera (Brivaracetam). If you experience any of these effects or notice them in a family member who is taking Brivlera (Brivaracetam), contact your doctor as soon as possible.

Dizziness and drowsiness: Brivlera (Brivaracetam) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Brivlera (Brivaracetam).

Hypersensitivity syndrome: A Anaphylaxis (severe allergic reaction) called hypersensitivity syndrome has occurred for some people with the use of Brivlera (Brivaracetam). Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Infection: Brivlera (Brivaracetam) can reduce the number of cells that fight infection in the body (white blood cells). If you experience fever, sore throat, fatigue, weakness, or generally feel unwell while taking Brivlera (Brivaracetam), contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: There is little information available regarding the effect of decreased kidney function on Brivlera (Brivaracetam). If you have decreased kidney function or Kidney Disease, discuss with your doctor how Brivlera (Brivaracetam) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Brivlera (Brivaracetam), and whether any special monitoring is needed. Brivlera (Brivaracetam) is not recommended for people with end-stage renal disease who are being treated with dialysis.

Liver function: Liver disease or reduced liver function may cause Brivlera (Brivaracetam) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Brivlera (Brivaracetam) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Brivlera (Brivaracetam), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Brivlera (Brivaracetam).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Mental health: In addition to behaviour changes, some people taking Brivlera (Brivaracetam) experience symptoms of psychosis and Depression. Some psychotic behaviours include experiencing hallucinations, having delusions (believing things to be something they aren't) and paranoia. People with depression often find they have poor concentration, changes in weight or sleep and they no longer find pleasure in things they used to enjoy. If you experience any of these, or notice these changes in a family member or friend, talk to your doctor.

Stopping the medication: Stopping Brivlera (Brivaracetam) suddenly may cause an increase in frequency or length of seizures. Before stopping Brivlera (Brivaracetam), talk to your doctor about the best way to gradually decrease the dose, to avoid these problems.

Suicidal thoughts and behaviour: Occasionally, people taking medications to treat seizures may experience thoughts of suicide. If you experience these symptoms or any other behaviour change while taking Brivlera (Brivaracetam), contact your doctor immediately. Family members or caregivers for people who are taking Brivlera (Brivaracetam) should contact the person's doctor immediately if they notice unusual behaviour changes.

Pregnancy: There is no information available regarding the safety and effectiveness of Brivlera (Brivaracetam) if it is taken during pregnancy. Brivlera (Brivaracetam) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Brivlera (Brivaracetam), contact your doctor immediately.

Breast-feeding: It is not known if Brivlera (Brivaracetam) passes into breast milk. If you are breast-feeding and are taking Brivlera (Brivaracetam), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Brivlera (Brivaracetam) have not been established for children under 4 years old.

This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. It is not advisable to stop using this product suddenly, particularly if you have been on it for several weeks. If you are considering stopping the medication, talk to your pharmacist first. If you forget a dose, contact your pharmacist. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. This medication may be taken with or without food. Consuming alcohol may intensify the effect of this product. Limit alcohol consumption to occasional small quantities.