Brivaracetam

How to take:

Take brivaracetam exactly as your health care provider prescribes it. Do not change your dose without talking to your provider first. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus). 

• Check the number of tablets and the strength of the pills you get from the pharmacy. If your provider changes your dose, the strength of pills may be different. 
• Brivaracetam is usually taken twice a day.
• Swallow the tablets whole - do not bite or chew them.
• It can be taken with or without food, but it's best to take it the same way every day.
• For the liquid form, always check the bottle for the amount to take and the strength. Brivaracetam liquid comes as 10 mg for each ml.
  • Shake the bottle well before measuring a dose.
  • Always use an accurate measuring spoon or syringe to make sure the amount is correct. Do not use a regular teaspoon.
• Take only the amount that your provider tells you to take. If you take an extra dose, call your provider for advice. If you take a larger number of pills or overdose, call the poison control center (800-222-1222) or call your hospital emergency room.

How to store:

• Store at room temperature (below 86^oF, 30^oC)l.
• Keep away from light and moisture.
• Keep all medicines out of reach of children.

Taking the right amount of seizure medicine on time every day is the most important way to control seizures. Try these steps to help you remember when to take brivaracetam.

• If you miss a dose, take it as soon as you remember it.
• If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. 
• Avoid taking 2 doses at the same time or taking extra doses. 
• If you are not sure about what to do, call your provider's office for advice. Do your best to follow their directions.
• To avoid missed doses, use a pillbox or to set an alarm on your watch or on phone.
• Use an online seizure diary or text message system like Texting 4 Control to send you reminders of when to take medicines. 
• Write down any missed doses in your seizure calendar. Share this with your health care provider at each visit.

Brain cells normally talk to each other using electrical signals and chemicals. Seizures can happen when the brain cells are not working or firing normally or working faster than normal. Most seizure medicines slow down these electrical discharges to stop seizures. 

• Brivaracetam works differently from most seizure medicines. It joins with a protein (called SV2A) that is involved with the release of certain chemicals called neurotransmitters in the brain. The exact way that these actions lead to decreased seizures is not fully known. 

• Dizziness
• Feeling tired or sleepy
• Nausea and vomiting

Suicidal thoughts and behavior: In 2008, the Food and Drug Administration (FDA) reviewed data from drug studies that showed a possible relationship between many seizure medicines and suicidal thoughts and behavior. Together, these thoughts and behavior are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance - 3.5 of 1,000 people taking a seizure medicine had suicidality compared to 1 of 1,000 people taking a placebo.

• Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
• Do not make any changes to the medicines without first talking to the prescribing health care provider.
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions
• Contact your health care provider before stopping any seizure meicine. This could possibly lead to worsening of seizure and mood. 

Thinning of the bones (osteopenia) or bone loss (osteoporosis) has been seen in some men and women taking certain seizure medicines. The impact of brivaracetam on bone health is not known. 

• People taking seizure medicine should talk to their health care team about the use of calcium, vitamin D, and exerise to help strengthen bones. 
• Blood tests and a test to check the strength of your bones may be recommended.

Do not take brivaracetam if your are allergic to this medicine or to any of its inactive ingredients (see packet insert for listing).

How the body absorbs, digests, and gets rid of a medicine or food is called metabolism. The way the body metabolizes a medicine affects how often it should be taken and if it will interact with other medicines or food. Some medical conditions such as liver disease or kidney probems can affect how the body handles a medicine.

• Brivaracetam is primarily eliminated or broken down by the liver.

All seizure medications may not work for everyone. Your health care provider may try a series of seizure medicines or more than one at a time to find one that works best for you.

Currently there are no other known uses for brivaracetam beyond seizure control.

Sometimes one kind of medicine changes the way another kind of medicine works in the body. This can happen with prescription and over-the-counter medicines, herbal products, vitamins, and some foods. Tell your health care team any time a new medicine is given to you or any time you take other products or substances. 

• Brivaracetam does not seem to interact with other medications, but it may be less effective when it is taken with levetiracetam.

Brivaracetam is FDA approved for use for treatment of focal (partial) seizures in children down to 1 month of age. This approval was based on safety data in children down to 1 month in age, and seizure outcome data from individuals 16 and above, based on the understanding that focal seizures in younger children are likely to respond to treatment similarly to seizures in adolescents and adults.

Effect of seizure medicines during pregnancy: In the United States, the FDA assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Brivatracetam is listed in Pregnancy Category C. This means that caution is advised, but the benefits of the medicine may outweigh the potential risks.

• Studies in animals show possible harmful effects of brivatracetam to the developing fetus. Yet this needs to be studied in humans as more women use the drug.
• Talk to your health are providers if you are pregnant or plan to become pregnant.
• The risk of birth defects is generally higher in children of women who:
  • Take more than one seizure medicine at the same time
  • Have a family history of birth defects

All women who are capable of becoming pregnant should take at least 0.4 mg (400 mcg) each day of the vitamin called folic acid (also called folate). This vitamin is thought to help prevent birth defects affecting the brain and spinal cord, called neural tube defects. The most common of these is known as spina bifida.  

• Women at high risk of having a child with a birth defect (such as those with a birth defect in a previous pregnancy or taking certain seizure medicines) may be asked to take 4 mg (4000 mcg) daily before and during pregnancy. 
• Talk to your health care provider about using folic acid and how much to take.
• Start taking this vitamin before you become pregnant. 

If you were taking brivaracetam while pregnant, consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 (www.aedpregnancyregistry.org).

Seizures during pregnancy: Some women may have more seizures during pregnancy, because of hormone changes and how seizure medicine is handled by your body. 

• Talk to your health care provider before pregnancy about seizures and if medicine changes may be needed.
• Know when to check blood levels of medicine during and after pregnancy.
• The dose of seizure medicine may need to be adjusted during and after pregnancy. 

Breastfeeding: Brivatracetam is found in breast milk in animal studies. No information is available on brivatracetam in a woman's breast milk.

• Women who wish to breastfeed should talk to their doctor about the best medicine to use during pregnancy and when breastfeeding.
• If you choose to breastfeed, have the baby followed closely by a health care professional. Check the baby for drowsiness and keep track of their weight gain and development, especially if you are taking more than one seizure medicine.
• Talk to your health care team about any concerns that arise and the benefits and risks of breastfeeding.

Contraception: There are no known interactions of brivatracetam with hormonal birth control.

No concerns have been noted when brivaracetam has been used in older adults.

The best amount of any seizure medicine is the amount that controls seizures without causing bothersome side effects. This depends on many factors, which are different for every individual.

The recommended starting dose of brivatracetam is 50mg twice a day. Depending on how well the medicine is tolerated the dose can be lowered to 25mg twice a day or increased to 200mg twice a day.

This is not yet known.