Pronunciation:

briv-a-RA-se-tam

Brand Names:

• Briviact

Dosage Forms:

• Tablet
• Solution

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Brivaracetam is used to help control partial onset seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to use it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of brivaracetam in children 1 month of age and older. However, safety and efficacy have not been established in children younger than 1 month of age.

Older adults—

Although appropriate studies on the relationship of age to the effects of brivaracetam have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving brivaracetam.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Calcifediol
• Rifampin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, or history of or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Kidney disease, severe (eg, end-stage) having dialysis—Use is not recommended in patients with this condition.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change your dose without checking first with your doctor.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole with liquid. Do not crush, break, or chew it.

Measure the oral liquid with a marked measuring spoon, dropper, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. You may also take the oral liquid using a nasogastric tube or gastrostomy tube.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution or tablets):
  • For partial onset seizures:
    • Adults and children 16 years of age and older—At first, 50 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 100 mg 2 times a day.
    • Children 1 month to less than 16 years of age—Dose is based on body weight and must be determined by your doctor:
      • Weighing 50 kilograms (kg) or more—At first, 25 to 50 mg 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 100 mg 2 times a day.
      • Weighing 20 kg to less than 50 kg—At first, 0.5 to 1 milligram per kilogram (mg/kg) of body weight 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 2 mg/kg 2 times a day.
      • Weighing 11 kg to less than 20 kg—At first, 0.5 to 1.25 mg/kg of body weight 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 2.5 mg/kg 2 times a day.
      • Weighing less than 11 kg—At first, 0.75 to 1.5 mg/kg of body weight 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 3 mg/kg 2 times a day.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid 5 months after first opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits, especially for the first few months you are taking this medicine to allow for a change in the dose and to check for any unwanted effects.

Brivaracetam may cause changes in mood or behavior, problems with coordination, or unusual tiredness or weakness. Tell your doctor right away if you start to feel depressed, anxious, angry, getting upset easily, restless, or have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you, especially if they are new or getting worse quickly.

This medicine may make you dizzy, drowsy, tired, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including bronchospasm and angioedema. Tell your doctor if you have difficulty in breathing or swallowing, a fever, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, nausea, reddening of the skin, especially around the ears, swelling of the eyes, face, or inside of the nose, or unusual tiredness or weakness.

Do not stop using brivaracetam without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Anxiety

changes in behavior

chest pain or discomfort

deep or fast breathing with dizziness

dizziness or lightheadedness

double vision

drowsiness

dry mouth

general feeling of discomfort or illness

irregular heartbeat

irritability

nausea

numbness of feet, hands, and around mouth

restlessness

seeing double

sensation of spinning

sleepiness or unusual drowsiness

thoughts of killing oneself

trouble sleeping

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusually deep sleep

unusually long duration of sleep

Less common

Shakiness and unsteady walk

uncontrolled eye movements

unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

Cough

difficulty breathing or swallowing

fever

hives

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

noisy breathing

reddening of the skin, especially around the ears

swelling of the eyes, face, or inside of the nose

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Difficulty having a bowel movement

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.