Pronunciation:

briv-a-RA-se-tam

Brand Names:

• Briviact

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Brivaracetam injection 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 to be given only by or under the supervision of your doctor.

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 injection 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 injection 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 injection.

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 receiving 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
• Carbamazepine
• 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:

A nurse or other trained health professional will give you this medicine in a hospital. Brivaracetam is given through a needle that is placed in one of your veins.

Once your condition improves, your doctor will switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

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

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for 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, or angry, getting upset easily, restless, or if you 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 cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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 sex organs, 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 interrupt or stop receiving this medicine without checking first with your doctor. 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 or nurse immediately if any of the following side effects occur:

More common

Anxiety

changes in behavior

chest pain or discomfort

dizziness or lightheadedness

double vision

drowsiness

dry mouth

general feeling of discomfort or illness

hyperventilation

irregular heartbeats

irritability

lack or loss of strength

loss of balance control

nausea

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

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

uncontrolled eye movements

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 sex organs

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

Change in taste

difficulty having a bowel movement (stool)

loss of taste

pain at the injection site

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.