Brivaracetam, Oral/Injection

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KEY POINTS

• This medicine is taken by mouth to treat partial-onset seizures in people with epilepsy. Take it exactly as directed. Carry some form of identification stating that you have seizures and are taking an antiseizure medicine.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiseizure

Generic and brand names: brivaracetam, oral; Briviact; brivaracetam, injection; Briviact Injection

What is this medicine used for?

This medicine is taken by mouth along with other medicines to treat partial-onset seizures in people with epilepsy.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Depression or thoughts of suicide
• Liver problems
• Problems with alcohol or drug abuse

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Contact your healthcare provider right away if you become pregnant while taking this medicine. You and your healthcare provider should decide if you should continue taking this medicine while you are pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not change your dosage or stop taking this medicine without your healthcare provider's approval. Your healthcare provider will reduce your dosage gradually. If you stop taking the medicine too quickly, you may have more seizures or constant seizures (status epilepticus).

This medicine comes in the form of tablets, oral solution, or an IV given by a healthcare provider.

If you have the tablets, swallow them whole. Do not crush or chew them.

If you take the oral solution, use a specially marked measuring device to measure each dose. The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist if you have any questions about how to use the oral solution.

Check with your healthcare provider before using this medicine in children under 16.

You may take this medicine with or without food. Take it with water unless your healthcare provider tells you otherwise.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, dizziness, restlessness, vision problems, aggression, slowed breathing, slow heartbeat, trouble walking, lack of coordination, nausea, coma.

What should I watch out for?

Antiseizure medicines may increase suicidal thoughts or actions in some people. Call your healthcare provider right away if you have any new or unusual changes in mood, thoughts, behavior, or thoughts of suicide.

Rarely, this medicine may cause hallucinations (seeing or hearing things that are not there), anxiety, hostility, or other severe emotional or mental changes. Contact your healthcare provider if you have any of these problems.

This medicine may make you drowsy or dizzy. It can also affect your coordination and reflexes. Do not drive or operate machinery unless you are fully alert.

This medicine increases the effects of alcohol and other medicines that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Your healthcare provider may want to check you regularly to see how this medicine affects you. Keep all appointments.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you may need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): New or worsening depression; thoughts of suicide; hallucinations (seeing or hearing things that are not there); anxiety; irritability; unusual thoughts or behavior; unusual mood changes; trouble sleeping; unexplained fever, cough, or sore throat; loss of coordination; trouble walking; severe drowsiness or dizziness; vision problems; unusual tiredness or weakness.

Other: Mild drowsiness, mild dizziness, mild tiredness, nausea, vomiting, constipation.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as isoniazid and rifampin (Rifadin)
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and meclizine (Dramamine)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, pimozide (Orap), thioridazine, and trifluoperazine
• Cancer medicines such as abiraterone (Zytiga) and bortezomib (Velcade)
• Doxepin (Silenor)
• Gemfibrozil (Lopid)
• HIV medicines such as delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), and lopinavir/ritonavir (Kaletra)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), and omeprazole (Prilosec)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), meperidine (Demerol), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Natural remedies such as evening primrose, ginkgo, gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Nicardipine (Cardene)
• Other antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), ethosuximide (Zarontin), felbamate (Felbatol), fosphenytoin (Cerebyx), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), methsuximide (Celontin), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), rufinamide (Banzel), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), valproic acid (Depacon, Depakene, Depakote), vigabatrin (Sabril), and zonisamide (Zonegran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), phenobarbital, suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. If you have the oral solution, discard the bottle 5 months after you open it, even if there is medicine left in the bottle.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.