Briviact

Treatment of Partial-Onset Seizures

Briviact is primarily used to manage partial-onset seizures, which are seizures that begin in one specific area of the brain. It belongs to a class of drugs known as antiepileptics or anticonvulsants. These medications work by helping to stabilize electrical activity in the brain to prevent or reduce the frequency of seizures.

Patient Populations

This medication is approved for use in a wide range of age groups, including:

• Adults
• Children and infants at least 1 month old

Administration Context

Briviact may be prescribed in different clinical situations depending on the patient's needs:

• It can be used as the sole medication for seizure control or in combination with other antiepileptic drugs.
• It is available in several forms, including tablets, an oral solution, and an intravenous injection.
• The injectable form is typically used in healthcare settings as a short-term alternative when the patient is temporarily unable to take the medication by mouth.

While Briviact helps control seizure activity, it is not a cure for epilepsy. It must be taken regularly as prescribed to remain effective.

Mechanism of Action

Briviact belongs to a class of drugs known as anticonvulsants. It is specifically designed to target and bind to a protein in the brain called synaptic vesicle protein 2A (SV2A).

While the precise way this medication works is not fully established, its interaction with the SV2A protein is believed to play a key role in its effectiveness. This protein is involved in the process of releasing neurotransmitters, which are chemical messengers that allow nerve cells to communicate with one another.

By binding to these proteins, Briviact is thought to help:

• Regulate the release of neurotransmitters in the brain.
• Reduce the abnormal or excessive electrical activity that triggers seizures.
• Stabilize nerve cell communication to prevent the spread of seizure activity.

This process helps to decrease the frequency of partial-onset seizures in patients with epilepsy.

Common Side Effects

The most frequently reported side effects of Briviact include:

• Drowsiness or extreme sleepiness
• Dizziness
• Nausea or vomiting
• Fatigue or feeling weak
• Constipation

Serious Side Effects

Some side effects can be serious and require immediate medical attention. Contact a healthcare provider right away if you experience:

• New or worsening mental health symptoms, such as depression, anxiety, or panic attacks
• Thoughts of self-harm or suicide
• Aggressive behavior, irritability, or agitation
• Hallucinations or loss of contact with reality
• Signs of a severe allergic reaction, including hives, swelling of the face, lips, or throat, and difficulty breathing
• Significant problems with balance, coordination, or walking

Suicidal Behavior and Ideation

Antiepileptic drugs, including Briviact, may increase the risk of suicidal thoughts or behaviors in a small number of people. This risk can appear as early as one week after starting treatment. It is important to monitor for any new or worsening depression, unusual changes in mood or behavior, or thoughts about self-harm.

Neurological Adverse Reactions

Briviact can cause significant neurological symptoms that may impair the ability to perform tasks requiring mental alertness. These effects include:

• Somnolence and Fatigue: Excessive sleepiness and tiredness are common, particularly during the start of treatment or following dose increases.
• Dizziness and Coordination Issues: Some individuals experience dizziness or difficulty with balance and walking (gait disturbances).

Caution is advised when driving or operating heavy machinery until the individual is certain the medication does not adversely affect their performance.

Psychiatric Adverse Reactions

Treatment with Briviact may lead to psychiatric symptoms, which are generally categorized as follows:

• Non-psychotic symptoms: These include irritability, anxiety, nervousness, aggression, and anger.
• Psychotic symptoms: Although less frequent, some individuals may experience hallucinations, paranoia, or other psychotic behaviors.

If these symptoms occur, a healthcare provider may need to adjust the dose or discontinue the medication.

Hypersensitivity

Briviact is contraindicated in patients with a known hypersensitivity to brivaracetam or any of its inactive ingredients. Serious allergic reactions, including anaphylaxis and angioedema (swelling of the face, lips, or tongue), have been reported. If signs of a serious allergic reaction occur, the medication should be stopped immediately and emergency medical care sought.

Withdrawal and Seizure Risk

Briviact should be withdrawn gradually rather than stopped abruptly. Sudden discontinuation of antiepileptic medications can increase the frequency of seizures or lead to status epilepticus, a condition of continuous seizure activity that is a medical emergency.

Pregnancy

The effects of Briviact on human pregnancy are not well-studied. Research in animals has shown that high doses of the medication may cause harm to a developing fetus. Because of the lack of human data, healthcare providers typically only prescribe this medication during pregnancy if the benefit to the mother outweighs the potential risk to the baby.

If you become pregnant while taking Briviact, do not stop taking the medication without consulting your doctor, as uncontrolled seizures can be dangerous for both the mother and the fetus. There is a pregnancy registry available that monitors the health of individuals and their babies who are exposed to antiepileptic drugs during pregnancy.

Breastfeeding

It is currently unknown whether Briviact passes into human breast milk. However, studies in animals have shown that the drug can be present in milk. If you are breastfeeding or planning to breastfeed, discuss the potential risks and benefits with your healthcare provider to determine the best course of action for you and your infant.

Oral Formulations

Briviact is available in two forms for oral administration:

• Tablets: These are film-coated tablets intended to be swallowed whole with liquid.
• Oral Solution: This is a liquid version of the medication.

Injectable Formulation

Briviact is also available as an injection for intravenous administration. This form is typically administered by a healthcare professional in a medical setting, often as a temporary alternative when the medication cannot be taken by mouth.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) first approved Briviact in February 2016. It is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. The medication is available in several forms, including oral tablets, an oral solution, and an injection for intravenous use.

Regulatory Classification

Briviact is classified by the Drug Enforcement Administration (DEA) as a Schedule V controlled substance. This classification is used for drugs that have a lower potential for abuse relative to substances in Schedule IV, but still require monitoring for potential misuse or dependency.

Safety and Monitoring

While Briviact does not carry a boxed warning, the FDA requires the prescribing information to include specific warnings regarding several risks:

• Suicidal Behavior and Ideation: Like other antiepileptic drugs, Briviact may increase the risk of suicidal thoughts or behavior in patients taking the drug for any indication.
• Neurological Adverse Reactions: The medication can cause somnolence (sleepiness), fatigue, dizziness, and coordination difficulties.
• Psychiatric Adverse Reactions: Patients may experience psychiatric symptoms, including irritability, depression, anxiety, or more severe psychotic symptoms.
• Hypersensitivity: Rare but serious allergic reactions, including swelling of the face or throat (angioedema) and hives, have been reported.

There are currently no Risk Evaluation and Mitigation Strategies (REMS) programs required for this medication.

Risks of Abrupt Discontinuation

Stopping Briviact suddenly can lead to serious complications. Antiepileptic drugs should generally be withdrawn gradually to minimize the risk of adverse effects. Potential risks of stopping the medication too quickly include:

• Increased Seizure Frequency: Seizures may return or happen more often than before.
• Status Epilepticus: This is a medical emergency where seizures last a long time or occur so close together that the person does not recover between them.

Gradual Tapering

If treatment with Briviact needs to be stopped, a healthcare provider will usually provide a schedule to slowly decrease the dose. This tapering process is designed to help the body adjust and prevent withdrawal-related seizures. It is important to follow this schedule exactly as prescribed.

Do not change your dose or stop taking Briviact without consulting your doctor, even if you feel better or believe the medication is no longer needed.