VAROCETAM 100 MG ( BRIVARACETAM ) 21 FILM-COATED TABLETS

Varocetam® (Brivaracetam 100 mg) Film-Coated Tablets

Active Ingredient: Brivaracetam 100 mg
Dosage Form: Film-coated tablets
Pack Size: 3 strips × 7 film-coated tablets (21 tablets)
Manufacturer: GYPTO PHARMA

Medical Description

Varocetam contains brivaracetam, a highly selective antiepileptic drug (AED) indicated primarily for the treatment of focal-onset (partial-onset) seizures, with or without secondary generalization. Brivaracetam belongs to the racetam class of antiepileptic medications and acts by selectively binding to Synaptic Vesicle Protein 2A (SV2A) in the brain, thereby modulating neurotransmitter release and reducing abnormal neuronal hyperexcitability responsible for seizures.

Compared with its predecessor levetiracetam, brivaracetam demonstrates 15–30 times greater affinity for SV2A, allowing potent antiseizure activity with rapid brain penetration and a favorable pharmacokinetic profile. Clinical studies have shown that brivaracetam effectively reduces seizure frequency while exhibiting relatively low potential for clinically significant drug interactions.

Brivaracetam may be used:

• As monotherapy (where approved)
• As adjunctive therapy in patients whose seizures are not adequately controlled by other antiepileptic medications.

Mechanism of Action

Brivaracetam:

• Selectively binds to Synaptic Vesicle Protein 2A (SV2A)
• Regulates synaptic neurotransmitter release
• Stabilizes neuronal electrical activity
• Suppresses abnormal hypersynchronous firing responsible for epileptic seizures
• Does not significantly affect sodium channels or GABA receptors at therapeutic doses.

FDA-Approved Indications

Brivaracetam is approved for:

• Treatment of focal-onset seizures in:
  • Adults
  • Pediatric patients (age approval depends on formulation and regulatory authority)

Some countries also approve:

• Oral tablets
• Oral solution
• Intravenous injection when oral therapy is temporarily unavailable.

→Adult Use

Indicated for

• Newly diagnosed focal epilepsy (where approved)
• Adjunctive treatment of uncontrolled focal seizures
• Patients switching from levetiracetam because of behavioral adverse effects (clinical practice experience)

Typical Adult Dose

Initial dose:

• 50 mg twice daily (100 mg/day)

Dose range:

• 25–100 mg twice daily
• Maximum:
  • 200 mg/day

Dose adjustment depends on:

• Clinical response
• Tolerability
• Hepatic function

→Pediatric Use

Brivaracetam is approved in many countries for pediatric patients.

Typical dosing is weight-based:

Children:

• Approximately 1–4 mg/kg/day
• Divided into two doses

Maximum dose follows regulatory labeling according to body weight.

Safety and efficacy have been demonstrated in pediatric focal epilepsy in several randomized and observational studies.

Clinical Benefits

Clinical trials demonstrate that brivaracetam:

• Reduces monthly seizure frequency
• Increases seizure-free intervals
• Improves seizure control in refractory epilepsy
• Has rapid onset of action
• Can be switched directly from levetiracetam in selected patients
• Shows relati  vely favorable neuropsychiatric tolerability in many patients

Pharmacokinetics

Absorption

• Rapid
• Oral bioavailability approximately 100%

Peak plasma concentration

• About 1 hour after oral administration

Protein binding

• Less than 20%

Half-life

• Approximately 9 hours

Metabolism

• Mainly hepatic
• Hydrolysis
• CYP2C19 contributes partially

Excretion

• Primarily renal as inactive metabolites

Administration

• May be taken with or without food
• Swallow tablets whole with water
• Take at the same time every day
• Do not discontinue abruptly without physician supervision because seizure frequency may increase.

►Common Adverse Effects

Most frequently reported:

• Drowsiness
• Dizziness
• Fatigue
• Nausea
• Somnolence
• Headache

Usually mild to moderate and often improve with continued therapy.

►Serious Adverse Effects

Although uncommon:

• Suicidal thoughts or behavior
• Depression
• Anxiety
• Aggression
• Mood changes
• Severe hypersensitivity reactions
• Angioedema
• Severe dizziness leading to falls

Patients and caregivers should promptly report significant behavioral or psychiatric changes.

►Contraindications

Do not use in patients with:

• Known hypersensitivity to brivaracetam
• Hypersensitivity to other pyrrolidone derivatives

►Warnings and Precautions

Use cautiously in patients with:

• Severe liver disease
• History of depression
• Previous suicidal behavior
• Psychiatric disorders
• Alcohol abuse

Avoid abrupt withdrawal because it may precipitate breakthrough seizures.

Driving or operating machinery should be avoided until the patient's individual response is known.

►Drug Interactions

Brivaracetam has relatively few clinically significant interactions.

Potential interactions include:

Rifampin

May significantly decrease brivaracetam concentrations.

Carbamazepine

May increase carbamazepine-epoxide levels.

Alcohol

May enhance CNS depression.

Other CNS depressants

Can increase dizziness and sedation.

►Pregnancy

Available human data remain limited.

Current evidence does not demonstrate a major increase in congenital malformations, but treatment decisions should balance maternal seizure control with fetal safety.

Women planning pregnancy should consult their neurologist before making any medication changes.

►Breastfeeding

Brivaracetam is excreted into breast milk.

The benefits of breastfeeding should be weighed against the potential exposure of the infant. Clinical monitoring of the infant is advised.

►Use in Hepatic Impairment

Dose reduction is recommended in all stages of hepatic impairment.

►Renal Impairment

Generally, no dose adjustment is required for mild-to-moderate renal impairment.

Clinical experience in end-stage renal disease is limited.

Monitoring

Patients should be monitored for:

• Seizure frequency
• Treatment response
• Behavioral or mood changes
• Suicidal ideation
• Adverse effects
• Liver function when clinically indicated

Routine serum drug level monitoring is generally not required.

Storage

• Store below 25–30°C according to local product labeling.
• Protect from moisture and excessive heat.
• Keep out of reach of children.

Evidence Supporting Brivaracetam

High-quality evidence supports the efficacy and safety of brivaracetam:

• Multiple randomized controlled trials published in Neurology, Epilepsia, and other peer-reviewed journals demonstrated significant reductions in focal seizure frequency compared with placebo.
• Systematic reviews and meta-analyses, including Cochrane analyses, conclude that adjunctive brivaracetam is effective for drug-resistant focal epilepsy, with acceptable tolerability.
• Regulatory approvals by the U.S. FDA and European Medicines Agency (EMA) are based on robust Phase III clinical trials.
• Brivaracetam is incorporated into contemporary epilepsy treatment recommendations from organizations such as the International League Against Epilepsy (ILAE) and is discussed in trusted clinical references including UpToDate, Merck Manual, and Medscape.

Key Counseling Points for Patients

• Take the medication exactly as prescribed.
• Do not stop taking brivaracetam suddenly.
• If you miss a dose, take it as soon as remembered unless it is nearly time for your next dose. Do not double the dose.
• Inform your healthcare provider if you experience mood changes, depression, or suicidal thoughts.
• Avoid alcohol and use caution with activities requiring alertness until you know how the medication affects you.
• Inform your physician about all prescription medications, over-the-counter products, and herbal supplements you are taking.

Patient Disclaimer

This information is intended for educational purposes only and should not replace professional medical advice. Varocetam® (Brivaracetam) should only be used under the supervision of a qualified healthcare provider. Do not start, stop, or change the dose of this medication without consulting your physician. Seek immediate medical attention if severe allergic reactions, worsening seizures, unusual mood changes, or suicidal thoughts occur. Always read the patient information leaflet provided with your medication for complete prescribing information.

References

1. U.S. Food and Drug Administration (FDA). Briviact® (Brivaracetam) Prescribing Information.
2. National Institutes of Health (NIH). DailyMed: Brivaracetam.
3. International League Against Epilepsy (ILAE). Recommendations for the management of focal epilepsy.
4. Cochrane Database of Systematic Reviews. Brivaracetam add-on therapy for drug-resistant focal epilepsy.
5. Kwan P, et al. Treatment of epilepsy. The Lancet.
6. Klein P, et al. Randomized Phase III trials of brivaracetam in focal epilepsy. Neurology / Epilepsia.
7. French JA, et al. Clinical studies of brivaracetam in focal seizures. Epilepsia.
8. Merck Manual Professional Edition. Epilepsy and Antiseizure Medications.
9. UpToDate. Brivaracetam: Drug Information.
10. Medscape Reference. Brivaracetam Monograph.

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