Afalino Tablet

Afalino is indicated for the treatment of partial-onset seizures in adult patients.

The precise mechanism by which Cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.

Recommended Dosage for Partial-Onset Seizures in Adult-

Initial Dosage: For Week 1 and 2 dose is 12.5 mg once daily

Titration Regimen:

• For Week 3 and 4 dose is 25 mg once daily
• For Week 5 and 6 dose is 50 mg once daily
• For Week 7 and 8 dose is 100 mg once daily
• For Week 9 and 10 dose is 150 mg once daily

Maintenance Dosage: For Week 11 and thereafter dose is 200 mg once daily

Maximum Dosage: Dose is 400 mg once daily

• Phenytoin: Gradually decrease phenytoin dosage by up to 50%
• Phenobarbital and Clobazam: Reduce dosage as needed when used concomitantly with Afalino.
• Lamotrigine, Carbamazepine: Increase dosage as needed when used concomitantly with Afalino.
• CYP2B6 and CYP3A Substrates: Increase dosage as needed when used concomitantly with Afalino.
• CYP2C19 Substrates: Reduce dosage as needed when used concomitantly with Afalino.
• Oral Contraceptives: Effectiveness of hormonal oral contraceptives may be reduced when administered concomitantly with Afalino. Women should use additional or alternative non-hormonal birth control

Cenobamate is contraindicated in patients with a known-

• Hypersensitivity to either Cenobamate or to any excipients in Cenobamate.
• Familial Short QT syndrome

The most common side-effects of Afalino include-somnolence, dizziness, fatigue, diplopia, headache etc.

There are no adequate and well-controlled studies in pregnant women with the use of Cenobamate. But it may cause fetal harm when administered to a pregnant woman. It should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. There are no data on the presence of Cenobamate in human milk, the effects of Cenobamate on the breastfed infant, or the effects of Cenobamate on milk production.

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) / Multi-Organ Hypersensitivity: Discontinue if no alternate etiology.
• QT Shortening: Use caution when administering Afalino with other drugs that shorten the QT interval
• Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation.
• Neurological Adverse Reactions: Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on Afalino. Concomitant use with other CNS depressants or alcohol may have additive effects.
• Withdrawal of Antiepileptic Drugs: Afalino should be gradually withdrawn to minimize the potential of increased seizure frequency

Pediatric use: Safety and effectiveness of Afalino has not been established in pediatric patients.

Geriatric use: Start at the low end of the dosing range.

Renal impairment: Afalino should be used with caution and dosage reduction may be considered in patients with mild to moderate (CLcr 30 to less than 90 mL/min) and severe (CLcr less than 30 mL/min) renal impairment. Use in patients with end-stage renal disease undergoing dialysis is not recommended.

Hepatic impairment: Afalino should be used with caution and in patients with mild to moderate hepatic impairment.

In the event of overdose, Afalino should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved.

Adjunct anti-epileptic drugs

Do not store above 30 degree C. Keep away from light and out of the reach of children.