Afalino Tablet

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

Cenobamate is a positive GABA-A modulator which inhibits voltage-gated sodium channels. Inhibition of voltage-gated sodium channels increases the threshold for generating action potentials and decreases the number of action potentials. Its dual, complementary mechanisms of action may contribute to superior anti-seizure activity.

Cenobamate can be taken with or without food, or as recommended by a physician. 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: If needed based on clinical response and tolerability, the dose may be increased above 200 mg by increments of 50 mg once daily every two weeks to 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

Common: Somnolence, fatigue, dizziness or feeling sleepy, nausea, constipation, double vision, decreased appetite, diarrhea, or weakness may occur.

Rare: A very serious allergic reaction to Afalino is rare.

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.

Potential adverse effects such as Multiorgan hypersensitivity reaction, QT shortening, and Suicidal thoughts. Somnolence and fatigue should be periodically re-evaluated. During Afalino therapeutic regimen, patients are advised not to drive or operate machinery. Afalino should be gradually withdrawn to minimize the potential or increased seizure frequency.

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: The safety and efficacy of Afalino in children under 18 years have not yet been established.

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

Renal impairment: Afalino should be used with caution and reduction of the target dose may be considered in patients with mild to moderate (creatinine clearance 30 to <90 ml/min) or severe (creatinine clearance <30 ml/min) renal impairment. The maximum recommended dose for patients with mild, moderate, or severe renal impairment is 300 mg/day. Afalino should not be used in patients with end-stage renal disease or patients undergoing hemodialysis.

Hepatic impairment: Use with caution in patients with mild to moderate hepatic impairment: lower maximum dose and additional dose reduction may be considered. The use of Afalino in patients with severe hepatic impairment is not recommended.

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.