Afalino 25 mg

INDICATIONS

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

PHARMACOLOGY

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.

DOSAGE & ADMINISTRATION

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 dailyTitration 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 dailyMaximum 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.

INTERACTION

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

SIDE EFFECTS

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 this drug is rare.

PREGNANCY & LACTATION

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.

PRECAUTIONS & WARNINGS

Potential adverse effects such as Multiorgan hypersensitivity reaction, QT shortening, and Suicidal thoughts. Somnolence and fatigue should be periodically re-evaluated. During cenobamate therapeutic regimen, patients are advised not to drive or operate machinery. Cenobamate 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 Cenobamate with other drugs that shorten the QT intervalSuicidal 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 Cenobamate. Concomitant use with other CNS depressants or alcohol may have additive effects.Withdrawal of Antiepileptic Drugs: Cenobamate should be gradually withdrawn to minimize the potential of increased seizure frequency

USE IN SPECIAL POPULATIONS

Pediatric use: The safety and efficacy of cenobamate in children under 18 years have not yet been established.Geriatric use: Start at the low end of the dosing range.Renal impairment: Cenobamate 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. Cenobamate 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 cenobamate in patients with severe hepatic impairment is not recommended.

THERAPEUTIC CLASS

Adjunct anti-epileptic drugs

STORAGE CONDITIONS

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