Cenomate
Cheaper & Alternative Brands
Same generic (Cenobamate), same form (Tablet)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Afalino is indicated for the treatment of partial-onset seizures in adult patients.
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 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.
Contraindications
Cenobamate is contraindicated in patients with a known-
Hypersensitivity to either Cenobamate or to any excipients in Cenobamate.
Familial Short QT syndrome
Side Effects & Adverse Reactions
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.
Warnings & Precautions
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 Afalino should be gradually withdrawn to minimize the potential or increased seizure frequency.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Withdrawal of Antiepileptic Drugs: Afalino should be gradually withdrawn to minimize the potential of increased seizure frequency
Pharmacology & Mechanism of Action
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.