Rufinamide

What it is and how it works

Mechanism of Action The precise mechanism(s) by which rufinamide exerts its antiepileptic effect is unknown. The results of in vitro studies suggest that the principal mechanism of action of rufinamide is modulation of the activity of sodium channels and, in particular, prolongation of the inactive state of the channel. Rufinamide (≥ 1 µM) significantly slowed sodium channel recovery from inactivation after a prolonged prepulse in cultured cortical neurons, and limited sustained repetitive firing of sodium-dependent action potentials (EC 50 of 3.8 µM).

Indications

Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults

Dosage and administration (summary)

• Rufinamide oral suspension should be given with food. • Measure oral suspension using provided adapter and dosing syringe Pediatric patients 1 year and older: • Starting daily dose: 10 mg/kg per day in two equally divided doses • Increase by 10 mg/kg increments every other day to maximum dose of 45 mg/kg per day, not to exceed 3200 mg per day, in two divided doses Adults: • Starting daily dose: 400 to 800 mg per day in two equally divided doses • Increase by 400 to 800 mg every other day until a maximum dose of 3200 mg per day, in two divided doses, is reached Dosage Information Pediatric patients (1 year to less than 17 years) The recommended starting daily dose of rufinamide oral suspens…

Contraindications

Rufinamide oral suspension is contraindicated in patients with Familial Short QT syndrome . Rufinamide oral suspension is contraindicated in patients with Familial Short QT syndrome

Warnings and precautions

• Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior • Central nervous system reactions can occur • Use caution when administering rufinamide with other drugs that shorten the QT interval • Discontinue rufinamide if multi-organ hypersensitivity reaction occurs • Withdraw rufinamide gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including rufinamide, increase the risk of suicidal thoughts or behavior in patients taki…

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as rufinamide, during pregnancy. Encourage women who are taking rufinamide during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting h…

Storage and supply

How Supplied Rufinamide oral suspension is a white orange flavored liquid supplied in a polyethylene terephthalate (PET) bottle with child-resistant closure. The oral suspension is packaged with a dispenser set which contains a calibrated oral dosing syringe and an adapter. Store the oral suspension in an upright position.

Source: Rufinamide (Rufinamide) — US FDA prescribing information, 2023-12-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.