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Banzel (Rufinamide) Information

Banzel (rufinamide) is an oral anticonvulsant medication used as an adjunctive therapy (added on to other treatments) for seizures associated with Lennox-Gastaut Syndrome (LGS) in adults and pediatric patients 1 year of age and older. LGS is a severe form of epilepsy characterized by multiple types of seizures, cognitive dysfunction, and a poorly formed electroencephalogram (EEG). Rufinamide's approval is specifically targeted to this challenging syndrome, helping to reduce the frequency of drop seizures and other seizure types associated with LGS. It is not generally used as a first-line treatment for other, more common forms of epilepsy. Its efficacy and safety have been established through clinical trials focusing on patients with this rare and debilitating condition.

The precise mechanism by which rufinamide exerts its anti-seizure effect is not fully understood. However, its primary action is believed to involve the sodium channel. Rufinamide prolongs the inactive state of voltage-gated sodium channels, particularly the slow-inactivating component, which is thought to stabilize hyperexcitable neuronal membranes. By limiting the sustained, repetitive firing of neurons, the drug helps to dampen the excessive electrical activity in the brain that causes seizures. This mechanism is distinct from many other anticonvulsants, making it a valuable addition to combination therapy for complex seizure disorders like LGS. Banzel is available as a prescription-only medication in both oral tablet and oral suspension forms. Dosing is often weight-based in children and must always begin at a low dose, gradually titrated (increased) over several weeks.

Banzel Side Effects

While Banzel is an effective treatment for LGS-associated seizures, it can cause various side effects. The most commonly reported side effects, especially during the initial titration phase, are generally mild to moderate and often subside with continued treatment. These common effects include dizziness, fatigue, headache, nausea, vomiting, somnolence (sleepiness), diplopia (double vision), tremor, anorexia (loss of appetite), and weight decrease. In pediatric patients, upper respiratory tract infections are also commonly reported. However, more serious side effects can occur, although they are rare. If any of the following symptoms are experienced, the patient should stop taking the medication and seek immediate medical attention:

• Seizure Worsening/Status Epilepticus: Although used to treat seizures, rufinamide can, in rare cases, increase seizure frequency or severity, which should be reported immediately.

• Severe Hypersensitivity Reactions (DRESS): This includes Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), which is a rare but severe and potentially life-threatening reaction. Symptoms may consist of a widespread skin rash, fever, swollen lymph nodes, and involvement of internal organs (e.g., liver, kidneys). Other severe reactions like Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) are also possible.

• Shortening of the QT Interval: Rufinamide is associated with a dose-related shortening of the QT interval on an electrocardiogram (ECG). While generally mild, caution is needed in patients with a history of heart issues.

• Suicidal Behaviour and Ideation (Boxed Warning): Antiepileptic drugs (AEDs), including rufinamide, carry a strong warning regarding an increased risk of suicidal thoughts or behaviour. This risk should be carefully monitored, especially during the first few months of treatment or following dose adjustments.

Banzel Precautions

Before starting Banzel, patients and caregivers must inform their healthcare provider of all existing medical conditions, especially a personal or family history of depression, suicidal thoughts, or mood problems. It is crucial to discuss all medications, as rufinamide can have significant drug interactions. Hepatic enzymes metabolize Rufinamide and can both induce and inhibit specific cytochrome P450 enzymes. It may decrease the concentration of hormonal contraceptives, rendering them less effective, necessitating the use of alternative or backup birth control. It can also decrease the concentration of some other antiepileptic drugs (AEDs), potentially reducing their effectiveness and requiring an increase in their dosage. Since rufinamide can cause dizziness and somnolence, patients should be cautioned about operating machinery or driving until they know how the drug affects them. Abrupt discontinuation of rufinamide is forbidden, as it can increase seizure frequency and potentially lead to status epilepticus. All changes in dose must be done gradually and under the supervision of a physician. The drug has been associated with decreased white blood cell counts, and blood cell counts should be monitored periodically during treatment.

Do I need a prescription to order Banzel?

Yes, a prescription is required from your physician to order Banzel.