Rufinamide

What is Rufinamide?

• Rufinamide (Banzel) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs) used with other medicines to treat seizures associated with Lennox-Gastaut Syndrome (LGS).

Rufinamide

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Rufinamide

What are the uses of this medicine?

• Rufinamide (Banzel) is a prescription medicine used with other medicines to treat seizures associated with Lennox-Gastaut Syndrome (LGS) in adults and pediatric patients 1 year of age and older.

How does this medicine work?

• Rufinamide (roo fin' a mide) is a unique triazole derivative that appears to act by prolonging the inactivation of voltage gated sodium channels in the central nervous system, thus slowing the rate of neurotransmission and decreasing rapid, repetitive neuronal firing.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a genetic condition called familial short QT syndrome, a problem that affects the electrical system of the heart.

What drug interactions can this medicine cause?

• Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults).
• Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception.

Is this medicine FDA approved?

• Rufinamide was approved for use in the United States in 2008 as an anticonvulsant to be used in combination with other agents (adjunctive therapy) for Lennox-Gastaut syndrome in adults and children 1 year of age and older.

How should this medicine be used?

Recommended dosage: 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: 400-800 mg per day in two equally divided doses.
• Increase by 400-800 mg every other day until a maximum dose of 3200 mg per day, in two divided doses, is reached.

Administration:

• Take BANZEL with food.
• BANZEL tablets can be swallowed whole, cut in half or crushed.
• If you take BANZEL Oral Suspension instead of BANZEL tablets, shake the bottle well before you take each dose.
• Measure your dose of BANZEL Oral Suspension using the bottle adapter and dosing syringes provided.
• If you take too much BANZEL, call your local Poison Control Center or get emergency medical help right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Film-coated tablets: 200 mg (pink), 400 mg (pink)
• Oral suspension: 40 mg/mL

This medicine is available in fallowing brand namesː

• BANZEL

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• dizziness
• tiredness
• sleepiness
• nausea
• vomiting

BANZEL may cause serious side effects including:

• suicidal thoughts or actions
• allergic reactions

What special precautions should I follow?

• Antiepileptic drugs (AEDs), including BANZEL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior.
• Use of BANZEL has been associated with central nervous system-related adverse reactions. Accordingly, patients should be advised not to drive or operate machinery until they have gained sufficient experience on BANZEL to gauge whether it adversely affects their ability to drive or operate machinery.
• Formal cardiac ECG studies demonstrated shortening of the QT interval with BANZEL. Patients with Familial Short QT syndrome should not be treated with BANZEL. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has been reported in patients taking antiepileptic drugs, including BANZEL. If DRESS is suspected, the patient should be evaluated immediately, BANZEL should be discontinued, and alternative treatment should be started.
• As with all antiepileptic drugs, BANZEL should be withdrawn gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus. BANZEL discontinuation was achieved by reducing the dose by approximately 25% every 2 days.
• BANZEL has been shown to reduce white cell count.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• The overdose was associated with no major signs or symptoms.

Management of overdosage:

• There is no specific antidote for overdose with BANZEL.
• If clinically indicated, elimination of unabsorbed drug should be attempted by induction of emesis or gastric lavage.
• Usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
• Standard hemodialysis procedures may result in limited clearance of rufinamide.
• Because strategies for the management of overdose are continually evolving, it is advisable to contact a Certified Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risks associated with use of BANZEL in pregnant women.
• If you become pregnant while taking BANZEL, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.
• You can enroll in this registry by calling 1-888-233-2334.
• The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.

Can this medicine be used in children?

• It is not known if BANZEL is safe and effective in the treatment of Lennox-Gastaut Syndrome in pediatric patients under 1 year of age.

What are the active and inactive ingredients in this medicine?

Tablets

• Active ingredient: rufinamide
• Inactive ingredients: colloidal silicon dioxide, corn starch crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

Oral Suspension

• Active ingredient: rufinamide
• Inactive ingredients: microcrystalline cellulose and carboxymethylcellulose sodium, hydroxyethyl cellulose, anhydrous citric acid, simethicone emulsion 30%, poloxamer 188, methylparaben, propylparaben, propylene glycol, potassium sorbate, non crystallizing sorbitol solution 70%, orange flavor.

Who manufactures and distributes this medicine?

• Distributed by Eisai Inc., Nutley, NJ

What should I know about storage and disposal of this medication?

• Store BANZEL tablets and oral suspension at 59ºF to 86ºF (15ºC to 30ºC).

Tablets

• Keep BANZEL tablets in a dry place.

Oral Suspension

• Replace the cap securely after opening.
• Keep BANZEL Oral Suspension in an upright position.
• Use BANZEL Oral Suspension within 90 days of first opening the bottle.

• Dailymed label info on Rufinamide
• FDA Rufinamide

Rufinamide Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

• Dailymed label info on Rufinamide
• FDA Rufinamide

Rufinamide Resources
Latest articles Most recent articles Ongoing trials	Wikipedia