Rufinamide

1 I NDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. BANZEL 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 ( 1 )

• BANZEL should be given with food
• Tablets can be administered whole, as half tablets, or crushed 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: 400-800 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 Dosage Information
• Pediatric patients ( 1 year to less than 17 years) The recommended starting daily dose of BANZEL
• In pediatric patients with Lennox-Gastaut Syndrome is approximately 10 mg/kg administered in two equally divided doses
• The dose should be increased by approximately 10 mg/kg increments every other day until a maximum daily dose of 45 mg/kg, not to exceed 3200 mg, administered in two equally divided doses, is reached
• It is not known whether doses lower than the target doses are effective
• Adults (17 years and older) The recommended starting daily dose of BANZEL
• In adults with Lennox-Gastaut Syndrome is 400 to 800 mg per day administered in two equally divided doses
• The dose should be increased by 400-800 mg every other day until a maximum daily dose of 3200 mg, administered in two equally divided doses, is reached
• It is not known whether doses lower than 3200 mg are effective. …

Film-coated Tablets: 200 mg (pink) and 400 mg (pink). Tablets are scored on both sides. Oral Suspension: 40 mg/mL. White to off-white opaque liquid. Film-coated tablets: 200 mg (pink), 400 mg (pink) ( 3 ) Oral suspension: 40 mg/mL ( 3 )

• Safety and effectiveness have been established
• In pediatric patients 1 to 17 years of age
• The effectiveness of BANZEL
• In pediatric patients 4 years of age and older was based upon an adequate and well-controlled trial of BANZEL that included both
• Adults and pediatric patients, 4 years of age and older, with Lennox-Gastaut Syndrome
• The effectiveness in patients 1 to less than 4 years was based upon a bridging pharmacokinetic and safety study [see Dosage and Administration , Adverse Reactions , and Clinical Studies ]. …

Clinical studies of BANZEL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. …

• Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use )
• Administration Information Advise patients to take BANZEL with food [see Dosage and Administration ]
• Advise patients who are prescribed the oral suspension to shake the bottle vigorously before every administration and to use the adaptor and oral dosing syringe [see Dosage and Administration ] . …

• BANZEL is contraindicated in patients with Familial Short QT syndrome [ see Warnings and Precautions ]
• BANZEL is contraindicated in patients with Familial Short QT syndrome

7 D RUG INTERACTION S Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Any effects, when they occur, have been more marked in the pediatric population. …

Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior ( 5.1 ) Central nervous system reactions can occur ( 5.2 ) Use caution when administering BANZEL with other drugs that shorten the QT interval ( 5.3 ) Discontinue BANZEL if multi-organ hypersensitivity reaction occurs ( 5.4 ) Withdraw BANZEL gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus ( 5.5 ) 5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including BANZEL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. …

The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] Central Nervous System Reactions [see Warnings and Precautions ( 5.2 )] QT Shortening [see Warnings and Precautions ( 5.3 )] Multi-Organ Hypersensitivity/Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.4 )] Leukopenia [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥ 10% and greater than placebo) were headache, dizziness, fatigue, somnolence, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. …

8.1 P regnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as BANZEL, during pregnancy. Encourage women who are taking BANZEL during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org Risk Summary There are no adequate data on the developmental risks a …

10 O VERDOSAGE 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. One overdose of 7200 mg per day BANZEL was reported in an adult during the clinical trials. The overdose was associated with no major signs or symptoms, no medical intervention was required, and the patient continued in the study at the target dose. Treatment or Management of Overdose: There is no specific antidote for overdose with BANZEL. …

Store the tablets at 25ºC (77ºF); excursions permitted to 15º- 30ºC (59ºF - 86ºF). Protect from moisture. Replace cap securely after opening. Store the oral suspension at 25ºC (77ºF); excursions permitted to 15º- 30ºC (59ºF - 86ºF). …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.