Rufinamide

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.

• 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.ICD-10: G40.909

• BANZEL is contraindicated in patients with Familial Short QT syndrome [ see Warnings and Precautions ( 5.3 ) ] .contraindicated

BANZEL should be given with food. Tablets can be administered whole, as half tablets, or crushed ( 2.2 ) Measure oral suspension using provided adapter and dosing syringe ( 2.2 ) Pediatric patients 1 year and older: Starting daily dose: 10 mg/kg per day in two equally divided doses ( 2.1 ) 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 ( 2.1 ) Adults: Starting daily dose: 400-800 mg per day in two equally divided doses ( 2.1 ) Increase by 400-800 mg every other day until a maximum dose of 3200 mg per day, in two divided doses, is reached ( 2.1 ) 2.1 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.

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. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.

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. at 1-888-274-2378 or www.banzel.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Patients ages 3 to 17 years of age In the pooled, double-blind, adjunctive therapy studies in adult and pediatric patients ages 3 to 17 years of age, the most common (≥10%) adverse reactions in BANZEL-treated patients, in all doses studied (200 to 3200 mg per day) with a higher frequency than in patients on placebo were: headache, dizziness, fatigue, somnolence, and nausea.

U SE IN S PECIFIC P OPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Renal impairment: Consider adjusting the BANZEL dose for the loss of drug upon dialysis ( 8.6 ) Not recommended in patients with severe hepatic impairment ( 8.7 ) 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 associated with use of BANZEL in pregnant women. In animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

Overview BANZEL oral suspension is bioequivalent on a mg per mg basis to BANZEL tablets. BANZEL is well absorbed after oral administration.

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. 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. Hemodialysis: Standard hemodialysis procedures may result in limited clearance of rufinamide. Although there is no experience to date in treating overdose with hemodialysis, the procedure may be considered when indicated by the patient’s clinical state.

• Nov 14, 2008NDANDA021911Eisai Inc
• Mar 3, 2011NDANDA201367Eisai Inc
• May 16, 2016ANDAANDA204988Hikma
• May 16, 2016ANDAANDA205075Glenmark Pharms Ltd
• Apr 23, 2019ANDAANDA207363Hikma
• Apr 23, 2019ANDAANDA211388Bionpharma
• Dec 18, 2020ANDAANDA213457Lupin
• Feb 23, 2021ANDAANDA213410Alkem Labs Ltd

1. 1Seizure62725%
2. 2Drug Ineffective38015%
3. 3Off Label Use2389.4%
4. 4Somnolence1787.0%
5. 5Diarrhoea1164.6%
6. 6Condition Aggravated1134.5%
7. 7Vomiting1054.2%
8. 8Fatigue1044.1%
9. 9Drug Interaction1014.0%
10. 10Multiple-drug Resistance933.7%
11. 11Fall853.4%
12. 12Generalised Tonic-clonic Seizure843.3%
13. 13Pneumonia843.3%
14. 14Decreased Appetite833.3%
15. 15Product Use In Unapproved Indication833.3%

The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Rufinamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Population Pharmacokinetics of Antiepileptic in Pediatrics
  Completed · Observational · 753 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT03196466updated 2025-11-20
• An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
  Available · Expanded access · Eisai Inc.
  NCT03778424updated 2025-07-17
• Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects
  Completed · Phase 1 · Interventional · 32 enrolled · Daiichi Sankyo
  NCT06740825updated 2024-12-18
• Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
  Completed · Observational · 707 enrolled · Eisai Co., Ltd.
  NCT02175173updated 2023-02-21
• Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
  Completed · Phase 3 · Interventional · 356 enrolled · Eisai Inc.
  NCT00334958updated 2021-06-14
• Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures
  Withdrawn · Phase 3 · Interventional · 0 enrolled · University of South Alabama
  NCT04558580updated 2020-09-22
• Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
  Terminated · Phase 3 · Interventional · 286 enrolled · Eisai Inc.
  NCT00448539updated 2019-11-22
• Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
  Completed · Phase 3 · Interventional · 37 enrolled · Eisai Inc.
  NCT01405053updated 2019-08-06
• A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
  Completed · Phase 3 · Interventional · 54 enrolled · Eisai Co., Ltd.
  NCT01151540updated 2019-03-11
• Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
  Completed · Phase 2 · Interventional · 239 enrolled · Biotie Therapies Inc.
  NCT00595231updated 2019-02-27

Frequently asked questions

How does Rufinamide work?

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.

What is Rufinamide used for?

According to FDA labeling, Rufinamide carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Rufinamide?

Rufinamide is classified as Carboxamide derivatives, Sodium Channel Interactions.

What are the brand names for Rufinamide?

Rufinamide is marketed under brand names including Banzel.

What are the contraindications for Rufinamide?

Rufinamide labeling lists contraindications including: BANZEL is contraindicated in patients with Familial Short QT syndrome [ see Warnings and Precautions ( 5.3 ) ] .. Always consult the full prescribing information and a clinician.