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Billing & Coding

NDCs help providers and payors identify specific product package sizes. The BANZEL® NDCs are listed below.

BANZEL® Package Size

NDC

BANZEL® 200 mg tablets

62856-582-52

BANZEL® 400 mg tablets

62856-583-52

BANZEL® Oral Suspension

62856-584-46

Some payors require providers to report 11-digit NDCs when reporting a drug on a claim form. Converting the 10-digit NDC for BANZEL® to an 11-digit NDC requires the use of a leading zero in the product code section of the NDC (i.e., the middle section). Below is one example of how to report using the 11-digit NDC.

10-Digit NDC Example

11-Digit NDC Example with Leading Zero

AAAAA-BBB-CC

AAAAA-0BBB-CC

 

BANZEL® 10-Digit NDC

BANZEL® 11-Digit NDC with Leading Zero

62856-582-52

62856-0582-52

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Adjunctive treatment of seizures associated with LGS

Add BANZEL® for powerful, broad spectrum efficacy in total seizure reduction

Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record

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Indication

BANZEL® (rufinamide) 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

Important Safety Information

Contraindication:

  • BANZEL® is contraindicated in patients with Familial Short QT syndrome.

Warnings:

  • AEDs increase the risk of suicidal thoughts or behavior in patients. Patients, their caregivers, and families should be informed of the risk and advised to monitor and report any emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, or thoughts of self-harm. If these symptoms occur, consider if it may be related to the AED or illness because epilepsy itself can increase these risks.
  • Use of BANZEL® has been associated with central nervous system–related adverse reactions, such as somnolence or fatigue, coordination abnormalities, dizziness, gait disturbances, and ataxia.

Precautions:

  • Formal cardiac ECG studies demonstrated shortening of the QT interval (mean = 20 msec, for doses ≥ 2400 mg twice daily) with BANZEL®. Caution should be used when administering BANZEL® with other drugs that shorten the QT interval.
  • Multi-organ hypersensitivity syndrome has been reported in association with BANZEL® therapy. In clinical trials, hypersensitivity reactions occurred in children less than 12 years of age and within 4 weeks of starting BANZEL® therapy. In addition, rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms and Stevens-Johnson syndrome have been reported in association with rufinamide therapy post marketing. If any of these reactions are suspected, BANZEL® should be discontinued and alternative treatment started. All patients who develop a rash while taking BANZEL® must be closely supervised.
  • As with all AEDs, BANZEL® should be gradually withdrawn to minimize the risk of increased seizure frequency.

Adverse reactions:

  • In the pooled, double-blind, adjunctive therapy studies in adults and pediatric patients ages 4 and older, the most commonly observed (≥10%) adverse reactions with BANZEL® vs placebo, respectively, were headache (25% vs 20%), dizziness (17% vs 10%), fatigue (15% vs 9%), somnolence (13% vs 9%), and nausea (11% vs 7%).
  • In a multicenter, parallel group, open-label study in pediatric patients (1 year to less than 4 years of age) the most commonly observed (≥10%) adverse reactions and with a higher frequency with BANZEL® vs any other AED, respectively, were vomiting (24 % vs 9%), somnolence (16% vs 0%), constipation (12% vs 9%), cough (12% vs 9%), bronchitis (12% vs 0%), rash (12% vs 9%), and decreased appetite (12% vs 9%).

For more information about BANZEL® please see Prescribing Information.

 

BANZEL® is available by prescription only.

BANZEL® Contact Information

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit
http://www.FDA.gov/medwatch or call 1-800-FDA-1088.

This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States.

This site contains information about products that may have different product labeling in different countries. This site is published by Eisai Inc.

BANZEL® is a registered trademark of Eisai R&D Management Co., Ltd., licensed to Eisai Inc.

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