ISI Page

Indication

BANZEL (rufinamide) is a prescription add-on medication approved for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.

Important Safety Information

Patients with a history of Familial Short QT syndrome should not be treated with BANZEL. Talk to your healthcare provider if you are unsure if this affects you or your loved one. BANZEL has been shown to reduce the QT interval. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.
All medications to treat seizures, including BANZEL, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you or your loved one experiences new or worsening symptoms of depression, unusual changes in mood or behavior, thoughts or actions about suicide or self-harm, aggression, agitation, anger, anxiety, or irritability.
Use of BANZEL has been associated with side effects such as sleepiness or feeling tired, difficulty with coordination, dizziness, and problems with walking or movement.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how BANZEL affects you. BANZEL can slow your thinking and motor skills.
- Alcohol, in combination with BANZEL, may increase or worsen these side effects.
Call your healthcare provider if you or your loved one experiences a rash. This can be a sign of a more serious condition, such as multi-organ hypersensitivity reaction.
You or your loved one should take BANZEL only as prescribed. Do not stop taking BANZEL without first talking to your healthcare provider. Stopping BANZEL suddenly can cause serious problems.
Tell your healthcare provider about all the medications you or your loved one takes, including prescription and non-prescription medications, vitamins, and herbal supplements. Using BANZEL with certain medications can affect each other, causing side effects.
In studies, the most commonly observed (≥10%) side effects with BANZEL were headache, dizziness, feeling tired, sleepiness, and nausea.

Important Information for Women

BANZEL may make hormonal contraceptives (birth control pills) less effective. Additional nonhormonal forms of birth control are recommended when using BANZEL.
Healthcare providers should be informed if patients are pregnant or planning on becoming pregnant. It is not known if BANZEL will pass into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if taking BANZEL.
Patients who are pregnant are encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334. Additional information about the registry can be found at www.aedpregnancyregistry.org.

There are risks associated with the use of BANZEL that you should know about. We encourage you to talk to your healthcare provider about these risks.

Please read the full Prescribing Information and discuss it with your doctor or healthcare professional.

To report suspected adverse reactions, contact Eisai Inc. at 1-888-274-2378 or the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

This Web site contains information relating to various medical conditions and treatment. Such information is provided for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare professionals. You should not use this information for diagnosing a health problem or disease. In order for you to make intelligent healthcare decisions, you should always consult with a physician or other healthcare provider for your, or your loved one’s, personal medical needs. All quotes included in this Web site represent the individual experience of some doctors, some patients, and their caregivers. Individual responses to treatment may vary.

This site is intended for residents of the United States only. Any products discussed herein may have different product labeling in different countries.

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