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BANZEL®
(rufinamide)
http://www.banzel.com
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BANZEL® is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults.
LGS is a rare form of epilepsy in which patients experience seizures of multiple types. LGS accounts for 1 to 4 percent of all childhood epilepsy cases.
In addition to the 200 mg and 400 mg tablets, BANZEL is also available in Oral Suspension (40mg/mL).
For more information about BANZEL, including full prescribing information and the medication guide, visit www.banzel.com or call 1-888-274-2378.
IMPORTANT SAFETY INFORMATION
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.
QT Shortening
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.
Suicidal Behavior and Ideation
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.
Adverse Reactions
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. Alcohol, in combination with BANZEL, may increase or worsen these side effects.
In studies, the most commonly observed (≥10%) side effects with BANZEL vs. placebo (sugar pill with no medicine in it) were headache (25%vs 20%), dizziness (17% vs 10%), feeling tired (15% vs 9%), sleepiness (13% vs. 9%), and nausea (11% vs 7%).
Your or your loved one should take BANZEL only as prescribed. Do not stop taking BANZEL without first taking to your healthcare provider. Stopping BANZEL suddenly can cause serious problems.
Drug Interactions
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.
Multi-organ Hypersensitivity Reactions
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.
Pregnancy and Nursing
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 you or your loved one are pregnant or planning on becoming pregnant. Also, BANZEL is likely to be passed through breast milk to the baby and could cause serious side effects in the baby. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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 http://www.aedpregnancyregistry.org.
For more information about BANZEL, please read the full Prescribing Information including the Medication Guide, click here:
Package Insert: Banzel_PI.pdf
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