What to Know About Banzel (Rufinamide)

Banzel (rufinamide) is an anti-epileptic drug (AED) used for controlling seizures in adults and in children age 1 year and older. It is taken orally (by mouth) as a tablet or liquid.

This medication is approved for the prevention of seizures in Lennox-Gastaut syndrome, a type of epilepsy that begins during childhood. It is approved for use as an adjunctive treatment, which means that it should be used along with another AED. Rufinamide can produce a number of side effects, including dizziness and headaches. It may also interact with other medications, especially with other AEDs.

This AED is believed to prevent seizures by inhibiting excessive activity of the nerves in the brain. It prolongs that resting state of sodium channels, which are proteins that facilitate nerve activation.

Uses

Rufinamide is used for controlling seizures that can occur due to Lennox-Gastaut syndrome. This epilepsy syndrome typically begins before the age of 4 years and is characterized by developmental delay and frequent seizures.

Children and adults who have Lennox-Gastaut syndrome may experience several seizures per day and generally have many types of seizures, including generalized tonic clonic seizures and myoclonic seizures. These seizures involve repetitive shaking and jerking of the whole body.

The seizures of Lennox-Gastaut syndrome can be especially difficult to prevent with medication.

Off-Label Uses 

In some instances, rufinamide may be used for the prevention of partial seizures in the absence of the diagnosis of Lennox-Gastaut syndrome. Partial seizures are seizures that affect a specific region of the brain and can cause symptoms such as shaking, jerking, or stiffness of one part of the body.

Before Taking

Often, the seizures of Lennox-Gastaut syndrome are not well controlled with monotherapy (use of only one AED), and an adjunctive AED may need to be added. Rufinamide is approved as an adjunctive medication that can be used when monotherapy is not sufficient to adequately reduce seizures in this syndrome.

Precautions and Contraindications

This medication is not recommended if you have a heart condition called familial short QT syndrome. This is a rare hereditary disease that causes an abnormal heart rhythm and can cause sudden death.

Rufinamide must be used with caution for women who are pregnant or breastfeeding because it can enter the baby’s system, potentially causing developmental problems. However, seizures are dangerous during pregnancy, so your healthcare provider may recommend that you take rufinamide during the months when you are pregnant or breastfeeding if it is the safest and most effective AED for management of your epilepsy.

Other Anti-Epileptic Drugs

In the United States, rufinamide is sold as the brand Banzel. In Europe, it is sold as the brand Inovelon.

Several AEDs are used for the management of Lennox-Gastaut syndrome, including Topamax (topiramate), Lamictal (lamotrigine), Klonopin (clonazapem), and Felbatol (felbamate).

Dosage

Banzel is available in 200 milligram (mg) tablets and 400 mg tablets. The liquid comes in a concentration of 40 mg per milliliter (mg/ml). Inovelon is available in 100 mg, 200 mg, and 400 mg tablets, and as a liquid with a concentration of 40 mg/ml.

The dosing for children is based on weight in kilograms (kg). For children and adults, your healthcare provider may prescribe the recommended dose for you, but you might be able to take a lower dose of rufinamide if your seizures are well controlled with a lower dose. In some situations, you might need to take a higher than recommended dose of rufinamide if that is what it takes to control your seizures and if you aren’t experiencing side effects from a higher than recommended dose.

Recommended dose for children age 1 year and over:

• Children start at a total dose of 10 mg/kg per day, which should be divided into two equal doses that need to be taken 12 hours apart. When you are starting the medication, your total daily dose will be increased every other day by 10 mg/kg per day.
• The maximum recommended total daily dose for children is 45 mg/kg per day or 3,200 mg per day (whichever is lower).

Recommended dose for adults:

• Adults start taking rufinamide at a total dose between 400 and 800 mg per day, which should be divided into two equal daily doses taken 12 hours apart. Every other day, the total daily dose is increased by 400 to 800 mg.
• The maximum recommended total daily dose is 3,200 mg per day.

Keep in mind that AEDs such as rufinamide should be taken at consistently spaced intervals to keep your blood level stable. This is the most effective way to prevent seizures. Take your medication at the same time every day and space the doses every 12 hours.

Modifications 

The manufacturer of Banzel recommends modifying the medication dose under certain circumstances.

Depakote: If you are taking Depakote (valproate), your healthcare provider may give you a prescription for a lower than standard dose of rufinamide. When taking rufinamide with valproate, the manufacturer recommends a dose of 10 mg/kg lower per day for children and a dose that is 400 mg lower per day for adults.

Dialysis: If you or your child is getting dialysis for kidney failure, you may need to have the medication dose adjusted because the effect of rufinamide can be reduced due to dialysis.

Liver failure: If you have liver failure, this medication is not recommended. However, if you have liver failure and absolutely must take rufinamide to prevent your seizures, your healthcare provider may prescribe a lower than standard dose to prevent toxicity.

How to Take and Store

You should take rufinamide with food. The tablet is scored so that it can be cut in half. You or your child can swallow a full tablet, cut it in half, or take it crushed.

If you are using the oral suspension, you should shake the bottle before every use. The oral form comes with a measuring syringe and an adapter. Make sure that you ask for detailed instructions when you pick up your medication from the pharmacy so you can confidently learn how to use the syringe and adaptor properly.

The tablets should be safeguarded from moisture, and you need to securely replace the cap after opening it. The bottle should be stored at a temperature of 77 F (25 C). If you need to take the medication out with you for a short time, the manufacturer says that it is safe to take it in a temperature of 59 to 86 F (15 to 30 C).

The oral suspension comes in a container with a cap and an adapter that fit back into place after use. Be sure to replace the cap securely after using the medication. The liquid, like the tablets, should be stored at a temperature of 77 F (25 C). If you need to take the medication out, it is safe to have it at a temperature of 59 to 86 F (15 to 30 C).

Side Effects

Rufinamide can cause side effects. As with all medications, you and your healthcare provider need to weigh the pros and cons of using rufinamide. Keep in mind that it is often difficult to predict how you will react to a medication before you start taking it.

You may not experience any side effects, you can experience mild and tolerable side effects, or the side effects can be very problematic for you.

Common 

The most common side effects that can occur from taking rufinamide are headaches, dizziness, fatigue, somnolence (severe tiredness and difficulty concentrating), and nausea.

Severe

Rufinamide has also been associated with severe reactions, although these severe side effects are not common.

Severe side effects of rufinamide include:

• Suicidal behavior and suicidal ideation (thinking about or planning suicide)
• Coordination problems
• Difficulty walking
• QT shortening
• Multi-organ hypersensitivity/drug reaction with eosinophilia and systemic symptoms (DRESS)
• Leukopenia (reduced white blood cell count)

Warnings and Interactions

As with other AEDs, it is not safe to abruptly stop taking rufinamide. Suddenly stopping this medication can trigger withdrawal effects such as seizures and status epilepticus (a prolonged seizure that requires urgent medical treatment).

If you need to discontinue rufinamide, your healthcare provider might give you a schedule to gradually decrease the dose. And if you experience severe side effects necessitating that you abruptly stop the medication, your healthcare provider may start you on another AED right away to prevent withdrawal effects.

Lennox-Gastaut syndrome often causes refractory epilepsy, which is epilepsy that does not respond to multiple treatment approaches, and the seizures may continue even when several AED therapies, including rufinamide, are used.

Drug Interactions 

Rufinamide interacts with several other medications. It decreases the effectiveness of hormonal contraceptives, so women who are taking rufinamide are advised to use another method of birth control if they want to prevent pregnancy.

Rufinamide reduces the concentration of carbamazepine and lamotrigine, and it increases the concentration of phenobarbital and phenytoin.

Carbamazepine, phenobarbital, phenytoin, and primidone decrease the concentration of rufinamide. Valproate increases the concentration of rufinamide.

These drug interactions become more complicated when a person is taking more than two of the AEDs that interact with rufinamide.