Rufinamide

Generic name: Rufinamide
Brand names: Banzel
Dosage form: oral tablet, oral suspension
Drug class: Dibenzazepine anticonvulsants

Usage of Rufinamide

Rufinamide is an anticonvulsant medication which is used as an add-on treatment alongside other antiepileptic medications to treat seizures in people with Lennox-Gastaut Syndrome. Lennox-Gastaut Syndrome is a rare and severe form of epilepsy that begins early in life.

Rufinamide is a type of drug called a triazole derivative. It is different to other antiepileptic drugs. It is not known exactly how rifinamide works to prevent seizures, but it is thought that it affects sodium channels in the brain that play a role in causing seizures.

Rufinamide was approved by the US Food and Drug Administration (FDA) in 2008.

Rufinamide side effects

See “Important information”

Rufinamide may cause serious side effects including:

Rufinamide can also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following. Symptoms may include:

swelling of your face, eyes, lips, or tongue

trouble swallowing or breathing

a skin rash

hives

fever, swollen glands, or sore throat that do not go away or come and go

swollen glands

yellowing of your skin or eyes

dark urine

unusual bruising or bleeding

severe fatigue or weakness

severe muscle pain

your seizures happen more often or become worse Call your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of rufinamide include:

headache

dizziness

tiredness

sleepiness

nausea

vomiting

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of rufinamide. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Rufinamide

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if rufinamide can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking rufinamide. You and your healthcare provider will decide if you should take rufinamide while you are pregnant.

If you become pregnant while taking rufinamide, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if rufinamide will pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take rufinamide.

Relate drugs

How to use Rufinamide

Rufinamide should be given with food. Tablets can be administered whole, as half tablets, or crushed.

Measure oral suspension using provided adapter and dosing syringe.

Pediatric patients year and older:

Starting daily dose: 10 mg/kg per day in two equally divided doses.

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.

Adults:

Starting daily dose: 400-800 mg per day in two equally divided doses.

Increase by 400-800 mg every other day until a maximum dose of 3200 mg per day, in two divided doses, is reached.

Warnings

Do not stop taking rufinamide without first talking to your healthcare provider.

Stopping rufinamide suddenly can cause serious problems.

Rufinamide can cause serious side effects, including:

1. Like other antiepileptic drugs, rufinamide may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying

attempt to commit suicide

new or worse depression

new or worse anxiety

feeling agitated or restless

panic attacks

trouble sleeping (insomnia)

new or worse irritability

acting aggressive, being angry, or violent

acting on dangerous impulses

an extreme increase in activity and talking (mania)

other unusual changes in behavior or mood

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop rufinamide without first talking to a healthcare provider.

Stopping rufinamide suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

2. Rufinamide may cause you to feel sleepy, tired, weak, dizzy, or have problems with coordination and walking.

What other drugs will affect Rufinamide

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking rufinamide with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Rufinamide may make certain types of birth control less effective. Talk to your healthcare provider about the best birth control methods for you while you take rufinamide.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

Disclaimer

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