Rufinamide

Rufinamide is a prescription medicine used to treat seizures associated with Lennox-Gastaut syndrome in adults and children. It belongs to a group of drugs called anticonvulsants which are thought to work by decreasing excitement in the brain by affecting sodium channels.

This medication comes in tablet form and in an oral suspension (liquid) which is usually taken twice a day with food.

The most common side effects are headache, sleepiness, and nausea.

Rufinamide is a prescription medicine used with other medicines to treat seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 1 year of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Rufinamide may be found in some form under the following brand names:

• Banzel

Rufinamide may cause serious side effects. See "Drug Precautions" section.

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.

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

• carbamazepine (Carbatrol, Equetro, Tegretol)
• divalproex (Depakote, Depakote ER)
• valproic acid (Depakene)
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• hormonal birth control (pills, patches, or rings)

This is not a complete list of rufinamide drug interactions. Ask your healthcare provider or pharmacist for more information.

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:

• 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.

• 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.

• 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:
  • 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 may happen more often or become worse.

Do not take rufinamide if you have a genetic condition called familial short QT syndrome, a problem that affects the electrical system of the heart.

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking rufinamide until you talk to your healthcare provider. Rufinamide taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how rufinamide affects you. Rufinamide can slow your thinking and motor skills.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of rufinamide, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take rufinamide, tell your healthcare provider if you:

• have heart problems
• have liver problems
• have any other medical problems
• have or have had suicidal thoughts or actions, depression or mood problems
• 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.
• are pregnant or breastfeeding

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. 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.

• 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.
• 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 healthcare provider if you are breastfeeding or plan to breastfeed. Rufinamide may pass into your breast milk. You and your healthcare provider should decide if you will take rufinamide or breastfeed. You should not do both.

• Take rufinamide exactly as your healthcare provider tells you. Your healthcare provider will tell you how much rufinamide to take.
• Your healthcare provider may change your dose. Do not change your dose of rufinamide without talking to your healthcare provider.
• Take rufinamide with food.
• Rufinamide tablets can be swallowed whole, cut in half or crushed.
• If you take rufinamide oral suspension instead of rufinamide tablets, shake the bottle well before you take each dose. Measure your dose of rufinamide oral suspension using the bottle adapter and dosing syringes provided.
• If you take too much rufinamide, call your local Poison Control Center or get emergency medical help right away.

What to avoid while taking rufinamide:

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking rufinamide until you talk to your healthcare provider. Rufinamide taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how rufinamide affects you. Rufinamide can slow your thinking and motor skills.

Take rufinamide exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Children one year and older with Lennox-Gastaut syndrome: Treatment should be started at a daily dose of approximately 10 mg/kg/day given in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day to a target dose of 45 mg/kg/day or 3200 mg/day, whichever is less, administered in two equally divided doses.

Adults with Lennox-Gastaut syndrome: Treatment should be started at a daily dose of 400-800 mg/day given in two equally divided doses. The dose should be increased by 400-800 mg every other day until a maximum daily dose of 3200 mg/day, given in two equally divided doses is reached. It is not known whether doses lower than 3200 mg are effective.

Patients on valproate should begin at a rufinamide dose lower than 10 mg/kg/day (children) or 400 mg/day (adults).

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store rufinamide tablets and oral suspension at 59°F to 86°F (15°C to 30°C).

Tablets

• Keep rufinamide tablets in a dry place.

Oral Suspension

• Replace the cap securely after opening.
• Keep rufinamide oral suspension in an upright position.
• Use rufinamide oral suspension within 90 days of first opening the bottle.
• Keep rufinamide and all medicines out of the reach of children.