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Rufinamide (roo FIN a mide) has been approved by the FDA to control seizures associated with Lennox-Gastaut syndrome in pediatric patients 1 year of age and older (when used with other anti-seizure medications) and in adults.

Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.

How can you take rufinamide? (Available formulations)

Rufinamide is available as film-coated tablets or as a suspension and is taken by mouth with food.

Who should not take rufinamide?

If you have a genetic heart rhythm disorder called Familial Short QT syndrome then you should not take rufinamide as it has been found to aggravate it. If you or a family member have a family history of heart troubles, please let your healthcare provider know.

Tell your healthcare provider if you:

  • have heart disease.
  • have liver disease.
  • have kidney disease (or if you are on dialysis).
  • have or have had depression, mental illness, or suicidal thoughts or actions.

What is important to know about taking rufinamide?

Do not stop taking rufinamide suddenly unless directed to do so by your healthcare provider.

As with all antiseizure medications, rufinamide should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using rufinamide suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.

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

Taking rufinamide with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take: drugs that cause sleepiness or dizziness.

Women or those who are/plan to become pregnant
Use in pregnancy

At this time, there is not enough evidence regarding developmental risks associated with the use of rufinamide in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.

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

Use during breastfeeding

It may not be safe to breastfeed while taking rufinamide. It is not known if rufinamide is present in breast milk, if there are effects on the breastfed infant, or if rufinamide impacts milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for rufinamide and the potential effect on the infant from rufinamide or from your epilepsy.

Effect on birth control and fertility

Rufinamide may decrease the effectiveness of hormonal contraceptives, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using rufinamide, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

The effect of rufinamide on fertility in humans is unknown. There is some evidence in animal studies to suggest impairment of fertility.

What are the side effects of rufinamide?

Rufinamide is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by rufinamide can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.

Common side effects

The most common side effects that were reported in studies of rufinamide are headache, dizziness, fatigue, drowsiness (somnolence), and nausea.

Rare, but serious side effects
Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including rufinamide may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.

Central nervous system reactions

For some patients who take rufinamide, central nervous system-related adverse reactions may occur. These were seen in the controlled clinical trial of patients 4 years or older with Lennox-Gastaut syndrome. The side effects can be classified into 2 general categories:

  • Sleepiness or fatigue
  • Lack of coordination, dizziness, trouble walking, and issues with balance

You should not drive or operate machinery until you have gained sufficient experience on rufinamide to gauge whether it will impact your ability to do so safely.

Do not drive or operate machinery until you have gained sufficient experience on rufinamide to gauge whether it adversely affects your abilities.

Serious reactions, including serious blood or liver problems

Rare but life-threatening reactions involving the immune system or multi-organ hypersensitivity, which can cause serious blood or liver problems have been reported with rufinamide use. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you experience fever, frequent infections, severe muscle pain, swelling of your face, eyes, lips, or tongue, swollen lymph glands, unusual bruising or bleeding, weakness, fatigue, yellowing of your skin, or the white part of your eyes, trouble walking or seeing, seizures happening more often, or pain/tenderness in the area toward the top of your stomach (enlarged liver/spleen).

Status epilepticus

Status epilepticus, a type of seizure emergency, has occurred during treatment with rufinamide though the exact incidence is difficult to determine. In a clinical trial in patients with Lennox-Gastaut syndrome, 4.1% of patients who were taking rufinamide had episodes that could be described as status epilepticus. In all clinical trials, which includes patients with all types of epilepsy, the rate was < 1% of rufinamide-treated patients.

Leukopenia

Rufinamide has been shown to reduce the number of white blood cells in your body, which is called leukopenia.