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Inovelon (i-NOVE-eh-lon) is the brand name for rufinamide, where it is approved for marketing in European countries. As of May 15, 2007, rufinamide has not been approved for use in the United States.
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Inovelon
is available in European Union countries as 100-, 200-, and 400-milligram (mg) tablets, which should be swallowed whole, not chewed.
How to take and store Inovelon
Follow the doctor’s directions. Call if you have any questions.
Store at room temperature (below 86°F, 30°C). Protect the tablets from moisture. Don't keep them in the bathroom, where it's damp.
What if I forget?
A forgotten dose should be taken right away, unless it is almost time for the next one. In that case, just use one dose, not a double dose, and call the doctor's office for more advice.
As of May 15, 2007, rufinamide has not been approved for use in the United States. The U.S. Food and Drug Administration is currently determining whether to approve rufinamide as 1) add-on therapy for partial seizures with or without secondary generalization in adults and adolescents 12 years of age and older, and 2) add-on therapy for Lennox-Gastaut syndrome in children ages 4 and over.
In the European Union countries, Inovelon was approved in January 2007 as add-on therapy for the treatment of Lennox-Gastaut syndrome.
Most people who take Inovelon don't have too much trouble with side effects.
The most common complaints during clinical studies of adults with partial seizures (usually mild to moderate in severity) were:
•Headache
•Dizziness
•Fatigue
•Nausea
•Sleepiness (somnolence)
Less common complaints were double vision and trouble with balance.
The most common complaints during clinical studies of patients with Lennox-Gastaut syndrome (usually mild to moderate in severity) were:
•Sleepiness (somnolence)
•Vomiting
Less commonly, a rash occurred.
Sometimes the doctor can help with these side effects by changing the prescription:
•reducing the overall amount of Inovelon
•prescribing smaller doses, taken more often
No one should stop taking Inovelon or change the amount they take without their doctor's guidance.
People who have just started taking Inovelon (or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.
Allergic reactions
Some people, especially children, who took Inovelon in the clinical studies developed serious reactions, particularly when Inovelon was first taken. The symptoms vary, but could include fever, rash, swelling of the lymph nodes, abnormal liver function, and blood in the urine. If any of these occur, tell the doctor or nurse immediately.
Long-term side effects
Because Inovelon is relatively new, it is not know if there are any long-term side effects.
Because Inovelon is relatively new, there is no available information on its safety when taken during pregnancy on the mother or the fetus.
Forms
Inovelon
is available in European Union countries as 100-, 200-, and 400-milligram (mg) tablets, which should be swallowed whole, not chewed.How to take and store Inovelon
Follow the doctor’s directions. Call if you have any questions.
Store at room temperature (below 86°F, 30°C). Protect the tablets from moisture. Don't keep them in the bathroom, where it's damp.
What if I forget?
A forgotten dose should be taken right away, unless it is almost time for the next one. In that case, just use one dose, not a double dose, and call the doctor's office for more advice.
As of May 15, 2007, rufinamide has not been approved for use in the United States. The U.S. Food and Drug Administration is currently determining whether to approve rufinamide as 1) add-on therapy for partial seizures with or without secondary generalization in adults and adolescents 12 years of age and older, and 2) add-on therapy for Lennox-Gastaut syndrome in children ages 4 and over.
In the European Union countries, Inovelon
was approved in January 2007 as add-on therapy for the treatment of Lennox-Gastaut syndrome.Most people who take Inovelon don't have too much trouble with side effects.
The most common complaints during clinical studies of adults with partial seizures (usually mild to moderate in severity) were:
•Headache
•Dizziness
•Fatigue
•Nausea
•Sleepiness (somnolence)
Less common complaints were double vision and trouble with balance.
The most common complaints during clinical studies of patients with Lennox-Gastaut syndrome (usually mild to moderate in severity) were:
•Sleepiness (somnolence)
•Vomiting
Less commonly, a rash occurred.
Sometimes the doctor can help with these side effects by changing the prescription:
•reducing the overall amount of Inovelon
•prescribing smaller doses, taken more often
No one should stop taking Inovelon or change the amount they take without their doctor's guidance.
People who have just started taking Inovelon (or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.
Allergic reactions
Some people, especially children, who took Inovelon in the clinical studies developed serious reactions, particularly when Inovelon was first taken. The symptoms vary, but could include fever, rash, swelling of the lymph nodes, abnormal liver function, and blood in the urine. If any of these occur, tell the doctor or nurse immediately.
Long-term side effects
Because Inovelon is relatively new, it is not know if there are any long-term side effects.
Because Inovelon is relatively new, there is no available information on its safety when taken during pregnancy on the mother or the fetus.
