卢非酰胺适应症,用法用量,效果,价格,副作用

Rufinamide indications

Rufinamide is a novel anticonvulsant drug that is a triazole derivative that is structurally unrelated to any other currently used anticonvulsant drug when used as an add-on treatment for refractory epilepsy. In January 2009, the U.S. Food and Drug Administration approved rufinamide for the treatment of children 4 years and older with Lennox-Gastaut syndrome. It is also approved as an add-on treatment for focal epileptic seizures in adults and adolescents.

Dosage form and strength

Film-coated tablets: 200 mg (pink) and 400 mg (pink). The tablets are scored on both sides.

Oral suspension: 40 mg/ml.

Usage and dosage

1. Pediatric patients (1 to 17 years old): The recommended starting daily dose of rufinamide for pediatric patients with Lennox-Gastaut syndrome is approximately 10 mg/kg, administered in two equal doses. The dose should be increased by approximately 10 mg/kg every other day until the maximum daily dose of 45 mg/kg is reached, not to exceed 3200 mg in two equally divided doses. It is unclear whether doses lower than the target dose are effective.

2. Adults (17 years and older): The recommended starting daily dose of rufinamide for adults with Lennox-Gastaut syndrome is 400 to 800 mg per day, administered in two equal doses. The dose should be increased by 400-800 mg every other day until the maximum daily dose of 320 mg is reached, given in two equally divided doses. It is unclear whether doses below 3200 mg are effective.

3. Dosage in patients receiving hemodialysis: Hemodialysis can reduce exposure to a limited extent (approximately 30%). Therefore, adjustment of the rufinamide dose during dialysis should be considered.

4. Dosage in patients with liver disease: Rufinamide has not been studied in patients with liver impairment. Therefore, its use is not recommended for patients with severe hepatic impairment. Caution should be used when treating patients with mild to moderate hepatic impairment.

5. Dosage for patients taking sodium valproate: When patients taking sodium valproate start taking rufinamide, the dose for pediatric patients should be less than 10 mg/kg per day, and for adult patients, the dose should be less than 400 mg per day.

1. Take rufinamide with food. Rufinamide film tablets can be taken as a whole tablet, half a tablet or crushed.

2. Rufinamide oral suspension should be shaken well before each administration. Oral suspension should be administered using the adapter and calibrated oral dosage syringe provided. The dosing syringe should be inserted into the adapter and the dose removed from the inverted bottle. The cap should be replaced after each use. When the adapter is in place, the cover is installed correctly.

3. Rufinamide is contraindicated in patients with familial short QT syndrome.

4. Because rufinamide can cause central nervous system reactions, patients should be advised not to drive or operate machinery until they have gained sufficient experience with rufinamide to assess whether it will adversely affect their ability to drive or operate machinery.

5. Patients should be monitored for new or worsening depression, suicidal thoughts/behavior, and abnormal changes in mood or behavior during treatment with rufinamide. If a multiorgan allergic reaction occurs, rufinamide should be discontinued and discontinued gradually to minimize the risk of sudden seizures, exacerbation of epileptic seizures, or status epilepticus.

6. During the period of medication, try not to eat irritating foods, such as spicy foods and acidic foods, avoid excessive drinking, and pay attention to your diet and living habits.

Rufinamide was granted orphan drug status in 2004 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥4 years and was subsequently approved for this indication in several countries, including Europe and the United States. Structurally unrelated to other antiepileptic drugs, rufinamide is thought to act primarily by prolonging the inactivation period of voltage-gated sodium channels. Rufinamide was approved based on an international, randomized, placebo-controlled Phase III trial in 138 patients with Lennox-Gastaut syndrome, which demonstrated that rufinamide was well tolerated and effective in significantly reducing the frequency of fall episodes and total seizures compared with placebo.

The efficacy, safety, and tolerability of rufinamide in the treatment of seizures associated with Lennox-Gastaut syndrome were subsequently confirmed in several other clinical trials and long-term extension studies. These findings are supported by "real world" data from a series of clinical practice studies conducted in Europe, the United States and South Korea. Rufinamide has been shown to be effective and well tolerated in one-year-old children and adults. It is particularly effective in the treatment of fall seizures and generalized tonic-clonic seizures, and it has been suggested that it may be superior to other antiepileptic drugs as a second-line treatment for Lennox-Gastaut syndrome in patients with frequent fall attacks.

side effects

The most common side effects of rufinamide treatment include drowsiness, headache, dizziness, nausea, vomiting, and fatigue. No new or unexpected safety signals emerged following long-term treatment with rufinamide, either in clinical trials or in clinical practice.

Side effects treatment measures

If you develop intolerance while using rufinamide, you need to contact your doctor promptly and receive treatment. In addition, liver function tests should be carried out regularly during the medication. If drug allergic reactions or severe liver function damage occur, you should stop using this drug and seek medical treatment in time.

Drug marketing information

As of September 18, 2023, rufinamide has been launched in Taiwan, Japan, Germany, South Korea, the United States, Canada and other regions, but it has not yet been launched in inland areas of China. Therefore, patients cannot purchase this drug in pharmacies and hospital pharmacies in mainland China.

drug prices

The prices of rufinamide from different manufacturers and different versions also vary. The reference price of Eisai’s Japanese version of rufinamide film tablets for 100mg*100 tablets is about 907$, and the reference price for 200mg*100 tablets is about 1500$.

Eisai's German version of rufinamide film tablets comes in three specifications. The reference price for 200mg*50 tablets is about 1048$, the reference price for 400mg*50 tablets is about 2000$, and the reference price for 40mg*460ml (liquid) is about 2200$.

However, due to the impact of foreign exchange rate fluctuations, drug prices will also vary. Patients can consult the medical companion travel service for specific price information and purchase procedures.

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