Medical Editor: John P. Cunha, DO, FACOEP
What Is Rufinamide?
Rufinamide is an anticonvulsant indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide is available in generic form.
What Are Side Effects of Rufinamide?
Common side effects of rufinamide include:
- runny or stuffy nose
- loss of appetite
- loss of balance or coordination
- double vision
- sinus infection
- abdominal pain
- ear infection
- eye movements
- blurred vision
- back pain
- abnormal walking (gait disturbance)
- spinning sensation (vertigo)
Antiepileptic drugs, including rufinamide, increase the risk of suicidal thoughts and behavior. Tell your doctor if this occurs.
Dosage for Rufinamide
The recommended starting daily dose of rufinamide in pediatric patients under 17 years of age with Lennox-Gastaut Syndrome is approximately 10 mg/kg administered in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day until a maximum daily dose of 45 mg/kg, not to exceed 3,200 mg, administered in two equally divided doses, is reached. The recommended starting daily dose of rufinamide in adults with Lennox-Gastaut Syndrome is 400 mg per day to 800 mg per day administered in two equally divided doses. The dose should be increased by 400 mg to 800 mg every other day until a maximum daily dose of 3200 mg, administered in two equally divided doses, is reached.
What Drugs, Substances, or Supplements Interact with Rufinamide?
Rufinamide may interact with carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, valproate, primidone, and benzodiazepines. Tell your doctor all medications and supplements you use.
Rufinamide During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant before taking rufinamide; it is unknown if it could affect a fetus. Patients are encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry if they become pregnant. It is likely rufinamide passes into breast milk. Breastfeeding while taking rufinamide is not recommended.
Our Rufinamide Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described below and elsewhere in the labeling:
- Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
- Central Nervous System Reactions [see WARNINGS AND PRECAUTIONS]
- QT Shortening [see WARNINGS AND PRECAUTIONS]
- Multi-Organ Hypersensitivity/Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see WARNINGS AND PRECAUTIONS]
- Leukopenia [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions In Adult And Pediatric Patients Ages 3 To 17 Years Of Age
In the pooled, double-blind, adjunctive therapy studies in adult and pediatric patients ages 3 to 17 years of age, the most common (≥10%) adverse reactions in rufinamide-treated patients, in all doses studied (200 mg to 3,200 mg per day) with a higher frequency than in patients on placebo were: headache, dizziness, fatigue, somnolence, and nausea.
Table 2 lists adverse reactions that occurred in at least 3% of pediatric patients (ages 3 to less than 17 years) with epilepsy treated with rufinamide in controlled adjunctive studies and were numerically more common in patients treated with rufinamide than in patients on placebo.
At the target dose of 45 mg/kg per day for adjunctive therapy in pediatric patients (ages 3 to less than 17 years), the most common (≥3%) adverse reactions with an incidence greater than in placebo for rufinamide were somnolence, vomiting, and headache.
Table 2: Adverse Reactions in Pediatric Patients (Ages 3 to less than 17 years) in Pooled Double-Blind Adjunctive Trials
|Upper Abdominal Pain||3||2|
|Disturbance in Attention||3||1|
Table 3 lists adverse reactions that occurred in at least 3% of adult patients with epilepsy treated with rufinamide (up to 3,200 mg per day) in adjunctive controlled studies and were numerically more common in patients treated with rufinamide than in patients on placebo. In these studies, either rufinamide or placebo was added to the current AED therapy.
At all doses studied of up to 3,200 mg per day given as adjunctive therapy in adults, the most common (≥ 3%) adverse reactions, and with the greatest increase in incidence compared to placebo, for rufinamide were dizziness, fatigue, nausea, diplopia, vision blurred, and ataxia.
Table 3: Adverse Reactions in Adults in Pooled Double-Blind Adjunctive Trials
|Upper Abdominal Pain||3||2|
Discontinuation In Controlled Clinical Studies
In controlled, double-blind, adjunctive clinical studies, 9% of pediatric and adult patients receiving rufinamide as adjunctive therapy and 4% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions most commonly leading to discontinuation of rufinamide (>1%) used as adjunctive therapy were generally similar in adults and pediatric patients.
In pediatric patients (ages 4 to less than 17 years) double-blind adjunctive clinical studies, 8% of patients receiving rufinamide as adjunctive therapy (at the recommended dose of 45 mg/kg per day) and 2% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions most commonly leading to discontinuation of rufinamide (>1%) used as adjunctive therapy are presented in Table 4.
Table 4: Most Common Adverse Reactions Leading to Discontinuation in Pediatric Patients (Ages 4 to less than 17 years) in Pooled Double-Blind Adjunctive Trials
In adult double-blind, adjunctive clinical studies, 10% of patients receiving rufinamide as adjunctive therapy (at doses up to 3,200 mg per day) and 6% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions most commonly leading to discontinuation of rufinamide (>1%) used as adjunctive therapy are presented in Table 5.
Table 5: Most Common Adverse Reactions Leading to Discontinuation in Adult Patients in Pooled Double-Blind Adjunctive Trials
Pediatric Patients Ages 1 To Less Than 4 Years
In a multi-center, parallel group, open-label study comparing rufinamide (45 mg/kg per day) adjunctive treatment (n=25) to the adjunctive treatment with an AED of the investigator’s choice (n=11) in pediatric patients (1 year to less than 4 years of age) with inadequately controlled Lennox-Gastaut Syndrome, the adverse reaction profile was generally similar to that observed in adults and pediatric patients 4 years of age and older treated with rufinamide. Adverse reactions that occurred in at least 2 (8 %) rufinamide-treated patients and with a higher frequency than in the AED comparator group were: vomiting (24%), somnolence (16%), bronchitis (12%), constipation (12%), cough (12%), decreased appetite (12%), rash (12%), otitis media (8%), pneumonia (8%), decreased weight (8%), gastroenteritis (8%), nasal congestion (8%), and pneumonia aspiration (8%).
Other Adverse Reactions Observed During Clinical Trials
Rufinamide has been administered to 1,978 individuals during all epilepsy clinical trials (placebo-controlled and open-label). Adverse reactions occurring during these studies were recorded by the investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of patients having adverse reactions, these events were grouped into standardized categories using the MedDRA dictionary. Adverse events occurring at least three times and considered possibly related to treatment are included in the System Organ Class listings below. Terms not included in the listings are those already included in the tables above, those too general to be informative, those related to procedures, and terms describing events common in the population. Some events occurring fewer than 3 times are also included based on their medical significance. Because the reports include events observed in open-label, uncontrolled observations, the role of rufinamide in their causation cannot be reliably determined.
Events are classified by body system and listed in order of decreasing frequency as follows: frequent adverse events—those occurring in at least 1/100 patients; infrequent adverse events—those occurring in 1/100 to 1/1,000 patients; rare—those occurring in fewer than 1/1,000 patients.
Blood and Lymphatic System Disorders: Frequent: anemia. Infrequent: lymphadenopathy, leukopenia, neutropenia, iron deficiency anemia, thrombocytopenia.
Cardiac Disorders: Infrequent: bundle branch block right, atrioventricular block first degree.
Metabolic and Nutritional Disorders: Frequent: decreased appetite, increased appetite.
Renal and Urinary Disorders: Frequent: pollakiuria. Infrequent: urinary incontinence, dysuria, hematuria, nephrolithiasis, polyuria, enuresis, nocturia, incontinence.
The following adverse reactions have been identified during post approval use of rufinamide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Stevens-Johnson syndrome and other serious skin rashes with mucosal involvement.
Read the entire FDA prescribing information for Rufinamide (Rufinamide Tablets)
© Rufinamide Patient Information is supplied by Cerner Multum, Inc. and Rufinamide Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.