Rufinamide

Rufinamide is a prescription medication used with other medicines to treat seizures associated with Lennox-Gastaut Syndrome. 

• Rufinamide is available under the following different brand names: Banzel

Common side effects of Rufinamide include:

• Headache,
• Dizziness,
• Drowsiness,
• Nausea, and
• Tiredness

Serious side effects of Rufinamide include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Skin rash,
• Fever,
• Swollen glands,
• Muscle aches,
• Severe weakness,
• Unusual bruising,
• Yellowing of the skin or eyes (jaundice),
• Mood or behavior changes,
• Depression,
• Anxiety,
• Panic attacks,
• Trouble sleeping,
• Impulsiveness,
• Agitation,
• Hostility,
• Aggression,
• Restlessness,
• Irritability,
• Hyperactivity,
• Talkativeness,
• Thoughts of self-harm,
• Loss of balance or coordination,
• Trouble walking, and
• Worsening or increased seizures

Rare side effects of Rufinamide include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 200 mg
• 400 mg

Oral suspension

• 40 mg/mL

Lennox-Gastaut Syndrome

Adult dosage

• Initial: 400-800 mg/day orally divided every 12 hours
• Target dose: Increase daily dose by 400-800 mg every other day until a maximum of 3200 mg/day divided every 12 hours is reached
• Unknown whether a dose lower than the target dose is effective

Pediatric dosage

• Below 1 year: Safety and efficacy not established
• Above 1 year
• Initial: 10 mg/kg/day orally divided every 12 hours  
• Target dose: Increase by approximately 10 mg/kg every other day until the maximum of 45 mg/kg/day divided every 12 hours is reached; not to exceed 3200 mg/day
• Unknown whether a dose lower than the target dose is effective

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Rufinamide has no noted severe interactions with any other drugs.
• Rufinamide has serious interactions with the following drugs:
  • dihydroergotamine
  • dihydroergotamine intranasal
  • dronedarone
  • ergotamine
  • erythromycin base
  • erythromycin ethylsuccinate
  • erythromycin lactobionate
  • erythromycin stearate
  • everolimus
  • lonafarnib
  • lovastatin
  • macimorelin
  • metoclopramide intranasal
  • pacritinib
  • ranolazine
  • silodosin
  • simvastatin
  • sirolimus
  • tolvaptan
• Rufinamide has moderate interactions with at least 105 other drugs.
• Rufinamide has minor interactions with at least 69 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Familial Short QT syndrome

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Rufinamide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Rufinamide?”

Cautions

• Shortens QT interval
• Not recommended in severe hepatic impairment
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported in patients taking antiepileptic drugs, including rufinamide; DRESS may be fatal or life-threatening; if DRESS suspected, evaluate the patient immediately; discontinue therapy and initiate alternative treatment
• Withdraw gradually
• May impair the ability to drive or perform hazardous tasks
• May render hormonal contraceptives ineffective

Pregnancy and Lactation

• Data are unavailable on the developmental risk associated with use in pregnant women
• Encourage women to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry at 1-888-233-2334 or http://www.aedpregnancyregistry.org
• Contraception
  • Use may reduce the effectiveness of hormonal contraceptives containing Ethinyl estradiol or norethindrone
  • Advise women of reproductive potential who are using hormonal contraceptives to use an additional nonhormonal contraceptive
• Infertility
  • Effect on fertility in humans has not been established
  • Oral administration of rufinamide (20, 60, 200, and 600 mg/kg/day) to male and female rats before mating, during mating, and early gestation (females only) resulted in fertility impairment at all dose levels tested
• Lactation
  • Data are not available regarding rufinamide presence in human milk, effects on breastfed infants, or effects on milk production
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from treatment or underlying maternal condition