rufinamide
Rufinamide (Banzel) is an antiepileptic medication that helps control seizures due to a type of epilepsy called Lennox-Gastaut syndrome (LGS). It's approved as add-on treatment to other anti-seizure medications for adults and children 1 year of age and older. Rufinamide (Banzel) is typically taken by mouth twice a day. It comes in tablet and oral suspension form. Rufinamide (Banzel) isn't a controlled substance, but it commonly causes drowsiness and vomiting as side effects.
What is Rufinamide (Banzel)?
What is Rufinamide (Banzel) used for?
- Seizures related to Lennox-Gastaut syndrome (LGS) - add-on treatment
How Rufinamide (Banzel) works
Rufinamide (Banzel) is an antiepileptic or anti-seizure medication. It's not clear exactly how it works to treat seizures. But we know that the medication slows down the activity of sodium channels in the brain. This might help calm down brain activity, which can help prevent seizures.
Drug facts
Side effects of Rufinamide (Banzel)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Children (age 1 to younger than 4 years old)
- Vomiting (24%)
- Drowsiness (16%)
- Bronchitis (12%)
- Constipation (12%)
- Cough (12%)
- Low appetite (12%)
- Rash (12%)
Children (age 3 to younger than 17 years old)
- Drowsiness (17%)
- Vomiting (17%)
- Headache (16%)
- Tiredness (9%)
- Dizziness (8%)
- Nausea (7%)
Adults
- Headache (27%)
- Dizziness (19%)
- Tiredness (16%)
- Nausea (12%)
- Drowsiness (11%)
Less Common Side Effects
Children
- Flu-like symptoms
- Cold symptoms
- Difficulty with movement or coordination
- Double vision
- Low appetite
- Rash
- Ear infection
Adults
- Vomiting
- Constipation
- Indigestion (upset stomach)
- Stomach pain
- Back pain
- Uncontrolled shaking (tremor)
- Problems with movement, coordination, or walking
- Anxiety
- Changes in vision (e.g., double vision, blurred vision)
- Eye twitching
Rufinamide (Banzel) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Thoughts of hurting yourself or suicide
- Worsened seizures or seizure attack
- Allergic reaction: fever, rash, swollen lymph nodes, swelling of the face or mouth
The following Rufinamide (Banzel) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Dizziness
shakiness in the legs, arms, hands, or feet
sleepiness or unusual drowsiness
trembling or shaking of the hands or feet
uncontrolled eye movements
Less common
Attack, assault, or force
black, tarry stools
chills
cough producing mucus
difficult or painful urination
difficulty with breathing
dizziness or lightheadedness
fear or nervousness
feeling of constant movement of self or surroundings
general feeling of discomfort or illness
headache
joint pain
loss of appetite
muscle aches and pains
pain or tenderness around the eyes and cheekbones
rash
restlessness
sensation of spinning
shakiness and unsteady walk
shivering
sores, ulcers, or white spots on the lips or in the mouth
stuffy or runny nose
sweating
swollen glands
tightness in the chest
trouble sitting still
trouble sleeping
trouble walking
unsteadiness, trembling, or other problems with muscle control or coordination
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
Rare
Bleeding gums
blood in the urine or stools
burning while urinating
fainting
inability to hold urine
increased urge to urinate during the night
increased volume of pale, dilute urine
lower back or side pain
pale skin
pinpoint red spots on the skin
pounding, slow heartbeat
sore tongue
swollen, painful, or tender lymph glands in the neck, armpit, or groin
troubled breathing with exertion
waking to urinate at night
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Blurred vision
double vision
seeing double
Less common
Acid or sour stomach
back pain
belching
change in hearing
decreased appetite
difficulty having a bowel movement (stool)
ear drainage
indigestion
itching skin
stomach discomfort, upset, or pain
upper abdominal or stomach pain
Rare
Increased appetite
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Rufinamide (Banzel)
Pros
- Works well to lessen the number of seizures in a month if you have Lennox–Gastaut syndrome
- Can give to children 1 year of age and older
- Comes as an orange-flavored suspension if you have trouble swallowing pills
- Not a controlled substance, so it doesn't have strict regulations from the government
Cons
- Must take with other anti-seizure medications (not by itself)
- Only used for seizures from Lennox-Gastaut syndrome; not for other seizure conditions
- Must take with food to help the body fully absorb the medication
- Can cause drowsiness
Pharmacist tips for Rufinamide (Banzel)
- You'll first start taking rufinamide (Banzel) at a low dose. Your prescriber might have a dosing schedule for you to follow so that you take a slightly higher dose every other day until you get to the dose that's right for you. Follow up with your prescriber about how often you're having seizures and what side effects you have to help with dose adjustments.
- Always take rufinamide (Banzel) with food so that your body absorbs it fully. If you take it on an empty stomach, you might not get the full effect of the medication.
- If you or your child has difficulty swallowing pills, you can cut the tablets in half with a pill splitter or crush them. You can also ask the prescriber for the liquid form of rufinamide (Banzel).
- Rufinamide (Banzel) can make you feel drowsy or dizzy. It can also affect your motor skills. Avoid activities that require you to be alert and coordinated, like riding a bike, driving a car, or operating machinery, until you know how this medication affects you. In particular, be aware of the effects of rufinamide (Banzel) when you first start taking it and after you switch to a higher dose.
- Avoid drinking alcohol with rufinamide (Banzel). Also avoid taking other medications can make you tired while you're taking rufinamide (Banzel). It can make side effects like drowsiness and tiredness more intense.
- Let your healthcare team know what other antiepileptic medications you're taking especially carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital, or valproate. Taking certain antiepileptic medications with rufinamide (Banzel) can affect the levels of the medications in the body. This can either cause more side effects or make them work less well. Make sure to tell your prescriber every time you start, stop, or change doses of your seizure medications.
- Rufinamide (Banzel) can make hormonal birth control work less well. If you're sexually active and you can become pregnant, use additional nonhormonal birth control (like condoms) while you're taking rufinamide (Banzel). This will help make sure your birth control works well to prevent unplanned pregnancies. Talk to your prescriber about which nonhormonal birth control options are best for you.
More tips for the liquid form of rufinamide (Banzel):
- Make sure to store the suspension liquid of rufinamide (Banzel) at room temperature (don't refrigerate). Throw out any unused medication 3 months after you open the original bottle.
- Shake the rufinamide (Banzel) bottle well each time before you measure out your dose.
- Use the adapter and oral syringe that comes in the rufinamide (Banzel) box. This makes sure that you draw up the right dose of the liquid medication. Talk to your pharmacist if you're not sure about how to use these supplies. It's important that you don't use household kitchen or measuring spoons for measuring your medication out since they might not be accurate.
Common questions about Rufinamide (Banzel)
No, rufinamide (Banzel) isn't a controlled substance. It doesn't appear to have a risk for misuse or addiction.
There isn't enough information to know whether rufinamide (Banzel) helps with neuropathic itch (itching due to damage to the nervous system). Some experts think that the nerve damage makes sodium channels in the nerve cells become too active. And in theory, rufinamide (Banzel) helps slow down the activity of sodium channels in nerve cells. But there are no studies looking at whether the medication actually improves neuropathic itch. And, rufinamide (Banzel) isn't FDA approved for this condition anyway. Talk to a healthcare professional about appropriate treatment options that can help if you have itchiness from nerve problems.
Yes, rufinamide (Banzel) can make you feel sleepy. In clinical studies, almost 20% of children and about 10% of adults reported feeling sleepy as a side effect of the medication. Don't drive or do anything that you need your full attention for until you know how rufinamide (Banzel) affects you. Let your prescriber know if you become too sleepy to do your normal daily activities.
Rufinamide (Banzel) can cause withdrawal if you stop taking it too suddenly. This withdrawal can look like more or worse seizures. Talk to your prescriber first if you want or need to stop this medication. To avoid withdrawal seizures, your prescriber will lower your dose every few days before you can stop rufinamide (Banzel) completely.
Weight loss isn't a typical side effect of rufinamide (Banzel). But in clinical studies, 8% of young children age 1 to 4 years old who took the medication experienced weight loss. had sometimes happen to young children who are taking rufinamide (Banzel). It's possible for weight loss to happen indirectly from some of the known side effects of rufinamide (Banzel), such as low appetite or upset stomach. Let the prescriber know if you notice concerning weight loss during treatment with rufinamide (Banzel).
In studies, some people 4 years and older with LGS who took rufinamide (Banzel) in addition to other anti-seizure medications had about a third fewer seizures per month than before. In comparison, some people who took a placebo (no active medication) with other antiepileptics had about 12% fewer seizures per month than before. Ask your prescriber if you have questions about how well rufinamide (Banzel) is working for you.
There aren't enough studies to say whether taking rufinamide (Banzel) during pregnancy is safe. Animal studies suggest that it might cause harm if it's taken during pregnancy. Your prescriber will weigh the risks and benefits for you to take rufinamide (Banzel) while you're pregnant. If you're currently pregnant and you're taking rufinamide (Banzel), it's encouraged that you enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This registry helps monitor how safe anti-seizure medications are during pregnancy. Enroll by visiting the website or by calling 1-888-233-2334.
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Risks and warnings for Rufinamide (Banzel)
Rufinamide (Banzel) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Suicidal thoughts or behavior
Antiepileptic (anti-seizure) medications like rufinamide (Banzel) can raise your risk of thoughts of suicide or suicidal behavior. Watch for new or worsening signs of depression and any unusual changes in mood or behavior, especially during the first few months of taking this medication and when your dose changes. Report anything concerning to your prescriber. Call 911 or get medical help right away if you have thoughts of hurting yourself.
Drowsiness, tiredness, and difficulty controlling movements
Rufinamide (Banzel) can cause drowsiness, tiredness, or weakness. It can also cause dizziness and problems with movement or coordination. These side effects usually happen when you first start the medication or when you switch to a higher dose. Avoid activities that require you to be alert, such as riding a bike, driving, or operating machinery, until you know how rufinamide (Banzel) affects you.
Heart rhythm problems
- Risk factors: Familial short QT syndrome | Taking other medications that can also shorten the QT interval (a specific change in the electrical activity of your heart)
Rufinamide (Banzel) can cause changes to the electrical activity of your heart. It makes the heart muscle recharge faster than usual between beats. This is known as QT shortening, which can lead to dizziness, fainting, and abnormal heart rhythms.
Tell your prescriber if you've had any heart rhythm problems. You can't take rufinamide (Banzel) if you have a genetic heart condition called familial short QT syndrome. This is because you're at higher risk for potentially life-threatening irregular heart rhythm.
Also make sure your healthcare team knows about all the medications you take. They can help you watch out for possibly dangerous drug interactions with rufinamide (Banzel). For example, certain medications, such as primidone (Mysoline), lamotrigine (Lamictal), and phenytoin (Dilantin), can raise your risk for QT shortening because they cause similar changes to the electrical activity of the heart as rufinamide (Banzel).
Severe allergic reaction
Some people who've taken rufinamide (Banzel) have had a severe allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS). This allergic reaction cause symptoms like fever, rash, swollen lymph nodes, or swelling of the face or mouth. It can also lead to low blood cell counts and damage to important organs, such as the liver, kidneys, and heart. Stop taking rufinamide (Banzel) and Gget medical attention as soon as possible if you notice any signs of a serious allergic reaction.
Seizures after stopping the medication too quickly
Don't stop taking rufinamide (Banzel) without talking to your prescriber first. You shouldn't stop taking antiepileptic (anti-seizure) medications like rufinamide (Banzel) too suddenly. It can lead to seizures due to medication withdrawal. Speak with your prescriber if you'd like to stop taking rufinamide (Banzel) or if it's necessary to stop taking it. Your prescriber will instruct you on how to lower your dose slowly over time.
Life-threatening seizure complication (status epilepticus)
In clinical studies, a few people who took rufinamide (Banzel) experienced status epilepticus, which is a seizure attack that lasts a long time and is life-threatening. In general, it's a good idea to have a plan with family and friends about how to help (and when to call 911) during a seizure attack if you or your child has epilepsy or a seizure condition.
Low white blood cell counts
Rufinamide (Banzel) can lower your white blood cell counts. This can make it harder for your body to fight off infections. Let your prescriber know if you're getting sick more than usual or if any infections last longer than normal.
Rufinamide (Banzel) dosage
Ml of oral suspension| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 40mg/ml | 460 ml | $108.02 | $0.23 |
Interactions between Rufinamide (Banzel) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Calcifediol
- Desogestrel
- Dienogest
- Drospirenone
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Etonogestrel
- Levonorgestrel
- Medroxyprogesterone Acetate
- Mestranol
- Nifedipine
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Orlistat
- Piperaquine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
How much does Rufinamide (Banzel) cost?
Rufinamide (Banzel) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Rufinamide (Banzel) will not be safe for you to take.
- Familial short QT syndrome (a genetic heart rhythm condition)
What are alternatives to Rufinamide (Banzel)?
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