vigabatrin
Vigabatrin (Sabril) can treat certain types of seizures: infantile spasms and complex partial seizures. It's available as a powder that's made into a solution and a tablet, both of which you take by mouth. The medication is typically taken twice daily. Vigabatrin (Sabril) is only available through the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) program because of the risk for permanent vision loss due to eye damage. Other side effects include sleepiness and dizziness. This medication is available as brand-name and lower-cost generic versions.
What is Vigabatrin (Sabril)?
What is Vigabatrin (Sabril) used for?
Difficult-to-treat complex partial seizures in people age 2 years and older (as add-on therapy to other medications)
Infantile spasms in children age 1 month to 2 years
How Vigabatrin (Sabril) works
Vigabatrin (Sabril) is an antiepileptic (another name for anti-seizure medication). It's not exactly clear how it works to treat seizures. But it's thought to raise the levels of gamma-aminobutyric acid (GABA), a chemical in the brain that calms nerves. This helps control seizures.
Drug Facts
What are the side effects of Vigabatrin (Sabril)?
Common Side Effects
- Headache (33%)
- Dizziness (24%)
- Tiredness (23%)
- Drowsiness (22%)
- Uncontrolled shaking (15%)
- Common cold symptoms (14%)
- Blurred vision (13%)
- Eye twitching (13%)
- Diarrhea (10%)
- Nausea (10%)
- Joint pain (10%)
- Abnormal coordination (6%)
- Weight gain (15%)
- Upper respiratory tract infection (e.g., cough, common cold; 15%)
- Tiredness (10%)
- Upper respiratory tract infection (up to 51%)
- Middle ear infection (up to 44%)
- Fever (up to 29%)
- Irritable behavior (up to 23%)
- Vomiting (up to 20%)
- Sleepiness (up to 19%)
Other Side Effects
- Vomiting
- Constipation
- Pain in the hands or feet
- Swelling in the hands or feet due to fluid buildup (edema)
- Weight gain
- Double vision
- General weakness
- Flu-like symptoms
- Memory problems
- Difficulty paying attention
- Tingling sensation
- Feeling irritable
- Depression
- Menstrual cramps (in women)
- Rash
Serious Side Effects
- Permanent vision loss
- Suicidal thoughts or behaviors
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision such as blurry vision, seeing halos around lights, vision loss
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain, tingling, or numbness in the hands or feet
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Dizziness
- Drowsiness
- Fatigue
- Loss of balance or coordination
- Swelling of the ankles, hands, or feet
- Tremors or shaking
- Weight gain
Pros and cons of Vigabatrin (Sabril)
Pros
A recommended medication for treating infantile spasms
Doesn't require regular blood work to check medication levels
Available as a tablet and oral solution
Available as a lower-cost generic form
Cons
Can cause weight gain, especially in children
Can raise the risk for suicidal thoughts or behaviors
Can cause permanent vision loss
Pharmacist tips for Vigabatrin (Sabril)
You can take vigabatrin (Sabril) with or without food, but if it upsets your stomach, try taking it with food to help.
Vigabatrin (Sabril) commonly causes sleepiness, tiredness, and dizziness. Don't drive or do anything requiring concentration until you know how this medication affects you. Also, avoid drinking alcohol because it can worsen these effects.
Vigabatrin (Sabril) can cause vision loss and changes in vision, including blurriness or difficulty seeing things that aren't directly in front of you. Make sure you see your provider for an eye exam every 3 months while you're taking this medication. Report any signs of vision changes to your provider right away.
Weight gain can be a side effect of vigabatrin (Sabril). It's important to closely keep track of your weight and keep a healthy diet and exercise routine while taking vigabatrin (Sabril). Contact your provider if you're concerned with any changes in weight you might experience during treatment.
Vigabatrin (Sabril) can raise the risk of suicidal thoughts. Contact your provider right away if you or your loved ones notice any new or worsening changes in your behavior or mood while taking this medication.
Don't change your dose or suddenly stop taking vigabatrin (Sabril) without talking to your provider first. Doing so can cause your seizures to come back. If you're interested in stopping the medication, contact your provider and follow their instructions on how to lower your dose slowly over a period of time to stop the medication completely.
More tips for the vigabatrin (Sabril) 500 mg powder packets for oral solution:
Make sure you know exactly how to prepare the powder for oral solution to get the right dose each time. The amount of water you'll need to use to mix the powder with depends on the number of powder packets you need for your dose. Once mixed, measure out the correct amount of solution with the oral syringe that's provided by the pharmacy. Review the helpful instructions on how to prepare the medication that comes with your vigabatrin (Sabril) prescription. Ask your provider or pharmacist if you have any questions on how to prepare vigabatrin (Sabril) properly.
Be sure to use the oral syringes that's given to you by the pharmacy to measure out your dose. Don't use household spoons because they aren't accurate and might cause you to take the wrong dose.
To give the vigabatrin (Sabril) solution to a young child, put the tip of the oral syringe into their mouth towards either cheek. Then, push the plunger down slowly so that a small amount of medication is given at a time. Give all the medication in the oral syringe.
Store the powder packets at room temperature. Mix the powder with water only when you're ready to take the dose.
Frequently asked questions about Vigabatrin (Sabril)
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What are the risks and warnings for Vigabatrin (Sabril)?
Vigabatrin (Sabril) 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.
Permanent vision loss
Risk factors: Taking higher doses of vigabatrin (Sabril) | Taking other medications that could affect vision or cause eye conditions like glaucoma
Vigabatrin (Sabril) can affect your vision, including causing blurry vision or making it hard to see things that aren't directly in front of you ("tunnel vision"). This medication can also cause vision loss, which can occur at any time after starting vigabatrin (Sabril) (within weeks of starting or after many months to years). This effect is permanent and might continue to get worse even after you stop taking the medication. Make sure to get your vision checked with a provider every 3 months while you're taking vigabatrin (Sabril) and at least one more time after you stop taking it. Tell your provider right away if you notice a change in your vision or if you're clumsier than usual, like tripping or bumping into things more easily.
Because of the risk of permanent vision loss with vigabatrin (Sabril), you, your provider, and your pharmacy are required to sign up with the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) program. This program makes sure that your provider checks your eye health regularly and that you understand this risk with taking the medication.
Abnormal brain MRI in young children
Risk factors: Children 6 years old or younger
Young children who take vigabatrin (Sabril) can have abnormal MRIs (brain scans). These abnormalities might be due to nerve swelling in certain parts of the brain. In studies with young children with infantile spasms, the abnormalities went away in most cases after the medication was stopped. But there have been a few cases where they stayed even after stopping treatment. This unusual brain scan imaging isn't usually a problem for adults or children over 6 years of age. If this happens, your child's provider might want to try a different medication instead.
Suicidal thoughts or behavior
Risk factors: Taking other anti-seizure medications
Vigabatrin (Sabril) raises your risk of having thoughts of suicide or harming yourself. This risk can appear as early as 1 week after you start taking vigabatrin (Sabril). If you or anyone around you notices that you have suicidal thoughts or unusual behavior (e.g., anxiety, panic attacks, difficulty sleeping, feeling angry or irritated, restlessness) while taking vigabatrin (Sabril), get medical help right away.
Withdrawal seizures after stopping the medication suddenly
Antiepileptic (anti-seizure) medications like vigabatrin (Sabril) shouldn't be stopped suddenly because it can cause your seizures to come back. Don't stop taking vigabatrin (Sabril) without talking to your provider first. They'll instruct you on how to lower your dose slowly over time until you can completely stop taking it.
Low red blood cell counts (anemia)
Some people taking vigabatrin (Sabril) developed anemia, a condition that happens when your red blood cell counts are low. Your provider might order tests to check your red blood cell count before and during treatment with vigabatrin (Sabril). Let your provider know if you notice possible symptoms of anemia, such as tiredness, weakness, pale skin, or getting short of breath more than usual.
Difficulty concentrating, extreme sleepiness or tiredness, and dizziness
Risk factors: Taking high doses of vigabatrin (Sabril) | Drinking alcohol | Taking other medications that can cause sleepiness
Vigabatrin (Sabril) can cause extreme dizziness, tiredness, or sleepiness. These side effects can lower your ability to think, react, and focus. Your risk might be higher if you're taking other medications that can cause you to feel sleepy (e.g., benzodiazepines, muscle relaxants, sleep medications). Make sure you know how this medication affects you before driving a car or doing activities that require your concentration. Talk to your healthcare provider right away if you feel too sleepy from taking vigabatrin (Sabril).
Nerve pain in adults
Vigabatrin (Sabril) can cause nerve problems (called peripheral neuropathy) in adults. These nerve problems can include pain, numbness, or tingling in your feet. It might also lead to gradual problems with movement or reflexes. Let your provider know if you experience any abnormal sensations in your toes, feet, or ankles while you're taking this medication.
Weight gain
Vigabatrin (Sabril) can cause weight gain. This tends to be more common in children, but this effect can happen in adults as well. In clinical studies, the average weight gain in adults was about 8 pounds. Let your provider know if you or your child has gained an abnormal amount of weight after starting this medication.
Vigabatrin (Sabril) dosage forms
Typical dosing for Vigabatrin (Sabril)
The dose is the same for the tablet and powder for liquid.
Complex partial seizures
Age 17 years or older: The typical dose is 500 mg to 1,500 mg by mouth twice per day.
Age 2 to less than 17 years: The dose is based on your child's body weight.
22 to 33 pounds: The typical dose is 175 mg to 525 mg by mouth twice per day.
33 to 44 pounds: The typical dose is 225 mg to 650 mg by mouth twice per day.
44 to 55 pounds: The typical dose is 250 mg to 750 mg by mouth twice per day.
55 to 132 pounds: The typical dose is 250 mg to 1,000 mg by mouth twice per day.
Greater than 132 pounds: The typical dose is 500 mg to 1,500 mg by mouth twice per day.
Infantile spasms: The dose is based on your child's body weight. The starting dose is 25 mg/kg by mouth twice per day. The maximum dose is 75 mg/kg twice per day.
Your provider will change the dose depending on how well the medication is working for you and if you're having side effects. Your dose might differ if you have kidney problems.
What are alternatives to Vigabatrin (Sabril)?
Difficult-to-treat complex partial seizures in people age 2 years and older (as add-on therapy to other medications)
Infantile spasms in children age 1 month to 2 years
Partial-onset seizures in people ages 4 years and older
Generalized tonic-clonic seizures in people ages 12 years and older (add-on therapy to other seizure medications)
Vigabatrin (Sabril) images
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References
Best studies we foundAmerican Society of Hematology. (n.d.). Anemia.
Amneal Pharmaceuticals NY LLC. (2022). Vigabatrin tablet [package insert]. DailyMed.
Djuric, M., et al. (2014). (2014). Long-term outcome in children with infantile spasms treated with vigabatrin: A cohort of 180 patients. Epilepsia.
Drugs and Lactation Database (LactMed). (2022). Vigabatrin. National Institute of Child Health and Human Development.
Go, C. Y., et al. (2012). Evidence-based guideline update: Medical treatment of infantile spasms. Neurology.
Hikma Pharmaceuticals USA Inc. (2023). Vigabatrin for oral solution USP, 500 mg- vigabatrin for solution [package insert]. DailyMed.
Jewett, B. E., et al. (2023). Physiology, GABA. StatPearls.
Lundbeck. (n.d.). Instructions for use: Sabril® (SAY-bril) (vigabatrin) for oral solution.
Lundbeck. (n.d.). Sabril® (vigabatrin) for infantile spasms (IS).
Lundbeck. (n.d.). Sabril® (vigabatrin) for refractory complex partial seizures (CPS).
Lundbeck. (n.d.). Side effects.
Vigabatrin REMS Program. (n.d.). Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) program.
Vigabatrin REMS. (n.d.). Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program.
Waterhouse, E. J., et al. (2009). Treatment of refractory complex partial seizures: Role of vigabatrin. Neuropsychiatric Disease and Treatment.
Wild, J. M., et al. (2006). Detecting vigabatrin toxicity by imaging of the retinal nerve fiber layer. Investigative Ophthalmology & Visual Science.
Ylinen, A., et al. (1999). Long-term treatment with vigabatrin – 10 years of clinical experience. Seizure.
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