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Vigabatrin
What is Sabril (Vigabatrin)?
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Related Clinical Trials
Summary: This is a phase II clinical trial in which children with refractory infantile spasms (also called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, and tolerability. Patients with infantile spasms that have not responded to treatment with vigabatrin and ACTH we will be invited to participate. Study participants will undergo baseline video-EEG, rece...
Summary: Infantile spasms (IS) are seizures associated with a severe infantile epileptic encephalopathy. Both cessation of spasms and electrographic response are necessary for the best neurodevelopmental outcomes. Adrenocorticotrophic hormone (ACTH), or prednisolone, or vigabatrin are considered the first-line treatment individually. However, ACTH expense and availability are the barriers in developing cou...
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Brand Information
- SABRIL can cause permanent bilateral concentric visual field constriction including tunnel vision that can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity
- The onset of vision loss from SABRIL is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years.
- Symptoms of vision loss from SABRIL are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function.
- The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.
- Vision assessment is recommended at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy.
- Once detected, vision loss due to SABRIL is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.
- Consider drug discontinuation, balancing benefit and risk, if visual loss is documented.
- Risk of new or worsening vision loss continues as long as SABRIL is used. It is possible that vision loss can worsen despite discontinuation of SABRIL.
- Because of the risk of visual loss, SABRIL should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2-4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious. Patient response to and continued need for SABRIL should be periodically reassessed.
- SABRIL should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks.
- SABRIL should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.
- Use the lowest dosage and shortest exposure to SABRIL consistent with clinical objectives
- Permanent Vision Loss
- Magnetic Resonance Imaging (MRI) Abnormalities in Infants
- Neurotoxicity
- Suicidal Behavior and Ideation
- Withdrawal of Antiepileptic Drugs (AEDs)
- Anemia
- Somnolence and Fatigue
- Peripheral Neuropathy
- Weight Gain
- Edema
Adults
Table 5 lists the adverse reactions that occurred in ≥2% and more than one patient per SABRIL-treated group and that occurred more frequently than in placebo patients from 2 U.S. adjunctive clinical studies of refractory CPS in adults.
In a randomized, placebo-controlled IS study with a 5 day double-blind treatment phase (n=40), the adverse reactions that occurred in >5% of patients receiving SABRIL and that occurred more frequently than in placebo patients were somnolence (SABRIL 45%, placebo 30%), bronchitis (SABRIL 30%, placebo 15%), ear infection (SABRIL 10%, placebo 5%), and acute otitis media (SABRIL 10%, placebo 0%).

Inform patients and caregivers of the risk of permanent vision loss, particularly loss of peripheral vision, from SABRIL, and the need for monitoring vision [see Warnings and Precautions (].
SABRIL is available only through a restricted program called the Vigabatrin REMS Program [see Warnings and Precautions (. Inform patients/caregivers of the following:
- Patients/caregivers must be enrolled in the program.
- SABRIL is only available through pharmacies that are enrolled in the Vigabatrin REMS Program.
Inform caregiver(s) of the possibility that infants may develop an abnormal MRI signal of unknown clinical significance [see Warnings and Precautions (].
Counsel patients, their caregiver(s), and families that AEDs, including SABRIL, may increase the risk of suicidal thoughts and behavior. Also advise patients and caregivers of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (
Instruct patients and caregivers not to suddenly discontinue SABRIL therapy without consulting with their healthcare provider. As with all AEDs, withdrawal should be gradual [see Warnings and Precautions (.
(vigabatrin)
tablets
(vigabatrin)
for oral solution
- Permanent vision loss
- Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS)
- Risk of suicidal thoughts or actions
- Vision loss and use of SABRIL in adults and children 2 years and older: Because of the risk of vision loss, SABRIL is used to treat complex partial seizures (CPS) only in people who do not respond well enough to several other medicines.
- might not be seeing as well as before starting SABRIL.
- start to trip, bump into things, or are more clumsy than usual.
- are surprised by people or things coming in front of you that seem to come out of nowhere.
- These changes can mean that you (or your child) have damage to your vision.
- It is recommended that your healthcare provider test your (or your child’s) vision (including peripheral vision) and visual acuity (ability to read an eye chart) before you (or your child) start SABRIL or within 4 weeks after starting SABRIL, and at least every 3 months after that until SABRIL is stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after SABRIL is stopped. Your vision loss may get worse after you stop taking Sabril.
- Some people are not able to complete testing of vision. Your healthcare provider will determine if you (or your child) can be tested. If you (or your child) cannot complete vision testing, your healthcare provider may continue prescribing SABRIL, but your healthcare provider will not be able to watch for any vision loss you (or your child) may get.
- Even if your vision (or your child’s vision) seems fine, it is important that you (or your child) get these regular vision tests because vision damage can happen before you (or your child) notice any changes.
- These vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow the healthcare provider to decide if you (or your child) should stop SABRIL if your vision has gotten worse.
- Vision testing may not detect vision loss before it is severe.
- If you do not have these vision tests regularly, your healthcare provider may stop prescribing SABRIL.
- If you drive and your vision is damaged by SABRIL, driving might be more dangerous, or you may not be able to drive safely at all. Talk about this with your healthcare provider.
- Vision loss in babies: Because of the risk of vision loss, SABRIL is used in babies 1 month to 2 years of age with infantile spasms (IS) only when you and your healthcare provider decide that the possible benefits of SABRIL are more important than the risks.
- Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe.
- It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting SABRIL or within 4 weeks after starting SABRIL, and every 3 months after that until SABRIL is stopped. Your baby should also have a vision test about 3 to 6 months after SABRIL is stopped.
- Your baby may not be able to be tested. Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing SABRIL, but your healthcare provider will not be able to watch for any vision loss.
- not seeing as well as before taking SABRIL.
- acting differently than normal.
- Even if your baby’s vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby’s vision before it is severe and permanent.
- Because SABRIL might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. SABRIL can only be prescribed to people who are enrolled in this program. As part of the Vigabatrin REMS Program, it is recommended that your healthcare provider test your (or your child’s) vision from time to time (periodically) while you (or your child) are being treated with SABRIL, and even after you (or your child) stop treatment. Your healthcare provider will explain the details of the Vigabatrin REMS Program to you. For more information, go to
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
- Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
- Do not stop SABRIL without first talking to a healthcare provider.
- Stopping SABRIL suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures.
- SABRIL
- SABRIL is also used to treat babies 1 month to 2 years of age who have infantile spasms (IS) if you and your healthcare provider decide the possible benefits of taking SABRIL are more important than the possible risk of vision loss.
- have or had an allergic reaction to SABRIL, such as hives, itching, or trouble breathing.
- have or had any vision problems.
- have or had any kidney problems.
- have or had low red blood cell counts (anemia).
- have or had any nervous or mental illnesses such as depression, mood problems, thoughts of suicide, or attempts at suicide.
- are breastfeeding or planning to breastfeed. SABRIL can pass into breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take SABRIL.
- are pregnant or plan to become pregnant. SABRIL can cause harm to your unborn baby. You and your healthcare provider will have to decide if you should take SABRIL while you are pregnant.
- an allergic reaction to SABRIL, such as hives, itching, or trouble breathing.
- any vision problems.
- any kidney problems.
- SABRIL comes as tablets or as packets containing powder for mixing with water to make an oral solution.
- You or your child will receive SABRIL from a specialty pharmacy.
- Take SABRIL exactly as your healthcare provider tells you to. SABRIL is usually taken 2 times each day.
- SABRIL may be taken with or without food.
- Before starting to take SABRIL, talk to your healthcare provider about what you or your child should do if a SABRIL dose is missed.
- If you or your child are taking SABRIL for CPS and the seizures do not improve enough within 3 months, your healthcare provider will stop prescribing SABRIL.
- If your child is taking SABRIL for IS and the seizures do not improve within 2 to 4 weeks, your healthcare provider will stop prescribing SABRIL.
- Do not stop taking SABRIL suddenly. This can cause serious problems. Stopping SABRIL or any seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures. You should follow your healthcare provider’s instructions on how to stop taking SABRIL.
- Tell your healthcare provider right away about any increase in seizures when SABRIL treatment is being stopped. Before your child starts taking SABRIL, speak to your child’s healthcare provider about what to do if your baby misses a dose, vomits, spits up, or only takes part of the dose of SABRIL.
- Do not stop taking SABRIL without talking to your healthcare provider. If SABRIL improves your (or your child’s) seizures, you and your healthcare provider should talk about whether the benefit of taking SABRIL is more important than the risk of vision loss, and decide if you (or your child) will continue to take SABRIL.
- If you are giving SABRIL for oral solution to your child, it can be given at the same time as their meal.
- See “Instructions for Use” for detailed information about how to mix and give SABRIL for oral solution to your child the right way.
- See “What is the most important information I should know about SABRIL?”
- sleepiness and tiredness. See “What should I avoid while taking SABRIL?”
- SABRIL may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable.
- weight gain that happens without swelling.
- low red blood cell counts (anemia).
- nerve problems. Symptoms of a nerve problem can include numbness and tingling in your toes or feet. It is not known if nerve problems will go away after you stop taking SABRIL.
- swelling.
- sleepiness - SABRIL may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding or may be irritable.
- swelling in the bronchial tubes (bronchitis)
- ear infection
- irritability
- Store SABRIL tablets and SABRIL packets at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
Active Ingredient: vigabatrin
Inactive Ingredients:
- Tablets: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide
- For oral solution: povidone
NDC 67386-111-01
Sabril®
(vigabatrin) Tablets
500 mg
DISPENSE THE ENCLOSED MEDICATION
GUIDE WITH EACH PRESCTIPTION.
Rx only
100 Tablets




