Sabril® (SAY-bril) (vigabatrin) tablets
Sabril® (SAY-bril) (vigabatrin) powder for oral solution
Read the Medication Guide that comes with SABRIL before you or your child starts taking SABRIL and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your or your child’s medical condition or treatment.
What is the most important information I should know about SABRIL?
SABRIL can cause serious side effects, including:
- Permanent vision damage
- Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS)
- Risk of suicidal thoughts or actions
- Permanent vision damage:
SABRIL can damage the vision of anyone who takes it. The most noticeable loss is in your ability to see to the side when you look straight ahead (peripheral vision). If this happens, it will not get better. People who take SABRIL do not lose all of their vision, but some people can have severe loss particularly to their peripheral vision. With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision.
Vision loss and use of SABRIL in adults and children 10 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.
Tell your healthcare provider right away if you (or your child):
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
o These changes can mean that you (or your child) have damage to your vision.
o Your healthcare provider will 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. You (or your child) may not be able to be tested in certain situations. Your healthcare provider will determine if you (or your child) can be tested.
o Some people are not able to complete testing of vision for medical reasons. 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.
o Even if your vision (or your child’s vision) seems fine, it is important that you get these regular vision tests because vision damage can happen before you (or your child) notice any changes.
o 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 vision has gotten worse, which usually will lessen further damage.
o If you do not have these vision tests regularly, your healthcare provider may stop prescribing SABRIL.
o You (or your child) should also have a vision test after SABRIL is stopped.
o 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.
o 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.
o 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.
o Your baby should have a vision test after SABRIL is stopped.
o Your baby may not be able to be tested in certain situations. 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.
Tell your healthcare provider right away if you think that your baby is:
not seeing as well as before taking SABRIL acting differently than normal
o 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 serious and permanent.
o If your baby does not have these vision tests regularly, your healthcare provider may stop prescribing SABRIL for your baby.
o If your baby is not able to complete vision testing, your healthcare provider may continue prescribing SABRIL for your baby. But, your healthcare provider will not be able to watch for vision loss in your baby.
In all people who take SABRIL:
- You are at risk for vision loss with any amount of SABRIL.
- Your risk of vision loss may be higher the more SABRIL you take daily and the longer you take it.
- It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting SABRIL or any time during treatment. It may even happen after treatment has stopped.
- Because SABRIL might cause vision loss, it is available to healthcare providers and patients only under a special program called the Support, Help and Resources for Epilepsy SHARE program. As part of the SHARE program, among other things, your healthcare provider will have to test you or your child’s vision frequently while you or your child are being treated with SABRIL, and even after you or your child stops treatment. You also have to agree to be in the SHARE program, and agree to have your or your child’s vision tested regularly. Your healthcare provider will explain the details of the SHARE program to you.
- Magnetic resonance imaging (MRI) changes in babies with infantile spasms:
Like other antiepileptic drugs, SABRIL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Call a healthcare provider right away if you or your child have any of these symptoms, especially if they are new, worse, or worry you:
- 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
Suicidal thoughts or actions can be caused by things other than medicines. If you or your child have suicidal thoughts or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
- 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 can be prescribed only to people who are enrolled in a program called SHARE. Before you or your child can begin taking SABRIL, you must read and agree to all of the instructions in the SHARE program.
What is SABRIL?
SABRIL is a prescription medicine used along with other treatments to treat adults and children 10 years and older with complex partial seizures (CPS) if:
o The CPS does not respond well enough to several other treatments, and
o You and your healthcare provider decide the possible benefit of taking SABRIL is more important than the risk of vision loss.
SABRIL should not be the first medicine used to treat CPS.
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.
If you or your child has CPS, you must sign an agreement form before you or your child can receive SABRIL.
If you are the parent or caregiver of a baby with IS, you must sign an agreement form before your baby can receive SABRIL.
What should I tell my healthcare provider before starting SABRIL?
If you or your child has CPS, before taking SABRIL tell your healthcare provider if you or your child have or had:
- depression, mood problems or suicidal thoughts or behavior
- an allergic reaction to SABRIL, such as hives, itching, or trouble breathing
- any vision problems
- any kidney problems
- low red blood cell counts (anemia)
- any nervous or mental illnesses, such as depression, thoughts of suicide, or attempts at suicide
- any other medical conditions
- 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. It is not known if SABRIL will harm your unborn baby. You and your healthcare provider will have to decide if you should take SABRIL while you are pregnant.
If you become pregnant while taking SABRIL, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
Before giving SABRIL to your baby, tell the healthcare provider about all of your baby’s medical conditions, including if your baby has or ever had:
- an allergic reaction to SABRIL, such as hives, itching, or trouble breathing
- any vision problems
- any kidney problems
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SABRIL and other medicines may affect each other causing side effects.
How should I take SABRIL?
- SABRIL comes as tablets or powder for 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 powder for oral solution to your child, it can be given to your baby at the same time with their meal. SABRIL for oral solution powder should be mixed with water only.
- See the detailed “Instructions for Use” for detailed information about how to mix and give SABRIL powder for oral solution to your baby the right way.
What should I avoid while taking SABRIL?
SABRIL causes sleepiness and tiredness. Adults taking SABRIL should not drive, operate machinery, or perform any hazardous task, unless you and your healthcare provider have decided that you can do these things safely.
What are the possible side effects of SABRIL? SABRIL can cause serious side effects, including:
- 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
The following serious side effects happen in adults. It is not known if these side effects also happen in babies who take SABRIL.
- 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.
If you or your child has CPS, SABRIL may make certain types of seizures worse. Tell your healthcare provider right away if your (or your child’s) seizures get worse.
The most common side effects of SABRIL in adults include:
- problems walking or feeling uncoordinated
- feeling dizzy
- shaking (tremor)
- joint pain
- memory problems and not thinking clearly
- eye problems: blurry vision, double vision and eye movements that you cannot control
The most common side effects of SABRIL in children 10 to 16 years of age include:
- weight gain
- upper respiratory tract infection
- Also expect side effects like those seen in adults
If you are giving SABRIL to your baby for IS:
SABRIL may make certain types of seizures worse. You should tell your baby’s healthcare provider right away if your baby’s seizures get worse. Tell your baby’s healthcare provider if you see any changes in your baby’s behavior.
The most common side effects of SABRIL in babies include: 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 Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away. These are not all the possible side effects of SABRIL. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SABRIL?
- Store SABRIL tablets and SABRIL packets at room temperature, between 680F to 770F (200C to 250C).
- Keep SABRIL tablets and SABRIL powder in the container they come in.
Keep SABRIL and all medicines out of the reach of children.
General information about the safe and effective use of SABRIL.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SABRIL for a condition for which it was not prescribed. Do not give SABRIL to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about SABRIL. If you would like more information about SABRIL, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about SABRIL that is written for health professionals. For more information, go to www.SABRIL.net or call 1-800-455-1141.
What are the ingredients in SABRIL?
Active Ingredient: vigabatrin
- Tablets: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide
- Powder for oral solution: povidone
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Marketed by: Lundbeck, Deerfield, IL 60015, U.S.A.
SABRIL is a registered trademark of Lundbeck
Revised: October 2013
Reference ID: 3396175
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