| Vigabatrin (vye ga' ba trin) Tablets |
| What is the most important information I should know about vigabatrin?
Vigabatrin can cause serious side effects, including:
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Permanent vision loss
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Risk of suicidal thoughts or actions
1. Permanent vision loss:
Vigabatrin can damage the vision of anyone who takes it. Some people can have severe loss particularly to their ability to see to the side when they look straight ahead (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. If this happens, it will not get better.
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Vision loss and use of vigabatrin in adults and children 2 years and older: Because of the risk of vision loss, vigabatrin 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 vigabatrin.
- 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 vigabatrin or within 4 weeks after starting vigabatrin, and at least every 3 months after that until vigabatrin is stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after vigabatrin is stopped.
Your vision loss may get worse after you stop taking vigabatrin.
- 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 vigabatrin, 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 vigabatrin, but they do allow the healthcare provider to decide if you (or your child) should stop vigabatrin 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 vigabatrin.
- If you drive and your vision is damaged by vigabatrin, driving might be more dangerous, or you may not be able to drive safely at all. Talk about this with your healthcare provider.
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All people who take vigabatrin:
- You are at risk for permanent vision loss with any amount of vigabatrin.
- Your risk of vision loss may be higher the more vigabatrin 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 vigabatrin or any time during treatment. It may even happen after treatment has stopped.
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- Because vigabatrin 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. Vigabatrin 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 vigabatrin, 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 www.vigabatrinREMS.com or call 1-866-244-8175.
2. Risk of suicidal thoughts or actions:
Like other antiepileptic drugs, vigabatrin 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.
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Do not stop vigabatrin without first talking to a healthcare provider.
- Stopping vigabatrin 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.
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What is vigabatrin?
- Vigabatrin is a prescription medicine used along with other treatments to treat adults and children 2 years and older with complex partial seizures (CPS) if:
- the CPS do not respond well enough to several other treatments, and
- you and your healthcare provider decide the possible benefit of taking vigabatrin is more important than the risk of vision loss.
Vigabatrin should not be the first medicine used to treat CPS.
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What should I tell my healthcare provider before starting vigabatrin?
If you or your child has CPS, before taking vigabatrin tell your healthcare provider about all of your medical conditions, including if you or your child:
- have or had an allergic reaction to vigabatrin, 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. Vigabatrin 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 vigabatrin.
- are pregnant or plan to become pregnant. Vigabatrin can cause harm to your unborn baby. You and your healthcare provider will have to decide if you should take vigabatrin while you are pregnant.
Pregnancy Registry:
If you become pregnant while taking vigabatrin, 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. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Vigabatrin and other medicines may affect each other causing side effects.
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How should I take vigabatrin?
- Vigabatrin comes as tablets.
- You or your child will receive vigabatrin from a specialty pharmacy.
- Take vigabatrin exactly as your healthcare provider tells you to. Vigabatrin is usually taken 2 times each day.
- Vigabatrin may be taken with or without food.
- Before starting to take vigabatrin, talk to your healthcare provider about what you or your child should do if a vigabatrin dose is missed.
- If you or your child are taking vigabatrin for CPS and the seizures do not improve enough within 3 months, your healthcare provider will stop prescribing vigabatrin.
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Do not stop taking vigabatrin suddenly. This can cause serious problems. Stopping vigabatrin 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 vigabatrin.
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Tell your healthcare provider right away about any increase in seizures when vigabatrin treatment is being stopped. Before your child starts taking vigabatrin, speak to your child’s healthcare provider about what to do if your child misses a dose, vomits, spits up, or only takes part of the dose of vigabatrin.
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Do not stop taking vigabatrin without talking to your healthcare provider. If vigabatrin improves your (or your child’s) seizures, you and your healthcare provider should talk about whether the benefit of taking vigabatrin is more important than the risk of vision loss, and decide if you (or your child) will continue to take vigabatrin.
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| What should I avoid while taking vigabatrin?
Vigabatrin causes sleepiness and tiredness. Adults taking vigabatrin 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.
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| What are the possible side effects of vigabatrin?
Vigabatrin can cause serious side effects, including:
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See “What is the most important information I should know about vigabatrin?”
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sleepiness and tiredness. See “What should I avoid while taking vigabatrin?”
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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 vigabatrin.
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low red blood cell counts (anemia).
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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 vigabatrin.
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swelling.
If you or your child has CPS, vigabatrin 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 vigabatrin in adults include blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor), and tiredness.
The most common side effects of vigabatrin in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults.
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 vigabatrin.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store vigabatrin?
- Store vigabatrin tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep vigabatrin and all medicines out of the reach of children.
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| General information about the safe and effective use of vigabatrin.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about vigabatrin that is written for health professionals. Do not use vigabatrin for a condition for which it was not prescribed. Do not give vigabatrin to other people, even if they have the same symptoms that you have. It may harm them.
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| What are the ingredients in vigabatrin tablets?
Active Ingredient: vigabatrin
Inactive Ingredients: hypromellose 2910, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide.
Manufactured in India by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA
Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454
For more information call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.
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