Generic Vigabatrin Tablets USP, 500 mg
Product rendering for illustrative purposes only.
For the Treatment of Seizures in Adults and Pediatric Patients with Epilepsy
Vigabatrin tablets is a prescription medicine used with other treatments in adults and children 2 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments. Vigabatrin tablets should not be the first medicine used to treat CPS.
Vigabatrin tablets is a prescription medicine that may be used without other medicines in babies, 1 month to 2 years of age, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.
How to Get Generic Vigabatrin
The process for filling, receiving and using your generic Vigabatrin prescription is different than most other medications. Due to the risk of vision loss associated with the use of this medication, it is only available through a restricted distribution program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS). You must be enrolled in this REMS program to receive your generic medication and it can only be dispensed by certified heathcare providers and pharmacies. For more on the Vigabatrin REMS program, visit vigabatrinrems.com.
Receiving Your Prescription
Important Safety Information for Vigabatrin Tablets USP, 500 mg
WARNING: PERMANENT VISION LOSS Vigabatrin can cause permanent vision loss.
Because vigabatrin can cause permanent vision loss, it is available only through a restricted program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this program to you. |
Vigabatrin tablets can damage the vision of anyone who takes them. Some people can have severe loss particularly in 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.
Tell your healthcare provider right away if you (or your child):
- Might not be seeing as well as before starting vigabatrin tablets
- Start to trip, bump into things or are more clumsy than usual
- Are surprised by people and 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 before or within 4 weeks after starting vigabatrin tablets and at least every 3 months after that until vigabatrin tablets are stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after vigabatrin is stopped. Vision loss may get worse after you (or your child) stop taking vigabatrin tablets.
It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if your baby’s vision can be tested. Parents and 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.
Even if your (or your child’s) vision seems fine, get routine vision tests because vision damage can happen before it becomes noticeable. If you do not have vision tests regularly, your healthcare provider may stop prescribing vigabatrin tablets.
Vision testing cannot prevent the vision damage that can happen with vigabatrin tablets, but they do allow your healthcare provider to decide if you (or your child) should stop vigabatrin tablets if vision has gotten worse. Even these regular vision tests may not show vision damage until it is severe and permanent.
Some people are unable to complete vision tests. Your healthcare provider will determine if you (or your child) can be tested. If you (or your child) cannot be tested, your healthcare provider may continue prescribing vigabatrin tablets. However, your healthcare provider will not be able to watch for vision loss.
Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given vigabatrin. It is not known if these changes are harmful.
Like other antiepileptic drugs, vigabatrin tablets may cause suicidal thoughts or actions in a very small number of people. Call your healthcare provider if you or your child have these symptoms, especially if they are new, worsen or worry you.
Do not stop taking vigabatrin tablets without first talking to your healthcare provider. Stopping vigabatrin tablets 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.
Before taking vigabatrin tablets, tell your healthcare provider about all of your (or your child’s) medical conditions, especially if you or your child have or had an allergic reaction to vigabatrin tablets, any vision problems, any kidney problems, low red blood cell counts (anemia) or any nervous or mental illnesses. Tell your healthcare provider about all the medicines you or your child take.
Tell your healthcare provider if you are breastfeeding or planning to breastfeed. Vigabatrin can pass into breast milk and may harm your baby. Vigabatrin may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable. Talk to your healthcare provider about the best way to feed your baby if you take vigabatrin tablets.
Tell your healthcare provider if you are pregnant or planning to become pregnant. Vigabatrin tablets can harm your unborn baby. You and your healthcare provider will need to decide if you should take vigabatrin tablets while you are pregnant.
If you become pregnant while taking vigabatrin tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll by calling 1-888-233-2334. You can find information about the registry at http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
Vigabatrin tablets can cause serious side effects, including anemia, tiredness and fatigue, nerve problems, weight gain and swelling. Vigabatrin may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable. Adults taking vigabatrin tablets 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.
The most common side effects of vigabatrin tablets in adults include blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking and tiredness. The most common side effect of vigabatrin tablets in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults. The most common side effects of vigabatrin in babies include sleepiness, ear infection, swelling in the bronchial tubes (bronchitis) and irritability.
If you or your child has complex partial seizures (CPS), vigabatrin may make certain types of seizures worse. Tell your healthcare provider right away if your (or your child’s) seizures get worse. If you are giving vigabatrin to your baby for infantile spasms (IS), vigabatrin may make certain types of seizures worse. Tell your baby’s healthcare provider right away if your baby’s seizures get worse or if you see any changes in your baby’s behavior.
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 tablets.
For more information, please see the Full Prescribing Information, including the Boxed Warning, and the Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.
Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922
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