Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, get worse, or worry you. Like other antiepileptic drugs, SABRIL may cause suicidal thoughts and actions in some people.A type of swelling in the brain called intramyelinic edema (IME) has been seen in autopsy examination of babies treated with vigabatrin.
It is not known if these changes are harmful. Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given SABRIL.If vision testing cannot be done, your healthcare provider may continue prescribing SABRIL, but will not be able to watch for any vision loss. Some people are not able to complete vision testing. If vision tests are not done regularly, your healthcare provider may stop prescribing SABRIL for you (or your child).Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe. Even these regular vision tests may not show vision damage before it is severe and permanent. Vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow SABRIL to be stopped if vision has gotten worse.Regular vision testing is important because damage can happen before any changes are noticed. Your healthcare provider will determine if testing can be done. It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your vision loss may get worse after you stop taking SABRIL. It is also recommended that vision be tested about 3 to 6 months after SABRIL is stopped. It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting SABRIL and at least every 3 months during treatment until SABRIL is stopped.
These changes can mean that vision damage has occurred. 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 or if your baby is acting differently than normal.With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). Some people can have severe loss particularly to their ability to see to the side when looking straight ahead (peripheral vision). SABRIL can damage the vision of anyone who takes it.Your healthcare provider will explain the details of this program to you. 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.It may even happen after treatment has stopped. It could happen soon after starting SABRIL or any time during treatment. It is not possible for your healthcare provider to know when vision loss will happen.Your risk of vision loss may be higher the more SABRIL you take daily and the longer you take it.You are at risk for vision loss with any amount of SABRIL.
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WARNING: PERMANENT VISION LOSS See Medication Guide and full Prescribing Information for complete information.
Indicate “Dispense as written (DAW)” or “Brand medically necessary” on the form (per your state regulations)
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Completing this form allows you and your patients/caregivers an opportunity to benefit from the support offered by SHARE Plus
The US Food and Drug Administration (FDA) has approved a single shared Risk Evaluation and Mitigation Strategy (REMS) program for all vigabatrin products.
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