VIGABATRIN FOR ORAL SOLUTION USP, 500 MG- vigabatrin for solution 
Hikma Pharmaceuticals USA Inc.

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SPL MEDICATION GUIDE

MEDICATION GUIDE

Vigabatrin (vye-GA-ba-trin) for Oral Solution, USP
  What is the most important information I should know about Vigabatrin for oral solution?  Vigabatrin for oral solution can cause serious side effects, including:
• Permanent vision loss
• Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS)
• Risk of suicidal thoughts or actions

 1. Permanent vision loss:
Vigabatrin for oral solution 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.
 •  Vision loss and use of Vigabatrin for oral solution in adults and children 2 years and older: Because of the risk of vision loss, Vigabatrin for oral solution 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):
      o  might not be seeing as well as before starting vigabatrin for oral solution.
      o  start to trip, bump into things, or are more clumsy than usual.
      o  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 for oral  solution or within 4 weeks after starting Vigabatrin for oral solution, and at least every 3 months after that until Vigabatrin for oral solution is stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after Vigabatrin for oral solution is stopped. Your vision loss may get worse after you stop taking Vigabatrin for oral solution.
 • 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 for oral solution, 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 for oral solution, but they do allow the healthcare provider to decide if you (or your child) should stop Vigabatrin for oral solution 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 for oral solution
 • If you drive and your vision is damaged by Vigabatrin for oral solution, 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, Vigabatrin for oral solution 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 Vigabatrin for oral solution 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 Vigabatrin for oral solution or within 4 weeks after starting Vigabatrin for oral solution, and every 3 months  after that until Vigabatrin for oral solution is stopped. Your baby should also have a vision test about 3 to 6 months after Vigabatrin for oral solution is stopped.
    o  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 Vigabatrin for oral solution, 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:
    o  not seeing as well as before taking Vigabatrin for oral solution
    o  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.
                 All people who take Vigabatrin for oral solution:
                 • You are at risk for permanent vision loss with any amount of Vigabatrin for oral solution
                 • Your risk of vision loss may be higher the more Vigabatrin for oral solution 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 for oral solution or any time during treatment. It may even happen after treatment has stopped.
• Because Vigabatrin for oral solution 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 for oral solution 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 for oral solution, 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.  Magnetic resonance imaging (MRI) changes in babies with infantile spasms:
Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given vigabatrin for oral solution. It is not known if these changes are harmful.
3.  Risk of suicidal thoughts or actions:
Like other antiepileptic drugs, vigabatrin for oral solution 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:
                    o   thoughts about suicide or dying                       o  attempts to commit suicide
                    o   new or worse depression                                 o  new or worse anxiety
                    o   feeling agitated or restless                               o  panic attacks
                    o   trouble sleeping (insomnia)                              o   new or worse irritability
                    o   acting aggressive, being angry, or violent        o  acting on dangerous impulses
                    o   an extreme increase in activity and talking       o  other unusual changes in behavior or mood
                        (mania)
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 Vigabatrin for oral solution without first talking to a healthcare provider.
• Stopping Vigabatrin for oral solution 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.
  What is vigabatrin for oral solution?
• Vigabatrin for oral solution is a prescription medicine used along with other treatments to treat adults and children 2 years and older with complex partial seizures (CPS) if:
      o the CPS do not respond well enough to several other treatments, and
      o you and your healthcare provider decide the possible benefit of taking Vigabatrin for oral solution is more important than the risk of vision loss.
    Vigabatrin for oral solution should not be the first medicine used to treat CPS.
• Vigabatrin for oral solution 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 Vigabatrin for oral solution are more important than the possible risk of vision loss.
What should I tell my healthcare provider before starting vigabatrin for oral solution?
 If you or your child has CPS, before taking Vigabatrin for oral solution tell your healthcare provider about all of your medical conditions, including if you or your child :
• have or had an allergic reaction to Vigabatrin for oral solution, 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 for oral solution.
• are pregnant or plan to become pregnant. Vigabatrin for oral solution can cause harm to your unborn baby. You and your healthcare provider will have to decide if you should take Vigabatrin for oral solution while you are pregnant. 
Pregnancy Registry:
If you become pregnant while taking Vigabatrin for oral solution, 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.aedpregnancy.org/. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
If you are a parent or caregiver whose baby has IS, before giving Vigabatrin to your baby, tell your healthcare provider about all of your baby's medical conditions, including if your baby has or ever had :
• an allergic reaction to Vigabatrin, 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. Vigabatrin and other medicines may affect each other causing side effects.
 How should I take Vigabatrin for oral solution?
• Vigabatrin for oral solution comes as powder for oral solution.
• You or your child will receive Vigabatrin for oral solution from a specialty pharmacy.
• Take Vigabatrin for oral solution exactly as your healthcare provider tells you to. Vigabatrin for oral solution is usually taken 2 times each day.
• Vigabatrin for oral solution may be taken with or without food.
• Before starting to take Vigabatrin for oral solution, talk to your healthcare provider about what you or your child should do if a Vigabatrin for oral solution dose is missed.
• If you or your child are taking Vigabatrin for oral solution for CPS and the seizures do not improve enough within 3 months, your healthcare provider will stop prescribing Vigabatrin for oral solution.
• If your child is taking Vigabatrin for oral solution for IS and the seizures do not improve within 2 to 4 weeks, your healthcare provider will stop prescribing Vigabatrin for oral solution
Do not stop taking Vigabatrin for oral solution 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 for oral solution
Tell your healthcare provider right away about any increase in seizures when Vigabatrin for oral solution treatment is being stopped. Before your child starts taking Vigabatrin for oral solution, 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 Vigabatrin for oral solution.
Do not stop taking Vigabatrin for oral solution without talking to your healthcare provider. If Vigabatrin for oral solution 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.
• If you are giving Vigabatrin for oral solution to your child, it can be given at the same time as their meal. Vigabatrin for oral solution powder
  should be   mixed with water only.

See “Instructions for Use” for detailed information about how to mix and give Vigabatrin powder for oral solution to your child the right way.
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.
What are the possible side effects of vigabatrin?
Vigabatrin can cause serious side effects, including:

See “What is the most important information I should know about vigabatrin?”
sleepiness and tiredness. See “What should I avoid while taking vigabatrin?”
Vigabatrin 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 vigabatrin.
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 vigabatrin for oral solution.
swelling.
If you or your child has CPS, vigabatrin for oral solution 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 for oral solution in adults include blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor), and tiredness.
The most common side effects of vigabatrin for oral solution in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults.
If you are giving Vigabatrin for oral solution to your baby for IS:
Vigabatrin for oral solution 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 Vigabatrin for oral solution in babies include:
        o sleepiness - Vigabatrin for oral                             o swelling in the bronchial tubes (bronchitis)
           solution may cause your baby to be
           sleepy. Sleepy babies may have a harder
           time suckling and feeding, or may be irritable.
        o ear infection                                                         o 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 Vigabatrin for oral solution.
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 Vigabatrin for oral solution?
• Store Vigabatrin for oral solution packets at room temperature between 68°F to 77°F (20°C to 25°C). Keep Vigabatrin for oral solution and all medicines out of the reach of children.
General information about the safe and effective use of Vigabatrin for oral solution?
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 for oral solution that is written for health professionals. Do not use Vigabatrin for oral solution for a condition for which it was not prescribed. Do not give Vigabatrin for oral solution to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in Vigabatrin for oral solution?Active Ingredient: vigabatrin, USP
Inactive Ingredients: povidone
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Granules Pharmaceuticals Inc.,
Chantilly, VA 20151
Distr. by:
Hikma Pharmaceuticals USA Inc.
Eatontown, NJ 07724

Rev. 06/2020
Revised: 7/2020
Hikma Pharmaceuticals USA Inc.