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MEDICATION GUIDE

Sabril®
(SAY-bril)
(vigabatrin) Tablet

Sabril®
(SAY-bril)
(vigabatrin) for Oral Solution

Read the Medication Guide that comes with SABRIL (vigabatrin oral solution) before you or your baby starts taking SABRIL (vigabatrin oral solution) and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your or your baby's medical condition or treatment.

What is the most important information I should know about SABRIL (vigabatrin oral solution) ?

SABRIL (vigabatrin oral solution) can cause serious side effects, including:

1. Permanent vision damage
2. Magnetic resonance imaging (MRI) changes
3. Risk of suicidal thoughts or actions

1. Permanent vision damage:

SABRIL (vigabatrin oral solution) 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 (vigabatrin oral solution) 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 (vigabatrin oral solution) in adults: Because of the risk of vision loss, SABRIL (vigabatrin 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 doctor right away if you:

• think you are not seeing as well as before you started taking SABRIL (vigabatrin oral solution)
• 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 have damage to your vision. Your doctor will test your visual fields (including peripheral vision) and visual acuity (ability to read an eye chart) before you start SABRIL (vigabatrin oral solution) or within 4 weeks after starting SABRIL (vigabatrin oral solution) , and at least every 3 months after that until SABRIL (vigabatrin oral solution) is stopped. Even if your vision seems fine, it is important that you get these regular vision tests because damage can happen to your vision before you notice any changes. These vision tests cannot prevent the vision damage that can happen with SABRIL (vigabatrin oral solution) , but they do allow you to stop SABRIL (vigabatrin oral solution) if vision has gotten worse, which usually will lessen further damage. If you do not have these vision tests regularly, your doctor may stop prescribing SABRIL (vigabatrin oral solution) for you. You should also have a vision test after SABRIL (vigabatrin oral solution) is stopped.

If you drive and your vision is damaged by SABRIL (vigabatrin oral solution) , driving might be more dangerous, or you may not be able to drive safely at all. You should discuss this with your doctor.

• Vision loss in babies: Because of the risk of vision loss, SABRIL (vigabatrin oral solution) is used in babies (1 month to 2 years old) with infantile spasms (IS) only when you and your doctor decide that the possible benefits of SABRIL (vigabatrin oral solution) are more important than the risks. Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Doctors may not find vision loss in babies until it is severe. It is difficult to test vision in babies, but all babies should have a vision test before starting SABRIL (vigabatrin oral solution) or within 4 weeks after starting SABRIL (vigabatrin oral solution) , and every 3 months after that until SABRIL (vigabatrin oral solution) is stopped. You should have a vision test for your baby after SABRIL (vigabatrin oral solution) is stopped.

Tell your doctor right away if you think that your baby is:

• not seeing as well as before taking SABRIL (vigabatrin oral solution)
• 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 serious and permanent. If your baby does not have these vision tests regularly, your doctor may stop prescribing SABRIL (vigabatrin oral solution) for your baby. If your baby is not able to complete vision testing, your doctor may continue prescribing SABRIL (vigabatrin oral solution) for your baby. But, your doctor will not be able to watch for vision loss in your baby.

In all people who take SABRIL (vigabatrin oral solution) :

• You are at risk for vision loss with any amount of SABRIL (vigabatrin oral solution)
• Your risk of vision loss may be higher the more SABRIL (vigabatrin oral solution) you take daily and the longer you take it
• It is not possible for your doctor to know when vision loss will happen. It could happen soon after starting SABRIL (vigabatrin oral solution) or any time during treatment. It may even happen after treatment has stopped.

Because SABRIL (vigabatrin oral solution) might cause vision loss, it is available to doctors and patients only under a special program called SHARE. As part of the SHARE program, among other things, your doctor will have to test your or your baby's vision frequently while you or your baby are being treated with SABRIL (vigabatrin oral solution) , and even after you or your baby stops treatment. You also have to agree to be in the SHARE program, and agree to have your or your baby's vision tested regularly. Your doctor will explain the details of the SHARE program to you.

2. Magnetic resonance imaging (MRI) changes:

Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given SABRIL (vigabatrin oral solution) . It is not known if these changes are harmful.

3. Risk of suicidal thoughts or actions:

Like other antiepileptic drugs, SABRIL (vigabatrin oral solution) may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Call a doctor right away if you 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 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 doctor as scheduled.
• Call your doctor between visits as needed, especially if you are worried about symptoms.

Do not stop SABRIL (vigabatrin oral solution) without first talking to a healthcare provider.

• Stopping SABRIL (vigabatrin 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.

SABRIL (vigabatrin oral solution) can be prescribed only to people who are enrolled in a program called SHARE. Before you or your baby can begin taking SABRIL (vigabatrin oral solution) , you must read and agree to all of the instructions in the SHARE program.

What is SABRIL (vigabatrin oral solution) ?

SABRIL (vigabatrin oral solution) Tablets is a prescription medicine used along with other treatments to treat adults with CPS if:

• The CPS does not respond well enough to several other treatments, and
• You and your doctor decide the possible benefit of taking SABRIL (vigabatrin oral solution) is more important than the risk of vision loss.

SABRIL (vigabatrin oral solution) should not be the first medicine used to treat your CPS.

SABRIL (vigabatrin oral solution) for Oral Solution is a prescription medicine used to treat babies, one month to two years old who have IS, if you and your doctor decide the possible benefits of taking SABRIL (vigabatrin oral solution) are more important than the possible risk of vision loss.

If you are an adult with CPS, you must sign an agreement form before you can receive SABRIL (vigabatrin oral solution) .

If you are the parent or caregiver of a baby with IS, you must sign an agreement form before your baby can receive SABRIL (vigabatrin oral solution) .

What should I tell my doctor before starting SABRIL (vigabatrin oral solution) ?

If you are an adult with CPS, before taking SABRIL (vigabatrin oral solution) tell your doctor if you have or had:

• depression, mood problems or suicidal thoughts or behavior
• an allergic reaction to SABRIL (vigabatrin oral solution) , 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 (vigabatrin oral solution) 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 (vigabatrin oral solution) .
• are pregnant or plan to become pregnant. It is not known if SABRIL (vigabatrin oral solution) will harm your unborn baby. You and your healthcare provider will have to decide if you should take SABRIL (vigabatrin oral solution) while you are pregnant.

Pregnancy Registry:

If you become pregnant while taking SABRIL (vigabatrin 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. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.

Before giving SABRIL (vigabatrin oral solution) to your baby, tell the doctor about all of your baby's medical conditions, including if your baby has or ever had:

• an allergic reaction to SABRIL (vigabatrin oral solution) , such as hives, itching, or trouble breathing
• any vision problems
• any kidney problems

Tell your doctor about all the medicines you or your baby take, including prescription and non-prescription medicines, vitamins, and herbal supplements. SABRIL (vigabatrin oral solution) and other medicines may affect each other causing side effects.

How should I take SABRIL (vigabatrin oral solution) ?

If you are an adult with CPS:

• Your doctor will explain the SHARE Program to you
• You will receive SABRIL (vigabatrin oral solution) from a specialty pharmacy
• Take SABRIL (vigabatrin oral solution) tablets exactly as prescribed by your doctor. SABRIL (vigabatrin oral solution) tablets are usually taken two times each day.
• You may take SABRIL (vigabatrin oral solution) tablets with or without food
• Before you start taking SABRIL (vigabatrin oral solution) , talk to your doctor about what you should do if you miss a dose of SABRIL (vigabatrin oral solution)
• Do not stop taking SABRIL (vigabatrin oral solution) suddenly. This can cause serious problems. Stopping SABRIL (vigabatrin oral solution) 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 doctor's instructions on how to stop taking SABRIL (vigabatrin oral solution) .
• Tell your doctor right away about any increase in seizures while you are stopping SABRIL (vigabatrin oral solution)
• If SABRIL (vigabatrin oral solution) does not improve your seizures enough within 3 months, your doctor will stop prescribing SABRIL (vigabatrin oral solution) for you
• Do not stop taking SABRIL (vigabatrin oral solution) without talking to your doctor. If SABRIL (vigabatrin oral solution) improves your seizures, you and your doctor should talk about whether the benefit of taking SABRIL (vigabatrin oral solution) is more important than the risk of vision loss, and decide if you will continue to take SABRIL (vigabatrin oral solution) .

If you are giving SABRIL (vigabatrin oral solution) to your baby for IS:

• Your doctor will explain the SHARE program to you
• You will receive SABRIL (vigabatrin oral solution) for oral solution from a specialty pharmacy
• Mix SABRIL (vigabatrin oral solution) for oral solution and give it to your baby exactly as prescribed by your doctor. Do not stop giving SABRIL (vigabatrin oral solution) for oral solution to your baby unless your doctor tells you to.
• SABRIL (vigabatrin oral solution) for oral solution is usually given two times each day
• SABRIL (vigabatrin oral solution) for oral solution can be given to your baby at the same time as their food, but the powder should not be mixed with their food. SABRIL (vigabatrin oral solution) for oral solution powder should be mixed with water only.
• See the end of this Medication Guide for detailed instructions for how to mix SABRIL (vigabatrin oral solution) for oral solution and give the medicine to your baby
• Before your baby starts taking SABRIL (vigabatrin oral solution) , speak to your baby's doctor about what to do if your baby misses a dose, vomits, spits up, or only takes part of the dose of SABRIL (vigabatrin oral solution)
• Stopping SABRIL (vigabatrin oral solution) suddenly can cause serious problems. Stopping SABRIL (vigabatrin oral solution) or any seizure medicine suddenly can cause seizures that will not stop. You should follow your doctor's instructions on how to stop giving SABRIL (vigabatrin oral solution) to your baby. SABRIL (vigabatrin oral solution) does not work in all babies. If your baby's seizures do not improve enough within 2 to 4 weeks, the doctor will stop SABRIL (vigabatrin oral solution) .
• Tell your doctor right away about any increase in your baby's seizures while stopping SABRIL (vigabatrin oral solution)

What should I avoid while taking SABRIL (vigabatrin oral solution) ?

SABRIL (vigabatrin oral solution) causes sleepiness and tiredness. Adults taking SABRIL (vigabatrin oral solution) should not drive, operate machinery, or perform any hazardous task, unless you and your doctor have decided that you can do these things safely.

What are the possible side effects of SABRIL (vigabatrin oral solution) ?

SABRIL (vigabatrin oral solution) can cause serious side effects. See "What is the most important information I should know about SABRIL (vigabatrin oral solution) ?"

These other serious side effects happen in adults. It is not known if these side effects also happen in babies who take SABRIL (vigabatrin oral solution) .

• Low red blood cell counts (anemia)
• Sleepiness and tiredness. See "What should I avoid while taking SABRIL (vigabatrin oral solution) ?"
• 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 (vigabatrin oral solution) .
• Weight gain that happens without swelling
• Swelling

If you are an adult with CPS, SABRIL (vigabatrin oral solution) may make certain types of seizures worse. Tell your doctor right away if your seizures get worse.

The most common side effects of SABRIL (vigabatrin oral solution) in adults include:

• problems walking or feel uncoordinated
• feel dizzy
• shaking (tremor)
• joint pain
• memory problems and not thinking clearly
• eye problems: blurry vision, double vision and eye movements that you cannot control

If you are giving SABRIL (vigabatrin oral solution) to your baby for IS

SABRIL (vigabatrin oral solution) may make certain types of seizures worse. You should tell your baby's doctor right away if your baby's seizures get worse. Tell your baby's doctor if you see any changes in your baby's behavior.

The most common side effects of SABRIL (vigabatrin oral solution) in babies and young children include:

• sleepiness - SABRIL (vigabatrin oral solution) may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable.
• ear infection
• irritability

Tell your doctor if you or your baby have any side effect that bother you or that does not go away. These are not all the possible side effects of SABRIL (vigabatrin oral solution) . For more information, ask your doctor 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 (vigabatrin oral solution) ?

Store SABRIL (vigabatrin oral solution) tablets and SABRIL (vigabatrin oral solution) packets at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep SABRIL (vigabatrin oral solution) tablets and SABRIL (vigabatrin oral solution) powder in the container they come in.

Keep SABRIL (vigabatrin oral solution) and all medicines out of the reach of children.

General information about SABRIL (vigabatrin oral solution)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SABRIL (vigabatrin oral solution) for a condition for which it was not prescribed. Do not give SABRIL (vigabatrin oral solution) 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 (vigabatrin oral solution) . If you would like more information about SABRIL (vigabatrin oral solution) , talk with your doctor. You can ask your pharmacist or doctor for information about SABRIL (vigabatrin oral solution) that is written for health professionals. For more information, go to www.SABRIL (vigabatrin oral solution) .net or call 1-800-455-1141.

What are the ingredients in SABRIL?

Active Ingredient: vigabatrin.

Inactive Ingredients in SABRIL (vigabatrin oral solution) tablets: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide.

Inactive Ingredient in SABRIL (vigabatrin oral solution) powder: povidone.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/7/2011
This monograph has been modified to include the generic and brand name in many instances.