MEDICATION GUIDE

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

Read the Medication Guide that comes with SABRIL before you or your baby starts taking SABRIL 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?

SABRIL 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 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 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 in adults: Because of the risk of vision loss, SABRIL 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
• 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 or within 4 weeks after starting SABRIL, and at least every 3 months after that until SABRIL is stopped. You may not be able to be tested in certain situations. Your doctor will determine if you can be tested. 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, but they do allow you to stop SABRIL 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 for you. You should also have a vision test after SABRIL is stopped. Some people are not able to complete testing of vision for medical reasons. If you cannot complete vision testing, your doctor may continue prescribing SABRIL, but your doctor will not be able to watch for any vision loss you may get.

If you drive and your vision is damaged by SABRIL, 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 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 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 their vision tested before starting SABRIL or within 4 weeks after starting SABRIL, and every 3 months after that until SABRIL is stopped. Your baby should have a vision test after SABRIL is stopped. Your baby may not be able to be tested in certain situations. Your doctor will determine if your baby can be tested.

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

• not seeing as well as before taking SABRIL
• 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 for your baby. If your baby is not able to complete vision testing, your doctor may continue prescribing SABRIL for your baby. But, your doctor will not be able to watch for vision loss in your baby.

In all people who take SABRIL: You are at risk for vision loss with any amount of SABRIL Your risk of vision loss may be higher the more SABRIL 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 or any time during treatment. It may even happen after treatment has stopped.

Because SABRIL 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, 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. It is not known if these changes are harmful.

3. Risk of suicidal thoughts or actions:

Like other antiepileptic drugs, SABRIL 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 without first talking to a healthcare provider.

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

What is SABRIL?

SABRIL 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 is more important than the risk of vision loss.

SABRIL should not be the first medicine used to treat your CPS.

SABRIL 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 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.

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

What should I tell my doctor before starting SABRIL?

If you are an adult with CPS, before taking SABRIL tell your doctor if you have or had:

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

Pregnancy Registry:

If you become pregnant while taking SABRIL, 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 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, 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 and other medicines may affect each other causing side effects.

How should I take SABRIL?

If you are an adult with CPS:

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

If you are giving SABRIL to your baby for IS:

• Your doctor will explain the SHARE program to you
• You will receive SABRIL for oral solution from a specialty pharmacy
• Mix SABRIL for oral solution and give it to your baby exactly as prescribed by your doctor. Do not stop giving SABRIL for oral solution to your baby unless your doctor tells you to.
• SABRIL for oral solution is usually given two times each day
• SABRIL 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 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 for oral solution and give the medicine to your baby
• Before your baby starts taking SABRIL, 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
• Stopping SABRIL suddenly can cause serious problems. Stopping SABRIL 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 to your baby. SABRIL 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.
• Tell your doctor right away about any increase in your baby's seizures while stopping SABRIL

What should I avoid while taking SABRIL?

SABRIL causes sleepiness and tiredness. Adults taking SABRIL 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?

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

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

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

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

The most common side effects of SABRIL 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 to your baby for IS

SABRIL 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 in babies and young children include:

• sleepiness - SABRIL 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. 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?

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

Keep SABRIL tablets and SABRIL powder in the container they come in.

Keep SABRIL and all medicines out of the reach of children.

General information about SABRIL

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

What are the ingredients in SABRIL?

Active Ingredient: vigabatrin.

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

Inactive Ingredient in SABRIL powder: povidone.

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

Marketed by: Lundbeck, Deerfield, IL 60015, U.S.A.

® Trademark of Lundbeck

Revised: December 2012