Sabril® (vigabatrin) for Infantile Spasms (IS)

Infant taking Sabril for his infantile spasms. Pictured with his mother.

Sabril is a prescription medicine used in babies, 1 month to 2 years old, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss. For infants, Sabril comes in a powder form that you mix with water.

Sabril was the first therapy approved by the US Food and Drug Administration (FDA) for the treatment of IS.

Possible Benefits of Sabril for IS

The possible benefit of treatment with Sabril is reducing spasm frequency in infants with infantile spasms (IS). The effectiveness of Sabril as a treatment for IS was established in 2 clinical trials reviewed by the FDA.

Some infants taking Sabril were spasm free or had a reduction in daily spasm frequency.

About Infantile Spasms (IS)

Infantile spasms (also called IS or sometimes West syndrome) is a specific type of epilepsy syndrome that affects babies.1

Symptoms of Infantile Spasms

Infantile spasms usually begin when a baby is between 4 and 8 months old.1

There are 3 main features of IS used to aid in diagnosis:1-4

Spasms

A baby may suddenly bend forward; stiffen his or her body, arms, and legs; and arch his or her torso (bend backward).

Hypsarrhythmia (hyp'sar•rhyth'mia')

An abnormal pattern of electrical activity seen on an EEG between seizures that is associated with IS. It shows chaotic and random electrical behavior in the brain.

Delayed development

A baby may not develop as expected of his or her age.5 A baby’s development is complex and may be affected by certain causes, known or unknown.

Sabril therapy has not been proven to improve an infant’s development.

A baby does not need to have all 3 features to receive a diagnosis of IS.5 The term infantile spasms is used to describe both the type of epilepsy and the seizure.Most spasms last 1 to 2 seconds. They often happen in groups (or clusters) of a few to more than 100 spasms. A baby may have up to 60 clusters of spasms each day. They may happen when the baby is waking up, or when the baby is sleepy. At first, the spasms may be so small and slight that they are hard to notice.2,3,5

IN 3 OF 10
BABIES WITH INFANTILE
SPASMS (IS), THE CAUSE
IS UNKNOWN

Causes of Infantile Spasms

Sometimes the cause of IS is unknown (cryptogenic). In 3 of 10 babies with IS, the cause is unknown. About 7 of 10 babies have IS with a known cause (symptomatic).1

Some of the possible causes include:1,6

  • Tuberous sclerosis complex
  • Central nervous system infection
  • Genetic abnormalities other than tuberous sclerosis complex
  • Brain development abnormalities
  • Lack of oxygen at birth

References

  1. 1. Shields WD. Infantile spasms: little seizures, big consequences. Epilepsy Curr. 2006;6(3):63-69.
  2. 2. Infantile spasms/West’s syndrome. Epilepsy Foundation website. http://www.epilepsy.com/learn/types-epilepsy-syndromes/infantile-spasms-wests-syndrome. Accessed February 16, 2017.
  3. 3. Infantile Spasms Information Page. National Institute of Neurological Disorders and Stroke. National Institutes of Health website. https://www.ninds.nih.gov/Disorders/All-Disorders/Infantile-Spasms-Information-Page. Accessed February 16, 2017.
  4. 4. Shields WD. Diagnosis of infantile spasms, Lennox-Gastaut syndrome, and progressive myoclonic epilepsy. Epilepsia. 2004;45(Suppl 5):2-4.
  5. 5. Glauser TA, Morita DA. Infantile spasm (West syndrome). eMedicine website. http://emedicine.medscape.com/article/1176431-overview. Updated October 16, 2014. Accessed February 16, 2017.
  6. 6. Tuberous Sclerosis Information Page. National Institute of Neurological Disorders and Stroke. National Institutes of Health website. https://www.ninds.nih.gov/Disorders/All-Disorders/Tuberous-Sclerosis-Information-Page. Accessed February 16, 2017.

SABRIL® (vigabatrin) Tablets and Powder for Oral Solution

Use

SABRIL (vigabatrin) is a prescription medicine used with other treatments in adults and children 10 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments and if the possible benefits outweigh the risk of vision loss. SABRIL should not be the first medicine used to treat CPS.

SABRIL (vigabatrin) is a prescription medicine used in babies, 1 month to 2 years old, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.

IMPORTANT
SAFETY INFORMATION

EXPAND

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

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 healthcare provider 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.

IMPORTANT
SAFETY INFORMATION

COLLAPSE

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

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 healthcare provider 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 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. Your healthcare provider will explain the details of this Program to you.
  • SABRIL can damage the vision of anyone who takes it. People who take SABRIL do not lose all of their vision, but some people can have severe loss particularly to their ability to see to the side when looking 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 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. These changes can mean that vision damage has occurred.
  • 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. It is also recommended that vision be tested about 3 to 6 months after SABRIL is stopped. 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 testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
  • 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, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
  • If vision tests are not done regularly, your healthcare provider may stop prescribing SABRIL for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing SABRIL, but will not be able to watch for any vision loss.
  • 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.
  • Like other antiepileptic drugs, SABRIL may cause suicidal thoughts and actions in some people. 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, worse, or worry you.
  • Do not stop SABRIL without first talking to a healthcare provider. Stopping SABRIL suddenly can cause seizures that will not stop.
  • SABRIL can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because SABRIL causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. SABRIL may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
  • Before starting SABRIL, tell your doctor about all of your (or your child’s) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to SABRIL, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illness. Tell your doctor about all the medicines you (or your child) take.
  • If you are breastfeeding or plan to breastfeed, SABRIL can pass into breast milk and may harm your baby. If you 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.
  • The most common side effects of SABRIL in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking (tremor), joint pain, memory problems and not thinking clearly, and eye problems like blurry vision, double vision, and eye movements that cannot be controlled. The most common side effects of SABRIL in children 10 to 16 years of age include weight gain, upper respiratory tract infection, tiredness, and aggression. Also expect side effects like those seen in adults.
  • The most common side effects of SABRIL in babies include: sleepiness—some babies may have a harder time suckling and feeding or may be irritable, swelling in the bronchial tubes (bronchitis), ear infection, and 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 of the possible side effects of SABRIL. For more information, ask your healthcare provider or pharmacist.

For more information, please see SABRIL Medication Guidefull Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call .

The product information provided in this site is intended only for residents of the U.S. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. Sabril may not be a fit for everyone. You and your doctor should decide if the possible benefits of taking Sabril are more important than the risk of permanent vision loss.

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Sabril is a registered trademark of Lundbeck