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 2 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.

 

 

 

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 1-800-FDA-1088.

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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