Sabril® (vigabatrin) for Refractory Complex Partial Seizures (CPS)

Patient taking Sabril for his refractory complex partial seizures.

Sabril is a prescription medicine used along with other treatments in adults and children 10 years of age and older with refractory complex partial seizures (CPS) if:

  • The complex partial seizures do not respond well enough to several other treatments, and
  • You and your doctor decide the possible benefits of taking Sabril are more important than the risk of permanent vision loss

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

Possible Benefits of Sabril for Refractory CPS

In adults and children 10 years of age and older for whom the possible benefits of treatment outweigh the risks of permanent vision loss, Sabril can be used as an add-on therapy to help reduce the number of refractory CPS. The effectiveness of Sabril in adults was established in 2 clinical trials reviewed by the US Food and Drug Administration (FDA). For children 10 to 16 years of age with refractory CPS, researchers looked at 2 studies in adults and at data in children, which together were used to show effectiveness and determine proper dosing in this age group.

About Refractory CPS

A complex partial seizure (CPS) is a type of seizure that starts in a specific area of the brain and can affect consciousness. Typically, complex partial seizures last between 30 and 90 seconds, and are often followed by a period of disorientation, confusion and/or fatigue. Complex partial seizures may happen in either side of the brain.1

Symptoms of Complex Partial Seizures1

Complex partial seizures may cause you to:

Lose consciousness

Be unaware of what is happening during the seizure

Stare blankly

Move or act without purpose. You may chew, mumble, pick at the air, or act strangely. These are called automatisms

Feel confused or sleepy after the seizure

Refractory Complex Partial Seizures

Sometimes a person’s seizures cannot be controlled even after he or she has tried several antiepileptic medicines. When this happens, it is called refractory epilepsy.2 In a medical study of people with epilepsy, about 1 of 3 had refractory epilepsy.3 Why this happens and whether it can be predicted is unclear.

References

  1. 1. Complex Partial Seizures. Epilepsy Foundation website. http://www.epilepsy.com/epilepsy/seizure_complexpartial. Accessed February 16, 2017.
  2. 2. Refractory Epilepsy. Epilepsy Foundation website. http://www.epilepsy.com/learn/refractory-epilepsy. Accessed February 16, 2017.
  3. 3. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342(5):314-319.

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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