Vigabatrin REMS Program for Prescribers

  • The US Food and Drug Administration (FDA) has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products, called the Vigabatrin REMS Program. The Vigabatrin REMS Program is required by the FDA to ensure informed risk-benefit decisions before initiating treatment, and to ensure appropriate use of vigabatrin while patients are treated. By clicking on the link below, prescribers will be taken to the website that now manages the process and contains the required vigabatrin REMS forms
  • Branded Sabril® (vigabatrin) is still available. Prescribers can continue to submit the Sabril Prescription Form through the SHAREPlus program

Sabril Prescription Form for Prescribers

  • The optional Sabril Prescription Form will continue to be available for physicians who choose to submit a Sabril prescription through Lundbeck’s SHAREPlus program. When completing the Sabril Prescription Form, indicate “Dispense as written (DAW)” or follow your state's instructions for indicating branded vs. generic product. Fax the completed form to SHAREPlus at
  • Alternatively, if you do not want to submit your Sabril prescription through SHAREPlus, you can send it directly to a certified pharmacy found on the Vigabatrin REMS website. Indicate “Dispense as written (DAW)” or follow your state's instructions for indicating branded vs. generic product

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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Sabril is a registered trademark of Lundbeck