Prescribing Sabril® (vigabatrin)

Vigabatrin REMS Program

Healthcare providers must be certified in the Vigabatrin REMS Program in order to prescribe branded Sabril or generic vigabatrin.

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. Clicking on the link below will take prescribers to the website that manages the process and contains the required vigabatrin REMS forms.

Vigabatrin REMS Program Enrollment and Treatment Initiation: Step by Step

Note: Prescribers who have been enrolled in the Sabril REMS Program will be transitioned into the new Vigabatrin REMS Program without being required to recertify. New patients will need to be enrolled in the Vigabatrin REMS Program.

Step 1: REVIEW

  • Review the Prescribing Information for vigabatrin
  • FOR NEW PRESCRIBERS ONLY: Complete and submit the Prescriber Enrollment and Agreement Form online or print the form and fax or mail it to the Vigabatrin REMS Program. An e-mail will be sent to confirm your enrollment

Step 2: COUNSEL

  • Counsel the patient/parent/legal guardian on the benefits and risks associated with vigabatrin and provide a copy of What You Need to Know About Vigabatrin Treatment: A Patient Guide
  • FOR NEW PATIENTS ONLY: Complete the Patient/Parent/Legal Guardian–Physician Agreement Form. Please note that the patient/parent/legal guardian will need to sign this form online or you will need to print this form, have the patient/parent/legal guardian sign it, and fax or e-mail it to the Vigabatrin REMS Program. Patients already enrolled in the Sabril REMS program do not need to complete the form again 

Step 3: DECIDE

  • Decide whether to prescribe branded Sabril or generic vigabatrin
    • If you decide that branded Sabril is clinically appropriate for your patient, download, print, and complete a Sabril Prescription Form. 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
    • If you choose to prescribe a generic vigabatrin, look up a certified pharmacy on the vigabatrin REMS website (www.vigabatrinREMS.com) and fax the prescription directly to the pharmacy. A prescription for branded Sabril can also be submitted this way, by indicating “DAW” or following your state's instructions for indicating branded vs. generic product 

Vigabatrin REMS program and the FDA-Mandated REMS Forms

www.vigabatrinREMS.com

Phone:

Fax:

Mail: Vigabatrin REMS Program

200 Pinecrest Plaza

Morgantown, WV 26505-8065

Click the links below for access to the Sabril Prescription Form or access to the Complete Terms and Conditions for the Sabril patient support programs that may be available for eligible, commercially insured patients.

www.Sabril.net

Phone:

Fax:

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