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.
[[brand-primary]Step 1: REVIEW]
- Review the Prescribing Information for vigabatrin
- FOR NEW PRESCRIBERS ONLY: Complete and submit the Prescriber Enrollment and Agreement Formonline or print the form and fax or mail it to the Vigabatrin REMS Program. An e-mail will be sent to confirm your enrollment
[[brand-primary]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
[[brand-primary]Step 3: DECIDE]
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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 1-877-742-1002
- 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
[[purple]Vigabatrin REMS program and the FDA-Mandated REMS Forms]
www.vigabatrinREMS.com
Phone:1-866-244-8175
Fax:1-866-205-3072
Mail: Vigabatrin REMS Program
200 Pinecrest Plaza
Morgantown, WV 26505-8065
[[purple]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.]
[[green]www.Sabril.net]
Phone:1-888-457-4273
Fax: 1-877-742-1002