Sabril® (vigabatrin) Tablets and Oral Solution

Sabril is indicated as monotherapy for pediatric patients one month to two years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss and as adjunctive (or add-on) treatment for adults with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first line agent for adults with CPS. Sabril causes permanent bilateral concentric visual field constriction in 30 percent or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation and can result in disability.  In some cases, Sabril also can damage the central retina and may decrease visual acuity.  Sabril causes permanent vision loss in infants, children and adults.  The onset is unpredictable and can occur within weeks of starting treatment, or sooner, or at anytime during treatment even after months or years.  Because of this risk of permanent vision loss, Sabril approval is accompanied by an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) and is available only through a special restricted distribution program called SHARE (Support Help and Resources for Epilepsy).

Sabril is the first and only therapy approved in the U.S. for the treatment of IS, a difficult-to-treat form of epilepsy that primarily affects infants and is characterized by spasms that typically occur in clusters of up to 100 at a time. Sabril, as add-on therapy, is also another option for adult patients CPS who do not respond well enough to several other treatments. Sabril should not be the first medicine used to treat CPS. In both IS and CPS, it is important that the patient and the patient’s doctor decide the possible benefit of taking SABRIL is more important than the risk of vision loss.

Sabril was synthesized in 1975 in a deliberate attempt to find a molecule that would increase central nervous system levels of the inhibitory neurotransmitter, gamma-aminobutyric acid (GABA). The precise mechanism of Sabril’s antiseizure effect is unknown, but is believed to be the result of its action as an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of GABA. This action results in increased levels of GABA in the central nervous system.  No direct correlation between plasma concentration and efficacy has been established. The duration of drug effect is presumed to be dependent on the rate of enzyme re-synthesis rather than on the rate of elimination of the drug from the systemic circulation.

Lundbeck Commitment
Lundbeck Inc. is committed to help ensure that its products are appropriately available to patients in need. SHARE (Support, Help and Resources for Epilepsy), the company’s comprehensive patient and physician support program, is designed to support use of all of Lundbeck’s epilepsy products, including Sabril. The FDA-mandated Sabril Risk Evaluation and Mitigation Strategy (REMS) is administered through SHARE and includes measures such as restricted distribution through a limited number of specialty pharmacies, mandatory benefit-risk assessments and required vision testing, to manage the risk of permanent vision loss associated with Sabril therapy. Additionally, through SHARE, Lundbeck offers programs to help facilitate access to Sabril for those who may potentially benefit from treatment. These programs include a starter prescription program, a reimbursement support program and additional assistance programs for eligible patients and where legally permissable. The newly established SHARE Call Center is also available to help patients and their caregivers and physicians fully understand and navigate the Sabril prescribing process step-by-step. To learn more about SHARE, please visit www.lundbeckshare.com.

Please refer to your local prescribing information including Boxed Warning for more specific details about Sabril^® in your country. If you are a patient or caregiver and have further questions on Sabril^®, please ask your physician or pharmacist.