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WARNING: VISION LOSS

• SABRIL (vigabatrin oral solution) 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 (vigabatrin oral solution) also can damage the central retina and may decrease visual acuity.
• The onset of vision loss from SABRIL (vigabatrin oral solution) is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years
• The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss
• Vision testing at baseline (no later than 4 weeks after starting SABRIL (vigabatrin oral solution) ) and at least every 3 months during therapy is required for adults on SABRIL (vigabatrin oral solution) . Vision testing is also required about 3 to 6 months after the discontinuation of SABRIL (vigabatrin oral solution) therapy. Once detected, vision loss due to SABRIL (vigabatrin oral solution) is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.
• It is possible that vision loss can worsen despite discontinuation of SABRIL (vigabatrin oral solution)
• Because of the risk of vision loss, SABRIL (vigabatrin oral solution) should be withdrawn from patients who fail to show substantial clinical benefit within 3 months of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for SABRIL (vigabatrin oral solution) should be periodically reassessed.
• Symptoms of vision loss from SABRIL (vigabatrin oral solution) are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient, can still adversely affect function.
• SABRIL (vigabatrin oral solution) should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from SABRIL (vigabatrin oral solution) has not been well-characterized, but is likely adverse.
• SABRIL (vigabatrin oral solution) should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks
• The lowest dose and shortest exposure to SABRIL (vigabatrin oral solution) should be used that is consistent with clinical objectives

Because of the risk of permanent vision loss, SABRIL (vigabatrin oral solution) is available only through a special restricted distribution program called SHARE, by calling 1-888-45-SHARE. Only prescribers and pharmacies registered with SHARE may prescribe and distribute SABRIL (vigabatrin oral solution) . In addition, SABRIL (vigabatrin oral solution) may be dispensed only to patients who are enrolled in and meet all conditions of SHARE [see WARNINGS AND PRECAUTIONS, Distribution Program for SABRIL (vigabatrin oral solution) ].