Vigadrone® (vigabatrin), an AB-rated generic version of Sabril®, is now available as a 500mg tablet in addition to the powder for oral solution formulation (500mg packets containing a granular powder for reconstitution).
Vigadrone is indicated for the treatment of refractory complex partial seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; it is not indicated as a first line agent.
It is also approved for infantile spasms as monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
Like Sabril, the prescribing information for Vigadrone includes a Boxed Warning regarding the risk of permanent vision loss and is only available under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program.
Vigadrone 500mg tablets are supplied in 100-count bottles.
This article originally appeared on MPR
- Upsher-Smith expands Vigadrone® (vigabatrin) franchise to include tablets. News release. Upsher-Smith Laboratories. August 1, 2023. https://www.prnewswire.com/news-releases/upsher-smith-expands-vigadrone-vigabatrin-franchise-to-include-tablets-301889716.html.
- Vigadrone Tablets. Package insert. Upsher-Smith; 2023. Accessed August 1, 2023. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=01f7f049-78c2-47c2-a66e-ec662ba48a98&type=display#S5.2.