Important news regarding changes to access and availability of everolimus.

Important news regarding changes to access and availability of everolimus, a drug used to treat several conditions associated with tuberous sclerosis complex (TSC) such as subependymal giant cell astrocytomas (SEGAs), kidney angiomyolipomas (AMLs) and certain types of seizures. Individuals with TSC may also use everolimus to treat other clinical manifestations of the disease. Until now, only the drug company Novartis exclusively made everolimus, which is sold under the brand name of Afinitor®. Afinitor is available both as tablets in strengths of 2.5 mg, 5 mg, 7.5 mg and 10 mg meant to be taken whole and as Afinitor Disperz®, which comes as 2 mg, 3 mg and 5 mg tablets to be taken after being dissolved in water. The Disperz type is most commonly used for seizures. Beginning in December 2019, a second drug company called PAR Pharmaceuticals was given permission from the United States Food and Drug Administration (FDA) to manufacture and sell a generic form of everolimus. Effective immediately, the 2.5 mg, 5 mg and 7.5 mg regular tablets will be available from BOTH Novartis and PAR Pharmaceuticals. The 10 mg tablets will only be available from Novartis for the time being. All strengths of Afinitor Disperz will only be available from Novartis at this time. We hope this email will explain how having everolimus tablets made from two different drug companies may impact your current everolimus treatment and answer some basic questions you may have about this change. First, how will you know if you are still able to get the Afinitor brand or will be switching over to the generic everolimus from PAR Pharmaceuticals? To a certain extent, this decision will be determined by your insurance company. Some plans will choose to have Afinitor as the preferred version on their formularies while others will choose the generic everolimus. We recognize this may create confusion for patients who need to take doses greater than 10 mg, which requires taking two pills of different strengths to make