The Tuberous Sclerosis Alliance has announced updates to access of everolimus, a drug used to treat several conditions associated with tuberous sclerosis complex.
This content is courtesy of the Dravet Syndrome Foundation. To view the original post, click here.
As of December 13, 2019, important information is available 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.
We hope information on this page 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.
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 up the total dose.
The 10 mg tablets will only be available as the Afinitor brand.
Your doctor or healthcare provider may have to change your prescription to accommodate these new combinations.
It is possible your level might change when switching from the brand name to the generic.
While both Afinitor and generic everolimus have the same amount of everolimus in the corresponding doses (ie, 5 mg tablet of Afinitor and a 5 mg tablet of the PAR Pharmaceuticals version both have 5 mg of everolimus), the major differences are all the other materials that go into making a tablet hold together as a “pill.” Each company may use a different combination of these other materials.
In addition, the TS Alliance has a track record in working with the PAR Pharmaceuticals; this is the same pharmaceutical company that makes one of the generic formulas of vigabatrin used to treat infantile spasms.
We hope this information helps answer some of your most important questions. However, please feel free to contact us at 800-225-6872 or firstname.lastname@example.org to request any additional information.