Afinitor Disperz Receives New Indication
April 10, 2018 – The U.S. FDA has approved a new indication for Afinitor Disperz® (everolimus tablets for oral suspension), manufactured by Novartis. It is now approved as an adjunct therapy for children at least two years of age who experience partial-onset seizures associated with tuberous sclerosis complex (TSC). This is the first such indication granted by the FDA.
Tuberous sclerosis complex, a chronic genetic disorder, causes the development of non-cancerous tumors in the brain and various other organs of the body. This can lead to epilepsy, which affects approximately 85% of TSC patients, and other significant health difficulties. Over 60% of patients with TSC experience intractable epilepsy that is resistant to current anti-epileptic treatments.
In clinical trials, patients who took Afinitor Disperz experienced a significant decrease in frequency of treatment-resistant seizures compared to patients who received a placebo. Recommended dosing is 5mg/m2 of body surface area once per day; the tablets can be dissolved in a small amount of water. During treatment with Afinitor Disperz, the blood concentrations of the drug in the patient should be monitored regularly, and the dosage adjusted as needed. Patients may take Afinitor Disperz until disease progression or treatment intolerance.
Originally approved in 2012, Afinitor Disperz is also indicated to treat renal angiomyolipoma, a form of kidney tumor, as well as subependymal giant cell astrocytoma (SEGA), a form of non-cancerous brain tumor. Both conditions are associated with TSC.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.