April 11, 2018
The US Food and Drug Administration (FDA) has approved Afinitor Disperz tablets for oral suspension (everolimus, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
The approval was based on the results of the randomized, double-blind, multicenter trial, EXIST-3. During the trial, researchers examined 366 participants with TSC-associated partial-onset seizures, inadequate seizure control with ≥ 2 sequential anti-epileptic drug (AED) regimens, and a TSC diagnosis. The trial demonstrated significant reductions in seizures for the Afinitor Disperz arms of the study compared to placebo. Further, the proportion of patients with 50% reduction in seizure frequency during the 12-week treatment period compared with baseline also was higher in the Afinitor Disperz arms compared with the placebo.
The recommended starting dose for this indication is 5 mg/m2 orally once daily with dose adjustments (in increments up to 5 mg) to achieve trough concentrations of 5-15 ng/mL. Additionally, the dose should be reduced in patients with severe hepatic impairment or in patients taking concurrent p-glycoprotein and moderate CYP3A4 inhibitors. For patients taking concurrent p-glycoprotein and strong CYP3A4 inducers, the dose of Afinitor Disperz should be increase.
Based on the trial findings, the most common adverse reactions include, stomatitis, diarrhea, vomiting, nasopharyngitis, upper respiratory tract infection, pyrexia, cough, and rash.
Currently, Afinitor Disperz is approved for two other manifestations of TSC, including TSC-associated subependymal giant cell astrocytoma (SEGA), and TSC-associated renal angiomyolipoma.
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