The Food and Drug Administration (FDA) has approved a twice-a-day formulation of Ferriprox® (deferiprone; Chiesi) for the treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. The product is now available in 2 different 1000mg tablet formulations: twice-a-day and three-times-a-day.
Ferriprox is a chelating agent that works by binding with ferric ions (iron III) to form neutral 3:1 (deferiprone:iron) complexes. The initial approval of Ferriprox was based on a reduction in serum ferritin levels; there have been no controlled trials demonstrating a direct treatment benefit. The twice-a-day product was evaluated in trials in healthy individuals; currently there are no clinical data in patients treated with the new formulation.
The new twice-a-day presentation of Ferriprox 1000mg oral film-coated tablets will be available in blister packs of 50 tablets. The three-times-a-day presentations will be available as 1000mg tablets in 50 count bottles, 500mg tablets in 100 count bottles, and 100mg/mL oral solution in 500mL bottles. To prevent medication errors, the tablet formulation should match to the appropriate dosing regimen prior to prescribing and dispensing. Each tablet has different identifying characteristics.
According to the Company, a single centralized pharmacy, Chiesi Total Care, will help patients who wish to eliminate their mid-day dose switch to the twice-a-day 1000mg tablets. Counseling will also be provided to these patients so that they are able to differentiate between the 2 formulations.
“In the management of patients with thalassemia, clinicians often see firsthand the difficulties they can have with dosing and compliance, and the impact that this can have on the effectiveness of treatment,” said Thomas Coates, MD Section Head, Hematology at Children’s Hospital Los Angeles. “A treatment option that reduces serum ferritin, cardiac iron and liver iron with an established safety profile and now twice-a-day tablet dosing can represent a significant advantage for patients.”
For more information visit chiesi.com.