title: The palatability and tolerability of deferasirox taken with different beverages or foods.
abstract: BACKGROUND
  Deferasirox is a once-daily, oral iron chelator that was developed out of a need for a long-acting, conveniently-administered chelator for patients with transfusional hemosiderosis. The approved mode of administration requires taking deferasirox on an empty stomach with water, apple juice, or orange juice to limit variation in bioavailability. This required administration schedule might not be palatable for patients. Additionally, approximately one-quarter of patients experience mild to moderate gastrointestinal (GI) symptoms, which may pose additional challenges, particularly in the younger and older age ranges. We present a trial to assess the palatability and safety of various administration modes of deferasirox in pediatric and adult patients.
  
  
  METHODS
  Participants rated palatability in a 4-week run-in phase, where deferasirox was administered per label. Subsequently, patients rated several administration modes during a 3-month assessment phase.
  
  
  RESULTS
  Palatability was more favorable during the assessment phase, with 47% of patient ratings for palatability being favorable while only 38% were favorable during the run-in phase. The most highly rated choice was deferasirox taken with a soft food at breakfast. In addition, there was an indication of improved GI tolerability during the assessment phase (symptoms were reported in 37% of patients during run-in and 32% during the assessment phase; rates of diarrhea decreased significantly). Although trough PK values increased, no major new toxicities were observed.
  
  
  CONCLUSIONS
  These data indicate that different administration options may improve palatability and GI tolerability, which could have a positive impact on treatment adherence. (ClinicalTrials.gov number, NCT00845871)
authors: John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey 07601, USA. sgoldberg@hackensackumc.org
authors: Stuart L
authors: SL
authors: Goldberg
authors: Patricia J
authors: PJ
authors: Giardina
authors: Deborah
authors: D
authors: Chirnomas
authors: Jason
authors: J
authors: Esposito
authors: Carole
authors: C
authors: Paley
authors: Elliott
authors: E
authors: Vichinsky
mesh_terms: D000293:Adolescent; D001565:Benzoates / Q000008:administration & dosage*; D001628:Beverages; D001803:Blood Transfusion; D002648:Child; D002675:Child, Preschool; D000077588:Deferasirox; D005260:Female; D005502:Food; D018565:Food-Drug Interactions; D006402:Hematologic Diseases / Q000628:therapy; D006486:Hemosiderosis / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007502:Iron Chelating Agents / Q000008:administration & dosage*; D008297:Male; D014230:Triazoles / Q000008:administration & dosage*
chemical_list: D001565:Benzoates; D007502:Iron Chelating Agents; D014230:Triazoles; D000077588:Deferasirox
keywords: administration; anemia; deferasirox; food; palatability; tolerability