Poster Presents Results of Exjade Food Study

August 17, 2011 – According to a poster presented at a recent American Society of Hematology/Oncology meeting, individuals who are prescribed the oral chelator Exjade may have greater options available to them in terms of when and how the drug may be ingested.

The poster, entitled “The Palatability and Tolerability of Deferasirox (Exjade) Taken With Meals, Different Liquids, or Crushed And Added to Food,” presents the results of a single-arm, open label, multi-center study following 65 patients over a 3-month assessment period. (30.8% of patients are thalassemic; individuals with sickle cell disease, myelodysplastic syndrome and other anemias were also included.)

“The Palatability and Tolerability of Deferasirox (Exjade) Taken With Meals, Different Liquids, or Crushed And Added to Food”
is the name of the study. Its authors are Patricia J. Giardina MD, Stuart L. Goldberg MD, Joan Parkhurst Cain MD, Deborah Chirnomas MD, Jason Esposito, Carole Paley MD, and Elliott Vichinsky MD.

The prescribing guidelines for Exjade indicate that it should be taken “on an empty stomach, at least 30 minutes prior to food” and should be dispersed in water, apple juice or orange juice. The study authors noted that “this mode of administration may be cumbersome for some patients and may impact adherence” and that “roughly 25% of patients complain of gastrointestinal (GI) adverse events (AEs); some patients also find the taste or texture of the dispersed drug unpalatable. This study would provide information on the possibility of expanding the options for taking Exjade with foods or liquids other than those included in the label.

Participants were given five options for taking the chelator:

• With breakfast, crushed and added to a soft food
• With breakfast and dispsered in a beverage of choice
• With dinner, crushed and added to a soft food
• With dinner and dispersed in a beverage of choice
• Dispersed in a beverage of choice with no meal

Study results include the following:

• The most frequently chosen mode of administration was dispersing in a liquid at no meal.
• The most highly rated choice was taking Exjade with a soft food at breakfast.
• The most popular soft foods for mixing with crushed tablets included apple sauce, yogurt, pudding and ice cream; other soft foods included cream of wheat, oatmeal, cereal, nut butters, mashed potatoes, gelatin, sandwiches, noodles, tacos, pizza, rice with gravy, whipped cream, cottage cheese and mashed banana.
• The most popular liquids chosen were orange juice, apple juice, milk and water. Other liquids include Gatorade, tea, vegetable juices and other fruit juices.

In addition, the authors concluded:

• There was some indication that GI (gastrointestinal) symptoms improved when deferasirox was taken with food or different liquid choices, though it was not statistically validated due to the small sample size;
• Ferritins trended down over the study period, although the small sample size again affected statistical significance;
• No safety signal was appreciated during the trial, but a larger study of longer duration is necessary.

Based on the results of this initial trial, the authors state that “a variety of foods and liquid options for taking deferasirox are tolerated by patients.”

Dr. Ellis Neufeld, CAF Medical Advisory Board Chair, says that “Medical Advisory Board physicians take these results to mean that deferasirox will be okay to take in food, at least the foods noted on the poster. This may result in a big improvement for many patients for two reasons: first for scheduling morning activities, school and work, without having to worry about fasting, and second for improved side effects in some individuals.”

Dr. Neufeld also states that Exjade should still not be subjected to heat of cooking, or warmed in a microwave.

We are not certain when or if these data will be presented as a paper. In the meantime, the entire poster may be viewed by clicking here.

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