Meeting Abstract

JL502. An Algorithm for Transitioning Patients From Deferasirox Dispersible Tablets to Deferasirox Film-Coated Tablets and Sprinkle Granules

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ABSTRACT

Abstracts From 
JADPRO Live at APSHO 2017
Marriott Marquis, Houston, Texas • November 2–5, 2017

The posters for the abstracts below can be found at:
eventscribe.com/2017/posters/JADPROLIVE/home.asp

Context: Iron chelation therapy for iron overload (IO) improves organ function and survival among patients. The deferasirox dispersible tablet (DT) has a well-defined safety and efficacy profile, yet patient adherence is not optimal secondary to gastrointestinal (GI) intolerability and palatability. This led to development of film-coated tablets (FCT) taken with or without a meal and sprinkle granules for sprinkling on soft food. Both contain the same active substance as DT but different excipients. In the ECLIPSE trial (2016), comparable FCT and DT safety profiles were demonstrated in patients with transfusion-dependent thalassemia or low-to-intermediate-risk myelodysplastic syndromes. Patients receiving FCT reported better compliance, continued treatment longer, and experienced greater serum ferritin (SF) reduction. Advanced practitioners (APs) need education regarding these new formulations and proper transition from the DT to them.

Method: An algorithm was developed based on the deferasirox prescribing information supplemented by practice recommendations. Results: Transitioning a patient from deferasirox DT to FCT is based on the patient’s response to deferasirox DT or other iron chelators, determined by SF and the degree of GI toxicity. Transitioning often begins at prescription renewal. Deferasirox FCT has greater bioavailability versus deferasirox DT; therefore, the recommended dose of FCT is ~30% lower than DT, rounded to the nearest whole tablet. Deferasirox FCT is available in 90, 180, and 360 mg tablets. The starting dose of FCT for treatment of chronic iron overload due to blood transfusions is 14 mg/kg/day (7 mg/kg/day for non–transfusion-dependent thalassemia [NTDT]). Monitoring for dose titration of deferasirox FCT follows the same schedules as DT but dose adjustment increments are lower for FCT than for DT (3.5–7 mg/kg for FCT; 5–10 mg/kg for DT), with maximum dose of 28 mg/kg/day for FCT. Transfusion-dependent patients should have SF monitored monthly and dose adjustments every 3 to 6 months based on SF trends, any weight change, therapeutic goals, and tolerability. Patients with NTDT should have SF monitored monthly and liver iron concentration monitored every 6 months (or if SF < 300 μg/L) with dose adjustment as needed. In renally impaired patients, the starting dose of FCT should be reduced by 50%. Conclusions: The algorithm should familiarize APs with new deferasirox formulations and educate them on appropriate administration and titration of these agents to enhance therapeutic compliance. This may lead to improved organ function and survival benefits among patients.

Recommendations: The algorithm should be published and distributed to APs to maximize its educational value among this audience.

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