ASH Clinical News March 2015 | Page 38

On Location ASH Meeting on Hematologic Malignancies malignancies – over the meeting’s three days. Personally, I think all of the sessions are essential in order to truly stay up-to-date on the medical advances and how to deliver the best care to your patients. The ASH Meeting on Hematologic Malignancies is accepting submissions for peer-reviewed abstracts and posters to be presented at the meeting — what can attendees expect from the abstract and poster presentations? Dr. Connors: There is a continually emerging evidence base in hematologic malignancies and we hope that people will bring insights to this meeting that will help us advance past the current evidence. The current evidence base is generally inadequate for all the potential questions regarding treatment and patient management that will arise. Dr. Anderson: Our hope is that trainees and early clinical researchers will present cutting- edge findings in the poster sessions. On top of that, I think the posters offer a good opportunity to meet with the studies’ primary investigators to discuss results and interact with those researchers. Dr. Tallman: We’d also like to emphasize to people who are considering submission of an abstract or poster that they may submit the identical abstract to this meeting and the 2015 ASH Annual Meeting – and that ELOCTATE THE FIRST AND ONLY rFVIII WITH A PROLONGED HALF-LIFE 5 DAYS WITH FACTOR LEVELS ABOVE 1% Mean Plasma FVIII Activity (IU/dL) MEAN FACTOR ACTIVITY PROFILE AFTER A SINGLE DOSE (50 IU/kg)† MEAN FACTOR ACTIVITY PROFILE AFTER A SINGLE DOSE (50 IU/kg)* 100 50 MEAN TERMINAL HALF-LIFE AFTER A SINGLE 5O IU/kg DOSE IN ADULTS*† 10 5 19.7 HOURS (17.4, 22.0) ABOVE 1 0 20 40 60 80 Time (Hours) 100 120 Mean terminal half-life after a single 50 IU/kg dose in pediatric and adolescent patients*†‡ • 16.4 (14.1, 18.6) hours in subjects 12 to 17 (n=11) • 14.6 (11.5, 17.7) hours in subjects 6 to 11 (n=27) • 12.0 (9.55, 14.4) hours in subjects 2 to 5 (n=10) 1% *The pharmacokinetics of ELOCTATE were evaluated following a single dose of 50 IU/kg in the Phase 3 study of 28 adults and 11 adolescent, previously treated patients (ages 12 to 17 years), and in an open-label, multicenter study of 37 pediatric, previously treated patients (ages 2 to 5 years and 6 to 11 years). † Presented in arithmetic mean (95% CI). ‡ Compared to adults and adolescents, clearance was higher in children 2 to 5 years of age, indicating a need for dose adjustments. For patients 6 years and older, dose adjustment is not required. Selected Important Safety Information • Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur Please see Brief Summary of full Prescribing Information on the following pages. This information is not intended to replace discussions with your healthcare provider.