ASH Clinical News July 2017 V2 - Page 27

between pomalidomide and placebo (16% [95% CI 11-23] vs. 16% [95% CI 8-26]; p=0.87). The median time to response was similar in the pomalido- mide cohort than in the placebo cohort (7 weeks [range = 0-20 weeks] vs. 2 weeks [range = 0-15 weeks]; p=0.22). Median durations of response in the pomalidomide and placebo 15” 4.75” conclude no efficacy of pomalid- omide in reversing RBC transfu- sion dependence,” Dr. Tefferi and co-authors wrote. They proposed that the pomalidomide responses were “spontaneous reversals of RBC transfusion dependence” that occurred at similar rates to those in the placebo cohort, and could potentially explain the similar response rates between the groups. “We were, there- fore, surprised to find several differences in variables associ- ated with response between the cohorts,” they added. Outcomes were analyzed ac- cording to age (≤65 vs. >65 years), white blood cell (WBC) count (<25 vs. ≥25x10 9 /L), and the intensity of RBC transfusion dependence prior to randomization (≤4 vs. >4 U/28 His treatment, designed for his lifestyle. The Kogenate FS needleless reconstitution system contains: 1 1 Product vial 2 Prefilled diluent syringe and separate plunger rod 3 Vial Adapter with built-in filter 2 4 4 Butterfly needle administration set 3 Wide range of vial sizes ■ Available vial sizes: 250 IU 500 IU 1000 IU 2000 IU and 3000 IU —for flexibility in dose preparation 1 ■ Small diluent volumes make reconstitution fast and easy § Diluent sizes are 2.5 mL for 250-IU, 500-IU, and 1000-IU vial sizes; 5.0 mL for 2000-IU and 3000-IU vial sizes. 1 § IMPORTANT SAFETY INFORMATION (CONT’D) Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate FS predominately in previously untreated patients. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration. ■ Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII. ■ Serious adverse reactions seen with Kogenate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII. ■ The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) associated infections. For additional important risk and use information, please see Brief Summary on the following pages. You are encouraged to report negative side eff ects of prescription drugs to the FDA. Visit, or call 1-800-FDA-1088. ■ Reference: 1. Kogenate® FS with Vial Adapter [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016. Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. © 2017 Bayer. All rights reserved. Printed in USA 03/17 PP-575-US-2847 FS:7.25” F:7.5” Store Kogenate FS at 36°F to 46°F for up to 30 months from the date of manufacture. Do not freeze. Within this period, Kogenate FS may be stored for a single period of up to 12 months at temperatures up to 77°F. Record the starting date of room-temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf life then expires after storage at room temperature for 12 months or after the expiration date on the product via