ASH Clinical News May 2017 NEW | Page 39

CLINICAL NEWS “acceptable” rate of GVHD (30%; 95% CI 9.9-50.1). Dr. Herbaux and colleagues collected patient data from the French Medical Drug Agency’s Authorization for Temporary Use program to identify participants who had undergone alloHCT between March and September 2015. Most patients were male (n=11; 55%) and had an Eastern Coopera- tive Oncology Group performance status score of ≤1 (n=15; 75%). Patients had received a median of seven prior therapies (range = 4-13 therapies). Most (n=13; 65%) had a history of GVHD: 10 had acute GVHD and three had chronic GVHD. Two patients had an improved response 100 days post-transplant, convert- ing from partial response (PR) to complete response (CR). Six patients (95% CI 9.9-50.1) experi- enced nivolumab-induced GVHD after a single infusion, which prompted discon- tinuation of the drug. Each of these cases occurred at least one week after infusion, and all patients who experienced GVHD had a history of acute GVHD, “which might reflect greater alloreactivity,” co- author Franck Morschhauser, MD, PhD, told ASH Clinical News. “Intriguingly, nivolumab did not induce chronic GVHD in any patients,” he noted. Other reasons for treatment discontinu- ation included second alloHCT (n=1), lack T:7” REVLIMID ® [lenalidomide] capsules, for oral use Allergic Reactions Inform patients of the potential for allergic reactions including hypersensitivity, angioedema, Stevens-Johnson Syndrome, or toxic epidermal necrolysis if they had such a reaction to THALOMID and report symptoms associated with these events to their healthcare provider for evaluation [see Warnings and Precautions (5.8)]. Tumor Lysis Syndrome Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.9)]. Tumor Flare Reaction Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.10)]. Dosing Instructions Inform patients how to take REVLIMID [see Dosage and Administration (2)] • REVLIMID should be taken once daily at about the same time each day, • REVLIMID may be taken either with or without food. • The capsules should not be opened, broken, or chewed. REVLIMID should be swallowed whole with water. • Instruct patients that if they miss a dose of REVLIMID, they may still take it up to 12 hours after the time they would normally take it. If more than 12 hours have elapsed, they should be instructed to skip the dose for that day. The next day, they should take REVLIMID at the usual time. Warn patients to not take 2 doses to make up for the one that they missed. Manufactured for: Celgene Corporation Summit, NJ 07901 REVLIMID ® , REVLIMID REMS ® and THALOMID ® are registered trademarks of Celgene Corporation. Pat. www.celgene.com/therapies ©2005-2017 Celgene Corporation, All Rights Reserved. REV_MM_MAINT_HCP_BSv.21 2_2017 REVLIMID REMS program Because of the risk of embryo-fetal toxicity, REVLIMID is only ava