ASH Clinical News July 2015_updated | Page 19

UP FRONT and Boston Children’s Hospital. He also served as director of pediatric hematology/oncology at Children’s Hospital Medical Center in Cincinnati, Ohio, and director and professor of pediatric oncology and professor of oncology and pediatrics at Johns Hopkins University School of Medicine in Baltimore, Maryland. Robert L. Meyer, president and chief executive officer of Phoenix Children’s Hospital said: “The tragic and sudden loss of Dr. Arceci has touched the Phoenix Gerald L. Logue, MD Children’s family deeply. Bob was known around the world as a brilliant cancer researcher and a skilled and compassionate pediatric oncologist. We will miss him, but the loss is felt most deeply by his dear family. We extend our heartfelt condolences to Bob’s wife Jean, who is also a member of the Phoenix Children’s family, his two sons, and his extended family and network of friends and colleagues.” (1941-2015) Gerald L. Logue, MD, professor of medicine and chief of hematology at the University of Buffalo School of Medicine and Biomedical Sciences, passed away suddenly on June 7. Dr. Logue, who was known for his commitment to medical training, had practiced medicine in Buffalo since 1982. Dr. Logue devoted himself to supporting and enhancing the dialogue regarding T:7” 4.2 Allergic Reactions REVLIMID is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide [see Warnings and Precautions (5.8)]. 5.2 REVLIMID REMS™ Program Because of the embryo-fetal risk [see Warnings and Precautions (5.1)], REVLIMID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), the REVLIMID REMS™ program (formerly known as the “RevAssist®” program). Required components of the REVLIMID REMS™ program include the following: • Prescribers must be certified with the REVLIMID REMS™ program by enrolling and complying with the REMS requirements. • Patients must sign a Patient-Physician agreement form and comply with the REMS requirements. In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.6)] and males must comply with contraception requirements [see Use in Specific Populations (8.6)]. • Pharmacies must be certified with the REVLIMID REMS™ program, must only dispense to patients who are authorized to receive REVLIMID and comply with REMS requirements. Further information about the REVLIMID REMS™ program is available at www.celgeneriskmanagement.com or by telephone at 1-888-423-5436. 5.3 Hematologic Toxicity REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medication that may increase risk of bleeding. Patients taking REVLIMID should have their complete blood counts assessed periodically as described below [see Dosage and Administration (2.1, 2.2, 2.3)]. Patients taking REVLIMID in combination with dexamethasone for MM should have their complete blood counts (CBC) assessed every 7 days (weekly) for the first 2 cycles, on Days 1 and 15 of Cycle 3, and every Patients taking REVLIMID for MDS should have their complete blood counts monitored weekly for the first 8 weeks and at least monthly thereafter. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in ѡ