ASH News Daily - Monday, December 12, 2011 - (Page B-21)

Monday, December 12, 2011 ASH NewS DAily Page B–21 ® career-development awardS Scholar Awards: ASH Invests in the Future of Hematology F or over 25 years, ASH has supported more than 200 fellows and junior faculty in both basic and clinical/translational research by providing partial salary or other support during the critical period required for completion of training and achievement of status as an independent investigator. The fol- lowing class of ASH Scholars began their awards on July 1, 2011. To find out more about the ASH Scholar Awards program, please visit www. hematology.org. Anil Chauhan, PhD Dr. Chauhan is an assistant professor in the Department of Inter- nal Medicine at the University of Iowa. Dr. Chauhan received his PhD from the International Centre for Biotechnology and Genetic Engineering in Italy, and he completed his postdoctoral training in the field of thrombosis and hemostasis at the Immune Disease Institute and Harvard Medical School. Research in Dr. 7 DRUG INTERACTIONS No formal drug-drug interaction studies have been conducted with ARZERRA. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: There are no adequate or well-controlled studies of ofatumumab in pregnant women. A reproductive study in pregnant cynomolgus monkeys that received ofatumumab at doses up to 3.5 times the recommended human dose of ofatumumab did not demonstrate maternal toxicity or teratogenicity. Ofatumumab crossed the placental barrier, and fetuses exhibited depletion of peripheral B cells and decreased spleen and placental weights. ARZERRA should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. There are no human or animal data on the potential short- and long-term effects of perinatal B-cell depletion in offspring following in utero exposure to ofatumumab. Ofatumumab does not bind normal human tissues other than B lymphocytes. It is not known if binding occurs to unique embryonic or fetal tissue targets. In addition, the kinetics of B-lymphocyte recovery are unknown in offspring with B-cell depletion [see Nonclinical Toxicology (13.3)]. 8.3 Nursing Mothers It is not known whether ofatumumab is secreted in human milk; however, human IgG is secreted in human milk. Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation. Because the effects of local gastrointestinal and limited systemic exposure to ofatumumab are unknown, caution should be exercised when ARZERRA is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of ARZERRA have not been established in children. 8.5 Geriatric Use Clinical studies of ARZERRA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects [see Clinical Pharmacology (12.3) of full prescribing information]. 8.6 Renal Impairment No formal studies of ARZERRA in patients with renal impairment have been conducted [see Clinical Pharmacology (12.3) of full prescribing information]. 8.7 Hepatic Impairment No formal studies of ARZERRA in patients with hepatic impairment have been conducted. 10 OVERDOSAGE No data are available regarding overdosage with ARZERRA. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenicity studies of ofatumumab have been conducted. In a repeat-dose toxicity study, no tumorigenic or unexpected mitogenic responses were noted in cynomolgus monkeys treated for 7 months with up to 3.5 times the human dose of ofatumumab. Effects on male and female fertility have not been evaluated in animal studies. 13.3 Reproductive and Developmental Toxicology Pregnant cynomolgus monkeys dosed with 0.7 or 3.5 times the human dose of ofatumumab weekly during the period of organogenesis (gestation days 20 to 50) had no maternal toxicity or teratogenicity. Both dose levels of ofatumumab depleted circulating B cells in the dams, with signs of initial B cell recovery 50 days after the final dose. Following Caesarean section at gestational day 100, fetuses from ofatumumab-treated dams exhibited decreases in mean peripheral B-cell counts (decreased to approximately 10% of control values), splenic B-cell counts (decreased to approximately 15 to 20% of control values), and spleen weights (decreased by 15% for the low-dose and by 30% for the high-dose group, compared to control values). Fetuses from treated dams exhibiting anti-ofatumumab antibody responses had higher B cell counts and higher spleen weights compared to the fetuses from other treated dams, indicating partial recovery in those animals developing anti-ofatumumab antibodies. When compared to control animals, fetuses from treated dams in both dose groups had a 10% decrease in mean placental weights. A 15% decrease in mean thymus weight compared to the controls was also observed in fetuses from dams treated with 3.5 times the human dose of ofatumumab. The biological significance of decreased placental and thymic weights is unknown. The kinetics of B-lymphocyte recovery and the potential long-term effects of perinatal B-cell depletion in offspring from ofatumumab-treated dams have not been studied in animals. 17 PATIENT COUNSELING INFORMATION Advise patients to contact a healthcare professional for any of the following: • igns and symptoms of infusion reactions including fever, chills, rash, S or breathing problems within 24 hours of infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] • leeding, easy bruising, petechiae, pallor, worsening weakness, or fatigue B [see Warnings and Precautions (5.2)] • igns of infections including fever and cough [see Warnings and S Precautions (5.2) and Adverse Reactions (6.1)] • ew neurological symptoms such as confusion, dizziness or loss of N balance, difficulty talking or walking, or vision problems [see Warnings and Precautions (5.3)] • ymptoms of hepatitis including worsening fatigue or yellow discoloration S of skin or eyes [see Warnings and Precautions (5.4)] • ew or worsening abdominal pain or nausea [see Warnings and N Precautions (5.5)] • regnancy or nursing [see Use in Specific Populations (8.1, 8.3)] P Advise patients of the need for: • eriodic monitoring for blood counts [see Warnings and Precautions (5.2)] P • voiding vaccination with live viral vaccines [see Warnings and A Precautions (5.6)] Manufactured by: GLAXO GROUP LIMITED Greenford, Middlesex, UB6 0NN, United Kingdom U.S. Lic. 1809 Distributed by: GlaxoSmithKline Research Triangle Park, NC 27709 ©2011, GlaxoSmithKline. All rights reserved. September 2011 ARZ:6BRS ©2011 The GlaxoSmithKline Group of Companies All rights reserved. Printed in USA. AZA295R0 September 2011 Chauhan’s laboratory is focused on the role of adhesion molecules in vascular diseases associated with thrombosis and in- Anil Chauhan, PhD flammation. By using intravital imaging, Dr. Chauhan’s laboratory studies how adhesion molecules regulate blood cell-endothelial (platelet and leukocyte) interaction followed by stimulation/ injury in vivo. In addition, Dr. Chauhan’s laboratory uses molecular and cellular techniques along with genetically modified mice to investigate the role of adhesion molecules in pathophysiology of cardiovascular diseases such as ischemic stroke and atherosclerosis. Using murine models, Dr. Chauhan hopes to understand the pathophysiology of human vascular inflammatory diseases that may lead to development of novel therapies. Dr. Chauhan’s ASH Scholar Award focuses on investigating the role of fibronectincontaining alternative spliced extra domain A in ischemic stroke. He is also the recipient of the 2011 Joanne Levy, MD, Memorial Award for Outstanding Achievement for submitting the highest-scoring abstract. Jill Johnsen, MD Dr. Johnsen is a clinically trained hematologist with a basic science research interest in genetics and hemostasis. She is an assistant member of the Puget Sound Blood Center Research Institute and assistant professor of medicine at the University of Washington in the Division of HematolJill Johnsen, MD ogy. Dr. Johnsen received her MD from Case Western Reserve University, completed her residency in internal medicine at University Hospitals of Cleveland, and trained in hematology/oncology at »» SCHOLARS Page B-31 B:15.125” T:14” S:12”  http://www.hematology.org http://www.hematology.org

Table of Contents for the Digital Edition of ASH News Daily - Monday, December 12, 2011

ASH News Daily - Monday, December 12, 2011

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