ASH News Daily - Saturday, December 10, 2011 - (Page B-21)

Saturday, December 10, 2011 ASH NewS DAily Page B–21 ® career-development awardS ASH Introduces Minority Graduate Student Abstract Achievement Award T his year, ASH introduces the Minority Graduate Student Abstract Achievement Awards in the amount of $1,500. These awards are given to select graduate students to acknowledge their accomplishments in the field of hematology. The Minority Graduate Student Abstract Achievement Award program is designed to encourage minority graduate students in the field of hematology and is part of the broader minority recruitment initia- tive at ASH, which also includes the Minority Medical Student Award Program (MMSAP) and the ASHHarold Amos Medical Faculty Development Program (ASH-AMFDP) in partnership with the Robert Wood Johnson Foundation. Muithi Mwanthi Indiana University School of Medicine Abstract #18 Patrice Capers Morehouse School of Medicine Abstract #2123 Nyasha Chambwe Weill Cornell Medical College Abstract #556 Colles Orrin Joseph Price University of Chicago Abstract #2453 Marthe-Sandrine Eiymo Mwa Mpollo University of Cincinnati Abstract #1078 Grace I. Aldana Masangkay University of California, LA Abstract #3607 D’Andra Parker McMaster University Abstract #1144 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: Did You Pay the Non-Member Rate? ubmit your membership application by March 1, 2012, and you can receive the discounted member registration rate at next year’s annual meeting. You’ll also gain other valuable benefits, including: • A print and online subscription to the journal, Blood • A print subscription to The Hematologist: ASH News and Reports • Exclusive access to the membersonly hotels at the 2012 annual meeting in Atlanta, GA • Access to Consult a Colleague, an online service that allows ASH members to submit clinical questions to respected colleagues who are knowledgeable in specific areas of hematology • Discounts on Highlights of ASH and the State-of-the-Art Symposium • Discounts on educational products such as the ASH Self-Assessment Program (ASH-SAP) • And much more Visit us online at www.hematology.org to download an application. S B:15.125” T:14” S:12” 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  http://www.hematology.org

Table of Contents for the Digital Edition of ASH News Daily - Saturday, December 10, 2011

ASH News Daily - Saturday, December 10, 2011

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