ASH News Daily 2013 - Day 3 - (Page B-16)

ASH News Daily Page B-16 Monday, December 9, 2013 ® career-development awardS Scholar Award «« From Page B-14 Eirini Papapetrou, MD, PhD Dr. Papapetrou is an assistant professor of medicine in the Division of Hematology at the University of Washington. She received her MD and PhD in human molecular genetics in Greece and trained at Memorial Sloan-Kettering Cancer Center with Dr. Michel Sadelain in genome engineering, directed hematopoietic where she established differentiation and are reprogramming techdriven by new opportunologies for human nities that hPSC research cells and was among offers for modeling disthe first investigators eases that are intractable to routinely generate in model organisms and patient-specific induced for functional human gepluripotent stem cells netics. (iPSCs). She currently uses Dr. Papapetrou's resomatic cell reprosearch uses human plugramming and genetic ripotent stem cell (hPSC) Eirini Papapetrou, engineering to derive models to study disor- MD, PhD patient-specific iPSCs ders of the hematopoietic system. and to engineer disease-associated Her research projects capitalize on a chromosomal deletions in normal set of expertise in somatic cell repro- iPSCs with the goal to better undergramming, genetic engineering, and stand the cellular, molecular, and 10-14 days, and the second test within 24 hours prior to prescribing REVLIMID. Once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. REVLIMID treatment must be discontinued during this evaluation. Males Lenalidomide is present in the semen of males who take REVLIMID. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID, during dose interruptions and for up to 28 days after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Male patients taking REVLIMID must not donate sperm * Advise males to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 28 days after discontinuing REVLIMID, even if they have undergone a successful vasectomy. * Advise male patients taking REVLIMID that they must not donate sperm [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)]. * All patients must be instructed to not donate blood while taking REVLIMID, during dose interruptions and for 1 month following discontinuation of REVLIMID [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)]. REVLIMID REMS™ program Because of the risk of embryo-fetal toxicity, REVLIMID is only available through a restricted program called the REVLIMID REMS™ program (formerly known as the "RevAssist®" program) [see Warnings and Precautions (5.2)]. 8.7 Renal Impairment Since lenalidomide is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID are recommended to provide appropriate drug exposure in patients with moderate (CLcr 30-60 mL/min) or severe renal impairment (CLcr < 30 mL/min) and in patients on dialysis [see Dosage and Administration (2.4)]. * Patients must sign a Patient-Prescriber agreement form and comply with the requirements to receive REVLIMID. In particular, females of reproductive potential must comply with the pregnancy testing, contraception requirements and participate in monthly telephone surveys. Males must comply with the contraception requirements [see Use in Specific Populations (8.6)]. 8.8 Hepatic Impairment No dedicated study has been conducted in patients with hepatic impairment. The elimination of unchanged lenalidomide is predominantly by the renal route. * REVLIMID is available only from pharmacies that are certified in REVLIMID REMS™ program. Provide patients with the telephone number and website for information on how to obtain the product. 10 OVERDOSAGE There is no specific experience in the management of lenalidomide overdose in patients; although in dose-ranging studies, some patients were exposed to up to 150 mg and in single-dose studies, some patients were exposed to up to 400 mg. In studies, the dose-limiting toxicity was essentially hematological. In the event of overdose, supportive care is advised. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, mutagenesis, impairment of fertility Carcinogenicity studies with lenalidomide have not been conducted. Lenalidomide was not mutagenic in the bacterial reverse mutation assay (Ames test) and did not induce chromosome aberrations in cultured human peripheral blood lymphocytes, or mutations at the thymidine kinase (tk) locus of mouse lymphoma L5178Y cells. Lenalidomide did not increase morphological transformation in Syrian Hamster Embryo assay or induce micronuclei in the polychromatic erythrocytes of the bone marrow of male rats. A fertility and early embryonic development study in rats, with administration of lenalidomide up to 500 mg/kg (approximately 200 times the human dose of 25 mg, based on body surface area) produced no parental toxicity and no adverse effects on fertility. 17 PATIENT COUNSELING INFORMATION See FDA-approved Patient labeling (Medication Guide) Embryo-Fetal Toxicity Advise patients that REVLIMID is contraindicated in pregnancy [see Contraindicatons (4.1)]. REVLIMID is a thalidomide analog and can cause serious birth defects or death to a developing baby. [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. * Advise females of reproductive potential that they must avoid pregnancy while taking REVLIMID and for at least 4 weeks after completing therapy. * Initiate REVLIMID treatment in females of reproductive potential only following a negative pregnancy test. * Advise females of reproductive potential of the importance of monthly pregnancy tests and the need to use two different forms of contraception including at least one highly effective form simultaneously during REVLIMID therapy, during dose interruption and for 4 weeks after she has completely finished taking REVLIMID. Highly effective forms of contraception other than tubal ligation include IUD and hormonal (birth control pills, injections, patch or implants) and a partner's vasectomy. Additional effective contraceptive methods include latex or synthetic condom, diaphragm and cervical cap. * Instruct patient to immediately stop taking REVLIMID and contact her doctor if she becomes pregnant while taking this drug, if she misses her menstrual period, or experiences unusual menstrual bleeding, if she stops taking birth control, or if she thinks FOR ANY REASON that she may be pregnant. * Advise patient that if her doctor is not available, she can call 1-888-668-2528 for information on emergency contraception [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6) ]. Cosmos Communications K Hematologic Toxicity Inform patients that REVLIMID is associated with significant neutropenia and thrombocytopenia [see Boxed Warnings and Warnings and Precautions (5.3)]. Venous Thromboembolism Inform patients that REVLIMID/dexamethasone has demonstrated significant increased risk of DVT and PE in patients with multiple myeloma [see Boxed Warnings and Warning and Precautions (5.4)]. Allergic Reactions Inform patients of the potential for allergic reactions including hypersensitivity, angioedema, Stevens Johnsons 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. 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. 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. Hepatotoxicity Inform patients of the risk of hepatotoxicity, including hepatic failure and death, and to report any signs and symptoms associated with this event to their healthcare provider for evaluation. Secondary Primary Malignancies Inform patients of the potential risk of developing second primary malignancies during treatment with REVLIMID. Dosing Instructions Inform patients to take REVLIMID once daily at about the same time each day, 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®, RevAssist®, and THALOMID® are registered trademarks of Celgene Corporation. REVLIMID REMS™ is a trademark of Celgene Corporation. U.S. Pat. Nos. 5,635,517; 6,045,501; 6,281,230; 6,315,720; 6,555,554; 6,561,976; 6,561,977; 6,755,784; 6,908,432; 7,119,106; 7,189,740; 7,468,363; 7,465,800; 7,855,217; 7,968,569 ©2005-2013 Celgene Corporation, All Rights Reserved. REV_MCL_HCP_BSv. REV_MCL_HCP_BSv.DRAFT 06/13 1 ja Q1 Q2 genetic pathogenesis of myelodysplasia, bone marrow failure, and progression to acute leukemia and to investigate their clonal evolution and identify new therapeutic targets. Dr. Papapetrou stated that the ASH Scholar Award is a big honor and an inspiration to make a significant contribution to the field of hematology. Vikram Paralkar, MD Dr. Paralkar has a research interest in long noncoding RNAs (lncRNAs) in hematopoiesis. He received his medical degree at Seth G.S. Medical College in Mumbai, India, and completed his residency and chief residency at Temple University Hospital in Vikram Paralkar, MD Philadelphia. He is currently a Hematology-Oncology fellow at the University of Pennsylvania, and his postdoctoral research is in the laboratory of Dr. Mitchell Weiss at the Children's Hospital of Philadelphia. Prior to entering the lab, Dr. Paralkar had become interested in the rapidly growing field of lncRNAs, a novel category of RNAs that appears to regulate gene expression in organisms as diverse as plants, worms, and humans. His research focus has been on identifying lncRNAs produced during erythropoiesis and characterizing their functions, and he has identified multiple novel lncRNAs that are required for normal erythroid maturation. Through an understanding of the roles that lncRNAs play during normal hematopoiesis, he hopes to discover how their dysregulation may contribute to disorders such as bone marrow failure or leukemia. Dr. Paralkar's initial work was funded by the ASH Research Training Award for Fellows in 2011. Now supported by the ASH Scholar Award, he intends to extend his research to lncRNA biology in human hematopoiesis, to dissect the molecular mechanisms of lncRNA function, and to identify lncRNAs that may be involved in the pathogenesis of leukemia. His clinical interests are in the treatment of myeloproliferative disorders, myelodysplastic syndromes, and acute myeloid leukemia. »» SCHOLAR AWARD Page B-18 

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ASH News Daily 2013 - Day 3

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