ASH Clinical News December 2014 | Page 10

Calendar 20th Congress of the European Hematology Association Lymphoma & Myeloma 2015 NEW! ASH Meeting on Hematologic Malignancies September 17 – 19, 2015 Chicago, IL ASH's newest clinical meeting will bring together top experts in hematologic malignancies to discuss the latest developments in clinical care and to find answers to challenging patient care questions. The 53rd Annual Meeting of the Japan Society of Clinical Oncology June 11 – 14, 2015 Vienna, Austria The EHA Annual Congress will provide a forum for presenting original unpublished data and sharing ideas for hematologic innovation, as well as disseminating evidence-based knowledge of primary clinical relevance. Chicago, Illinois October 22 – 24, 2015 New York, NY Providing a forum to discuss the latest advances in lymphoma and myeloma, the latest L&M meeting features an interdisciplinary approach and a mixture of basic, translational, and clinical research. October 24 – 26, 2015 Kyoto, Japan Japan’s largest multidisciplinary academic society of clinical oncology will hold its annual meeting as an open discussion of the latest advances in current cancer treatment. USE IN SPECIFIC POPULATIONS tissue distribution study in rats, administration of 2 mg/m2 of intravenous liposomal or Pregnancy non-liposomal vincristine sulfate showed greater accumulation of vincristine sulfate in Pregnancy Category D [see Warnings and Precautions] sciatic and tibial nerves (as well as the lymph nodes, spleen, and bone marrow) of the animals following vincristine sulfate liposome injection. Based on its mechanism of action and findings from animal studies, Marqibo can cause fetal harm when administered to pregnant women. PATIENT COUNSELING INFORMATION Physicians are advised to discuss the following with patients prior to treatment with If this drug is used during pregnancy, or if the patient becomes pregnant while taking this Marqibo: drug, the patient should be apprised of the potential hazard to a fetus. In an embryofetal developmental study, pregnant rats were administered vincristine sulfate liposome injection Extravasation Tissue Injury: Advise patients to report immediately any burning or local intravenously during the period of organogenesis at vincristine sulfate doses of 0.022 to irritation during or after the infusion [see Warnings and Precautions]. 0.09 mg/kg/day. Drug-related adverse effects included fetal malformations (skeletal and Ability to Drive or Operate Machinery or Impairment of Mental Ability: Marqibo visceral), decreases in fetal weights, increased numbers of early resorptions and postmay cause fatigue and symptoms of peripheral neuropathy. Advise patients not to drive implantation losses, and decreased maternal body weights. Malformations were observed or operate machinery if they experience any of these symptoms [see Warnings and at doses ≥0.044 mg/kg/day in animals at systemic exposures approximately 20-40% of Precautions]. those reported in patients at the recommended dose. Gastrointestinal/Constipation: Patients receiving Marqibo may experience constipation. Nursing Mothers Advise patients how to avoid constipation by a diet high in bulk fiber, fruits and vegetables, It is not known whether this drug is excreted in human milk. Because many drugs are and adequate fluid intake as well as use of a stool softener, such as docusate. Instruct excreted in human milk and because of the potential for serious adverse reactions in nursing patients to seek medical advice if they experience symptoms of constipation such bowel infants, a decision should be made whether to discontinue nursing or discontinue the drug movement infrequency, abdominal pain, bloating, diarrhea, nausea, or vomiting [see taking into account the importance of the drug to the mother. Warnings and Precautions]. Pediatric Use Pregnancy/Nursing: Advise patients to use effective contraceptive measures to prevent The safety and effectiveness of Marqibo in pediatric patients have not been established. pregnancy during treatment with Marqibo [see Warnings and Precautions]. Instruct patients to report pregnancy to their physicians immediately. Advise patients that they Geriatric Use should not receive Marqibo while pregnant or breastfeeding. If a patient wishes to re-start Safety and effectiveness in elderly individuals have not been established. In general, dose breastfeeding after treatment, she should be advised to discuss the appropriate timing with selection for an elderly patient should be cautious, reflecting the greater frequency of her physician [see Use in Specific Populations]. decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking [see Drug Interactions]. Renal Impairment The influence of renal impairment on the safety, efficacy, and pharmacokinetics of Marqibo has Peripheral Neuropathy: Advise patients to contact their physicians if they experience not been evaluated. new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the feet or hands [see Warnings and Hepatic Impairment Precautions]. Non-liposomal vincristine sulfate is excreted primarily by the liver. The influence of severe hepatic impairment on the safety and efficacy of Marqibo has not been evaluated. Other: Instruct patients to notify their physicians if they experience fever, productive cough, or decreased appetite [see Warnings and Precautions]. The pharmacokinetics of Marqibo was evaluated in patients with moderate hepatic d