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unpublished data and sharing ideas for hematologic innovation, as well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