American Association of Blood Banks
Annual Meeting
October 24 – 27, 2015
Anaheim, CA
The 2015 AABB Annual Meeting covers the latest
research in transfusion medicine and cellular therapies,
with more than 120 educational sessions and approximately 700 scientific and administrative abstracts.
57th ASH Annual Meeting and Exposition
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the 57th ASH Annual Meeting
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December 5 – 8, 2015
Orlando, Florida
The American Society of Hematology (ASH) invites you
to attend the 57th ASH Annual Meeting in Orlando,
Florida. As the premier event in malignant and non-malignant hematology, this meeting will provide attendees
with an invaluable educational experience.
Orlando, Florida
and 1.4% of patients in the Tasigna 300 mg bid and 400 mg bid arms,
respectively, and in no patients in the imatinib arm.
5.13 Total Gastrectomy
Since the exposure of nilotinib is reduced in patients with total gastrectomy, perform more frequent monitoring of these patients. Consider
dose increase or alternative therapy in patients with total gastrectomy
[see Clinical Pharmacology (12.3) in the full prescribing information].
5.14 Lactose
Since the capsules contain lactose, Tasigna is not recommended for
patients with rare hereditary problems of galactose intolerance, severe lactase deficiency with a severe degree of intolerance to lactose-containing
products, or of glucose-galactose malabsorption.
5.15 Monitoring Laboratory Tests
Complete blood counts should be performed every 2 weeks for the
first 2 months and then monthly thereafter. Perform chemistry panels,
including electrolytes, calcium, magnesium, liver enzymes, lipid profile,
and glucose prior to therapy and periodically. ECGs should be obtained
at baseline, 7 days after initiation and periodically thereafter, as well as
following dose adjustments [see Warnings and Precautions (5.2)]. Monitor lipid profiles and glucose periodically during the first year of Tasigna
therapy and at least yearly during chronic therapy. Should treatment with
any HMG-CoA reductase inhibitor (a lipid lowering agent) be needed to
treat lipid elevations, evaluate the potential for a drug-drug interaction
before initiating therapy as certain HMG-CoA reductase inhibitors are
metabolized by the CYP3A4 pathway [see Drug Interactions (7.1) in the
full prescribing information]. Assess glucose levels before initiating
treatment with Tasigna and monitor during treatment as clinically indicated. If test results warrant therapy, physician should follow their local
standards of practice and treatment guidelines.
5.16 Embryo-Fetal Toxicity
There are no adequate and well controlled studies of Tasigna in pregnant
women. However, Tasigna may cause fetal harm when administered to a
pregnant woman. Nilotinib caused embryo-fetal toxicities in animals at
maternal exposures that were lower than the expected human exposure
at the recommended doses of nilotinib. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the
patient should be apprised of the potential hazard to the fetus. Women
of child-bearing potential should avoid becoming pregnant while taking
Tasigna [see Use in Specific Populations (8.1) in the full prescribing
information].
5.17 Fluid Retention
In the randomized trial in patients with newly diagnosed Ph+ CML in
chronic phase, severe (Grade 3 or 4) fluid retention occurred in 3.9%
and 2.9% of patients receiving Tasigna 300 mg bid and 400 mg bid,
respectively, and in 2.5% of patients receiving imatinib. Effusions
(including pleural effusion, pericardial effusion, ascites) or pulmonary
edema, were observed in 2.2% and 1.1% of patients receiving Tasigna
300 mg bid and 400 mg bid, respectively, and in 2.1% of patients receiving imatinib. Effusions were severe (Grade 3 or 4) in 0.7% and 0.4% of
patients receiving Tasigna 300 mg bid and 400 mg bid, respectively, and
in no patients receiving imatinib. Similar events were also observed in
postmarketing reports. Monitor patients for signs of severe fluid retention (e.g., unexpected rapid weight gain or swelling) and for symptoms
of respiratory or cardiac compromise (e.g., shortness of breath) during
Tasigna treatment; evaluate etiology and treat patients accordingly.
6 ADVERSE REACTIONS
The following serious adverse reactions can occur with Tasigna and are
discussed in greater detail in other sections of the package insert [see
Boxed Warning, Warnings and Precautions (5)].
• Myelosuppression [see Warnings and Precautions (5.1)]
• QT Prolongation [see Boxed Warning, Warnings and Precautions (5.2)]
• Sudden Deaths [see Boxed Warning, Warnings and Precautions (5.3)]
• Cardiac and Arterial Vascular Occlusive Events [see Warnings and Precautions (5.4)]
• Pancreatitis and Elevated Serum Lipase [see Warnings and Precautions (5.5)]
• Hepatotoxicity [see Warnings and Precautions (5.6)]
• Electrolyte Abnormalities [see Boxed Warning, Warnings and Precautions (5.7)]
• Hemorrhage [see Warnings and Precautions (5.12)]
• Fluid Retention [see Warnings and Precautions (5.17)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions,
adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of another drug and may
not reflect the rates observed in practice.
In Patien