CLINICAL NEWS
spending (for either Part B or D).
• The drug is associated with a high
annual per-user spending based on
claims data analyses (e.g., greater than
$10,000 per user) and is ranked in the
top 15 by overall program spending.
• The drug is ranked among the top 10
high unit-cost increases.
Data from 2014 drug expenditures were analyzed to create this dashboard. CMS plans to
update the list regularly and launch a version
for Medicaid drug spending next year.
For more information on this online
tool, visit cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs.
Sources: Centers for Medicare & Medicaid Services news release,
December 21, 2015; Associated Press, “Medicare unveiling online tool to
analyze costly drugs,” December 21, 2015.
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 potenti