CLINICAL NEWS
Examining Conditioning Regimens
with Busulfan plus Fludarabine or
Cyclophosphamide in Older AML Patients
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 sy \