TASIGNA
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Package(a):
CAPSULES: 28 x 200 mg.
Dosage(a):
See prescribing information for full details.
Prescribing Restrictions:
Package(b):
CAPSULES: 112 x 200 mg.
Dosage(b):
See prescribing information for full details.
Prescribing Restrictions:
Package(c):
FILM COATED TABLETS: 28 x 150
Dosage(c):
See prescribing information for full details.
Prescribing Restrictions: None
Package(d):
FILM COATED TABLETS: 112 x 150
Dosage(d):
See prescribing information for full details.
Prescribing Restrictions: None
Indications:
150 mg and 200 mg: Treatment of adult patients with newly diagnosed Philadelphia chromosome positive CML in chronic phase.
200 mg only: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph
+CML) in chronic or accelerated phase in patients resistant to or experiencing significant toxicity during treatment with imatinib.
Contra-Indications:
Hypersensitivity to nilotinib or to any of the excipients.
Special Precautions:
Treatment is associated with thrombocytopenia, neutropenia and anemia. Complete blood counts should be performed every two weeks for the first 2 months and then monthly thereafter, or as clinically indicated. Nilotinib has the potential to prolong QT interval and should therefore be used with caution in patients who have or may develop prolongation of QTc. This includes patients with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicines or other drugs that may lead to QT prolongation, and cumulative high-dose anthracycline therapy. Caution is recommended in patients with hepatic impairment or history of pancreatitis. Not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or of glucose-galactose malabsorption.
Pregnancy and lactation: Should not be used during pregnancy unless necessary. If the drug is used during pregnancy, the patient must be informed of the potential risk to the fetus. Women should not breast-feed during treatment. Women of childbearing potential must be advised to use effective contraception during treatment, as should all sexually active male or female patients.
Side Effects:
Anorexia, headache, nausea, constipation, diarrhea, vomiting, abdominal pain. Rash, pruritus, alopecia. Myalgia, arthralgia, muscle spasms, bone pain. Fatigue, asthenia, peripheral edema.
Drug Interactions:
CYP3A4 inhibitors and inducers, antiarrhythmics or other drugs that may lead to QT prolongation.
