Nilotinib - Tasigna ®
Important Safety Information
Contraindications
Hypersensitivity to the active substance or any of the excipients.
Warnings/Precautions
Myelosuppression
Treatment with TASIGNA is associated with (National Cancer Institute Common Toxicity Criteria Grades 3/4) thrombocytopenia, neutropenia, and anemia. Occurrence is more frequent in patients with Ph+ CML in the
accelerated phase. Complete blood counts should be performed every 2 weeks for the first 2 months of treatment and then monthly thereafter, or as clinically indicated. Myelosuppression was generally reversible
and usually managed by withholding TASIGNA temporarily or dose reduction.
QT prolongation
TASIGNA should be used with caution in patients who have or who are at significant risk of developing prolongation of QTc. Close monitoring for an effect on the QTc interval is advisable and a baseline electrocardiogram is recommended prior to initiating therapy with TASIGNA and as clinically indicated.
Hypokalemia or hypomagnesemia should be corrected prior to TASIGNA administration and should be monitored periodically during therapy.
Interactions With Other Medicinal Products
Concurrent administration of TASIGNA with strong CYP3A4 inhibitors (eg, ketoconzaole, itraconazole, voriconazole, moxifloxacin, clarithromycin, telithromycin, ritonavir) should be avoided. Concomitant use of TASIGNA with potent CYP3A4 inducers (eg, phenytoin, rifampicin, carbamazepine, phenobarbital, St. John’s Wort) is likely to reduce exposure to nilotinib to a clinically relevant extent. Concomitant use of antacids, H2 blockers, or proton pump inhibitors with TASIGNA is not recommended.
Hepatic Impairment
Metabolism of nilotinib is mainly hepatic. Patients with hepatic impairment should be treated with caution.
Serum Lipase
Elevation in serum lipase has been observed. Caution is recommended in patients with previous history of pancreatitis.
Lactose
TASIGNA capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Pregnancy and Lactation
Pregnancy: TASIGNA should not be used during pregnancy unless clearly necessary. If it used during pregnancy, the patient must be informed of the potential risk to the fetus. Women of childbearing potential must be advised to use effective contraception during treatment with TASIGNA.
Lactation: Women should not breast-feed during treatment with TASIGNA, as a risk to the infant cannot be excluded. Adverse Reactions (³5% of all patients, n=438)
Very common: rash, pruritis, nausea, fatigue, headache, constipation, diarrhea, elevated lipase, neutropenia, thrombocytopenia, anemia, hypophosphatemia.
Common: vomiting, myalgia, alopecia, arthralgia, muscle spasms, bone pain, asthenia, abdominal pain, anorexia, peripheral edema, blood amylase increased, alanine aminotransferase increase, aspartate aminotransferase increase, blood bilirubin increase, blood alkaline phosphatase increase, gamma-glutamyltransferase increase, blood creatinine phosphokinase increase, blood glucose increase, weight decrease, weight increase, palpitations, electrocardiogram QT prolongation, febril febrile neutropenia, pancytopenia, dizziness, paresthesia, vertigo, dyspnea, exertional dyspnea, cough, dysphonia, abdominal
discomfort, dyspepsia, flatulence, night sweats, eczema, urticaria, erythema, hyperhidrosis, dry skin, musculoskeletal chest pain, musculoskeletal pain, hypomagnesemia, hyperkalemia, hyperglycemia, hypertension, flushing, pyrexia, insomnia.
Potentially serious: pleural and pericardial effusions, fluid retention and edema, cardiac failure, angina pectoris, myocardial infarction, atrial fibrillation, cardiomegaly, electrocardiogram QT prolongation, pericarditis, ventricular dysfunction, coronary artery disease, cardiac flutter, bradycardia, hypertensive crisis,
pneumonia, candidiasis, herpes simplex, sepsis, pancytopenia, thrombocythemia, febrile neutropenia, intracranial hemorrhage, brain edema, peripheral neuropathy, optic neuritis, eye hemorrhage, hypotension,
thrombosis, pleurisy, pulmonary edema, pulmonary hypertension, pancreatitis, melena, gastrointestinal ulcer perforation, hematemesis, hepatitis, hepatomegaly, renal failure, bronchitis, hypokalemia, hypomagnesemia, hypocalcemia, diabetes mellitus, shock hemorrhagic, gastrointestinal haemorrhage, retroperitoneal haemorrhage, dehydration.