Composition
Cap 150 mg/200 mg: Nilotinib 150 mg/200 mg.
Indications & Dosage
Treatment of newly diagnosed chronic myeloid leukaemiain the chronic phase: Adult: 300 mg twice daily. Treatment of chronic and accelerated phase chronic myeloid leukaemia in patients who have resistance to or intolerance of previous therapy, including imatinib: Adult: 400 mg twice daily.
Contraindications
Do not use in patients with hypokalaemia, hypomagnaesemia or long QT syndrome.
Precautions
Myelosuppression, hepatic impairment, uncontrolled or significant cardiac disease, history of pancreatitis, patients with total gastrectomy, tumourlysis syndrome, galactose intolerance, severe lactase deficiency, glucose-galactose malabsorption,hepatitis B infection, history of pancreatitis, susceptibility to QT-interval prolongation (including electrolyte disturbances). Monitor QTc, CBC.
Interactions
Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, telithromycin), CYP3A4 inducers (e.g. phenytoin, rifampicin, carbamazepine, phenobarb, ST Johns wort), CYP2C8, CYP2C9 and CYP2D6 substrates, antiarrhythmics (e.g. amiodarone, disopyramide, procainamide, quinidine, sotalol), drugs that prolong QT interval (e.g. chloroquinine, halofantrine, clarithromycin, haloperidol, methadone, moxi-floxacin, bepridil, pimozide), grapefruit juice and foods.
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Abdominal pain, anorexia, arthralgia, asthenia, bone pain, GI upset, cough, dizziness, dyspepsia, dysphonia, dyspnea, erythema, fatigue, flushing, headache, hyperhidrosis, hyperkalaemia, hypertension, hypomagnesaemia, insomnia, muscle spasm, oedema, palpitation, paraesthesia, pruritus, QT-interval prolongation, rash, urticaria, vertigo, weight changes, alopecia, bone-marrow suppression, hepatic failure (fatal cases reported), hepatitis B reactivation, hyperuricaemia, nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting