TASIGNA

*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.

Do not use in patients with hypokalaemia, hypomagnaesemia or long QT syndrome.

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.

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.

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