Drug Action
Nilotinib is a tyrosine kinase inhibitor.
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Drug reference
Nilotinib is a tyrosine kinase inhibitor.
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Newly diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukaemia (initiated by a specialist) ▶BY MOUTH ▶Adult: 300 mg twice daily, for dose adjustments due to side-effects—consult product literature Chronic and accelerated phase Philadelphia chromosome- positive chronic myeloid leukaemia resistant or intolerant to previous therapy, including imatinib (initiated by a specialist) ▶BY MOUTH ▶Adult: 400 mg twice daily, for dose adjustments due to side-effects—consult product literature
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Clinically significant bradycardia. congestive heart failure. hepatitis B infection. history of pancreatitis. recent myocardial infarction. susceptibility to QT-interval prolongation (including electrolyte disturbances). unstable angina CAUTIONS, FURTHER INFORMATION ▶Hepatitis B infection The MHRA advises that patients who are carriers of hepatitis B virus should be closely monitored for signs and symptoms of active infection throughout treatment and for several months after stopping treatment; expert advice should be sought for patients who test positive for hepatitis B virus and in those with active infection.
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All prescribers should be familiar with the Summary of Key Safety Recommendations for Tasigna ® (nilotinib) provided by the manufacturer.
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NICE decisions ▶Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia (CML) (December 2016) NICE TA426 Nilotinib (Tasigna ®) is recommended, within its marketing authorisation, as an option for untreated chronic phase Philadelphia-chromosome-positive CML in adults, only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta426 ▶Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia (CML) (December 2016) NICE TA425 Nilotinib (Tasigna ®) is recommended as an option for treating chronic or accelerated phase Philadelphia- chromosome-positive CML in adults, if they cannot have imatinib, or their disease is imatinib-resistant, and the manufacturer provides nilotinib with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta425
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938. MHRA/CHM ADVICE (MAY 2016): RISK OF HEPATITIS B VIRUS REACTIVATION WITH TYROSINE KINASE INHIBITORS An EU wide review has concluded that nilotinib can cause hepatitis B virus reactivation; the MHRA recommends establishing hepatitis B virus status in all patients before initiation of treatment.
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→Appendix 1: nilotinib
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▶Common or very common Alopecia. anaemia. angina pectoris. anxiety. appetite abnormal. arrhythmias. arthralgia. asthenia. bone marrow disorders. cardiac conduction disorders. chest discomfort. constipation. cough. decreased leucocytes. depression. diabetes mellitus. diarrhoea. dizziness. dry eye. dyslipidaemia. dyspnoea. electrolyte imbalance. eosinophilia. eye discomfort. eye disorders. eye inflammation. fever. flushing. gastrointestinal discomfort. gastrointestinal disorders. headaches. hepatic disorders. hyperbilirubinaemia. hyperglycaemia. hypertension. increased risk of infection. insomnia. muscle complaints. muscle weakness. myocardial infarction. nausea. neoplasms. neutropenia. oedema. pain. palpitations. peripheral neuropathy. QT interval prolongation. respiratory disorders. sensation abnormal. skin reactions. sweat changes. taste altered. thrombocytopenia. vertigo. vomiting. weight changes ▶Uncommon Atherosclerosis. cerebrovascular insufficiency . chills. cyanosis. erectile dysfunction. gout. haemorrhage. heart failure. hyperaemia. malaise. oral disorders. pancreatitis. peripheral vascular disease. temperature sensation altered. vision disorders ▶Frequency not known Breast abnormalities. chorioretinopathy. diastolic dysfunction. dry mouth. facial swelling. gynaecomastia. hepatitis B reactivation. hyperparathyroidism. hyperuricaemia. hypoglycaemia. lethargy. memory loss. menorrhagia. oesophageal pain. oropharyngeal pain. pericardial effusion. pericarditis. restless legs. sebaceous hyperplasia. syncope. tremor. urinary disorders. urine discolouration Immune system and malignant disease
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Manufacturer advises highly effective contraception in women of childbearing potential during treatment and for up to two weeks after stopping treatment.
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Manufacturer advises avoid unless potential benefit outweighs risk—toxicity in animal studies; see also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises caution (risk of increased exposure).
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▶Manufacturer advises monitor lipid profiles before initiating treatment, at 3 and 6 months, and then yearly thereafter; monitor blood glucose before initiating treatment and then periodically during treatment, as clinically indicated. ▶Manufacturer advises monitor full blood count every 2 weeks for the first 2 months of treatment, then monthly thereafter, or as clinically indicated. ▶Manufacturer advises perform baseline ECG before treatment and as clinically indicated thereafter; correct any electrolyte disturbances before treatment and monitor periodically during treatment. ▶Manufacturer advises monitor and actively manage cardiovascular risk factors during treatment.
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Manufacturer advises capsules should either be swallowed whole or the contents of each capsule may be dispersed in one teaspoon of apple sauce and taken immediately.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 23, 25, 27 ▶Tasigna (Novartis Pharmaceuticals UK Ltd) Nilotinib (as Nilotinib hydrochloride monohydrate) 50 mg Tasigna 50mg capsules | 120 capsule P £2,432.85 DT = Immune system and malignant disease £2,432.85 Nilotinib (as Nilotinib hydrochloride monohydrate) 150 mg Tasigna 150mg capsules | 112 capsule P £2,432.85 DT = £2,432.85 Nilotinib (as Nilotinib hydrochloride monohydrate) 200 mg Tasigna 200mg capsules | 112 capsule P £2,432.85 DT = £2,432.85
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Manufacturer advises patients and carers should seek immediate medical attention if signs or symptoms of cardiovascular events occur. All patients should be provided with the Important Information About How to Take Your Medication leaflet provided by the manufacturer.
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300 mg twice daily, for dose adjustments due to
First-line fragment. Read the complete Indications and Dose section above.
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400 mg twice daily, for dose adjustments due to
First-line fragment. Read the complete Indications and Dose section above.
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