Chronic phase Philadelphia chromosome-positive chronic
myeloid leukaemia resistant or intolerant to previous
therapy, including imatinib (initiated by a specialist)
▶BY MOUTH
▶Child 6–17 years:(consult product literature)IMPORTANT SAFETY INFORMATION
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES
See Cytotoxic drugs p. 531.
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.lCAUTIONSClinically 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 infectionThe 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.
lINTERACTIONS→Appendix 1 : nilotinib
lSIDE-EFFECTS
▶Common or very commonAlopecia.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
▶UncommonAtherosclerosis.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 knownBreast abnormalities.
chorioretinopathy.diastolic dysfunction.dry mouth.
facial swelling.gynaecomastia.hepatitis B reactivation.
hyperparathyroidism.hyperuricaemia.hypoglycaemia.
lethargy.memory loss.menorrhagia.oropharyngeal pain
.pericardial effusion.pericarditis.restless legs.sebaceous
hyperplasia.syncope.tremor.urinary disorders.urine
discolouration
lCONCEPTION AND CONTRACEPTIONManufacturer advises
highly effective contraception in women of childbearing
potential during treatment and for up to two weeks after
stopping treatment.
lPREGNANCYManufacturer advises avoid unless potential
benefit outweighs risk—toxicity inanimalstudies; see also
Pregnancy and reproductive functionin Cytotoxic drugs
p. 531.
lBREAST FEEDINGManufacturer advises avoid—present in
milk inanimalstudies.
lHEPATIC IMPAIRMENTManufacturer advises caution.
lMONITORING REQUIREMENTS
▶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 thefirst 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.
▶Manufacturer advises monitor liver function (including
bilirubin and hepatic transaminases) monthly or as
clinically indicated.
lDIRECTIONS FOR ADMINISTRATIONManufacturer 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.
lPRESCRIBING AND DISPENSING INFORMATIONAll
prescribers should be familiar with theSummary of Key
Safety Recommendations for Tasigna®(nilotinib)provided
by the manufacturer.
lPATIENT AND CARER ADVICEManufacturer advises
patients and carers should seek immediate medical
attention if signs or symptoms of cardiovascular events
occur.
All patients should be provided with theImportant
Information About How to Take Your Medicationleaflet
provided by the manufacturer.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Capsule
CAUTIONARY AND ADVISORY LABELS23, 25, 27
▶Tasigna(Novartis Pharmaceuticals UK Ltd)
Nilotinib (as Nilotinib hydrochloride monohydrate)
150 mgTasigna 150 mg capsules| 112 capsuleP£ 2 , 432. 85
Nilotinib (as Nilotinib hydrochloride monohydrate)
200 mgTasigna 200 mg capsules| 112 capsuleP£ 2 , 432. 85BNFC 2018 – 2019 Targeted therapy responsive malignancy 561
Immune system and malignant disease8