Tablet
CAUTIONARY AND ADVISORY LABELS 25
▶Votubia(Novartis Pharmaceuticals UK Ltd)
Everolimus 2.5 mgVotubia 2. 5 mg tablets| 30 tabletP
£ 1 , 200. 00
Everolimus 5 mgVotubia 5 mg tablets| 30 tabletP£ 2 , 250. 00
Everolimus 10 mgVotubia 10 mg tablets| 30 tabletP£ 2 , 970. 00Imatinib 21-Jul-2016
lDRUG ACTIONImatinib is a tyrosine kinase inhibitor.lINDICATIONS AND DOSE
Treatment of newly diagnosed Philadelphia-chromosome-
positive chronic myeloid leukaemia when bone marrow
transplantation is not considered first line treatment|
Treatment of Philadelphia-chromosome-positive chronic
myeloid leukaemia in chronic phase after failure of
interferon alfa, or in accelerated phase, or in blast crisis
|Treatment of newly diagnosed Philadelphia-
chromosome-positive acute lymphoblastic leukaemia in
combination with chemotherapy
▶BY MOUTH
▶Child:(consult local protocol)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 BCR-ABL TYROSINE KINASE INHIBITORS
An EU wide review has concluded that imatinib can
cause hepatitis B reactivation; the MHRA recommends
establishing hepatitis B virus status in all patients before
initiation of treatment.lCAUTIONSCardiac disease.hepatitis B infection.history
of renal failure.risk factors for heart failure
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 : imatinib
lSIDE-EFFECTS
▶Common or very commonAlopecia.anaemia.appetite
abnormal.asthenia.bone marrow disorders.chills.
constipation.cough.diarrhoea.dizziness.dry eye.dry
mouth.dyspnoea.excessive tearing.eye inflammation.
fever.fluid imbalance.flushing.gastrointestinal
discomfort.gastrointestinal disorders.haemorrhage.
headaches.insomnia.joint disorders.muscle complaints.
nausea.neutropenia.oedema.pain.photosensitivity
reaction.sensation abnormal.skin reactions.sweat
changes.taste altered.thrombocytopenia.vision blurred.
vomiting.weight changes
▶UncommonAnxiety.arrhythmias.ascites.breast
abnormalities.broken nails.burping.chest pain.CNS
haemorrhage.congestive heart failure.depression.
drowsiness.dysphagia.electrolyte imbalance.
eosinophilia.eye discomfort.gout.gynaecomastia.
hearing impairment.hepatic disorders.
hyperbilirubinaemia.hyperglycaemia.hypertension.
hyperuricaemia.hypotension.increased risk of infection.
laryngeal pain.lymphadenopathy.lymphopenia.malaise
.memory loss.menstrual cycle irregularities.nerve
disorders.oral disorders.palpitations.pancreatitis.
peripheral coldness.pulmonary oedema.Raynaud’s
phenomenon.renal impairment.renal pain.respiratorydisorders.restless legs.scrotal oedema.sepsis.sexual
dysfunction.syncope.thrombocytosis.tremor.urinary
frequency increased.vertigo
▶Rare or very rareAngina pectoris.angioedema.arthritis.
cardiac arrest.cataract.confusion.glaucoma.haemolytic
anaemia.haemorrhagic ovarian cyst.hepatic failure
(including fatal cases).hypersensitivity vasculitis.
inflammatory bowel disease.intracranial pressure
increased.muscle weakness.myocardial infarction.
myopathy.nail discolouration.pericardial disorders.
pulmonary hypertension.seizure.severe cutaneous
adverse reactions (SCARs).tumour lysis syndrome
▶Frequency not knownEmbolism and thrombosis.growth
retardation.hepatitis B reactivation.neoplasm
complications.osteonecrosis.pericarditis
lCONCEPTION AND CONTRACEPTIONEffective
contraception required during treatment.
lPREGNANCYManufacturer advises avoid unless potential
benefit outweighs risk. See alsoPregnancy and reproductive
functionin Cytotoxic drugs p. 531.
lBREAST FEEDINGDiscontinue breast-feeding.
lHEPATIC IMPAIRMENT
Dose adjustmentsStart with minimum recommended dose;
reduce dose further if not tolerated; consult local
treatment protocol.
lRENAL IMPAIRMENT
Dose adjustmentsStart with minimum recommended dose;
reduce dose further if not tolerated; consult local
treatment protocol.
lMONITORING REQUIREMENTS
▶Monitor for gastrointestinal haemorrhage.
▶Monitor complete blood counts regularly.
▶Monitor forfluid retention.
▶Monitor liver function.
▶Monitor growth in children (may cause growth
retardation).
lDIRECTIONS FOR ADMINISTRATIONTablets may be
dispersed in water or apple juice.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer imatinib tablets.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
CAUTIONARY AND ADVISORY LABELS21, 27
▶Imatinib (Non-proprietary)
Imatinib (as Imatinib mesilate) 100 mgImatinib 100 mg tablets|
30 tabletP£ 486. 66 | 60 tabletP£ 973. 32 DT = £ 405. 85
Imatinib (as Imatinib mesilate) 400 mgImatinib 400 mg tablets|
30 tabletP£ 1 , 946. 67 DT = £ 811. 72 | 60 tabletP£ 3 , 893. 34
▶Glivec(Novartis Pharmaceuticals UK Ltd)A
Imatinib (as Imatinib mesilate) 100 mgGlivec 100 mg tablets|
60 tabletP£ 973. 32 DT = £ 405. 85
Imatinib (as Imatinib mesilate) 400 mgGlivec 400 mg tablets|
30 tabletP£ 1 , 946. 67 DT = £ 811. 72Nilotinib 10-Apr-2018
lDRUG ACTIONNilotinib is a tyrosine kinase inhibitor.lINDICATIONS AND DOSE
Newly diagnosed chronic phase Philadelphia
chromosome-positive chronic myeloid leukaemia
(initiated by a specialist)
▶BY MOUTH
▶Child 10–17 years:(consult product literature)560 Targeted therapy responsive malignancy BNFC 2018 – 2019
Immune system and malignant disease8