BNF for Children (BNFC) 2018-2019

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lHEPATIC IMPAIRMENTUse with caution—consult local
treatment protocol.
lMONITORING REQUIREMENTS
▶Cardiac toxicityCardiac function should be monitored
before and at regular intervals throughout treatment and
afterwards.


lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for infusion
▶Mitoxantrone (Non-proprietary)
Mitoxantrone (as Mitoxantrone hydrochloride) 2 mg per
1mlMitoxantrone 20 mg/ 10 ml concentrate for solution for infusion
vials| 1 vialP£ 121. 85 (Hospital only)| 1 vialP£ 51. 43
▶Onkotrone(Baxter Healthcare Ltd)
Mitoxantrone (as Mitoxantrone hydrochloride) 2 mg per
1mlOnkotrone 20 mg/ 10 ml solution for infusion vials| 1 vialP
£ 103. 57
Onkotrone 25 mg/ 12. 5 ml solution for infusion vials| 1 vialP
£ 129. 48


ANTINEOPLASTIC DRUGS›ANTIMETABOLITES


Clofarabine


lINDICATIONS AND DOSE
Relapsed or refractory acute lymphoblastic leukaemia in
patients who have received at least two previous
regimens
▶BY INTRAVENOUS INFUSION
▶Child 1–17 years:(consult local protocol)

lUNLICENSED USENot licensed for use in children under
1 year.


lCAUTIONSCardiac disease
lINTERACTIONS→Appendix 1 : clofarabine


lSIDE-EFFECTS
▶Common or very commonAlopecia.anxiety.appetite
decreased.arthralgia.capillary leak syndrome.chills.
cough.dehydration.diarrhoea.dizziness.drowsiness.
dyspnoea.fatigue.feeling abnormal.feeling hot.fever.
flushing.gastrointestinal discomfort.haemorrhage.
headache.hearing impairment.hepatic disorders.
hyperbilirubinaemia.hyperhidrosis.hypersensitivity.
hypotension.increased risk of infection.irritability.
mucositis.multi organ failure.myalgia.nausea.
neutropenia.oedema.oral disorders.pain.paraesthesia.
pericardial effusion.peripheral neuropathy.psychiatric
disorder.renal impairment.respiratory disorders.sepsis.
sinusoidal obstruction syndrome.skin reactions.systemic
inflammatory response syndrome.tachycardia.tremor.
tumour lysis syndrome.vomiting.weight decreased
▶Frequency not knownAntibiotic associated colitis.
gastrointestinal disorders.hyponatraemia.pancreatitis.
severe cutaneous adverse reactions (SCARs)


lCONCEPTION AND CONTRACEPTIONContraceptive advice
required, seePregnancy and reproductive functionin
Cytotoxic drugs p. 531.


lPREGNANCYManufacturer advises avoid (teratogenic in
animalstudies). See alsoPregnancy and reproductive
functionin Cytotoxic drugs p. 531.


lBREAST FEEDINGDiscontinue breast-feeding.


lHEPATIC IMPAIRMENTManufacturer advises caution in
mild to moderate impairment. Avoid in severe
impairment.


lRENAL IMPAIRMENTManufacturer advises caution in mild
to moderate impairment. Avoid in severe impairment.


lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for infusion
ELECTROLYTES:May contain Sodium
▶Clofarabine (Non-proprietary)
Clofarabine 1 mg per 1 mlClofarabine 20 mg/ 20 ml concentrate for
solution for infusion vials| 1 vialP£ 1 , 259. 87 (Hospital only)
▶Evoltra(Sanofi)A
Clofarabine 1 mg per 1 mlEvoltra 20 mg/ 20 ml concentrate for
solution for infusion vials| 1 vialP£ 1 , 326. 18 (Hospital only)

Cytarabine


lDRUG ACTIONCytarabine acts by interfering with
pyrimidine synthesis.

lINDICATIONS AND DOSE
Acute lymphoblastic leukaemia|Acute myeloid leukaemia
|Non-Hodgkin’s lymphoma
▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION,
OR BY SUBCUTANEOUS INJECTION
▶Child:(consult local protocol)
Meningeal leukaemia|Meningeal neoplasms
▶BY INTRATHECAL INJECTION
▶Child:(consult local protocol)

lUNLICENSED USEDepocyte®intrathecal injection not
licensed for use in children.

IMPORTANT SAFETY INFORMATION
Not all cytarabine preparations can be given by
intrathecal injection—consult product literature.

lINTERACTIONS→Appendix 1 : cytarabine
lSIDE-EFFECTS
▶Common or very commonAlopecia.anaemia.appetite
decreased.consciousness impaired.diarrhoea.dysarthria
.dysphagia.eye disorders.eye inflammation.eye stinging
.fever.gastrointestinal discomfort.gastrointestinal
disorders.haemorrhagic conjunctivitis (consider
prophylactic corticosteroid eye drops).hyperuricaemia.
leucopenia.nausea.oral disorders.renal impairment.
skin reactions.thrombocytopenia.urinary retention.
vasculitis.vision disorders.vomiting
▶UncommonArthralgia.dyspnoea.headache.increased
risk of infection.myalgia.nerve disorders.pain.paralysis
.pericarditis.sepsis.skin ulcer.throat pain
▶Rare or very rareArrhythmias
▶Frequency not knownAcute respiratory distress syndrome
(ARDS).amenorrhoea.ataxia.azoospermia.bone marrow
disorders.cardiomyopathy.cerebellar dysfunction.chest
pain.coma.confusion.cytarabine syndrome.dizziness.
drowsiness.haemorrhage.hepatic disorders.
hyperbilirubinaemia.neurotoxicity.neurotoxicity rash.
neutropenia.pancreatitis.personality change.pulmonary
oedema.reticulocytopenia.rhabdomyolysis.seizure.
tremor
lCONCEPTION AND CONTRACEPTIONContraceptive advice
required, seePregnancy and reproductive functionin
Cytotoxic drugs p. 531.
lPREGNANCYAvoid (teratogenic inanimalstudies). See
alsoPregnancy and reproductive functionin Cytotoxic drugs
p. 531.
lBREAST FEEDINGDiscontinue breast-feeding.
lHEPATIC IMPAIRMENT
Dose adjustmentsReduce dose—consult product literature.
lRENAL IMPAIRMENTConsult local treatment protocols.

BNFC 2018 – 2019 Cytotoxic responsive malignancy 541


Immune system and malignant disease

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