BNF for Children (BNFC) 2018-2019

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SIDE-EFFECTS, FURTHER INFORMATIONCardiotoxicity is
cumulative and may be irreversible, however responds to
treatment if detected early.

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


lPREGNANCYAvoid (teratogenic and carcinogenic in
animalstudies). See alsoPregnancy and reproductive
functionin Cytotoxic drugs p. 531.


lBREAST FEEDINGDiscontinue breast-feeding.


lHEPATIC IMPAIRMENTAvoid in severe impairment.
Dose adjustmentsReduce dose according to serum
bilirubin concentration—consult local protocol for details.


lRENAL IMPAIRMENTAvoid in severe impairment.
Dose adjustmentsReduce dose—consult local treatment
protocol for details.


lMONITORING REQUIREMENTS
▶Cardiac monitoring essential.
▶Cardiac 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
▶DaunoXome(Galen Ltd)
Daunorubicin (as Daunorubicin hydrochloride citrate) 2 mg per
1mlDaunoXome 50 mg/ 25 ml concentrate for solution for infusion
vials| 1 vialP£ 250. 00
Powder for solution for infusion
▶Daunorubicin (Non-proprietary)
Daunorubicin (as Daunorubicin hydrochloride)
20 mgDaunorubicin 20 mg powder for solution for infusion vials|
10 vialP£ 650. 00 (Hospital only)


Doxorubicin hydrochloride 04-Oct-2017


lINDICATIONS AND DOSE
Some paediatric malignancies|Ewing’s sarcoma|
Osteogenic sarcoma|Wilm’s tumour|Neuroblastoma|
Retinoblastoma|Some liver tumours|Acute
lymphoblastic leukaemia|Hodgkin’s lymphoma|Non-
Hodgkin’s lymphoma
▶BY INTRAVENOUS INFUSION
▶Child:(consult local protocol)

lCONTRA-INDICATIONSAcute inflammatory heart disease.
consult product literature.increased haemorrhagic
tendency.marked persisting myelosuppression induced by
previous treatment.marked persisting stomatitis induced
by previous treatment.previous myocardial infarction.
previous treatment with maximum cumulative doses of
doxorubicin.previous treatment with maximum
cumulative doses of other anthracycline.severe
arrhythmia.severe myocardial insufficiency
CONTRA-INDICATIONS, FURTHER INFORMATION
Anthracycline antibiotics should not normally be used in
children with left ventricular dysfunction.


lCAUTIONSCaution in handling—irritant to tissues.
consult product literature


lINTERACTIONS→Appendix 1 : anthracyclines


lSIDE-EFFECTS
▶Common or very commonAlopecia.anaemia.anxiety.
appetite decreased.arrhythmias.arthralgia.asthenia.
bone marrow depression.breast pain.cachexia.
cardiovascular disorder.chest discomfort.chills.
constipation.cough.decreased leucocytes.dehydration.
depression.diarrhoea.dizziness.drowsiness.dry mouth.
dysphagia.dyspnoea.dysuria.electrolyte imbalance.
epistaxis.eye inflammation.fever.gastrointestinal


discomfort.gastrointestinal disorders.headache.
hyperhidrosis.hypersensitivity.hypertension.
hyperthermia.hypotension.increased risk of infection.
influenza like illness.infusion related reaction.insomnia.
malaise.mucosal abnormalities.muscle complaints.
muscle tone increased.muscle weakness.nail disorder.
nausea.nerve disorders.neutropenia.oedema.oral
disorders.pain.scrotal erythema.sensation abnormal.
sepsis.skin reactions.skin ulcer.syncope.taste altered.
thrombocytopenia.vasodilation.vision blurred.vomiting
.weight decreased
▶UncommonConfusion.embolism and thrombosis
▶Rare or very rareSecondary oral neoplasms.severe
cutaneous adverse reactions (SCARs)
▶Frequency not knownAsthma.congestive heart failure.
secondary malignancy.throat tightness
SIDE-EFFECTS, FURTHER INFORMATIONExtravasation can
cause tissue necrosis.
CardiotoxicityAll anthracycline antibiotics have been
associated with varying degrees of cardiac toxicity—this
may be idiosyncratic and reversible, but is commonly
related to total cumulative dose and is irreversible.
lCONCEPTION AND CONTRACEPTIONManufacturer advises
effective contraception during and for at least 6 months
after treatment in men or women.
lPREGNANCYAvoid (teratogenic and toxic inanimal
studies). See alsoPregnancy and reproductive functionin
Cytotoxic drugs p. 531.
lBREAST FEEDINGDiscontinue breast-feeding.
lHEPATIC IMPAIRMENTAvoid in severe impairment.
Dose adjustmentsReduce dose according to bilirubin
concentration—consult product literature or local
treatment protocol for details.
lRENAL IMPAIRMENTConsult product literature in severe
impairment.
lMONITORING REQUIREMENTSCardiac 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. Forms available from special-order
manufacturers include: solution for infusion
Solution for injection
▶Doxorubicin hydrochloride (Non-proprietary)
Doxorubicin hydrochloride 2 mg per 1 mlDoxorubicin 10 mg/ 5 ml
solution for injection vials| 1 vialP£ 18. 54 (Hospital only)
Doxorubicin 50 mg/ 25 ml solution for injection Cytosafe vials|
1 vialP£ 103. 00 (Hospital only)
Doxorubicin 50 mg/ 25 ml solution for infusion vials| 1 vialP
£ 103. 00 (Hospital only)
Doxorubicin 10 mg/ 5 ml solution for injection Cytosafe vials|
1 vialP£ 20. 60 (Hospital only)
Doxorubicin 10 mg/ 5 ml concentrate for solution for infusion vials|
1 vialP£ 19. 57
Doxorubicin 10 mg/ 5 ml solution for infusion vials| 1 vialP£ 20. 60
(Hospital only)
Doxorubicin 50 mg/ 25 ml solution for injection vials| 1 vialP
£ 92. 70 (Hospital only)
Doxorubicin 50 mg/ 25 ml concentrate for solution for infusion vials|
1 vialP£ 97. 85
Solution for infusion
▶Doxorubicin hydrochloride (Non-proprietary)
Doxorubicin hydrochloride 2 mg per 1 mlDoxorubicin
200 mg/ 100 ml solution for injection Cytosafe vials| 1 vialP
£ 412. 00 (Hospital only)
Doxorubicin 200 mg/ 100 ml solution for infusion vials| 1 vialP
£ 412. 00 (Hospital only)
Doxorubicin 200 mg/ 100 ml concentrate for solution for infusion vials
| 1 vialP£ 391. 40
▶Caelyx(Janssen-Cilag Ltd)
Doxorubicin hydrochloride (as Doxorubicin hydrochloride
liposomal pegylated) 2 mg per 1 mlCaelyx 50 mg/ 25 ml concentrate
for solution for infusion vials| 1 vialP£ 712. 49

BNFC 2018 – 2019 Cytotoxic responsive malignancy 539


Immune system and malignant disease

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