lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder for solution for injection
▶Erwinase(Jazz Pharmaceuticals UK)
Crisantaspase 10000 unitErwinase 10 , 000 unit powder for solution
for injection vials| 5 vialP£ 3 , 065. 00Hydroxycarbamide 22-Mar-2018
(Hydroxyurea)
lINDICATIONS AND DOSE
SIKLOS®
Sickle-cell disease [prevention of recurrent vaso-occlusive
crises] (initiated by a specialist)
▶BY MOUTH
▶Child 2–17 years:Initially 10 – 15 mg/kg once daily,
increased in steps of 2. 5 – 5 mg/kg daily, dose to be
increased every 12 weeks according to response; usual
dose 15 – 30 mg/kg daily; maximum 35 mg/kg per dayIMPORTANT SAFETY INFORMATION
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES
See Cytotoxic drugs p. 531.lCAUTIONSLeg ulcers (review treatment if cutaneous
vasculitic ulcerations develop)
lINTERACTIONS→Appendix 1 : hydroxycarbamide
lSIDE-EFFECTS
▶Common or very commonAlopecia.anaemia.appetite
decreased.asthenia.bone marrow failure.chills.
constipation.cutaneous vasculitis.dermatomyositis.
diarrhoea.disorientation.dizziness.drowsiness.
dyspnoea.dysuria.fever.gastrointestinal discomfort.
hallucination.headache.hepatic disorders.leucopenia.
malaise.melaena.mucositis.nail disorder.nausea.
pancreatitis.peripheral neuropathy.pulmonary oedema.
respiratory disorders.seizure.skin cancer.skin reactions.
skin ulcer.sperm abnormalities.stomatitis.
thrombocytopenia.vomiting
▶Rare or very rareGangrene
lCONCEPTION AND CONTRACEPTIONManufacturer advises
effective contraception before and during treatment.
lPREGNANCYAvoid (teratogenic inanimalstudies). 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, unless used for malignant conditions.
lRENAL IMPAIRMENTIn sickle-cell disease, avoid if
estimated glomerularfiltration rate less than
30 mL/minute/ 1. 73 m^2.
Dose adjustmentsIn sickle-cell disease, reduce initial dose
by 50 % if estimated glomerularfiltration rate less than
60 mL/minute/ 1. 73 m^2.
lMONITORING REQUIREMENTS
▶Monitor renal and hepatic function before and during
treatment.
▶Monitor full blood count before treatment, and repeatedly
throughout use; in sickle-cell disease monitor every
2 weeks for thefirst 2 months and then every 2 months
thereafter (or every 2 weeks if on maximum dose).
▶Patients receiving long-term therapy for malignant disease
should be monitored for secondary malignancies.
lPATIENT AND CARER ADVICEPatients receiving long-term
therapy with hydroxycarbamide should be advised to
protect skin from sun exposure.Medicines for Children leaflet: Hydroxycarbamide for sickle cell
diseasewww.medicinesforchildren.org.uk/hydroxycarbamide-
for-sickle-cell-diseaselMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
▶Siklos(Nordic Pharma Ltd)
Hydroxycarbamide 100 mgSiklos 100 mg tablets| 60 tabletP
£ 100. 00 DT = £ 100. 00
Hydroxycarbamide 1 gramSiklos 1000 mg tablets| 30 tabletP
£ 500. 00 DT = £ 500. 00Mitotane
lDRUG ACTIONMitotane selectively inhibits the activity of
the adrenal cortex, necessitating corticosteroid
replacement therapy.lINDICATIONS AND DOSE
Symptomatic treatment of advanced or inoperable
adrenocortical carcinoma
▶BY MOUTH
▶Child:(consult local protocol)lUNLICENSED USENot licensed for use in children.IMPORTANT SAFETY INFORMATION
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES
See Cytotoxic drugs p. 531.lCAUTIONSAvoid in Acute porphyrias p. 603 .risk of
accumulation in overweight patients
lINTERACTIONS→Appendix 1 : mitotane
lSIDE-EFFECTS
▶Common or very commonAdrenal insufficiency.anaemia.
appetite decreased.asthenia.cognitive impairment.
confusion.diarrhoea.dizziness.drowsiness.
dyslipidaemia.gastrointestinal discomfort.
gynaecomastia.headache.hepatic disorders.leucopenia.
movement disorders.mucositis.muscle weakness.nausea
.paraesthesia.polyneuropathy.rash.thrombocytopenia.
vertigo.vomiting
▶Frequency not knownEncephalopathy.eye disorders.
flushing.fungal infection.generalised pain.growth
retardation.haemorrhage.hyperpyrexia.hypersalivation
.hypertension.hypothyroidism.hypouricaemia.lens
opacity.neuro-psychological retardation.ovarian cyst.
postural hypotension.proteinuria.taste altered.thyroid
disorder.vision disorders
lCONCEPTION AND CONTRACEPTIONContraceptive advice
required, seePregnancy and reproductivefunction in
Cytotoxic drugs p. 531.
lPREGNANCYManufacturer advises avoid. See also
Pregnancy and reproductive functionin Cytotoxic drugs
p. 531.
lBREAST FEEDINGDiscontinue breast-feeding.
lHEPATIC IMPAIRMENTManufacturer advises caution in
mild to moderate impairment. Avoid in severe
impairment.
MonitoringIn mild to moderate hepatic impairment,
monitoring of plasma-mitotane concentration is
recommended.
lRENAL IMPAIRMENTManufacturer advises caution in mild
to moderate impairment. Avoid in severe impairment.
MonitoringIn mild to moderate renal impairment,
monitoring of plasma-mitotane concentration is
recommended.552 Cytotoxic responsive malignancy BNFC 2018 – 2019
Immune system and malignant disease8