lMONITORING REQUIREMENTS
▶Haematological monitoringCytarabine is a potent
myelosuppressant and requires careful haematological
monitoring.
lPRESCRIBING AND DISPENSING INFORMATIONDose is
based on weight or body-surface area, children may
tolerate higher doses of cytarabine than adults.
lNATIONAL FUNDING/ACCESS DECISIONS
DEPOCYTE®
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (July 2007 )
that liposomal cytarabine suspension (DepoCyte®) is not
recommended for use within NHS Scotland for the
intrathecal treatment of lymphomatous meningitis.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 injection
Solution for injection
▶Cytarabine (Non-proprietary)
Cytarabine 20 mg per 1 mlCytarabine 500 mg/ 25 ml solution for
injection vials| 1 vialP£ 19. 50 (Hospital only)| 1 vialP
£ 19. 50
Cytarabine 100 mg/ 5 ml solution for injection vials| 5 vialP
£ 20. 48 – £ 30. 00 (Hospital only)| 5 vialP£ 20. 98
Cytarabine 100 mg per 1 mlCytarabine 500 mg/ 5 ml solution for
injection vials| 5 vialP£ 100. 00 (Hospital only)| 5 vialP
£ 89. 78
Cytarabine 100 mg/ 1 ml solution for injection vials| 5 vialP
£ 26. 93
Cytarabine 2 g/ 20 ml solution for injection vials| 1 vialP£ 77. 50 –
£ 79. 00 (Hospital only)| 1 vialP£ 73. 63 – £ 77. 50
Cytarabine 1 g/ 10 ml solution for injection vials| 1 vialP£ 39. 00 –
£ 40. 00 (Hospital only)| 1 vialP£ 37. 05 – £ 39. 00
Suspension for injection
▶DepoCyte(Napp Pharmaceuticals Ltd)
Cytarabine 10 mg per 1 mlDepoCyte 50 mg/ 5 ml suspension for
injection vials| 1 vialP£ 1 , 223. 75 (Hospital only)Fludarabine phosphate
lINDICATIONS AND DOSE
Poor prognosis or relapsed acute myeloid leukaemia|
Relapsed acute lymphoblastic leukaemia|Conditioning
before bone marrow transplantation
▶BY MOUTH, OR BY INTRAVENOUS INJECTION, OR BY
INTRAVENOUS INFUSION
▶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.lCONTRA-INDICATIONSHaemolytic anaemia
lCAUTIONSIncreased susceptibility to skin cancer.
worsening of existing skin cancer
CAUTIONS, FURTHER INFORMATION
▶ImmunosuppressionFludarabine has a potent and prolonged
immunosuppresive effect. Patients treated with
fludarabine are more prone to serious bacterial,
opportunistic fungal, and viral infections, and prophylactic
therapy is recommended in those at risk. To prevent
potentially fatal transfusion-related graft-versus-host
reaction, only irradiated blood products should be
administered. Prescribers should consult specialist
literature when using highly immunosuppressive drugs.
lINTERACTIONS→Appendix 1 :fludarabinelSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonAnaemia.appetite decreased.
asthenia.bone marrow depression (may be cumulative).
chills.cough.diarrhoea.fever.increased risk of infection
.malaise.mucositis.nausea.neoplasms.nerve disorders.
neutropenia.oedema.stomatitis.thrombocytopenia.
vision disorders.vomiting
▶UncommonAutoimmune disorder.confusion.
haemorrhage.respiratory disorders.tumour lysis
syndrome
▶Rare or very rareAgitation.arrhythmia.coma.heart
failure.seizure.severe cutaneous adverse reactions
(SCARs)
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With oral useProgressive multifocal leukoencephalopathy.
skin reactions.viral infection reactivation
▶With parenteral useRash
▶Uncommon
▶With oral useAcquired haemophilia.crystalluria.dyspnoea
.electrolyte imbalance.haemolytic anaemia.
hyperuricaemia.metabolic acidosis.renal failure
▶Frequency not known
▶With parenteral useEncephalopathy.intracranial
haemorrhage
lCONCEPTION AND CONTRACEPTIONManufacturer advises
effective contraception during and for at least 6 months
after treatment in men or women.
lPREGNANCYAvoid (embryotoxic and teratogenic inanimal
studies). See alsoPregnancy and reproductive functionin
Cytotoxic drugs p. 531.
lBREAST FEEDINGDiscontinue breast-feeding.
lRENAL IMPAIRMENTAvoid if creatinine clearance less than
30 mL/minute/ 1. 73 m^2.
Dose adjustmentsReduce dose by up to 50 % if creatinine
clearance 30 – 70 mL/minute/ 1. 73 m^2.
lMONITORING REQUIREMENTS
▶Monitor for signs of haemolysis.
▶Monitor for neurological toxicity.
lDIRECTIONS FOR ADMINISTRATIONConcentrate for
intravenous injection or infusion must be diluted before
administration (consult product literature).lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
▶Fludarabine phosphate (Non-proprietary)
Fludarabine phosphate 25 mg per 1 mlFludarabine phosphate
50 mg/ 2 ml concentrate for solution for injection vials| 1 vialP
£ 156. 00 (Hospital only)| 1 vialP£ 155. 00
Tablet
▶Fludara(Sanofi)
Fludarabine phosphate 10 mgFludara 10 mg tablets|
15 tabletP£ 302. 48 (Hospital only)| 20 tabletP£ 403. 31
(Hospital only)
Powder for solution for injection
▶Fludarabine phosphate (Non-proprietary)
Fludarabine phosphate 50 mgFludarabine phosphate 50 mg
powder for solution for injection vials| 1 vialP£ 155. 00 (Hospital
only)
▶Fludara(Sanofi)
Fludarabine phosphate 50 mgFludara 50 mg powder for solution
for injection vials| 5 vialP£ 735. 34 (Hospital only)542 Cytotoxic responsive malignancy BNFC 2018 – 2019
Immune system and malignant disease8