Pregnancy and reproductive functionin Cytotoxic drugs
p. 531.
lBREAST FEEDINGDiscontinue breast-feeding.
lHEPATIC IMPAIRMENT
Dose adjustmentsReduce dose.
lRENAL IMPAIRMENT
Dose adjustmentsReduce dose.
lPRE-TREATMENT SCREENINGConsider measuring
thiopurine methyltransferase (TPMT) activity before
starting tioguanine therapy.
lMONITORING REQUIREMENTSMonitor liver function
weekly—discontinue if liver toxicity develops.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: capsule
Tablet
▶Tioguanine (Non-proprietary)
Tioguanine 40 mgTioguanine 40 mg tablets| 25 tabletP
£ 109. 57
ANTINEOPLASTIC DRUGS›CYTOTOXIC
ANTIBIOTICS AND RELATED SUBSTANCES
Bleomycin
lINDICATIONS AND DOSE
Some germ cell tumours|Hodgkin’s lymphoma
▶BY INTRAVENOUS INFUSION
▶Child:(consult local protocol)lUNLICENSED USENot licensed for use in children.
lCONTRA-INDICATIONSAcute pulmonary infection.
significantly reduced lung function
lCAUTIONSCaution in handling—irritant to tissues
lINTERACTIONS→Appendix 1 : bleomycin
lSIDE-EFFECTS
▶Common or very commonAlopecia.angular stomatitis.
appetite decreased.chills.fever (after administration).
haemorrhage.headache.interstitial pneumonia.
leucopenia.malaise.nail discolouration.nail disorder.
nausea.pain.pulmonaryfibrosis (dose-related).
scleroderma.skin reactions.stomatitis.vomiting.weight
decreased
▶UncommonDiarrhoea.dizziness.hepatocellular injury.
oliguria.shock.urinary disorders.vein wall hypertrophy.
venous stenosis
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.
lRENAL IMPAIRMENT
Dose adjustmentsReduce dose—consult local treatment
protocol for details.
lMONITORING REQUIREMENTSEnsure monitoring of
pulmonary function—investigate any shortness of breath
before initiation.
lPRESCRIBING AND DISPENSING INFORMATIONTo conform
to the European Pharmacopoeia vials previously labelled
as containing‘ 15 units’of bleomycin are now labelled as
containing15 000units. The amount of bleomycin in the
vial has not changed.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder for solution for injection
▶Bleo-Kyowa(Kyowa Kirin Ltd)
Bleomycin (as Bleomycin sulfate) 15000 unitBleo-Kyowa
15 , 000 unit powder for solution for injection vials| 10 vialP
£ 190. 60Dactinomycin
(Actinomycin D)
lINDICATIONS AND DOSE
Wilms’tumour|Childhood rhabdomyosarcoma and other
soft-tissue sarcomas|Ewing’s sarcoma
▶BY INTRAVENOUS INJECTION
▶Child:(consult local protocol)lUNLICENSED USENot licensed for use in children under
12 years.
lCAUTIONSCaution in handling—irritant to tissues
lINTERACTIONS→Appendix 1 : dactinomycin
lSIDE-EFFECTSAgranulocytosis.alopecia.anaemia.
appetite decreased.ascites.bone marrow disorders.
diarrhoea.dysphagia.fatigue.fever.gastrointestinal
discomfort.gastrointestinal disorders.growth retardation
.healing impaired.hepatic disorders.hypocalcaemia.
increased risk of infection.lethargy.leucopenia.
leukaemia secondary.malaise.myalgia.nausea.
neutropenia.oedema.oral disorders.pneumonitis.renal
impairment.reticulocytopenia.secondary neoplasm.
sepsis.severe cutaneous adverse reactions (SCARs).
sinusoidal obstruction syndrome.skin reactions.soft
tissue damage.thrombocytopenia.tumour lysis syndrome
.venous thrombosis.vomiting
lCONCEPTION AND CONTRACEPTIONExclude pregnancy
before treatment with cytotoxic drugs. Contraceptive
advice should be given to men and women before cytotoxic
therapy begins (and should cover the duration of
contraception required after therapy has ended). Regimens
that do not contain an alkylating drug or procarbazine may
have less effect on fertility, but those with an alkylating
drug or procarbazine carry the risk of causing permanent
male sterility (there is no effect on potency). Pretreatment
counselling and consideration of sperm storage may be
appropriate. Women are less severely affected, though the
span of reproductive life may be shortened by the onset of
a premature menopause. No increase in fetal
abnormalities or abortion rate has been recorded in
patients who remain fertile after cytotoxic chemotherapy.
lPREGNANCYAvoid (teratogenic inanimalstudies). Most
cytotoxic drugs are teratogenic and should not be
administered during pregnancy, especially during thefirst
trimester. Considerable caution is necessary if a pregnant
woman presents with cancer requiring chemotherapy, and
specialist advice should always be sought.
lBREAST FEEDINGDiscontinue breast-feeding.
lHEPATIC IMPAIRMENT
Dose adjustmentsConsider dose reduction if raised serum
bilirubin or biliary obstruction; consult local treatment
protocols.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder for solution for injection
▶Cosmegen(Orphan Europe (UK) Ltd)
Dactinomycin 500 microgramCosmegen Lyovac 500 microgram
powder for solution for injection vials| 1 vialP£ 52. 58BNFC 2018 – 2019 Cytotoxic responsive malignancy 547
Immune system and malignant disease8