Variety of cancers including leukaemias, lymphomas, and
some solid tumours (e.g. breast and lung cancer)
▶ Adult: (consult product literature)
Vindesine injections are for intravenous
administration only. Inadvertent intrathecal
administration can cause severe neurotoxicity, which is
The National Patient Safety Agency has advised
(August 2008) that adult and teenage patients treated in
an adult or adolescent unit should receive their vinca
alkaloid dose in a 50 mL minibag. Teenagers and children
treated in a child unit may receive their vinca alkaloid
CONTRA-INDICATIONS, FURTHER INFORMATION
Intrathecal injection contra-indicated.
l CAUTIONS Caution in handling—irritant to tissues . neuromuscular disease
l INTERACTIONS → Appendix 1: vinca alkaloids
▶ Common or very common Alopecia
maculopapular.reflexes absent. seizure . sensation
abnormal .thrombocytopenia .thrombocytosis . vertigo . vestibular damage . vision loss . vomiting
SIDE-EFFECTS, FURTHER INFORMATION Neurotoxicity,
usually as peripheral or autonomic neuropathy; it occurs
less often with vindesine than with vincristine. Patients
with neurotoxicity commonly have peripheral
paraesthesia, loss of deep tendon reflexes; and ototoxicity
has been reported. There have been instances in which
neurotoxicity has made it necessary to reduce the dosage
or temporarily discontinue use of vindesine.
l CONCEPTION AND CONTRACEPTION Contraceptive advice
required, see Pregnancy and reproductive function in
l PREGNANCY Avoid (teratogenic in animal studies). See
also Pregnancy and reproductive function in Cytotoxic drugs
l BREAST FEEDING Discontinue breast-feeding.
Dose adjustments Dose reduction may be necessary.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for injection
▶ Eldisine (Genus Pharmaceuticals Ltd)
Vindesine sulfate 5 mg Eldisine 5mg powder for solution for
injection vials | 1 vial P £78.30 (Hospital only)
Treatment of advanced or metastatic transitional cell
carcinoma of the urothelial tract after failure of a
platinum-containing regimen (monotherapy)
▶ Adult: (consult local protocol)
Vinflunine injections are for intravenous
administration only. Inadvertent intrathecal
administration can cause severe neurotoxicity, which is
The National Patient Safety Agency has advised
(August 2008) that adult and teenage patients treated in
an adult or adolescent unit should receive their vinca
alkaloid dose in a 50 mL minibag. Teenagers and children
treated in a child unit may receive their vinca alkaloid
CONTRA-INDICATIONS, FURTHER INFORMATION
Intrathecal injection contra-indicated.
l CAUTIONS Cardiovascular disease . QT-interval
prolongation (avoid hypokalaemia)
l INTERACTIONS → Appendix 1: vinca alkaloids
▶ Common or very common Alopecia . anaemia . appetite
▶ Rare or very rare Posterior reversible encephalopathy
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception during and for up to 3 months after
l PREGNANCY Avoid unless essential—teratogenicity and
embryotoxicity in animal studies. See also Pregnancy and
reproductive function in Cytotoxic drugs p. 888.
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises caution (no
information available in severe impairment).
Dose adjustments Manufacturer advises dose reduction.
Dose adjustments Reduce dose if creatinine clearance less
than 60 mL/minute—consult product literature.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Vinflunine for the treatment of advanced or metastatic
transitional cell carcinoma of the urothelial tract (January
Vinflunine (Javlor ®) is not recommended for the
treatment of advanced or metastatic transitional cell
carcinoma of the urothelial tract that has progressed after
treatment with platinum-based chemotherapy.
www.nice.org.uk/guidance/ta272
930 Cytotoxic responsive malignancy BNF 78
Immune system and malignant disease
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Vinflunine (as Vinflunine ditartrate) 25 mg per 1 ml Javlor
250mg/10ml concentrate for solution for infusion vials | 1 vial P £1,062.50
Javlor 50mg/2ml concentrate for solution for infusion vials | 1 vial P £212.50
l DRUG ACTION Vinorelbine is a semi-synthetic vinca
Advanced breast cancer | Advanced non-small cell lung
▶ Adult: 60 mg/m2 once weekly for 3 weeks, then
increased if tolerated to 80 mg/m2 once weekly (max.
▶ BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: (consult product literature)
Vinorelbine injections are for intravenous
administration only. Inadvertent intrathecal
administration can cause severe neurotoxicity, which is
The National Patient Safety Agency has advised
(August 2008) that adult and teenage patients treated in
an adult or adolescent unit should receive their vinca
alkaloid dose in a 50 mL minibag. Teenagers and children
treated in a child unit may receive their vinca alkaloid
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES
resection of small bowel . previous significant surgical
CONTRA-INDICATIONS, FURTHER INFORMATION
Intrathecal injection contra-indicated.
l CAUTIONS Caution in handling—irritant to tissues . ischaemic heart disease
l INTERACTIONS → Appendix 1: vinca alkaloids
▶ Common or very common Alopecia . anaemia . appetite
▶ Uncommon Flushing . peripheral coldness .respiratory
▶ Rare or very rare Circulatory collapse . hyponatraemia . myocardial infarction . pancreatitis
headache . insomnia . liver disorder. neuromuscular
▶ With intravenous use Paraesthesia
▶ With intravenous use Febrile neutropenia
▶ With oral use Gastrointestinal haemorrhage . hypersensitivity
SIDE-EFFECTS, FURTHER INFORMATION Bronchospasm
Severe bronchospasm following administration of the
vinca alkaloids is more common when used in combination
Neurotoxicity Neurotoxicity reported in clinical trials,
most commonly as constipation, paresthesia,
hypersthesia, and hyporeflexia.
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception during and for 3 months after
treatment; men must avoid fathering a child during and
for at least 3 months after treatment.
l PREGNANCY Avoid unless essential (teratogenicity, and
fetal loss in animal studies). See also Pregnancy and
reproductive function in Cytotoxic drugs p. 888.
l BREAST FEEDING Discontinue breast-feeding.
▶ With oral use Manufacturer advises caution in moderate
impairment; avoid in severe impairment (no information
▶ With intravenous use Manufacturer advises caution in severe
Dose adjustments ▶ With oral use Manufacturer advises
dose reduction in moderate impairment—consult product
▶ With intravenous use Manufacturer advises dose reduction
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Vinorelbine (Non-proprietary)
Vinorelbine (as Vinorelbine tartrate) 10 mg per 1 ml Vinorelbine
50mg/5ml concentrate for solution for infusion vials | 1 vial P £139.00 | 10 vial P £1,539.80
Vinorelbine 10mg/1ml concentrate for solution for infusion vials |
1 vial P £29.00 | 10 vial P £329.50
▶ Navelbine (Pierre Fabre Ltd)
Vinorelbine (as Vinorelbine tartrate) 10 mg per 1 ml Navelbine
10mg/1ml concentrate for solution for infusion vials | 10 vial P £297.45 (Hospital only)
Navelbine 50mg/5ml concentrate for solution for infusion vials |
10 vial P £1,399.79 (Hospital only)
CAUTIONARY AND ADVISORY LABELS 21, 25
▶ Navelbine (Pierre Fabre Ltd)
Vinorelbine (as Vinorelbine tartrate) 20 mg Navelbine 20mg
capsules | 1 capsule P £43.98 (Hospital only)
Vinorelbine (as Vinorelbine tartrate) 30 mg Navelbine 30mg
capsules | 1 capsule P £65.98 (Hospital only)
Vinorelbine (as Vinorelbine tartrate) 80 mg Navelbine 80mg
capsules | 1 capsule P £175.92 (Hospital only)
BNF 78 Cytotoxic responsive malignancy 931
Immune system and malignant disease
Acute leukaemia (refractory to anthracycline
chemotherapy used alone or in combination with other
chemotherapy agents) (specialist use only)
▶ Adult: (consult product literature)
l CAUTIONS Hypokalaemia—increased risk of ventricular
fibrillation (correct hypokalaemia before initiating
l INTERACTIONS → Appendix 1: amsacrine
▶ Frequency not known Cardiac arrest. hyperuricaemia
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception during and for 3 months after
treatment in women of child-bearing potential, and during
and for 6 months after treatment in men.
l PREGNANCY Manufacturer advises avoid—toxicity in
animal studies. See also Pregnancy and reproductive
function in Cytotoxic drugs p. 888.
l BREAST FEEDING Manufacturer advises avoid—no
l HEPATIC IMPAIRMENT Manufacturer advises caution
Dose adjustments Manufacturer advises consider dose
reduction (consult product literature).
l RENAL IMPAIRMENT Manufacturer advises monitor renal
function at baseline and during treatment—increased risk
Dose adjustments Manufacturer advises consider dose
reduction in renal impairment.
▶ Manufacturer advises monitor full blood count, liver
function and renal function regularly; electrolytes should
be re-evaluated prior to each treatment.
▶ Manufacturer advises monitor for cardiotoxicity during
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Amsidine (Eurocept International bv)
Amsacrine 50 mg per 1 ml Amsidine 75mg/1.5ml solution for
infusion ampoules and diluent | 6 ampoule P £1,200.00 (Hospital
Acute promyelocytic leukaemia in patients who have
relapsed or failed to respond to previous treatment with
▶ Adult: (consult local protocol)
treatment with anthracyclines (increased risk of QT
l INTERACTIONS → Appendix 1: arsenic trioxide
▶ Common or very common Abdominal pain . alveolar
haemorrhage . anaemia . arrhythmias . arthralgia . chest
SIDE-EFFECTS, FURTHER INFORMATION Signs and
symptoms of differentiation syndrome (leucocyte
activation syndrome) include unexplained fever,
dyspnoea, weight gain, pulmonary infiltrates, pleural or
pericardial effusions, with or without leucocytosis—treat
with high dose corticosteroids, consult product literature.
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception during treatment in men and
l PREGNANCY Avoid (teratogenic and embryotoxic in animal
studies). See also Pregnancy and reproductive function in
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises use with
caution—no information available.
l RENAL IMPAIRMENT Manufacturer advises caution—
limited information available.
l MONITORING REQUIREMENTS ECG required before and
during treatment—consult product literature.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Arsenic trioxide for treating acute promyelocytic leukaemia
Arsenic trioxide is recommended, within its marketing
authorisation, as an option for inducing remission and
consolidation in acute promyelocytic leukaemia
(characterised by the presence of the t[15;17] translocation
or the PML/RAR-alpha gene) in adults with:
. untreated, low-to-intermediate risk disease (defined as a
white blood cell count of 10x103 per microlitre or less),
when given with all-trans-retinoic acid (ATRA)
. relapsed or refractory disease, after a retinoid and
www.nice.org.uk/guidance/ta526
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (January
2019) that arsenic trioxide (Trisenox ®) is not
recommended for use within NHS Scotland in combination
with all-trans-retinoic acid (ATRA [tretinoin]) for the
induction of remission, and consolidation in adults with
newly diagnosed, low-to-intermediate risk acute
promyelocytic leukaemia (characterised by the presence of
the t(15;17) translocation and/or the presence of the
PML/RAR-alpha gene), as the economic case was not
932 Cytotoxic responsive malignancy BNF 78
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