l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Arsenic trioxide 1 mg per 1 ml Trisenox 10mg/10ml concentrate for
solution for infusion ampoules | 10 ampoule P £2,920.00
l DRUG ACTION Asparaginase is an enzyme which acts by
breaking down L-asparagine to aspartic acid and ammonia,
this disrupts protein synthesis of tumour cells.
Acute lymphoblastic leukaemia (in combination with
other antineoplastic drugs) (specialist use only)
▶ Adult: 5000 units/m2 every 3 days
l CONTRA-INDICATIONS History of pancreatitis related to
asparaginase therapy . history of serious haemorrhage
related to asparaginase therapy . history of serious
thrombosis related to asparaginase therapy . pancreatitis . pre-existing known coagulopathy
l CAUTIONS Diabetes (may raise blood glucose). hypersensitivity reactions . hypertriglyceridaemia
(severe)—increased risk of acute pancreatitis
▶ Hypersensitivity reactions Serious hypersensitivity reactions,
including life-threatening anaphylaxis, can occur—
asparaginase should only be administered when
appropriately trained staff and resuscitation facilities are
immediately available; in the event of a hypersensitivity
reaction, treatment should be stopped immediately and
appropriate management initiated. Manufacturer advises
an intracutaneous or small intravenous test dose can be
used but is of limited value for predicting which patients
will experience an allergic reaction.
l INTERACTIONS → Appendix 1: asparaginase
▶ Uncommon Headache . hyperammonaemia . hyperuricaemia
▶ Rare or very rare Coma . consciousness impaired . diabetic
pancreatitis . pancreatic pseudocyst. posterior reversible
encephalopathy syndrome (PRES). seizure .tremor
SIDE-EFFECTS, FURTHER INFORMATION There have been
rare reports of cholestasis, icterus, hepatic cell necrosis
and hepatic failure with fatal outcome; manufacturer
advises interrupt treatment if these symptoms develop.
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception in men and women of childbearing potential during treatment and for at least
3 months after last dose; asparaginase may reduce
effectiveness of oral contraceptives—additional
precautions (e.g. barrier method) are required, see also
Pregnancy and reproductive function in Cytotoxic drugs
l PREGNANCY Manufacturer advises avoid unless
essential—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 avoid in
severe impairment—no information available.
▶ Manufacturer advises monitor trough serum asparaginase
levels 3 days after administration; consider switching to a
different asparaginase preparation if target levels not
▶ Manufacturer advises monitor bilirubin, hepatic
transaminases, and coagulation parameters before and
during treatment; in addition, monitor plasma and urinary
glucose, amylase, lipase, triglycerides, cholesterol and
serum protein levels during treatment.
l HANDLING AND STORAGE Manufacturer advises store in a
refrigerator (2–8°C)—consult product literature for storage
conditions after reconstitution and dilution.
Driving and skilled tasks Manufacturer advises
asparaginase has moderate influence on driving and
performance of skilled tasks—increased risk of dizziness
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2018)
that asparaginase (Spectrila ®) is accepted for use within
NHS Scotland when used as a component of antineoplastic
combination therapy for the treatment of acute
lymphoblastic leukaemia in paediatric patients from birth
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
Asparaginase 10000 unit Spectrila 10,000unit powder for
concentrate for solution for infusion vials | 1 vial P £450.00
l DRUG ACTION Crisantaspase is the enzyme asparaginase
produced by Erwinia chrysanthemi.
▶ BY INTRAMUSCULAR INJECTION, OR BY SUBCUTANEOUS
INJECTION, OR BY INTRAVENOUS INJECTION
▶ Adult: (consult product literature)
l CONTRA-INDICATIONS History of pancreatitis related to
l CAUTIONS Diabetes (may raise blood glucose)
l INTERACTIONS → Appendix 1: crisantaspase
▶ Rare or very rare Arthritis reactive . coma . diabetic
BNF 78 Cytotoxic responsive malignancy 933
Immune system and malignant disease
myocardial infarction . necrotising pancreatitis . neutropenia . paresis . sepsis .thrombocytopenia
l CONCEPTION AND CONTRACEPTION Contraceptive advice
required, see Pregnancy and reproductive function in
l PREGNANCY Avoid. See also, Pregnancy and reproductive
function in Cytotoxic drugs p. 888.
l BREAST FEEDING Discontinue breast-feeding.
l DIRECTIONS FOR ADMINISTRATION Facilities for the
management of anaphylaxis should be available.
l MEDICINAL 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 unit Erwinase 10,000unit powder for solution
for injection vials | 5 vial P £3,065.00
Treatment of locally advanced or metastatic breast cancer
when the disease has progressed after treatment with at
least 1 chemotherapy regimen for advanced disease
▶ Adult: Give on day 1 and day 8 of a 21-day cycle,
previous therapy should have included an
anthracycline and a taxane in either the adjuvant or
metastatic setting unless the patient is unsuitable for
these treatments (consult local protocol)
l CONTRA-INDICATIONS Congenital long QT syndrome
l CAUTIONS Bradyarrhythmias (increased susceptibility to
QT-interval prolongation). congestive heart failure
l INTERACTIONS → Appendix 1: eribulin
▶ Common or very common Alopecia . anaemia . appetite
▶ Uncommon Angioedema . hepatotoxicity . interstitial lung
disease . pancreatitis . proteinuria .renal failure . sepsis
▶ Rare or very rare Disseminated intravascular coagulation
▶ Frequency not known QT interval prolongation . severe
cutaneous adverse reactions (SCARs)
l CONCEPTION AND CONTRACEPTION Ensure effective
contraception during and for up to 3 months after
l PREGNANCY Avoid unless essential (teratogenic in animal
studies). See also Pregnancy and reproductive function in
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises caution
(increased risk of neutropenia).
Dose adjustments Manufacturer advises dose reduction—
Dose adjustments Consider dose reduction if creatinine
clearance less than 40 mL/minute.
▶ Monitor for signs of peripheral neuropathy—severe
peripheral neurotoxicity requires treatment delay or dose
reduction (consult product literature).
▶ ECG monitoring recommended in patients prescribed
concomitant use of drugs that prolong the QT-interval or
who are susceptible to QT-interval prolongation.
▶ Monitor electrolytes periodically.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Eribulin for treating locally advanced or metastatic breast
cancer after 2 or more chemotherapy regimens (December
Eribulin (Halaven ®) is recommended for the treatment of
locally advanced or metastatic breast cancer, only if:
. the condition has progressed after at least 2
chemotherapy regimens (which may include an
anthracycline or a taxane, and capecitabine), and
. the manufacturer provides eribulin with the discount
agreed in the patient access scheme.
Patients whose treatment was started within the NHS
before this guidance was published should continue
treatment, without change to their funding arrangements,
until they and their NHS clinician consider it appropriate
www.nice.org.uk/guidance/ta423
▶ Eribulin for treating locally advanced or metastatic breast
cancer after 1 chemotherapy regimen (March 2018)
Eribulin (Halaven ®) is not recommended for treating
locally advanced or metastatic breast cancer in adults who
have had only 1 chemotherapy regimen.
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
www.nice.org.uk/guidance/ta515
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (March
2016) that eribulin (Halaven ®) is accepted for restricted
use within NHS Scotland for the treatment of patients with
locally advanced or metastatic breast cancer that has
progressed after at least two prior chemotherapy regimens
for advanced disease, which includes capecitabine if
indicated. This advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland
or a list price that is equivalent or lower.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Ethanol
Eribulin.44 mg per 1 ml Halaven 0.88mg/2ml solution for injection
vials | 1 vial P £361.00 (Hospital only)
934 Cytotoxic responsive malignancy BNF 78
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