▶ Monitor for myelodysplastic syndrome.
▶ Monitor for secondary malignancies.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Temozolomide for the treatment of recurrent malignant
glioma (brain cancer) (April 2001) NICE TA23
Temozolomide may be considered for the treatment of
recurrent malignant glioma, which has not responded to
▶ Carmustine implants and temozolomide for the treatment of
newly diagnosed high-grade glioma (June 2007) NICE TA121
Temozolomide is an option for the treatment of newly
diagnosed glioblastoma multiforme in patients with a
WHO performance status of 0 or 1.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension
CAUTIONARY AND ADVISORY LABELS 23, 25
▶ Temozolomide (Non-proprietary)
Temozolomide 5 mg Temozolomide 5mg capsules | 5 capsule P £10.06–£16.00
Temozolomide 20 mg Temozolomide 20mg capsules | 5 capsule P £40.23–£65.00
Temozolomide 100 mg Temozolomide 100mg capsules | 5 capsule P £201.18–£325.00
Temozolomide 140 mg Temozolomide 140mg capsules |
Temozolomide 180 mg Temozolomide 180mg capsules | 5 capsule P £381.18–£586.00
Temozolomide 250 mg Temozolomide 250mg capsules | 5 capsule P £529.42–£814.00
▶ Temodal (Merck Sharp & Dohme Ltd)
Temozolomide 5 mg Temodal 5mg capsules | 5 capsule P £10.59 (Hospital only)
Temozolomide 20 mg Temodal 20mg capsules | 5 capsule P £42.35 (Hospital only)
Temozolomide 100 mg Temodal 100mg capsules | 5 capsule P £211.77 (Hospital only)
Temozolomide 140 mg Temodal 140mg capsules | 5 capsule P £296.48 (Hospital only)
Temozolomide 180 mg Temodal 180mg capsules | 5 capsule P £381.19 (Hospital only)
Temozolomide 250 mg Temodal 250mg capsules | 5 capsule P £529.43 (Hospital only)
Conditioning treatment before haematopoietic stem cell
transplantation in the treatment of haematological
disease or solid tumours, in combination with other
▶ Adult: (consult local protocol)
l CAUTIONS Avoid in Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: alkylating agents
discomfort. gastrointestinal disorders . generalised
. infertility . intracranial aneurysm . intracranial
haemorrhage . leucopenia . lymphoedema . menopausal
malignancy . seizure . sepsis . sinusoidal obstruction
▶ Uncommon Cardiomyopathy . hallucination . hypoxia . myocarditis
▶ Frequency not known Severe cutaneous adverse reactions
l CONCEPTION AND CONTRACEPTION Contraceptive advice
required, see Pregnancy and reproductive function in
l PREGNANCY Avoid (teratogenic and embryotoxic in
animals). See also Pregnancy and reproductive function in
l BREAST FEEDING Discontinue breast-feeding.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (June 2012)
that thiotepa (Tepadina ®) is not recommended for use
within NHS Scotland in combination with other
chemotherapy as conditioning treatment in adults or
children with haematological diseases, or solid tumours
prior to haematopoietic stem cell transplantation.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
▶ Tepadina (Adienne Pharma & Biotech)
Thiotepa 15 mg Tepadina 15mg powder for concentrate for solution
for infusion vials | 1 vial P s
Thiotepa 100 mg Tepadina 100mg powder for concentrate for
solution for infusion vials | 1 vial P s
▶ BY MOUTH, OR BY INTRAVENOUS INJECTION, OR BY
INTRAVENOUS INFUSION, OR BY INTRAPERITONEAL
▶ Adult: (consult product literature)
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES
l CAUTIONS Avoid in Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: alkylating agents
▶ Common or very common Alopecia . anaemia . bone marrow
▶ Uncommon Neoplasms .treatment related secondary
illness . paraesthesia .respiratory disorders . scleroderma . sepsis
BNF 78 Cytotoxic responsive malignancy 899
Immune system and malignant disease
▶ With intravenous use Inflammation localised
SIDE-EFFECTS, FURTHER INFORMATION Prolonged use of
treosulfan is associated with an increased incidence of
acute non-lymphocytic leukaemia.
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 MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 25
▶ Treosulfan (Non-proprietary)
Treosulfan 250 mg Treosulfan 250mg capsules | 100 capsule P £653.20
Powder for solution for injection
▶ Treosulfan (Non-proprietary)
Treosulfan 1 gram Treosulfan 1g powder for solution for injection
Treosulfan 5 gram Treosulfan 5g powder for solution for injection
ANTINEOPLASTIC DRUGS › ANTHRACYCLINES
Acute myelogenous leukaemia | Acute lymphocytic
▶ Adult: (consult local protocol)
Advanced AIDS-related Kaposi’s sarcoma (liposomal
▶ Adult: (consult product literature)
l CONTRA-INDICATIONS Myocardial insufficiency . previous
treatment with maximum cumulative doses of
daunorubicin or other anthracycline .recent myocardial
infarction . severe arrhythmia
l CAUTIONS Caution in handling—irritant to tissues
l INTERACTIONS → Appendix 1: anthracyclines
inflammation . cardiomyopathy . chills . congestive heart
red . venous sclerosis . vomiting
SIDE-EFFECTS, FURTHER INFORMATION Cardiotoxicity is
cumulative and may be irreversible, however responds to
l CONCEPTION AND CONTRACEPTION Contraceptive advice
required, see Pregnancy and reproductive function in
l PREGNANCY Avoid (teratogenic and carcinogenic in
animal studies). See also Pregnancy and reproductive
function in Cytotoxic drugs p. 888.
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT For solution for infusion
manufacturer advises caution. For powder for solution for
infusion manufacturer advises caution in mild to moderate
impairment; avoid in severe impairment.
Dose adjustments Manufacturer advises dose reduction
according to serum bilirubin concentration—consult
l RENAL IMPAIRMENT Avoid in severe impairment.
Dose adjustments Reduce dose by 25% if serum creatinine
Reduce dose by 50% if serum creatinine greater than
l MONITORING REQUIREMENTS Cardiac monitoring
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Daunorubicin (as Daunorubicin hydrochloride citrate liposomal
pegylated) 2 mg per 1 ml DaunoXome 50mg/25ml concentrate for
solution for infusion vials | 1 vial P £250.00
Powder for solution for infusion
▶ Daunorubicin (Non-proprietary)
Daunorubicin (as Daunorubicin hydrochloride)
20 mg Daunorubicin 20mg powder for solution for infusion vials | 10 vial P £715.00 (Hospital only)
Daunorubicin with cytarabine 24-Jan-2019
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, daunorubicin above, cytarabine p. 908.
▶ Adult: (consult product literature)
l CAUTIONS Wilson’s disease or other copper-related
disorders (each vial contains 100 mg of copper gluconate,
equivalent to 14 mg of elemental copper)
l INTERACTIONS → Appendix 1: anthracyclines . cytarabine
l HEPATIC IMPAIRMENT Manufacturer advises caution in
l RENAL IMPAIRMENT Manufacturer advises caution in
l PRESCRIBING AND DISPENSING INFORMATION
Daunorubicin with cytarabine is not interchangeable with
other daunorubicin or cytarabine containing preparations.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Liposomal cytarabine–daunorubicin for untreated acute
myeloid leukaemia (December 2018) NICE TA552
Liposomal cytarabine–daunorubicin (Vyxeos ®) is
recommended, within its marketing authorisation, as an
option for untreated therapy-related acute myeloid
leukaemia or acute myeloid leukaemia with
myelodysplasia-related changes in adults. It is
recommended only if the manufacturer provides it
according to the commercial arrangement.
www.nice.org.uk/guidance/ta552
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (March
2019) that liposomal daunorubicin with cytarabine
(Vyxeos ®) is accepted for use within NHS Scotland for the
treatment of adults with newly diagnosed, therapy-related
acute myeloid leukaemia (AML) or AML with
myelodysplasia-related changes. This advice is contingent
upon the continuing availability of the patient access
900 Cytotoxic responsive malignancy BNF 78
Immune system and malignant disease
scheme in NHS Scotland or a list price that is equivalent or
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
▶ Vyxeos (Jazz Pharmaceuticals UK)
Daunorubicin 44 mg, Cytarabine 100 mg Vyxeos 44mg/100mg
powder for concentrate for solution for infusion vials | 1 vial P £4,581.00 (Hospital only)
Doxorubicin hydrochloride 04-Oct-2017
Acute leukaemias | Hodgkin’s lymphoma | Non-Hodgkin’s
lymphoma | Some solid tumours including breast cancer |
▶ Adult: (consult product literature)
Some papillary bladder tumours (bladder instillation)|
Recurrent superficial bladder tumours (bladder
instillation)| Transitional cell carcinoma (bladder
instillation)| Carcinoma in situ (bladder instillation)
▶ BY INTRAVESICAL INSTILLATION
▶ Adult: (consult product literature)
For AIDS-related Kaposi’s sarcoma in patients with low
CD4 count and extensive mucocutaneous or visceral
disease | Advanced ovarian cancer when platinum-based
chemotherapy has failed | Progressive multiple myeloma
(in combination with bortezomib) in patients who have
received at least one prior therapy and who have
undergone or are unsuitable for bone-marrow
transplantation | Monotherapy for metastatic breast
cancer in patients with increased cardiac risk
▶ Adult: (consult product literature)
For use with cyclophosphamide for metastatic breast
▶ Adult: (consult product literature)
l CONTRA-INDICATIONS Consult product literature
l CAUTIONS Cardiac disease . caution in handling—irritant
to tissues . consult product literature . elderly . hypertension . previous myocardial irradiation
l INTERACTIONS → Appendix 1: anthracyclines
▶ Uncommon Confusion . embolism and thrombosis
▶ Rare or very rare Secondary oral neoplasms . severe
cutaneous adverse reactions (SCARs)
▶ Frequency not known Asthma . congestive heart failure . secondary malignancy .throat tightness
SIDE-EFFECTS, FURTHER INFORMATION Extravasation can
Cardiomyopathy Higher cumulative doses are
associated with cardiomyopathy and it is usual to limit
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