ANTINEOPLASTIC DRUGS › PODOPHYLLOTOXIN
Small cell carcinoma of the bronchus, the lymphomas and
▶ Adult: 120–240 mg/m2 daily for 5 days
▶ Adult: (consult product literature)
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES
l INTERACTIONS → Appendix 1: etoposide
▶ Common or very common Abdominal pain . acute
infarction . nausea . neutropenia . skin reactions . thrombocytopenia . vomiting
▶ Rare or very rare Dysphagia . neurotoxicity .radiation
recall reaction .respiratory disorders . seizure . severe
cutaneous adverse reactions (SCARs).taste altered . vision
▶ With intravenous use Anaphylactic reaction . hypotension . infection
▶ With oral use Oesophagitis . stomatitis .transient systolic
▶ With intravenous use Haemorrhage
▶ With intravenous use Angioedema . extravasation necrosis . infertility .tumour lysis syndrome
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.
l HEPATIC IMPAIRMENT Manufacturer advises caution
(increased risk of accumulation).
Dose adjustments Consider dose reduction—consult local
treatment protocol for details.
l DIRECTIONS FOR ADMINISTRATION Etoposide may be given
orally or by slow intravenous infusion, the oral dose being
double the intravenous dose. A preparation containing
etoposide phosphate can be given by intravenous injection
or infusion. Etoposide is usually given daily for 3–5 days
and courses should not be repeated more frequently than
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Etoposide 20 mg per 1 ml Etoposide 100mg/5ml concentrate for
solution for infusion vials | 1 vial P £11.50–£15.51 (Hospital only)
Etoposide 200mg/10ml concentrate for solution for infusion vials | 1 vial P s (Hospital only)
CAUTIONARY AND ADVISORY LABELS 23
▶ Vepesid (Bristol-Myers Squibb Pharmaceuticals Ltd)
Etoposide 50 mg Vepesid 50mg capsules | 20 capsule P £99.82
Etoposide 100 mg Vepesid 100mg capsules | 10 capsule P £87.23 (Hospital only)
Powder for solution for injection
▶ Etopophos (Bristol-Myers Squibb Pharmaceuticals Ltd)
Etoposide (as Etoposide phosphate) 100 mg Etopophos 100mg
powder for solution for injection vials | 10 vial P £261.68
ANTINEOPLASTIC DRUGS › TAXANES
Treatment of hormone refractory metastatic prostate
cancer in patients who have previously been treated
with a docetaxel-containing regimen (in combination
with prednisone or prednisolone)
▶ Adult: (consult product literature or local protocols)
l CAUTIONS Avoid in Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: taxanes
thrombosis . dehydration . diarrhoea . dizziness . dry
failure (fatal cases of renal failure reported). sensation
disorders . vasodilation . vertigo . vomiting . weight
▶ Frequency not known Respiratory disorders
l CONCEPTION AND CONTRACEPTION Ensure effective
contraception during treatment (women) and for up to
6 months after treatment (men).
l PREGNANCY See also Pregnancy and reproductive function
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment.
Dose adjustments Manufacturer advises dose reduction in
mild to moderate impairment—consult product literature.
l RENAL IMPAIRMENT Use with caution if creatinine
clearance less than 50 mL/minute.
l MONITORING REQUIREMENTS Monitor electrolytes—
BNF 78 Cytotoxic responsive malignancy 923
Immune system and malignant disease
l DIRECTIONS FOR ADMINISTRATION Intravenous infusion
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Cabazitaxel for hormone-relapsed metastatic prostate cancer
treated with docetaxel (updated August 2016) NICE TA391
Cabazitaxel (Jevtana ®) in combination with prednisone or
prednisolone is recommended as an option for treating
metastatic hormone-relapsed prostate cancer in patients
whose disease has progressed during or after docetaxel
chemotherapy, only if the following criteria are met:
. the patient has an eastern cooperative oncology group
(ECOG) performance status of 0 or 1
. the patient has had 225 mg/m2 or more of docetaxel
. treatment with cabazitaxel is stopped when the disease
progresses or after a maximum of 10 cycles
. the manufacturer provides cabazitaxel with the discount
agreed in the patient access scheme
. NHS trusts purchase cabazitaxel in accordance with the
commercial access agreement, either in vials (at a
reduced price to reflect the average cost of waste per
patient), or in pre-prepared intravenous infusion bags.
Patients currently receiving cabazitaxel that is not
recommended according to the above criteria should have
the option to continue treatment until they and their NHS
clinician consider it appropriate to stop.
www.nice.org.uk/guidance/ta391
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (December
2016) that cabazitaxel (Jevtana ®) in combination with
prednisone or prednisolone is accepted for restricted use
within NHS Scotland for the treatment of patients with
hormone refractory metastatic prostate cancer previously
treated with a docetaxel-containing regimen (patients who
have received at least 225 mg/m2 (three cycles) of
docetaxel and have an Eastern Cooperative Oncology
Group (ECOG) performance status of 0 or 1).This advice is
contingent upon the continuing availability of the patient
access scheme in NHS Scotland or a list price that is
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Ethanol
Cabazitaxel 40 mg per 1 ml JEVTANA 60mg/1.5ml concentrate and
solvent for solution for infusion vials | 1 vial P £3,696.00
Adjuvant treatment of operable node-positive and
operable node-negative breast cancer (in combination
with doxorubicin and cyclophosphamide)| Initial
chemotherapy of locally advanced or metastatic breast
cancer (with doxorubicin)| Locally advanced or
metastatic breast cancer where cytotoxic chemotherapy
with an anthracycline or an alkylating drug has failed
(monotherapy)| Locally advanced or metastatic breast
cancer where cytotoxic chemotherapy with an
anthracycline has failed (with capecitabine)| Initial
chemotherapy of metastatic breast cancer which
overexpresses human epidermal growth factor-2 (with
trastuzumab)| Locally advanced or metastatic non-small
cell lung cancer where previous chemotherapy has failed
| Initial chemotherapy of unresectable, locally advanced
or metastatic non-small cell lung cancer (with cisplatin)|
Hormone-resistant metastatic prostate cancer (in
combination with prednisone or prednisolone)| Initial
treatment of metastatic gastric adenocarcinoma,
including adenocarcinoma of the gastro-oesophageal
junction (with cisplatin and fluorouracil)| Induction
treatment of locally advanced squamous cell carcinoma
of the head and neck (with cisplatin and fluorouracil)
▶ Adult: (consult product literature or local protocols)
l CAUTIONS Avoid in Acute porphyrias p. 1058 . consult
l INTERACTIONS → Appendix 1: taxanes
disorders . nausea . neutropenia . pain . peripheral
neuropathy . sepsis . skin reactions . stomatitis .taste
altered .thrombocytopenia . vomiting
▶ Uncommon Gastrointestinal disorders . heart failure
SIDE-EFFECTS, FURTHER INFORMATION Pretreatment with
dexamethasone by mouth is recommended for reducing
fluid retention and hypersensitivity reactions.
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception for men and women during
treatment, and for at least 6 months after stopping
l PREGNANCY Avoid (toxicity in animal studies). See also
Pregnancy and reproductive function in Cytotoxic drugs
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate and to avoid in severe impairment.
Dose adjustments Manufacturer advises dose reduction
according to liver function tests in mild to moderate
impairment —consult product literature.
924 Cytotoxic responsive malignancy BNF 78
Immune system and malignant disease
Monitoring Monitor liver function in hepatic impairment.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Docetaxel for the treatment of hormone-refractory metastatic
prostate cancer (June 2006) NICE TA101
Docetaxel is an option for hormone-refractory metastatic
prostate cancer only if their Karnofsky score is at least 60%
[Karnofsky score is a measure of the ability to perform
www.nice.org.uk/guidance/ta101
▶ Docetaxel for the adjuvant treatment of early node-positive
breast cancer (September 2006) NICE TA109
Docetaxel, when given concurrently with doxorubicin and
cyclophosphamide (TAC regimen), is recommended as an
option for the adjuvant treatment of women with early
www.nice.org.uk/guidance/ta109
▶ Pertuzumab with trastuzumab and docetaxel for treating
HER2-positive breast cancer (March 2018) NICE TA509
Pertuzumab, in combination with trastuzumab and
docetaxel, is recommended, within its marketing
authorisation, for treating HER2-positive metastatic or
locally recurrent unresectable breast cancer, in adults who
have not had previous anti-HER2 therapy or chemotherapy
for their metastatic disease, only if the manufacturer
provides pertuzumab within the agreed commercial access
www.nice.org.uk/guidance/ta509
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (May 2007)
that docetaxel (Taxotere ®) in combination with cisplatin
and fluorouracil is accepted for restricted use within NHS
Scotland for the induction treatment of patients with
unresectable locally advanced squamous cell carcinoma of
The Scottish Medicines Consortium has advised (July
2008) that docetaxel (Taxotere ®) in combination with
cisplatin and fluorouracil is accepted for restricted use
within NHS Scotland for the induction treatment of
patients with resectable locally advanced squamous cell
carcinoma of the head and neck.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Ethanol
Docetaxel 10 mg per 1 ml Docetaxel 80mg/8ml concentrate for
solution for infusion vials | 1 vial P £534.75 (Hospital only)
Docetaxel 20mg/2ml concentrate for solution for infusion vials |
1 vial P £162.75 (Hospital only)
Docetaxel 20 mg per 1 ml Docetaxel 80mg/4ml concentrate for
solution for infusion vials | 1 vial P £300.67–£676.44 (Hospital
only) | 1 vial P £479.06–£530.00
Docetaxel 140mg/7ml concentrate for solution for infusion vials | 1 vial P £900.00
Docetaxel 20mg/1ml concentrate for solution for infusion vials |
1 vial P £91.51–£194.48 (Hospital only) | 1 vial P £145.80–
l DRUG ACTION Paclitaxel is a member of the taxane group
Treatment of ovarian cancer (advanced or residual
disease following laparotomy) in combination with
cisplatin (conventional paclitaxel only)| Treatment of
metastatic ovarian cancer where platinum-containing
therapy has failed (conventional paclitaxel only)|
Treatment of locally advanced or metastatic breast
cancer (in combination with other cytotoxics or alone if
other cytotoxics have failed or are inappropriate)
(conventional paclitaxel only)| Adjuvant treatment of
node-positive breast cancer following treatment with
anthracycline and cyclophosphamide (conventional
paclitaxel only)| Treatment of non-small cell lung cancer
(in combination with cisplatin) when surgery or
radiotherapy not appropriate (conventional paclitaxel
only)| Treatment of advanced AIDS-related Kaposi’s
sarcoma where liposomal anthracycline therapy has
failed (conventional paclitaxel only)| First-line
treatment of metastatic adenocarcinoma of the
pancreas (in combination with gemcitabine)
(conventional paclitaxel only)| Monotherapy of
metastatic breast cancer when first-line treatment has
failed and standard, anthracycline-containing therapy is
not indicated (albumin-bound paclitaxel only)| In
combination with gemcitabine for the first-line
treatment of metastatic adenocarcinoma of the
pancreas (albumin-bound paclitaxel only)
▶ Adult: (consult product literature or local protocols)
l CAUTIONS Avoid in Acute porphyrias p. 1058 . consult
product literature . patients aged over 75 years with
metastatic adenocarcinoma of the pancreas
l INTERACTIONS → Appendix 1: taxanes
disorders . mucositis . muscle complaints . nail
▶ Uncommon Allergic rhinitis . breast pain . catheter related
infection . dry mouth . dysphagia . ear pain . embolism and
SIDE-EFFECTS, FURTHER INFORMATION Manufacturer
advises routine premedication with a corticosteroid, an
BNF 78 Cytotoxic responsive malignancy 925
Immune system and malignant disease
antihistamine and a histamine H2-receptor antagonist is
recommended to prevent severe hypersensitivity
reactions; hypersensitivity reactions may occur rarely
l CONCEPTION AND CONTRACEPTION Ensure effective
contraception during and for at least 6 months after
l PREGNANCY Avoid (toxicity in animal studies). See also
Pregnancy and reproductive function in Cytotoxic drugs
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT (Consult product literature)
▶ Cardiac monitoring should be undertaken, particularly if
patients have underlying cardiac disease or previous
▶ Patients should be monitored for signs and symptoms of
l PRESCRIBING AND DISPENSING INFORMATION Paclitaxel is
available as both conventional and albumin-bound
formulations. The different formulations vary in their
licensed indications, pharmacokinetics, dosage and
administration, and are not interchangeable.
Prescribers should specify the brand to be dispensed.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Paclitaxel for ovarian cancer (January 2003) NICE TA55
Either paclitaxel in combination with a platinum
compound (cisplatin or carboplatin) or a platinum
compound alone are alternatives for the first-line
treatment of ovarian cancer (usually following surgery).
▶ Paclitaxel for the adjuvant treatment of early node-positive
breast cancer (September 2006) NICE TA108
Paclitaxel, within its licensed indication, is not
recommended for the adjuvant treatment of women with
early node-positive breast cancer.
www.nice.org.uk/guidance/TA108
▶ Bevacizumab in combination with paclitaxel and carboplatin
for the first-line treatment of advanced ovarian cancer (May
Bevacizumab in combination with paclitaxel and
carboplatin is not recommended for the first-line
treatment of advanced ovarian cancer (including fallopian
tube and primary peritoneal cancer).
www.nice.org.uk/guidance/TA284
▶ Topotecan, pegylated liposomal doxorubicin hydrochloride,
paclitaxel, trabectedin and gemcitabine for treating recurrent
ovarian cancer (April 2016) NICE TA389
Paclitaxel, in combination with platinum or as
monotherapy, is recommended as an option for treating
www.nice.org.uk/guidance/TA389
▶ Paclitaxel as albumin-bound nanoparticles with gemcitabine
for untreated metastatic pancreatic cancer (September 2017)
for untreated metastatic adenocarcinoma of the pancreas
. other combination chemotherapies are unsuitable and
they would otherwise have gemcitabine monotherapy,
. the manufacturer provides nab-paclitaxel with the
discount agreed in the patient access scheme.
Patients whose treatment with nab-paclitaxel was started
before this guidance was published, should have the
option to continue treatment until they and their NHS
clinician consider it appropriate to stop.
www.nice.org.uk/guidance/TA476
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2010)
that paclitaxel albumin (Abraxane ®) is accepted for
restricted use within NHS Scotland for treatment of
standard anthracycline containing therapy is not
indicated; use is restricted to patients who would
otherwise receive docetaxel or 3-weekly solvent-based
paclitaxel as second-line treatment for metastatic breast
The Scottish Medicines Consortium has advised (February
2015) that paclitaxel albumin (Abraxane ®) is accepted for
use within NHS Scotland in combination with gemcitabine
for the first-line treatment of adult patients with
metastatic adenocarcinoma of the pancreas.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Polyoxyl castor oils
▶ Paclitaxel (Non-proprietary)
Paclitaxel 6 mg per 1 ml Paclitaxel 150mg/25ml concentrate for
solution for infusion vials | 1 vial P £504.90–£561.00 (Hospital
Powder for suspension for infusion
ELECTROLYTES: May contain Sodium
Paclitaxel albumin 100 mg Abraxane 100mg powder for suspension
for infusion vials | 1 vial P £246.00 (Hospital only)
ANTINEOPLASTIC DRUGS › TOPOISOMERASE I
Irinotecan hydrochloride 15-Apr-2019
l DRUG ACTION Irinotecan inhibits topoisomerase I, an
enzyme involved in DNA replication.
Metastatic colorectal cancer in combination with
fluorouracil and folinic acid or as monotherapy when
treatment containing fluorouracil has failed | Treatment
of epidermal growth factor receptor-expressing
metastatic colorectal cancer after failure of
chemotherapy that has included irinotecan (in
combination with cetuximab)| First-line treatment of
metastatic carcinoma of the colon or rectum (in
combination with fluorouracil, folinic acid and
bevacizumab)| First-line treatment of metastatic
colorectal carcinoma (in combination with capecitabine
▶ Adult: (consult product literature or local protocols)
926 Cytotoxic responsive malignancy BNF 78
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