ventricular ejection fraction . history of arrhythmias . QT
l CAUTIONS Avoid in Acute porphyrias p. 1058 . history of
l INTERACTIONS → Appendix 1: toremifene
▶ Rare or very rare Alopecia . corneal opacity . endometrial
cancer. hepatic disorders . uterine haemorrhage . vertigo
▶ Frequency not known Anaemia . leucopenia . thrombocytopenia
SIDE-EFFECTS, FURTHER INFORMATION Increased
endometrial changes, including hyperplasia, polyps and
l HEPATIC IMPAIRMENT Manufacturer advises caution; avoid
in severe hepatic failure (risk of decreased elimination).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Fareston (Orion Pharma (UK) Ltd)
Toremifene (as Toremifene citrate) 60 mg Fareston 60mg tablets
HORMONE ANTAGONISTS AND RELATED
Adjuvant treatment of oestrogen-receptor-positive early
invasive breast cancer in postmenopausal women |
Adjuvant treatment of oestrogen-receptor-positive early
breast cancer in postmenopausal women following
2–3 years of tamoxifen therapy | Advanced breast cancer
in postmenopausal women which is oestrogen-receptorpositive or responsive to tamoxifen
Breast cancer [chemoprevention in postmenopausal
women at moderate to high risk] (initiated under
▶ Adult: 1 mg daily for 5 years
l UNLICENSED USE g Anastrozole is used for
chemoprevention of breast cancer, lbut it is not
l CONTRA-INDICATIONS Not for premenopausal women
l CAUTIONS Susceptibility to osteoporosis
reactions .taste altered . vaginal haemorrhage . vomiting . vulvovaginal dryness
▶ Uncommon Hepatitis . hypercalcaemia .trigger finger
▶ Rare or very rare Angioedema . Stevens-Johnson syndrome . vasculitis
▶ Frequency not known Mood altered
l HEPATIC IMPAIRMENT Manufacturer advises use with
caution in moderate-to-severe impairment.
l RENAL IMPAIRMENT Avoid if creatinine clearance less than
l PRE-TREATMENT SCREENING Laboratory test for
▶ Osteoporosis Assess bone mineral density before treatment
Driving and skilled tasks Asthenia and drowsiness may
initially affect ability to drive or operate machinery.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (August
2005 and October 2006) that anastrozole (Arimidex ®) is
accepted for restricted use within NHS Scotland, within
the licensed indications, for early breast cancer and early
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Anastrozole (Non-proprietary)
Anastrozole 1 mg Anastrozole 1mg tablets | 28 tablet P £68.56
▶ Arimidex (AstraZeneca UK Ltd)
Anastrozole 1 mg Arimidex 1mg tablets | 28 tablet P £68.56 DT
Adjuvant treatment of oestrogen-receptor-positive early
breast cancer in postmenopausal women following
2–3 years of tamoxifen therapy | Advanced breast cancer
in postmenopausal women in whom anti-oestrogen
l CONTRA-INDICATIONS Not indicated for premenopausal
l INTERACTIONS → Appendix 1: exemestane
reactions .thrombocytopenia . vomiting
▶ Rare or very rare Acute generalised exanthematous
pustulosis (AGEP). drowsiness . hepatic disorders
l HEPATIC IMPAIRMENT Manufacturer advises caution.
l RENAL IMPAIRMENT Manufacturer advises caution.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (October
2005) that exemestane (Aromasin ®) is accepted for
restricted use within NHS Scotland as an adjuvant
2–3 years of initial adjuvant tamoxifen therapy.
954 Hormone 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.
CAUTIONARY AND ADVISORY LABELS 21
▶ Exemestane (Non-proprietary)
Exemestane 25 mg Exemestane 25mg tablets | 30 tablet P £88.80 DT = £6.35
Exemestane 25 mg Aromasin 25mg tablets | 30 tablet P £88.80
First-line treatment in postmenopausal women with
hormone-dependent advanced breast cancer | Adjuvant
treatment of oestrogen-receptor-positive invasive early
breast cancer in postmenopausal women | Advanced
breast cancer in postmenopausal women (naturally or
artificially induced menopause) in whom other antioestrogen therapy has failed | Extended adjuvant
treatment of hormone-dependent invasive breast cancer
in postmenopausal women who have received standard
adjuvant tamoxifen therapy for 5 years | Neo-adjuvant
treatment in postmenopausal women with localised
hormone-receptor-positive, human epidermal growth
factor-2 negative breast cancer where chemotherapy is
not suitable and surgery not yet indicated
l CONTRA-INDICATIONS Not indicated for premenopausal
l CAUTIONS Susceptibility to osteoporosis
reactions . vaginal haemorrhage . vomiting . weight
irritation . fever. insomnia . irritability . ischaemic heart
increased . urinary tract infection . vision blurred . vulvovaginal disorders
▶ Frequency not known Angioedema . hepatitis .toxic
epidermal necrolysis .trigger finger
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception required until postmenopausal
status fully established (return of ovarian function
reported in postmenopausal women).
l PREGNANCY Avoid (isolated cases of birth defects
l BREAST FEEDING Manufacturer advises avoid.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment (increased exposure and half-life).
l RENAL IMPAIRMENT Manufacturer advises caution if
creatinine clearance less than 10 mL/minute.
▶ Osteoporosis Assess bone mineral density before treatment
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Letrozole 2.5 mg Letrozole 2.5mg tablets | 14 tablet P £49.90
DT = £0.95 | 28 tablet P £1.72–£84.86
▶ Femara (Novartis Pharmaceuticals UK Ltd)
Letrozole 2.5 mg Femara 2.5mg tablets | 30 tablet P £90.92
ANTINEOPLASTIC DRUGS › ANTINEOPLASTICS,
Talimogene laherparepvec 10-Feb-2017
l DRUG ACTION Talimogene laherparepvec is an oncolytic
immunotherapy derived from herpes simplex virus type-1
which causes tumour lysis and the release of tumourderived antigens.
Unresectable metastatic melanoma with no bone, brain,
▶ Adult: (consult product literature)
l CONTRA-INDICATIONS Severely immunocompromised
CONTRA-INDICATIONS, FURTHER INFORMATION
Manufacturer advises avoid in patients who are severely
immunocompromised, for example, those with severe
congenital or acquired cellular and/or humoral immune
deficiency—may be at increased risk of disseminated
l CAUTIONS Administration of antivirals (may interfere with
plasmacytoma at injection site)
▶ Immunocompromised patients Manufacturer advises caution
in patients who are immunocompromised, for example,
those with HIV/AIDS, leukaemia, lymphoma, common
variable immunodeficiency, or in those who require
chronic high-dose steroids or other immunosuppressive
agents—risk of disseminated herpetic infection.
pain . pain . peripheral oedema . procedural pain . secretion
discharge . skin reactions .tachycardia . vomiting . weight
decreased . wound complications
▶ Uncommon Glomerulonephritis . injection site
plasmacytoma . post procedural infection .respiratory
SIDE-EFFECTS, FURTHER INFORMATION Necrosis or
ulceration of tumour tissue may occur, and impaired
healing at the injection site has been reported.
Manufacturer advises careful wound care and infection
precautions; if persistent infection or delayed healing
develops, the risks and benefits of continuing treatment
BNF 78 Immunotherapy responsive malignancy 955
Immune system and malignant disease
l CONCEPTION AND CONTRACEPTION Manufacturer advises
l PREGNANCY Manufacturer advises avoid—no information
l BREAST FEEDING Manufacturer advises avoid—no
l DIRECTIONS FOR ADMINISTRATION Consult product
literature for information on injection technique.
l HANDLING AND STORAGE Manufacturer advises caution in
handling—risk of accidental exposure; avoid preparation
or administration if immunocompromised or pregnant. For
further information, see the Physician’s Brochure provided
by the manufacturer. Store and transport frozen at -90ºC
to -70ºC—consult product literature for further
information on thawing and storage after thawing.
l PATIENT AND CARER ADVICE Manufacturer advises that
patients and carers should be informed about the risks of
treatment, advised to avoid touching or scratching
injection sites, and to keep these sites covered with
occlusive dressings. Close contacts should avoid direct
contact with injected lesions or body fluids of treated
patients during treatment and for up to 30 days after last
treatment—if exposed, clean the affected area and seek
medical attention if symptoms of herpetic infection
develop; close contacts who are immunocompromised or
pregnant should not be exposed to potentially
contaminated materials. For further information, see the
Information for Patients and Close Contacts provided by the
Provide patient alert card—record batch number for each
Driving and skilled tasks Manufacturer advises that
patients and their carers should be counselled on the
effects on driving and performance of skilled tasks—risk of
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Talimogene laherparepvec for treating unresectable
metastatic melanoma (September 2016)
Talimogene laherparepvec is recommended as an option
for treating unresectable, regionally or distantly
metastatic (Stage IIIB, IIIC or IVM1a) melanoma that has
not spread to bone, brain or other internal organs, only if:
. treatment with systemically administered
immunotherapies is not suitable and,
. the manufacturer provides talimogene laherparepvec
with the discount agreed in the patient access scheme.
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 clinician consider it
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Sorbitol
ELECTROLYTES: May contain Sodium
Talimogene laherparepvec 1 million plaque forming units per
1 ml Imlygic 1million plaque forming units/1ml solution for injection
Talimogene laherparepvec 100 million plaque forming units per
1 ml Imlygic 100million plaque forming units/1ml solution for
injection vials | 1 vial P £1,670.00
IMMUNOSTIMULANTS › INTERFERONS
l DRUG ACTION Interferon alfa has shown some antitumour
effect in certain lymphomas and solid tumours.
Chronic myelogenous leukaemia (as monotherapy or in
combination with cytarabine)| Hairy cell leukaemia |
Follicular lymphoma | Lymph or liver metastases of
carcinoid tumour | Chronic hepatitis B | Chronic hepatitis
C | Adjunct to surgery in malignant melanoma |
Maintenance of remission in multiple myeloma
▶ Adult: (consult local protocol)
Chronic myelogenous leukaemia (as monotherapy or in
combination with cytarabine)| Hairy cell leukaemia |
Follicular lymphoma | Lymph or liver metastases of
carcinoid tumour | Chronic hepatitis B | Chronic hepatitis
C | Adjunct to surgery in malignant melanoma |
Maintenance of remission in multiple myeloma
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: (consult local protocol)
Chronic myelogenous leukaemia | Hairy cell leukaemia |
Chronic hepatitis B | Chronic hepatitis C | Adjunct to
surgery in malignant melanoma | AIDS-related Kaposi’s
sarcoma | Advanced renal cell carcinoma | Progressive
cutaneous T-cell lymphoma | Follicular non-Hodgkin’s
▶ Adult: (consult local protocol)
CONTRA-INDICATIONS, FURTHER INFORMATION
For contra-indications consult product literature and local
CAUTIONS, FURTHER INFORMATION For cautions consult
product literature and local treatment protocol.
l INTERACTIONS → Appendix 1: interferons
inflammation . eye pain . fever. flushing . gastrointestinal
disorder. vertigo . vision disorders . vomiting . weight
▶ Uncommon Behaviour abnormal . hypotension . memory
loss . nerve disorders . pericarditis . proteinuria . psychiatric disorders
▶ Rare or very rare Agranulocytosis . angioedema . aplastic
anaemia . autoimmune disorder. cardiac arrest.
956 Immunotherapy responsive malignancy BNF 78
Immune system and malignant disease
(sometimes severe). injection site necrosis . mucosal
ischaemia . psychosis . pulmonary oedema .renal
impairment.retinopathy . sarcoidosis . seizure (more
common at high doses). sepsis . severe cutaneous adverse
reactions (SCARs). suicidal tendencies . systemic lupus
erythematosus (SLE) .thyroid disorder. ulcerative colitis . vasculitis
hypertension . pure red cell aplasia .tongue discolouration .transplant rejection
l CONCEPTION AND CONTRACEPTION Effective
contraception required during treatment—consult product
l PREGNANCY Avoid unless potential benefit outweighs risk
l BREAST FEEDING Unlikely to be harmful.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment.
Monitoring Close monitoring required in mild to moderate
l RENAL IMPAIRMENT Avoid in severe renal impairment.
Monitoring Close monitoring required in mild to moderate
l MONITORING REQUIREMENTS Monitoring of lipid
l DIRECTIONS FOR ADMINISTRATION
INTRONA ® VIALS IntronA ® injection vials for
subcutaneous injection or intravenous infusion.
ROFERON-A ® Roferon-A ® injection for subcutaneous
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Peginterferon alfa, interferon alfa, and ribavirin for moderate
to severe chronic hepatitis C (January 2004 and September
Interferon alfa for either monotherapy or combined
therapy should be used only if neutropenia and
thrombocytopenia are a particular risk. Patients receiving
interferon alfa may be switched to peginterferon alfa.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Benzyl alcohol
▶ IntronA (Merck Sharp & Dohme Ltd)
Interferon alfa-2b 10 mega u per 1 ml IntronA 10million units/1ml
solution for injection vials | 1 vial P s
IntronA 25million units/2.5ml solution for injection multidose vials |
Interferon alfa-2b 15 mega u per 1 ml IntronA 18million units/1.2ml
solution for injection multidose pens | 1 pre-filled disposable
Interferon alfa-2b 25 mega u per 1 ml IntronA 30million
units/1.2ml solution for injection multidose pens | 1 pre-filled
disposable injection P £124.72
Interferon alfa-2b 50 mega u per 1 ml IntronA 60million
units/1.2ml solution for injection multidose pens | 1 pre-filled
disposable injection P £249.45
▶ Roferon-A (Roche Products Ltd)
Interferon alfa-2a 6 mega u per 1 ml Roferon-A 3million
units/0.5ml solution for injection pre-filled syringes | 1 pre-filled
disposable injection P £14.20 DT = £14.20
Interferon alfa-2a 9 mega u per 1 ml Roferon-A 4.5million
units/0.5ml solution for injection pre-filled syringes | 1 pre-filled
disposable injection P £21.29 DT = £21.29
Interferon alfa-2a 12 mega u per 1 ml Roferon-A 6million
units/0.5ml solution for injection pre-filled syringes | 1 pre-filled
disposable injection P £28.37 DT = £28.37
To reduce the frequency of serious infection in chronic
▶ Adult: 50 micrograms/m2 3 times a week
To reduce the frequency of serious infection in severe
▶ Adult: 50 micrograms/m2 3 times a week
l CONTRA-INDICATIONS Simultaneous administration of
foreign proteins including immunological products (such
as vaccines)—risk of exaggerated immune response
l CAUTIONS Arrhythmias . cardiac disease . congestive heart
failure . ischaemia . seizure disorders (including seizures
▶ Common or very common Abdominal pain . arthralgia . back
pain . chills . depression . diarrhoea . fatigue . fever. headache . nausea .rash . vomiting
▶ Frequency not known Atrioventricular block . chest
l CONCEPTION AND CONTRACEPTION Effective
contraception required during treatment—consult product
l PREGNANCY Manufacturers recommend avoid unless
potential benefit outweighs risk (toxicity in animal
l BREAST FEEDING Manufacturers advise avoid—no
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment (increased risk of accumulation).
l RENAL IMPAIRMENT Manufacturer advises caution in
severe impairment—risk of accumulation.
l MONITORING REQUIREMENTS Monitor before and during
treatment: haematological tests (including full blood
count, differential white cell count, and platelet count),
blood chemistry tests (including renal and liver function
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Immukin (Horizon Pharma Ireland Ltd)
Interferon gamma-1b (recombinant human) 200 microgram per
1 ml Immukin 100micrograms/0.5ml solution for injection vials |
BNF 78 Immunotherapy responsive malignancy 957
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