l PRESCRIBING AND DISPENSING INFORMATION
Switching between formulations
▶ When used for Cushing’s disease There are no clinical data
available on switching between formulations; if a switch is
required, manufacturer advises to maintain an interval of
at least 28 days between the last intramuscular injection
and the first subcutaneous injection—for further
information, consult product literature.
l PATIENT AND CARER ADVICE Manufacturer advises
patients and their carers should be informed of the signs
and symptoms of hypocortisolism (including weakness,
fatigue, anorexia, nausea, vomiting, hypotension,
hyperkalaemia, hyponatraemia, hypoglycaemia).
Driving and skilled tasks Manufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of fatigue and
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Signifor (Novartis Pharmaceuticals UK Ltd)
Pasireotide (as Pasireotide diaspartate) 300 microgram per
1 ml Signifor 0.3mg/1ml solution for injection ampoules | 60 ampoule P £2,800.00
Pasireotide (as Pasireotide diaspartate) 600 microgram per
1 ml Signifor 0.6mg/1ml solution for injection ampoules | 60 ampoule P £3,240.00
Pasireotide (as Pasireotide diaspartate) 900 microgram per
1 ml Signifor 0.9mg/1ml solution for injection ampoules |
Powder and solvent for suspension for injection
▶ Signifor (Novartis Pharmaceuticals UK Ltd)
Pasireotide (as Pasireotide pamoate) 10 mg Signifor 10mg powder
and solvent for suspension for injection vials | 1 vial P £2,300.00
Pasireotide (as Pasireotide pamoate) 20 mg Signifor 20mg
powder and solvent for suspension for injection vials | 1 vial P £2,300.00
Pasireotide (as Pasireotide pamoate) 30 mg Signifor 30mg
powder and solvent for suspension for injection vials | 1 vial P £2,300.00
Pasireotide (as Pasireotide pamoate) 40 mg Signifor 40mg
powder and solvent for suspension for injection vials | 1 vial P £2,300.00
Pasireotide (as Pasireotide pamoate) 60 mg Signifor 60mg
powder and solvent for suspension for injection vials | 1 vial P £2,300.00
l CONTRA-INDICATIONS Acute porphyrias p. 1058 . breast
cancer (unless progestogens are being used in the
management of this condition). genital cancer (unless
progestogens are being used in the management of this
condition). history during pregnancy of idiopathic
jaundice . history during pregnancy of pemphigoid
l CAUTIONS Asthma . cardiac dysfunction . conditions that
may worsen with fluid retention . diabetes (progestogens
dysfunction . flatulence . glucose tolerance impaired . heart
l PREGNANCY Avoid. Reversible feminisation of male
fetuses reported in animal studies. Risk of hypospadias in
male fetuses and masculinisation of female fetuses.
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: tablet, capsule, oral
▶ Megestrol acetate (Non-proprietary)
Megestrol acetate 40 mg per 1 ml Megestrol 200mg/5ml oral
▶ Megestrol acetate (Non-proprietary)
Megestrol acetate 40 mg Megestrol 40mg tablets | 100 tablet s
▶ Megace (Swedish Orphan Biovitrum Ltd)
Megestrol acetate 160 mg Megace 160mg tablets | 30 tablet P £19.52 DT = £19.52
ANTINEOPLASTIC DRUGS › ANTI-OESTROGENS
Oestrogen-receptor-positive breast cancer
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: 500 mg every 2 weeks for the first 3 doses, then
500 mg every month, to be administered into the
l INTERACTIONS → Appendix 1: fulvestrant
haemorrhage . venous thromboembolism . vomiting
▶ Uncommon Hepatic disorders . vaginal discharge
l PREGNANCY Manufacturer advises avoid—increased
incidence of fetal abnormalities and death in animal
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment—risk of increased exposure;
avoid in severe impairment—no information available.
l RENAL IMPAIRMENT Manufacturer advises caution if
creatinine clearance less than 30 mL/minute—no
l DIRECTIONS FOR ADMINISTRATION 500 mg dose should be
administered as one 250-mg injection (slowly over
1–2 minutes) into each buttock.
952 Hormone responsive malignancy BNF 78
Immune system and malignant disease
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Fulvestrant for untreated locally advanced or metastatic
oestrogen-receptor positive breast cancer (January 2018)
Fulvestrant is not recommended, within its marketing
authorisation, for treating locally advanced or metastatic
oestrogen-receptor positive breast cancer in
postmenopausal women who have not had endocrine
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/ta503
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Faslodex (AstraZeneca UK Ltd)
Fulvestrant 50 mg per 1 ml Faslodex 250mg/5ml solution for
injection pre-filled syringes | 2 pre-filled disposable injection P £522.41 DT = £522.41
l DRUG ACTION An anti-oestrogen which induces
gonadotrophin release by occupying oestrogen receptors
in the hypothalamus, thereby interfering with feedback
mechanisms; chorionic gonadotrophin is sometimes used
as an adjunct in the treatment of female infertility.
Pre- and perimenopausal women with oestrogenreceptor-positive breast cancer not previously treated
▶ Adult: Initially 20 mg daily on days 2, 3, 4 and 5 of
cycle, if necessary the daily dose may be increased to
40 mg then 80 mg for subsequent courses; if cycles
irregular, start initial course on any day, with
subsequent course starting 45 days later or on day 2 of
Gynaecomastia [prevention in men undergoing long-term
bicalutamide treatment, if radiotherapy unsuccessful]
Breast cancer [chemoprevention in women at moderateto-high risk]
▶ Adult: 20 mg daily for 5 years
l UNLICENSED USE Tamoxifen may be used as detailed
below, although these situations are considered outside
. g the prevention of gynaecomastia in men;
. the chemoprevention of breast cancer l.
thromboembolism or genetic predisposition to
l CAUTIONS Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: tamoxifen
reactions .taste altered . uterine disorders . vaginal
haemorrhage . vomiting . vulvovaginal disorders
▶ Rare or very rare Agranulocytosis . angioedema . corneal
changes . cutaneous lupus erythematosus . cutaneous
▶ Frequency not known Amenorrhoea
SIDE-EFFECTS, FURTHER INFORMATION Endometrial
changes Increased endometrial changes, including
hyperplasia, polyps, cancer, and uterine sarcoma reported;
prompt investigation required if abnormal vaginal
bleeding including menstrual irregularities, vaginal
discharge, and pelvic pain or pressure in those receiving
(or who have received) tamoxifen.
Risk of thromboembolism Tamoxifen can increase the
risk of thromboembolism particularly during and
immediately after major surgery or periods of immobility
(consider interrupting treatment and initiating
l CONCEPTION AND CONTRACEPTION Unless being used in
the treatment of female infertility, effective contraception
must be used during treatment and for 2 months after
stopping. Patients being treated for infertility should be
warned that there is a risk of multiple pregnancy (rarely
l PREGNANCY Avoid—possible effects on fetal development.
l BREAST FEEDING Suppresses lactation. Avoid unless
potential benefit outweighs risk.
Endometrial changes Patients should be informed of the risk
of endometrial cancer and told to report relevant
Thromboembolism Patients should be made aware of the
symptoms of thromboembolism and advised to report
sudden breathlessness and any pain in the calf of one leg.
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, oral
Tamoxifen (as Tamoxifen citrate) 2 mg per 1 ml Tamoxifen
10mg/5ml oral solution sugar free sugar-free | 150 ml P £35.00
Tamoxifen (as Tamoxifen citrate) 10 mg Tamoxifen 10mg tablets | 30 tablet P £47.21 DT = £38.55
Tamoxifen (as Tamoxifen citrate) 20 mg Tamoxifen 20mg tablets | 30 tablet P £7.80 DT = £2.43
Tamoxifen (as Tamoxifen citrate) 40 mg Tamoxifen 40mg tablets
| 30 tablet P £63.93–£64.88 DT = £63.93
Hormone-dependent metastatic breast cancer in
l CONTRA-INDICATIONS Bradycardia . electrolyte
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