ANTINEOPLASTIC DRUGS › ANTI-ANDROGENS
Abiraterone acetate 27-Apr-2019
Metastatic castration-resistant prostate cancer in
patients whose disease has progressed during or after
treatment with a docetaxel-containing chemotherapy
regimen (in combination with prednisone or
prednisolone)| Metastatic castration-resistant prostate
cancer in patients who are asymptomatic or mildly
symptomatic after failure of androgen deprivation
therapy in whom chemotherapy is not yet clinically
indicated (in combination with prednisone or
▶ Adult: 1 g once daily, for dose of concurrent prednisone
or prednisolone—consult product literature
l CAUTIONS Diabetes (increased risk of hyperglycaemia—
monitor blood sugar frequently). history of cardiovascular
▶ Cardiovascular disease Correct hypertension and
hypokalaemia before treatment (if significant risk of
congestive heart failure, such as history of cardiac failure,
uncontrolled hypertension or cardiac events, consult
product literature for management and increased
l INTERACTIONS → Appendix 1: abiraterone
failure . hepatic disorders . hypertension . hypertriglyceridaemia . hypokalaemia . left ventricular
dysfunction . osteoporosis . peripheral oedema .rash . sepsis . urinary tract infection
▶ Uncommon Adrenal insufficiency . myopathy
▶ Rare or very rare Alveolitis allergic
▶ Frequency not known Myocardial infarction . QT interval
l CONCEPTION AND CONTRACEPTION Men should use
condoms if their partner is pregnant, and use condoms in
combination with another effective contraceptive method
if their partner is of child-bearing potential—toxicity in
l HEPATIC IMPAIRMENT Manufacturer advises use with
caution in moderate impairment and only if benefit clearly
outweighs risk; avoid in severe impairment.
l RENAL IMPAIRMENT Use with caution in severe
impairment—no information available.
▶ Monitor blood pressure, serum potassium concentration,
and fluid balance before treatment, and at least monthly
during treatment—consult product literature for
management of hypertension, hypokalaemia and oedema.
▶ Monitor liver function before treatment, then every
2 weeks for the first 3 months of treatment, then monthly
thereafter—interrupt treatment if serum alanine
aminotransferase or aspartate aminotransferase greater
than 5 times the upper limit (consult product literature for
details of restarting treatment at a lower dose) and
discontinue permanently if 20 times the upper limit.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Abiraterone for castration-resistant metastatic prostate
cancer previously treated with a docetaxel-containing
regimen (updated July 2016) NICE TA259
Abiraterone in combination with prednisone or
prednisolone is recommended as an option for the
treatment of castration-resistant metastatic prostate
. their disease has progressed on or after one docetaxelcontaining chemotherapy regimen, and
. the manufacturer provides abiraterone in accordance
with the commercial access arrangement as agreed with
Patients currently receiving abiraterone in combination
with prednisone or prednisolone whose disease does not
meet the first criteria should be able to continue therapy
until they and their clinician consider it appropriate to
www.nice.org.uk/guidance/ta259
▶ Abiraterone for treating metastatic hormone-relapsed
prostate cancer before chemotherapy is indicated (updated
Abiraterone, in combination with prednisone or
prednisolone, is recommended, within its marketing
authorisation, as an option for treating metastatic
hormone-relapsed prostate cancer:
. in people who have no or mild symptoms after androgen
deprivation therapy has failed, and before chemotherapy
. only when the manufacturer provides abiraterone in
accordance with the commercial access arrangement as
www.nice.org.uk/guidance/ta387
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (August
2012) that abiraterone acetate (Zytiga ®), in combination
with prednisone or prednisolone, is accepted for restricted
use within NHS Scotland for the treatment of metastatic
castration-resistant prostate cancer in patients whose
disease has progressed during or after treatment with
docetaxel-containing chemotherapy regimen, and have
received only one prior chemotherapy regimen. This
advice is contingent upon the continuing availability of
the patient access scheme in NHS Scotland.
The Scottish Medicines Consortium has advised (October
2015) that abiraterone acetate (Zytiga ®) in combination
with prednisone or prednisolone, is accepted for use
within NHS Scotland for the treatment of metastatic
castration-resistant prostate cancer in patients who are
asymptomatic or mildly symptomatic, after failure of
androgen deprivation therapy in whom chemotherapy is
not yet clinically 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.
CAUTIONARY AND ADVISORY LABELS 23
Abiraterone acetate 500 mg Zytiga 500mg tablets | 56 tablet P £2,735.00
l DRUG ACTION Apalutamide is an androgen receptor
inhibitor that decreases tumour cell proliferation and
Prostate cancer (specialist use only)
▶ Adult: 240 mg once daily, for dose adjustments due to
side-effects—consult product literature
l CONTRA-INDICATIONS History or risk of seizures
946 Hormone responsive malignancy BNF 78
Immune system and malignant disease
l CAUTIONS History or risk of QT-interval prolongation . recent cardiovascular disease
l INTERACTIONS → Appendix 1: apalutamide
▶ Common or very common Arthralgia . autoimmune
thyroiditis . bone fractures . conjunctivitis . costal cartilage
fracture . skin reactions . weight decreased
▶ Uncommon Seizure (discontinue permanently)
▶ Frequency not known QT interval prolongation
l CONCEPTION AND CONTRACEPTION Manufacturer advises
men should use condoms in combination with another
highly effective contraceptive method during treatment
and for 3 months after stopping treatment if their partner
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
severe impairment (no information available).
l RENAL IMPAIRMENT Manufacturer advises caution in
severe impairment (no information available).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Erleada (Janssen-Cilag Ltd) A
Apalutamide 60 mg Erleada 60mg tablets | 112 tablet P £2,735.00
Locally advanced prostate cancer at high risk of disease
progression either alone or as adjuvant treatment to
other medical intervention inappropriate
Advanced prostate cancer, in combination with
gonadorelin analogue or surgical castration
▶ Adult: 50 mg once daily, to be started at the same time
as surgical castration or at least 3 days before
Prostate cancer (metastatic) with the aim of retaining
l UNLICENSED USE g Bicalutamide is used in prostate
cancer (metastatic) with the aim of retaining sexual
function, hbut it is not licensed for this indication.
l CAUTIONS Risk of photosensitivity—avoid excessive
exposure to UV light and sunlight
l INTERACTIONS → Appendix 1: bicalutamide
▶ Common or very common Alopecia . anaemia . appetite
dysfunction . skin reactions . weight increased
▶ Uncommon Angioedema . interstitial lung disease
▶ Rare or very rare Photosensitivity reaction
▶ Frequency not known QT interval prolongation
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate to severe impairment (increased risk of
l MONITORING REQUIREMENTS Consider periodic liver
Risk of photosensitivity Patients should be advised to
consider the use of sunscreen.
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
▶ Bicalutamide (Non-proprietary)
Bicalutamide 50 mg Bicalutamide 50mg tablets | 28 tablet P £128.00 DT = £5.55
Bicalutamide 150 mg Bicalutamide 150mg tablets | 28 tablet P £240.00 DT = £9.60
▶ Casodex (AstraZeneca UK Ltd)
Bicalutamide 50 mg Casodex 50mg tablets | 28 tablet P £119.79 DT = £5.55
Bicalutamide 150 mg Casodex 150mg tablets | 28 tablet P £240.00 DT = £9.60
Metastatic castration-resistant prostate cancer in
patients whose disease has progressed during or after
▶ Adult: 160 mg once daily, for dose adjustments due to
side-effects, consult product literature
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Manufacturer advises if concurrent use of potent
inhibitors of CYP2C8 is unavoidable, reduce dose to
l CAUTIONS Alcoholism . bradycardia . brain injury . brain
metastases . brain tumours . history of QT-interval
prolongation . history or risk of seizure .recent
cardiovascular disease .risk factors for QT-interval
prolongation . stroke . uncontrolled hypertension
l INTERACTIONS → Appendix 1: enzalutamide
▶ Uncommon Cognitive disorder. leucopenia . neutropenia . seizure . visual hallucinations
▶ Frequency not known Back pain . diarrhoea . muscle
interval prolongation .throat oedema .thrombocytopenia . vomiting
l CONCEPTION AND CONTRACEPTION Men should use
condoms during treatment and for 3 months after
stopping treatment if their partner is pregnant, and use
condoms in combination with another effective
contraceptive method if their partner is of child-bearing
potential—toxicity in animal studies.
l RENAL IMPAIRMENT Caution in severe impairment—no
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Enzalutamide for treating metastatic hormone-relapsed
prostate cancer before chemotherapy is indicated (January
Enzalutamide is recommended as an option for treating
metastatic hormone-relapsed prostate cancer in patients
who have mild or no symptoms after androgen deprivation
therapy has failed, and before chemotherapy is indicated,
BNF 78 Hormone responsive malignancy 947
Immune system and malignant disease
and only if the manufacturer provides enzalutamide with
the discount agreed in the patient access scheme.
▶ Enzalutamide for metastatic hormone-relapsed prostate
cancer previously treated with a docetaxel-containing
regimen (July 2014) NICE TA316
Enzalutamide is recommended, within its marketing
authorisation, as an option for treating metastatic
hormone-relapsed prostate cancer in adults only if, their
enzalutamide with the discount agreed in the patient
access scheme. This guidance does not cover the use of
enzalutamide for metastatic hormone-relapsed prostate
cancer previously treated with abiraterone.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 25
▶ Xtandi (Astellas Pharma Ltd)
Enzalutamide 40 mg Xtandi 40mg capsules | 112 capsule P £2,734.67 DT = £2,734.67
Advanced prostate cancer | Metastatic prostate cancer
refractory to gonadorelin analogue therapy
l CAUTIONS Avoid excessive alcohol consumption . avoid in
Acute porphyrias p. 1058 . cardiac disease (oedema
(sometimes fatal). hepatitis (sometimes fatal). insomnia . nausea . vomiting
discomfort. gastrointestinal disorders . hair growth
cramps . oedema . photosensitivity reaction . skin reactions .thirst. vision blurred
▶ Frequency not known QT interval prolongation
l HEPATIC IMPAIRMENT Manufacturer advises caution.
l MONITORING REQUIREMENTS Liver function tests,
monthly for first 4 months, periodically thereafter and at
the first sign or symptom of liver disorder (e.g. pruritus,
dark urine, persistent anorexia, jaundice, abdominal pain,
unexplained influenza-like symptoms).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Flutamide 250 mg Flutamide 250mg tablets | 84 tablet P £106.24 DT = £106.24
Diethylstilbestrol 06-Aug-2018
Breast cancer in postmenopausal women
l CAUTIONS Cardiovascular disease
l SIDE-EFFECTS Bone pain (in breast cancer). breast
l PREGNANCY In first trimester, high doses associated with
vaginal carcinoma, urogenital abnormalities, and reduced
fertility in female offspring. Increased risk of hypospadias
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe or active
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Diethylstilbestrol (Non-proprietary)
Diethylstilbestrol 1 mg Diethylstilbestrol 1mg tablets |
28 tablet P £117.85 DT = £117.61
Diethylstilbestrol 5 mg Diethylstilbestrol 5mg tablets | 28 tablet P £185.00–£208.00 DT = £208.00
PITUITARY AND HYPOTHALAMIC HORMONES
AND ANALOGUES › ANTI-GONADOTROPHINRELEASING HORMONES
Advanced hormone-dependent prostate cancer
▶ Adult: Initially 240 mg, to be administered as
2 injections of 120 mg, then 80 mg every 28 days, dose
to be administered into the abdominal region
l CAUTIONS Diabetes . susceptibility to QT-interval
flush . influenza like illness . insomnia . musculoskeletal
discomfort. musculoskeletal pain . nausea . sexual
dysfunction . skin reactions . sweat changes .testicular
948 Hormone responsive malignancy BNF 78
Immune system and malignant disease
QT interval prolongation .renal impairment. urinary
disorders . vision blurred . vomiting
l HEPATIC IMPAIRMENT Manufacturer advises caution
(limited information available)—monitor liver function.
l RENAL IMPAIRMENT Manufacturer advises caution in
severe impairment—no information available.
l MONITORING REQUIREMENTS Monitor bone density.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Degarelix for treating advanced hormone-dependent prostate
cancer (August 2016) NICE TA404
Degarelix (Firmagon ®) is recommended as an option for
treating advanced hormone-dependent prostate cancer in
patients with spinal metastases, only if at least the same
discounted drug cost which was available to the NHS in
June 2016 is achieved by the commissioner.
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/ta404
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder and solvent for solution for injection
▶ Firmagon (Ferring Pharmaceuticals Ltd)
Degarelix (as Degarelix acetate) 80 mg Firmagon 80mg powder
and solvent for solution for injection vials | 1 vial P £129.37 DT =
Degarelix (as Degarelix acetate) 120 mg Firmagon 120mg powder
and solvent for solution for injection vials | 2 vial P £260.00 DT =
PITUITARY AND HYPOTHALAMIC HORMONES
AND ANALOGUES › SOMATOSTATIN ANALOGUES
Somatostatin analogues, malignant
Lanreotide below, octreotide p. 950 and pasireotide p. 951
are analogues of the hypothalamic release-inhibiting
hormone somatostatin. Lanreotide and octreotide are
indicated for the relief of symptoms associated with
neuroendocrine (particularly carcinoid) tumours and
acromegaly. Additionally, lanreotide is licensed for the
treatment of thyroid tumours and octreotide is also licensed
for the prevention of complications following pancreatic
surgery. Lanreotide (Somatuline Autogel ®) is also licensed for
the treatment of unresectable locally advanced or metastatic
gastroenteropancreatic neuroendocrine tumours of midgut,
pancreatic or unknown origin where hindgut sites of origin
have been excluded. Octreotide long-acting depot injection
is licensed for treatment of advanced neuroendocrine
tumours of the midgut, or treatment where primary origin is
not known but non-midgut sites of origin have been
excluded. Octreotide may also be valuable in reducing
vomiting in palliative care and in stopping variceal bleeding
[unlicensed indication]—see also vasopressin p. 669 and
terlipressin acetate p. 90. Pasireotide is licensed for the
treatment of Cushing’s disease when surgery has failed or is
l CAUTIONS Diabetes mellitus (antidiabetic requirements
may be reduced). insulinoma (increased depth and
duration of hypoglycaemia may occur—observe patients
and monitor blood glucose levels when initiating
treatment and changing doses). may cause growth
hormone-secreting pituitary tumour expansion during
treatment (causing serious complications)
(following long term use). headache . hyperglycaemia
(long term use). hypoglycaemia . myalgia . nausea . pruritus . sinus bradycardia . vomiting
▶ Monitor for signs of tumour expansion (e.g. visual field
▶ Ultrasound examination of the gallbladder is
recommended before treatment and at intervals of
l DIRECTIONS FOR ADMINISTRATION Injection sites should
Acromegaly (if somatostatin analogue not given
▶ BY DEEP SUBCUTANEOUS INJECTION
▶ Adult: Initially 60 mg every 28 days, adjusted according
to response, (consult product literature), for patients
treated previously with somatostatin analogue, consult
product literature for initial dose, dose to be given in
Neuroendocrine (particularly carcinoid) tumours
▶ BY DEEP SUBCUTANEOUS INJECTION
▶ Adult: Initially 60–120 mg every 28 days, adjusted
according to response, dose to be given in the gluteal
Unresectable locally advanced or metastatic
gastroenteropancreatic neuroendocrine tumours of
midgut, pancreatic or unknown origin where hindgut
sites of origin have been excluded
▶ BY DEEP SUBCUTANEOUS INJECTION
Acromegaly and neuroendocrine (particularly carcinoid)
▶ Adult: Initially 30 mg every 14 days, increased to 30 mg
every 7–10 days, adjusted according to response
▶ Adult: Initially 30 mg every 14 days, increased to 30 mg
every 10 days, adjusted according to response
an obstructive intestinal tumour before treatment
l INTERACTIONS → Appendix 1: lanreotide
▶ Common or very common Biliary dilatation . lethargy . musculoskeletal pain . weight decreased
▶ Uncommon Hot flush . insomnia
▶ Frequency not known Pancreatitis
l PREGNANCY Manufacturer advises use only if potential
BNF 78 Hormone responsive malignancy 949
Immune system and malignant disease
l BREAST FEEDING Manufacturer advises caution—no
l MONITORING REQUIREMENTS Monitor for hypothyroidism
l NATIONAL FUNDING/ACCESS DECISIONS
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised
(September 2018) that lanreotide (Somatuline ® Autogel ®)
is recommended as an option for use within NHS Wales for
the treatment of grade 1 and a subset of grade 2 (Ki67
index up to 10%) gastroenteropancreatic neuroendocrine
tumours of midgut, pancreatic or unknown origin where
hindgut sites of origin have been excluded, in adults with
unresectable locally advanced or metastatic disease.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Somatuline Autogel (Ipsen Ltd)
Lanreotide (as Lanreotide acetate) 120 mg per 1 ml Somatuline
Autogel 60mg/0.5ml solution for injection pre-filled syringes with
safety system | 1 pre-filled disposable injection P £551.00 DT =
Lanreotide (as Lanreotide acetate) 180 mg per 1 ml Somatuline
Autogel 90mg/0.5ml solution for injection pre-filled syringes with
safety system | 1 pre-filled disposable injection P £736.00 DT =
Lanreotide (as Lanreotide acetate) 240 mg per 1 ml Somatuline
Autogel 120mg/0.5ml solution for injection pre-filled syringes with
safety system | 1 pre-filled disposable injection P £937.00 DT =
Powder and solvent for suspension for injection
Lanreotide (as Lanreotide acetate) 30 mg Somatuline LA 30mg
powder and solvent for suspension for injection vials | 1 vial P £323.00 DT = £323.00
Symptoms associated with carcinoid tumours with
features of carcinoid syndrome, VIPomas, glucagonomas
▶ Adult: Initially 50 micrograms 1–2 times a day,
adjusted according to response; increased to
200 micrograms 3 times a day, higher doses may be
required exceptionally; maintenance doses are
variable; in carcinoid tumours, discontinue after
1 week if no effect, if rapid response required, initial
dose may be given by intravenous injection (with ECG
monitoring and after dilution)
Acromegaly, short-term treatment before pituitary
surgery or long-term treatment in those inadequately
controlled by other treatment or until radiotherapy
▶ Adult: 100–200 micrograms 3 times a day, discontinue
if no improvement within 3 months
Prevention of complications following pancreatic surgery
▶ Adult: (consult product literature)
Test dose before use of depot preparation
▶ Adult: Test dose 50–100 micrograms for 1 dose, test
dose should be given if subcutanous octreotide not
Acromegaly | Neuroendocrine (particularly carcinoid)
tumour adequately controlled by subcutaneous
▶ BY DEEP INTRAMUSCULAR INJECTION USING DEPOT INJECTION
▶ Adult: Initially 20 mg every 4 weeks for 3 months then
adjusted according to response, increased if necessary
up to 30 mg every 4 weeks, to be administered into the
gluteal muscle, for acromegaly, start depot 1 day after
the last dose of subcutaneous octreotide, for
neuroendocrine tumours, continue subcutaneous
octreotide for 2 weeks after first dose of depot
Advanced neuroendocrine tumours of the midgut, or
tumours of unknown primary origin where non-midgut
sites of origin have been excluded
▶ BY DEEP INTRAMUSCULAR INJECTION USING DEPOT INJECTION
Reduce intestinal secretions in palliative care | Reduce
vomiting due to bowel obstruction in palliative care
▶ BY CONTINUOUS SUBCUTANEOUS INFUSION
▶ Adult: 0.25–0.5 mg/24 hours (max. per dose
0.75 mg/24 hours), occasionally doses higher than the
maximum are sometimes required
l INTERACTIONS → Appendix 1: octreotide
▶ Frequency not known Hepatic disorders . pancreatitis acute
(after administration).thrombocytopenia
bedtime may reduce gastrointestinal side-effects.
l CONCEPTION AND CONTRACEPTION Effective
contraception required during treatment.
l PREGNANCY Possible effect on fetal growth; manufacturer
advises use only if potential benefit outweighs risk.
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution (risk
of increased half-life in cirrhosis).
Dose adjustments Manufacturer advises consider dose
reduction—consult product literature.
▶ Monitor thyroid function on long-term therapy.
▶ With intravenous use ECG monitoring required with
l DIRECTIONS FOR ADMINISTRATION For intravenous
injection or intravenous infusion, dilute with Sodium
Chloride 0.9% to a concentration of 10–50%.
l PRESCRIBING AND DISPENSING INFORMATION
Palliative care For further information on the use of
octreotide in palliative care, see www.medicinescomplete.
com/#/content/palliative/octreotide.
l NATIONAL FUNDING/ACCESS DECISIONS
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised
(September 2018) that octreotide (Sandostatin ® LAR ®) is
recommended as an option for use within NHS Wales for
the treatment of patients with advanced neuroendocrine
tumours of the midgut or of unknown primary origin
where non-midgut sites of origin have been excluded.
950 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.
▶ Octreotide (Non-proprietary)
Octreotide (as Octreotide acetate) 50 microgram per
1 ml Octreotide 50micrograms/1ml solution for injection pre-filled
syringes | 5 pre-filled disposable injection P £18.85 DT = £18.85
Octreotide 50micrograms/1ml solution for injection vials | 5 vial P £22.00 DT = £22.00
Octreotide 50micrograms/1ml solution for injection ampoules | 5 ampoule P £14.85–£18.60 DT = £14.87
Octreotide (as Octreotide acetate) 100 microgram per
1 ml Octreotide 100micrograms/1ml solution for injection ampoules
| 5 ampoule P £32.65 DT = £27.97
Octreotide 100micrograms/1ml solution for injection pre-filled
syringes | 5 pre-filled disposable injection P £30.34–£32.90 DT =
Octreotide 100micrograms/1ml solution for injection vials | 5 vial P £32.65 DT = £32.65
Octreotide (as Octreotide acetate) 200 microgram per
1 ml Octreotide 1mg/5ml solution for injection vials | 1 vial P £65.00 DT = £65.00
Octreotide (as Octreotide acetate) 500 microgram per
1 ml Octreotide 500micrograms/1ml solution for injection vials | 5 vial P £158.25
Octreotide 500micrograms/1ml solution for injection ampoules |
5 ampoule P £135.47–£169.35 DT = £135.47
Octreotide 500micrograms/1ml solution for injection pre-filled
syringes | 5 pre-filled disposable injection P £154.22–£169.00 DT
▶ Sandostatin (Novartis Pharmaceuticals UK Ltd)
Octreotide (as Octreotide acetate) 50 microgram per
1 ml Sandostatin 50micrograms/1ml solution for injection ampoules
| 5 ampoule P £14.87 DT = £14.87
Octreotide (as Octreotide acetate) 100 microgram per
1 ml Sandostatin 100micrograms/1ml solution for injection ampoules
| 5 ampoule P £27.97 DT = £27.97
Octreotide (as Octreotide acetate) 500 microgram per
1 ml Sandostatin 500micrograms/1ml solution for injection ampoules
| 5 ampoule P £135.47 DT = £135.47
Powder and solvent for suspension for injection
▶ Sandostatin LAR (Novartis Pharmaceuticals UK Ltd)
Octreotide (as Octreotide acetate) 10 mg Sandostatin LAR 10mg
powder and solvent for suspension for injection vials | 1 vial P £549.71 DT = £549.71
Octreotide (as Octreotide acetate) 20 mg Sandostatin LAR 20mg
powder and solvent for suspension for injection vials | 1 vial P £799.33 DT = £799.33
Octreotide (as Octreotide acetate) 30 mg Sandostatin LAR 30mg
powder and solvent for suspension for injection vials | 1 vial P £998.41 DT = £998.41
Cushing’s disease [when surgery has failed or is
▶ Adult: Initially 600 micrograms twice daily for
2 months, then increased if necessary to
900 micrograms twice daily, consider discontinuation if
no response after 2 months of treatment, for dose
adjustment due to side-effects—consult product
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: Initially 10 mg every 4 weeks, increased if
necessary up to 40 mg every 4 weeks, dose may be
titrated every 2–4 months based on response and
tolerability, consider discontinuation if no clinical
benefit observed, for dose adjustment due to sideeffects—consult product literature
Acromegaly [when surgery has failed or is inappropriate,
and control with another somatostatin analogue is
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: Initially 40 mg every 4 weeks, increased if
necessary up to 60 mg every 4 weeks, dose may be
3 months of initial dosing, for dose adjustment due to
side-effects—consult product literature
l INTERACTIONS → Appendix 1: pasireotide
▶ Common or very common Adrenal insufficiency . arthralgia . hypotension . QT interval prolongation
l PREGNANCY Manufacturer advises avoid—toxicity in
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment (risk of increased exposure); avoid
Dose adjustments ▶ With subcutaneous use for Cushing’s
disease Manufacturer advises reduce initial dose to
300 micrograms twice daily (max. dose 600 micrograms
twice daily) in moderate impairment.
▶ With intramuscular use for Cushing’s disease Manufacturer
advises max. dose 20 mg every four weeks in moderate
▶ When used for Acromegaly Manufacturer advises reduce
initial dose to 20 mg every four weeks (max. dose 40 mg
every four weeks) in moderate impairment.
l RENAL IMPAIRMENT Manufacturer advises caution in
severe impairment—increased plasma-pasireotide
▶ Manufacturer advises consider monitoring pituitary
function before treatment initiation and periodically
▶ With subcutaneous use Manufacturer advises monitor liver
function before treatment initiation, after 1, 2, 4, 8, and
12 weeks of treatment, and thereafter as clinically
indicated. Manufacturer advises assess glycaemic status
before treatment initiation, weekly for the first
2–3 months of treatment, over the first 2–4 weeks after
any dose increase, periodically thereafter, and 3 months
after treatment is complete—if glycaemic control is poor,
diabetes management and monitoring should be
intensified before and during treatment. Manufacturer
advises monitor ECG and electrolytes before treatment
initiation, after one week of treatment, and periodically
▶ With intramuscular use Manufacturer advises monitor liver
function before treatment initiation, after the first
2–3 weeks of treatment, then monthly for 3 months, and
thereafter as clinically indicated. Manufacturer advises
assess glycaemic status before treatment initiation, weekly
for the first 3 months of treatment, over the first
4–6 weeks after any dose increase, periodically thereafter,
and 3 months after treatment is complete—if glycaemic
control is poor, diabetes management and monitoring
should be intensified before and during treatment.
Manufacturer advises monitor ECG and electrolytes before
treatment initiation, after 3 weeks of treatment, and
BNF 78 Hormone responsive malignancy 951
No comments:
Post a Comment
اكتب تعليق حول الموضوع