▶ Prostap SR DCS (Takeda UK Ltd)

Leuprorelin acetate 3.75 mg Prostap SR DCS 3.75mg powder and

solvent for suspension for injection pre-filled syringes | 1 pre-filled

disposable injection P £75.24 DT = £75.24

Nafarelin

l DRUG ACTION Administration of gonadorelin analogues

produces an initial phase of stimulation; continued

administration is followed by down-regulation of

gonadotrophin-releasing hormone receptors, thereby

reducing the release of gonadotrophins (follicle

stimulating hormone and luteinising hormone) which in

turn leads to inhibition of androgen and oestrogen

production.

l INDICATIONS AND DOSE

Endometriosis

▶ BY INTRANASAL ADMINISTRATION

▶ Adult (female): 200 micrograms twice daily for

maximum 6 months (do not repeat), one spray in one

nostril in the morning, and one spray in the other

nostril in the evening (starting on days 2–4 of

menstruation).

Pituitary desensitisation before induction of ovulation by

gonadotrophins for in vitro fertilisation (under expert

supervision)

▶ BY INTRANASAL ADMINISTRATION

▶ Adult: 400 micrograms twice daily, one spray in each

nostril, to be started in early follicular phase (day 2) or,

after exclusion of pregnancy, in midluteal phase (day

21) and continued until down regulation achieved

(usually within 4 weeks) then maintained (usually for

8–12 days) during gonadotrophin administration

(stopping gonadotrophin and nafarelin on

administration of chorionic gonadotrophin at follicular

maturity), discontinue if down-regulation not achieved

within 12 weeks

l CONTRA-INDICATIONS Undiagnosed vaginal bleeding . use

longer than 6 months in the treatment of endometriosis

(do not repeat)

l CAUTIONS Patients with metabolic bone disease (decrease

in bone mineral density can occur)

l SIDE-EFFECTS

▶ Common or very common Artificial menopause . breast

abnormalities . chest pain . depression . dyspnoea . emotional lability . headaches . hirsutism . hot flush . hypersensitivity . hypertension . hypotension . insomnia . myalgia . oedema . oestrogen deficiency . paraesthesia . rhinitis . seborrhoea . sexual dysfunction . skin reactions . uterine haemorrhage . vulvovaginal dryness . weight

changes

▶ Uncommon Alopecia . arthralgia . ovarian cyst (may require

discontinuation)

▶ Frequency not known Ovarian hyperstimulation syndrome . palpitations . vision blurred

l CONCEPTION AND CONTRACEPTION Non-hormonal, barrier

methods of contraception should be used during entire

treatment period. Pregnancy should be excluded before

treatment, the first dose should be given during

menstruation or shortly afterwards or use barrier

contraception for 1 month beforehand.

l PREGNANCY Avoid.

l BREAST FEEDING Avoid.

l DIRECTIONS FOR ADMINISTRATION Avoid use of nasal

decongestants before and for at least 30 minutes after

treatment; repeat dose if sneezing occurs during or

immediately after administration.

l PATIENT AND CARER ADVICE Patients or carers should be

given advice on how to administer nafarelin nasal spray.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Spray

CAUTIONARY AND ADVISORY LABELS 10

▶ Synarel (Pfizer Ltd)

Nafarelin (as Nafarelin acetate) 200 microgram per

1 dose Synarel 200micrograms/dose nasal spray | 60 dose P £52.43 DT = £52.43

Triptorelin 27-Apr-2017

l DRUG ACTION Administration of gonadorelin analogues

produces an initial phase of stimulation; continued

administration is followed by down-regulation of

gonadotrophin-releasing hormone receptors, thereby

reducing the release of gonadotrophins (follicle

stimulating hormone and luteinising hormone) which in

turn leads to inhibition of androgen and oestrogen

production.

l INDICATIONS AND DOSE

DECAPEPTYL ® SR 11.25MG

Locally advanced non-metastatic prostate cancer as an

alternative to surgical castration | Metastatic prostate

cancer | Adjuvant treatment to radiotherapy in high-risk

localised or locally advanced prostate cancer |

Neoadjuvant treatment prior to radiotherapy in patients

with high-risk localised or locally advanced prostate

cancer | Adjuvant treatment to radical prostatectomy in

patients with locally advanced prostate cancer at high

risk of disease progression

▶ BY INTRAMUSCULAR INJECTION

▶ Adult: 11.25 mg every 3 months

Endometriosis

▶ BY INTRAMUSCULAR INJECTION

▶ Adult: 11.25 mg every 3 months for maximum

6 months (not to be repeated), to be started during first

5 days of menstrual cycle

DECAPEPTYL ® SR 22.5MG

Locally advanced non-metastatic prostate cancer as an

alternative to surgical castration | Metastatic prostate

cancer | Adjuvant treatment to radiotherapy in high-risk

localised or locally advanced prostate cancer |

Neoadjuvant treatment prior to radiotherapy in patients

with high-risk localised or locally advanced prostate

cancer | Adjuvant treatment to radical prostatectomy in

patients with locally advanced prostate cancer at high

risk of disease progression

▶ BY INTRAMUSCULAR INJECTION

▶ Adult: 22.5 mg every 6 months

DECAPEPTYL ® SR 3MG

Locally advanced non-metastatic prostate cancer as an

alternative to surgical castration | Metastatic prostate

cancer | Adjuvant treatment to radiotherapy in high-risk

localised or locally advanced prostate cancer |

Neoadjuvant treatment prior to radiotherapy in patients

with high-risk localised or locally advanced prostate

cancer | Adjuvant treatment to radical prostatectomy in

patients with locally advanced prostate cancer at high

risk of disease progression

▶ BY INTRAMUSCULAR INJECTION

▶ Adult: 3 mg every 4 weeks

Endometriosis

▶ BY INTRAMUSCULAR INJECTION

▶ Adult: 3 mg every 4 weeks maximum duration of

6 months (not to be repeated), to be started during first

5 days of menstrual cycle continued→

BNF 78 Gonadotrophin responsive conditions 741

Endocrine system

6

Reduction in size of uterine fibroids

▶ BY INTRAMUSCULAR INJECTION

▶ Adult: 3 mg every 4 weeks for at least 3 months,

maximum duration of treatment 6 months (not to be

repeated), to be started during first 5 days of menstrual

cycle

GONAPEPTYL DEPOT ®

Advanced prostate cancer

▶ BY SUBCUTANEOUS INJECTION, OR BY DEEP INTRAMUSCULAR

INJECTION

▶ Adult: 3.75 mg every 4 weeks

Endometriosis | Reduction in size of uterine fibroids

▶ BY SUBCUTANEOUS INJECTION, OR BY DEEP INTRAMUSCULAR

INJECTION

▶ Adult: 3.75 mg every 4 weeks maximum duration of

6 months (not to be repeated), to be started during first

5 days of menstrual cycle

SALVACYL ®

Male hypersexuality with severe sexual deviation

▶ BY INTRAMUSCULAR INJECTION

▶ Adult: 11.25 mg every 12 weeks

l CONTRA-INDICATIONS In endometriosis do not use for

longer than 6 months (do not repeat). undiagnosed

vaginal bleeding

SALVACYL ® Severe osteoporosis

l CAUTIONS

GENERAL CAUTIONS Patients with metabolic bone disease

(decrease in bone mineral density can occur)

SPECIFIC CAUTIONS

▶ When used for prostate cancer Risk factors for osteoporosis . risk of spinal cord compression in men .risk of ureteric

obstruction in men

SALVACYL ® Increased risk of sensitivity to restored

testosterone if treatment interrupted—consider

administration of an antiandrogen before stopping

treatment.transient increase in serum testosterone occurs

on initiation—consider administration of an antiandrogen

l SIDE-EFFECTS

▶ Common or very common Asthenia . depression . dizziness . dysuria . gastrointestinal discomfort. gynaecomastia . haemorrhage . headache . hot flush . hyperhidrosis . hypersensitivity . joint disorders . menstrual cycle

irregularities . mood altered . muscle complaints . nausea . oedema . ovarian and fallopian tube disorders . pain . painful sexual intercourse . paraesthesia . pelvic pain . sexual dysfunction . sleep disorders . vulvovaginal dryness

▶ Uncommon Alopecia . appetite abnormal . asthma

exacerbated . breast pain . chills . constipation . diarrhoea . drowsiness . dry mouth . dyspnoea . embolism . gout. hypertension . muscle weakness . skin reactions .testicular

disorders .tinnitus . vision disorders . vomiting . weight

changes

▶ Rare or very rare Abnormal sensation in eye . chest pain . confusion . diabetes mellitus . difficulty standing .fever. flatulence . hypotension . influenza like illness . memory

loss . musculoskeletal stiffness . nasopharyngitis . orthopnoea . osteoarthritis .taste altered . vertigo

▶ Frequency not known Angioedema . anxiety . bone disorder . malaise . QT interval prolongation

SIDE-EFFECTS, FURTHER INFORMATION During the initial

stage increased production of testosterone may be

associated with progression of prostate cancer. In

susceptible patients this tumour ‘flare’ may cause spinal

cord compression, ureteric obstruction or increased pain.

l CONCEPTION AND CONTRACEPTION Non-hormonal, barrier

methods of contraception should be used during entire

treatment period. Pregnancy should be excluded before

treatment, the first injection should be given during

menstruation or shortly afterwards or use barrier

contraception for 1 month beforehand.

l PREGNANCY Avoid.

l BREAST FEEDING Avoid.

l MONITORING REQUIREMENTS

▶ When used for Prostate cancer Men at risk of tumour ‘flare’

should be monitored closely during the first month of

therapy.

l DIRECTIONS FOR ADMINISTRATION Rotate injection site to

prevent atrophy and nodule formation.

l PRESCRIBING AND DISPENSING INFORMATION

DECAPEPTYL ® SR 22.5MG Each vial includes an overage to

allow accurate administration of a 22.5 mg dose.

DECAPEPTYL ® SR 3MG Each vial includes an overage to

allow accurate administration of 3 mg dose.

DECAPEPTYL ® SR 11.25MG Each vial includes an overage

to allow accurate administration of an 11.25 mg dose.

l NATIONAL FUNDING/ACCESS DECISIONS

All Wales Medicines Strategy Group (AWMSG) decisions

The All Wales Medicines Strategy Group has advised (March

2017) that triptorelin (Decapeptyl ® SR) is recommended as

an option for use within NHS Wales as an adjuvant

treatment to radiotherapy and as a neoadjuvant treatment

prior to radiotherapy, in patients with high-risk localised

or locally advanced prostate cancer.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Powder and solvent for suspension for injection

▶ Decapeptyl SR (Ipsen Ltd)

Triptorelin (as Triptorelin acetate) 3 mg Decapeptyl SR 3mg

powder and solvent for suspension for injection vials | 1 vial P £69.00 DT = £69.00

Triptorelin 11.25 mg Decapeptyl SR 11.25mg powder and solvent for

suspension for injection vials | 1 vial P £207.00 DT = £207.00

Triptorelin (as Triptorelin embonate) 22.5 mg Decapeptyl SR

22.5mg powder and solvent for suspension for injection vials | 1 vial P £414.00 DT = £414.00

▶ Gonapeptyl Depot (Ferring Pharmaceuticals Ltd)

Triptorelin (as Triptorelin acetate) 3.75 mg Gonapeptyl Depot

3.75mg powder and solvent for suspension for injection pre-filled

syringes | 1 pre-filled disposable injection P £81.69 DT = £81.69

▶ Salvacyl (Ipsen Ltd)

Triptorelin 11.25mg Salvacyl 11.25 mg powder and solvent for

suspension for injection vials | 1 vial P £248.00 DT = £207.00

6.1 Hereditary angioedema

PITUITARY AND HYPOTHALAMIC HORMONES

AND ANALOGUES › ANTI-GONADOTROPHINRELEASING HORMONES

Danazol 08-Mar-2017

l DRUG ACTION Danazol inhibits pituitary gonadotrophins;

it combines androgenic activity with antioestrogenic and

antiprogestogenic activity.

l INDICATIONS AND DOSE

Endometriosis

▶ BY MOUTH

▶ Adult: 200–800 mg daily in up to 4 divided doses

usually for 3–6 months, dose to be adjusted to achieve

amenorrhoea, in women of child-bearing potential,

treatment should start during menstruation, preferably

on day 1

742 Gonadotrophin responsive conditions BNF 78

Endocrine system

6

Severe pain and tenderness in benign fibrocystic breast

disease not responding to other treatment

▶ BY MOUTH

▶ Adult: 300 mg daily in divided doses usually for

3–6 months, in women of child-bearing potential,

treatment should start during menstruation, preferably

on day 1

Hereditary angioedema

▶ BY MOUTH

▶ Adult: Initially 100–200 mg daily, dose to be reduced

according to response, in women of child-bearing

potential, treatment should start during menstruation,

preferably on day 1

l UNLICENSED USE Not licensed for use in hereditary

angioedema.

l CONTRA-INDICATIONS Acute porphyrias p. 1058 . androgen-dependent tumours .thromboembolic disease . undiagnosed genital bleeding

l CAUTIONS Cardiac impairment (avoid if severe). diabetes

mellitus . elderly . epilepsy . history of thrombosis or

thromboembolic disease . hypertension . lipoprotein

disorder. migraine . polycythaemia

l INTERACTIONS → Appendix 1: danazol

l SIDE-EFFECTS Alopecia . aminolevulinic acid synthetase

induction . anxiety . appetite increased . breast atrophy . carpal tunnel syndrome . clitoris enlarged . contact lens

intolerance . cutaneous lupus erythematosus . depressed

mood . dizziness . embolism and thrombosis . emotional

lability . eosinophilia . epigastric pain . epilepsy

exacerbated . face oedema . fatigue . fever. fluid retention . flushing . glucose tolerance impaired . haematuria . headaches . hepatic disorders . hirsutism . hypertension . idiopathic intracranial hypertension . insulin resistance . joint disorders . leucopenia . libido disorder. menstrual

cycle irregularities . muscle contractions involuntary . muscle cramps . myocardial infarction . nausea . neoplasms . pain . palpitations . pancreatitis . photosensitivity

reaction . polycythaemia .respiratory disorders . seborrhoea . skin reactions . speech pitch disorder. spermatogenesis reduced . splenic peliosis .tachycardia . throat pain .thrombocytopenia .tremor. vertigo . vision

disorders . voice alteration . vulvovaginal disorders . weight

increased

SIDE-EFFECTS, FURTHER INFORMATION Withdraw if

virilisation effects occur—may be irreversible on continued

use.

l CONCEPTION AND CONTRACEPTION Ensure patients with

amenorrhoea are not pregnant. Non-hormonal

contraceptive methods should be used, if appropriate.

l PREGNANCY Avoid; has weak androgenic effects and

virilisation of female fetus reported.

l BREAST FEEDING No data available but avoid because of

possible androgenic effects in infant.

l HEPATIC IMPAIRMENT Manufacturer advises caution; avoid

in marked impairment.

l RENAL IMPAIRMENT Caution in renal impairment (avoid if

severe).

l MONITORING REQUIREMENTS Manufacturer advises

periodic monitoring of hepatic function and

haematological state (including biannual hepatic

ultrasonography for treatment exceeding 6 months or

repeated courses of treatment).

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: capsule

Capsule

▶ Danazol (Non-proprietary)

Danazol 100 mg Danazol 100mg capsules | 28 capsule P £18.40

DT = £

Danazol 200 mg

7.64e Danazol 200mg capsules | 56 capsule P

£

Danol

30.27–

(Sanofi)

£66.20 DT = £30.27e

Danazol 100 mg Danol 100mg capsules | 60 capsule P £

Danazol 200 mg

16.38e Danol 200mg capsules | 60 capsule P £32.43e

7 Hypothalamic and anterior

pituitary hormone related

disorders

Hypothalamic and anterior pituitary

hormones

Anterior pituitary hormones

Corticotrophins

Tetracosactide p. 744 (tetracosactrin), an analogue of

corticotropin (ACTH), is used to test adrenocortical function;

failure of the plasma cortisol concentration to rise after

administration of tetracosactide indicates adrenocortical

insufficiency.

Both corticotropin and tetracosactide were formerly used

as alternatives to corticosteroids in conditions such as

Crohn’s disease; their value was limited by the variable and

unpredictable therapeutic response and by the waning of

their effect with time.

Gonadotrophins

Follicle-stimulating hormone (FSH) and luteinising hormone

(LH) together, or follicle-stimulating hormone alone (as in

follitropin), are used in the treatment of infertility in

women with proven hypopituitarism or who have not

responded to clomifene citrate p. 766, or in superovulation

treatment for assisted conception (such as in vitro

fertilisation).

The gonadotrophins are also occasionally used in the

treatment of hypogonadotrophic hypogonadism and

associated oligospermia. There is no justification for their

use in primary gonadal failure.

Growth hormone

Growth hormone is used to treat deficiency of the hormone

in children and in adults. In children it is used in PraderWilli syndrome, Turner syndrome, chronic renal

insufficiency, short children considered small for gestational

age at birth, and short stature homeobox-containing gene

(SHOX) deficiency.

Growth hormone of human origin (HGH; somatotrophin)

has been replaced by a growth hormone of human sequence,

somatropin p. 748, produced using recombinant DNA

technology.

Mecasermin, a human insulin-like growth factor-I (rhIGFI), is licensed to treat growth failure in children and

adolescents with severe primary insulin-like growth factor-I

deficiency.

Hypothalamic hormones

Gonadorelin p. 744 when injected intravenously in normal

subjects leads to a rapid rise in plasma concentrations of

both luteinising hormone (LH) and follicle-stimulating

hormone (FSH). It has not proved to be very helpful,

BNF 78 Hypothalamic and anterior pituitary hormone related disorders 743

Endocrine system

6

however, in distinguishing hypothalamic from pituitary

lesions. Gonadorelin analogues are indicated in

endometriosis and infertility and in breast and prostate

cancer.

7.1 Adrenocortical function

testing

PITUITARY AND HYPOTHALAMIC HORMONES

AND ANALOGUES › CORTICOTROPHINS

Tetracosactide

(Tetracosactrin)

l INDICATIONS AND DOSE

Diagnosis of adrenocortical insufficiency (diagnostic

30-minute test)

▶ BY INTRAVENOUS INJECTION, OR BY INTRAMUSCULAR

INJECTION

▶ Adult: 250 micrograms for 1 dose

Diagnosis of adrenocortical insufficiency (diagnostic

5-hour test)

▶ BY INTRAMUSCULAR INJECTION USING DEPOT INJECTION

▶ Adult: 1 mg for 1 dose

Alternative to corticosteroids in conditions such as

Crohn’s disease or rheumatoid arthritis (formerly used

but value was limited by the variable and unpredictable

therapeutic response and by the waning of effect with

time)

▶ BY INTRAMUSCULAR INJECTION USING DEPOT INJECTION

▶ Adult: Initially 1 mg daily, alternatively initially 1 mg

every 12 hours, (in acute cases), then reduced to 1 mg

every 2–3 days, followed by 1 mg once weekly,

alternatively 500 micrograms every 2–3 days

l CONTRA-INDICATIONS Acute psychosis . adrenogenital

syndrome . allergic disorders . asthma . avoid injections

containing benzyl alcohol in neonates . Cushing’s

syndrome . infectious diseases . peptic ulcer. primary

adrenocortical insufficiency .refractory heart failure

l CAUTIONS Active infectious diseases (should not be used

unless adequate disease-specific therapy is being given). active systemic diseases (should not be used unless

adequate disease-specific therapy is being given). diabetes

mellitus . diverticulitis . history of asthma . history of

atopic allergy . history of eczema . history of hayfever. history of hypersensitivity . hypertension . latent

amoebiasis (may become activated). latent tuberculosis

(may become activated). myasthenia gravis . ocular herpes

simplex . osteoporosis . predisposition to thromboembolic . pscyhological disturbances may be triggered .recent

intestinal anastomosis .reduced immune response (should

not be used unless adequate disease-specific therapy is

being given). ulcerative colitis

CAUTIONS, FURTHER INFORMATION

▶ Risk of anaphylaxis Should only be administered under

medical supervision. Consult product literature.

▶ Hypertension Patients already receiving medication for

moderate to severe hypertension must have their dosage

adjusted if treatment started.

▶ Diabetes mellitus Patients already receiving medication for

diabetes mellitus must have their dosage adjusted if

treatment started.

l SIDE-EFFECTS Abdominal distension . abscess . adrenocortical unresponsiveness . angioedema . appetite

increased . bone fractures . congestive heart failure . Cushing’s syndrome . diabetes mellitus exacerbated . dizziness . dyspnoea . electrolyte imbalance .

exophthalmos . fluid retention . flushing . gastrointestinal

disorders . glaucoma . growth retardation . haemorrhage . headache . healing impaired . hirsutism . hyperglycaemia . hyperhidrosis . hypersensitivity (may be more severe in

patients susceptible to allergies, especially asthma). hypertension . idiopathic intracranial hypertension

exacerbated . increased risk of infection . leucocytosis . malaise . menstruation irregular. muscle weakness . myopathy . nausea . osteonecrosis . osteoporosis . pancreatitis . papilloedema . pituitary unresponsiveness . posterior subcapsular cataract. protein catabolism . psychiatric disorder. seizure . skin reactions .tendon

rupture .thromboembolism . vasculitis necrotising . vertigo . vomiting . weight increased

l ALLERGY AND CROSS-SENSITIVITY Contra-indicated in

patients with history of hypersensitivity to

tetracosactide/corticotrophins or excipients.

l PREGNANCY Avoid (but may be used diagnostically if

essential).

l BREAST FEEDING Avoid (but may be used diagnostically if

essential).

l HEPATIC IMPAIRMENT For depot injection, manufacturer

advises caution in cirrhosis (may enhance effect of

tetracosactide therapy).

l RENAL IMPAIRMENT Use with caution in patients with

renal impairment.

l EFFECT ON LABORATORY TESTS May suppress skin test

reactions.

Post administration total plasma cortisol levels during

30-minute test for diagnosis of adrenocotical insufficiency

might be misleading due to altered cortisol binding

globulin levels in some special clinical situations

including, patients on oral contraceptives, post-operative

patients, critical illness, severe liver disease and nephrotic

syndrome.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for injection

▶ Synacthen (Mallinckrodt Specialty Pharmaceuticals Ireland Ltd)

Tetracosactide acetate 250 microgram per 1 ml Synacthen

250micrograms/1ml solution for injection ampoules | 1 ampoule P £38.00 DT = £38.00

Suspension for injection

EXCIPIENTS: May contain Benzyl alcohol

▶ Synacthen Depot (Mallinckrodt Specialty Pharmaceuticals Ireland

Ltd)

Tetracosactide acetate 1 mg per 1 ml Synacthen Depot 1mg/1ml

suspension for injection ampoules | 1 ampoule P £346.28 DT =

£346.28

7.2 Assessment of pituitary

function

PITUITARY AND HYPOTHALAMIC HORMONES

AND ANALOGUES › GONADOTROPIN-RELEASING

HORMONES

Gonadorelin

(Gonadotrophin-releasing hormone; GnRH; LH–

RH)

l INDICATIONS AND DOSE

Assessment of pituitary function

▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAVENOUS INJECTION

▶ Adult: 100 micrograms for 1 dose

l CAUTIONS Pituitary adenoma

744 Hypothalamic and anterior pituitary hormone related disorders BNF 78

Endocrine system

6

l SIDE-EFFECTS

▶ Uncommon Pain . skin reactions . swelling

▶ Rare or very rare Abdominal discomfort. bronchospasm . dizziness . eye erythema . flushing . headache . nausea . tachycardia

▶ Frequency not known Menorrhagia . sepsis . thrombophlebitis

l PREGNANCY Avoid.

l BREAST FEEDING Avoid.

l MEDICINAL FORMS No licensed medicines listed.

7.3 Gonadotrophin replacement

therapy

GONADOTROPHINS

Choriogonadotropin alfa

(Human chorionic gonadotropin)

l INDICATIONS AND DOSE

Treatment of infertility in women with proven

hypopituitarism or who have not responded to clomifene

| Superovulation treatment for assisted conception (such

as in vitro fertilisation)

▶ BY SUBCUTANEOUS INJECTION

▶ Adult (female): Adjusted according to response.

l CONTRA-INDICATIONS Active thromboembolic disorders . ectopic pregnancy in previous 3 months . hypothalamus

malignancy . mammary malignancy . ovarian enlargement

or cyst (unless caused by polycystic ovarian disease). ovarian malignancy . pituitary malignancy . uterine

malignancy

l CAUTIONS Acute porphyrias p. 1058

l SIDE-EFFECTS

▶ Common or very common Abdominal pain . fatigue . headache . nausea . ovarian hyperstimulation syndrome . vomiting

▶ Uncommon Breast pain . depression . diarrhoea . irritability .restlessness

▶ Rare or very rare Rash . shock .thromboembolism

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for injection

▶ Ovitrelle (Merck Serono Ltd)

Choriogonadotropin alfa 500 microgram per 1 ml Ovitrelle

250micrograms/0.5ml solution for injection pre-filled syringes | 1 preOvitrelle

filled disposable injection

250micrograms/0

P.5ml solution for injection pre-filled pen

£37.66 DT = £37.66e

| 1 pre-filled disposable injection P £37.66 DT = £37.66e

Follitropin alfa

(Recombinant human follicle stimulating

hormone)

l INDICATIONS AND DOSE

Infertility in women with proven hypopituitarism or who

have not responded to clomifene | Superovulation

treatment for assisted conception (such as in vitro

fertilisation)

▶ BY SUBCUTANEOUS INJECTION

▶ Adult (female): Adjusted according to response.

Hypogonadotrophic hypogonadism

▶ BY SUBCUTANEOUS INJECTION

▶ Adult (male): (consult product literature).

l CONTRA-INDICATIONS Ovarian cysts (not caused by

polycystic ovarian syndrome). ovarian enlargement (not

caused by polycystic ovarian syndrome).tumours of breast .tumours of hypothalamus .tumours of ovaries .tumours

of pituitary .tumours of prostate .tumours of testes . tumours of uterus . vaginal bleeding of unknown cause

l CAUTIONS Acute porphyrias p. 1058 . history of tubal

disease

l SIDE-EFFECTS

▶ Common or very common Acne . diarrhoea . gastrointestinal

discomfort. gynaecomastia . headache . nausea . ovarian

and fallopian tube disorders . varicocele . vomiting . weight

increased

▶ Rare or very rare Asthma exacerbated .thromboembolism

l PREGNANCY Avoid.

l BREAST FEEDING Avoid.

l PRESCRIBING AND DISPENSING INFORMATION Follitropin

alfa is a biological medicine. Biological medicines must be

prescribed and dispensed by brand name, see Biological

medicines and Biosimilar medicines, under Guidance on

prescribing p. 1.

l PATIENT AND CARER ADVICE

Conception and contraception Patients planning to

conceive should be warned that there is a risk of multiple

pregnancy.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for injection

▶ Bemfola (Gedeon Richter (UK) Ltd) A

Follitropin alfa 600 unit per 1 ml Bemfola 225units/0.375ml

solution for injection pre-filled pen | 1 pre-filled disposable

injection P £70.50

Bemfola 300units/0.5ml solution for injection pre-filled pen | 1 prefilled disposable injection P £94.00

Bemfola 150units/0.25ml solution for injection pre-filled pen | 1 prefilled disposable injection P £47.00

Bemfola 75units/0.125ml solution for injection pre-filled pen | 1 prefilled disposable injection P £23.50

Bemfola 450units/0.75ml solution for injection pre-filled pen | 1 prefilled disposable injection P £141.00

▶ Gonal-f (Merck Serono Ltd)

Follitropin alfa 600 unit per 1 ml Gonal-f 900units/1.5ml solution

for injection pre-filled pen | 1 pre-filled disposable injection P £338.40

Gonal-f 300units/0.5ml solution for injection pre-filled pen | 1 prefilled disposable injection P £112.80

Gonal-f 450units/0.75ml solution for injection pre-filled pen | 1 prefilled disposable injection P £169.20

▶ Ovaleap (Theramex HQ UK Ltd)

Follitropin alfa 600 unit per 1 ml Ovaleap 450units/0.75ml solution

for injection cartridges | 1 cartridge P £112.80

Ovaleap 900units/1.5ml solution for injection cartridges | 1 cartridge P £225.60

Ovaleap 300units/0.5ml solution for injection cartridges |

1 cartridge P £75.20

Powder and solvent for solution for injection

▶ Gonal-f (Merck Serono Ltd)

Follitropin alfa 75 unit Gonal-f 75unit powder and solvent for

solution for injection vials | 1 vial P £25.22

Follitropin alfa 450 unit Gonal-f 450unit powder and solvent for

solution for injection vials | 1 vial P £151.32

Follitropin alfa 1050 unit Gonal-f 1,050unit powder and solvent for

solution for injection vials | 1 vial P £353.06

BNF 78 Gonadotrophin replacement therapy 745

Endocrine system

6

Follitropin alfa with lutropin alfa

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, follitropin alfa p. 745, lutropin alfa below.

l INDICATIONS AND DOSE

Infertility in women with proven hypopituitarism or who

have not responded to clomifene | Superovulation

treatment for assisted conception (such as in vitro

fertilisation)

▶ BY SUBCUTANEOUS INJECTION

▶ Adult (female): Adjusted according to response.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Powder and solvent for solution for injection

ELECTROLYTES: May contain Sodium

▶ Pergoveris (Merck Serono Ltd)

Lutropin alfa 75 unit, Follitropin alfa 150 unit Pergoveris

150unit/75unit powder and solvent for solution for injection vials |

1 vial P £72.35

Follitropin delta 06-Sep-2017

l DRUG ACTION Follitropin delta is a recombinant human

follicle stimulating hormone, which causes development

of multiple mature follicles.

l INDICATIONS AND DOSE

Superovulation treatment for assisted conception (such

as in vitro fertilisation) (initiated under specialist

supervision)

▶ BY SUBCUTANEOUS INJECTION

▶ Adult (female): Initial dosing based on serum antiMüllerian hormone concentration and body-weight—

consult product literature.

l CONTRA-INDICATIONS Ovarian cysts (not caused by

polycystic ovarian syndrome). ovarian enlargement (not

caused by polycystic ovarian syndrome).tumours of breast .tumours of hypothalamus .tumours of ovaries .tumours

of pituitary .tumours of uterus . vaginal bleeding of

unknown cause

l CAUTIONS Acute porphyrias p. 1058 . history of tubal

disease (increased risk of ectopic pregnancy)

l SIDE-EFFECTS

▶ Common or very common Fatigue . headache . nausea . ovarian and fallopian tube disorders . pelvic disorders . uterine pain

▶ Uncommon Abdominal discomfort. breast abnormalities . constipation . diarrhoea . dizziness . drowsiness . mood

swings . vaginal haemorrhage . vomiting

▶ Rare or very rare Thromboembolism

SIDE-EFFECTS, FURTHER INFORMATION If ovarian

hyperstimulation syndrome occurs, the patient should be

advised to withhold hCG and avoid intercourse or use

barrier contraceptive methods for at least 4 days.

l PREGNANCY Manufacturer advises avoid—not indicated

during pregnancy.

l BREAST FEEDING Manufacturer advises avoid—not

indicated during breastfeeding.

l MONITORING REQUIREMENTS Manufacturer advises

regular monitoring of ovarian response with ultrasound

alone, or in combination with serum estradiol levels.

Frequent monitoring of follicular development is required

to reduce the risk of ovarian hyperstimulation syndrome

during treatment, and for at least 2 weeks after triggering

of final follicular maturation—consult product literature.

l DIRECTIONS FOR ADMINISTRATION Manufacturer

recommends the cartridge should be used with the

Rekovelle ® injection pen. The first injection should be

performed under direct medical supervision; selfadministration should only be performed by patients who

are well motivated, adequately trained and have access to

expert advice.

l PRESCRIBING AND DISPENSING INFORMATION Follitropin

delta is a biological medicine. Biological medicines must

be prescribed and dispensed by brand name, see Biological

medicines and Biosimilar medicines, under Guidance on

prescribing p. 1.

l HANDLING AND STORAGE Manufacturer advises store in a

refrigerator (2–8 °C)—consult product literature for

further information regarding storage conditions outside

refrigerator.

l PATIENT AND CARER ADVICE

Conception and contraception Manufacturer advises that

patients planning to conceive should be warned that there

is a risk of multiple pregnancy.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for injection

▶ Rekovelle (Ferring Pharmaceuticals Ltd) A

Follitropin delta 33.33 microgram per 1 ml Rekovelle

12micrograms/0.36ml solution for injection cartridges | 1 cartridge P £118.31

Rekovelle 36micrograms/1.08ml solution for injection cartridges | 1 cartridge P £354.94

Rekovelle 72micrograms/2.16ml solution for injection cartridges |

1 cartridge P £709.89

Lutropin alfa

(Recombinant human luteinising hormone)

l INDICATIONS AND DOSE

Treatment of infertility in women with proven

hypopituitarism or who have not responded to clomifene

(in conjunction with follicle-stimulating hormone)|

Superovulation treatment for assisted conception (such

as in vitro fertilisation) (in conjunction with folliclestimulating hormone)

▶ BY SUBCUTANEOUS INJECTION

▶ Adult (female): Adjusted according to response.

l CONTRA-INDICATIONS Mammary carcinoma . ovarian

carcinoma . ovarian enlargement or cyst (unless caused by

polycystic ovarian disease).tumours of hypothalamus . tumours of pituitary . undiagnosed vaginal bleeding . uterine carcinoma

l CAUTIONS Acute porphyrias p. 1058

l SIDE-EFFECTS

▶ Common or very common Breast pain . diarrhoea . gastrointestinal discomfort. headache . nausea . ovarian

and fallopian tube disorders . pelvic pain . vomiting

▶ Rare or very rare Thromboembolism

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Powder and solvent for solution for injection

▶ Luveris (Merck Serono Ltd)

Lutropin alfa 75 unit Luveris 75unit powder and solvent for solution

for injection vials | 1 vial P £31.38

746 Hypothalamic and anterior pituitary hormone related disorders BNF 78

Endocrine system

6

Menotrophin

l INDICATIONS AND DOSE

Infertility in women with proven hypopituitarism or who

have not responded to clomifene | Superovulation

treatment for assisted conception (such as in vitro

fertilisation)

▶ BY SUBCUTANEOUS INJECTION, OR BY DEEP INTRAMUSCULAR

INJECTION

▶ Adult (female): Adjusted according to response.

Hypogonadotrophic hypogonadism

▶ BY DEEP INTRAMUSCULAR INJECTION, OR BY SUBCUTANEOUS

INJECTION

▶ Adult (male): (consult product literature).

l CONTRA-INDICATIONS Ovarian cysts (not caused by

polycystic ovarian syndrome). ovarian enlargement (not

caused by polycystic ovarian syndrome).tumours of breast .tumours of hypothalamus .tumours of ovaries .tumours

of pituitary .tumours of prostate .tumours of testes . tumours of uterus . vaginal bleeding of unknown cause

l CAUTIONS Acute porphyrias p. 1058 . history of tubal

disease

l SIDE-EFFECTS

▶ Common or very common Gastrointestinal discomfort. headache . nausea . ovarian hyperstimulation syndrome . pelvic pain . vomiting

▶ Uncommon Deep vein thrombosis

l PREGNANCY Avoid.

l BREAST FEEDING Avoid.

l PRESCRIBING AND DISPENSING INFORMATION

Menotrophin is purified extract of human postmenopausal urine containing follicle-stimulating

hormone (FSH) and luteinising hormone (LH) in a ratio of

1:1

l PATIENT AND CARER ADVICE

Conception and contraception Patients planning to

conceive should be warned that there is a risk of multiple

pregnancy.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Powder and solvent for solution for injection

▶ Menopur (Ferring Pharmaceuticals Ltd)

Menotrophin 75 unit Menopur 75unit powder and solvent for

solution for injection vials | 10 vial P £180.18 DT = £180.18

Menotrophin 150 unit Menopur 150unit powder and solvent for

solution for injection vials | 10 vial P £360.36 DT = £360.36

Menotrophin 600 unit Menopur 600unit powder and solvent for

solution for injection vials | 1 vial P £144.14 DT = £144.14

Menotrophin 1200 unit Menopur 1,200unit powder and solvent for

solution for injection vials | 1 vial P £288.29 DT = £288.29

▶ Meriofert (Pharmasure Ltd) A

Menotrophin 75 unit Meriofert 75unit powder and solvent for

solution for injection vials | 10 vial P £279.00 DT = £180.18

Menotrophin 150 unit Meriofert 150unit powder and solvent for

solution for injection vials | 10 vial P £558.00 DT = £360.36

▶ Merional (Pharmasure Ltd)

Menotrophin 75 unit Merional 75unit powder and solvent for

solution for injection vials | 10 vial P £279.00 DT = £180.18

Menotrophin 150 unit Merional 150unit powder and solvent for

solution for injection vials | 10 vial P £558.00 DT = £360.36

Urofollitropin

l INDICATIONS AND DOSE

Infertility in women with proven hypopituitarism or who

have not responded to clomifene | Superovulation

treatment for assisted conception (such as in vitro

fertilisation)

▶ BY SUBCUTANEOUS INJECTION, OR BY DEEP INTRAMUSCULAR

INJECTION

▶ Adult (female): Adjusted according to response.

l CONTRA-INDICATIONS Ovarian cysts (not caused by

polycystic ovarian syndrome).tumours of breast.tumours

of hypothalamus .tumours of ovaries .tumours of pituitary .tumours of uterus . vaginal bleeding of unknown cause

l CAUTIONS Acute porphyrias p. 1058

l SIDE-EFFECTS

▶ Common or very common Breast tenderness . constipation . diarrhoea . gastrointestinal discomfort. headache . hot

flush . increased risk of infection . muscle spasms . nausea . ovarian hyperstimulation syndrome . pain . pelvic pain . rash . vaginal discharge . vaginal haemorrhage . vomiting

l PREGNANCY Avoid.

l BREAST FEEDING Avoid.

l PRESCRIBING AND DISPENSING INFORMATION

Urofollitropin is purified extract of human postmenopausal urine containing follicle-stimulating

hormone (FSH).

l PATIENT AND CARER ADVICE

Conception and contraception Patients planning to

conceive should be warned that there is a risk of multiple

pregnancy.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Powder and solvent for solution for injection

▶ Fostimon (Pharmasure Ltd)

Follicle stimulating hormone human (as Urofollitropin)

75 unit Fostimon 75unit powder and solvent for solution for injection

vials | 10 vial P £279.00

Follicle stimulating hormone human (as Urofollitropin)

150 unit Fostimon 150unit powder and solvent for solution for

injection vials | 10 vial P £558.00

7.4 Growth hormone disorders

Other drugs used for Growth hormone disorders

Pasireotide, p. 951

PITUITARY AND HYPOTHALAMIC HORMONES

AND ANALOGUES › GROWTH HORMONE

RECEPTOR ANTAGONISTS

Pegvisomant 30-Nov-2018

l DRUG ACTION Pegvisomant is a genetically modified

analogue of human growth hormone and is a highly

selective growth hormone receptor antagonist.

l INDICATIONS AND DOSE

Treatment of acromegaly in patients with inadequate

response to surgery, radiation, or both, and to treatment

with somatostatin analogues (initiated by a specialist)

▶ BY SUBCUTANEOUS INJECTION

▶ Adult: Initially 80 mg for 1 dose, followed by 10 mg

daily, then increased in steps of 5 mg daily, adjusted

according to response; maximum 30 mg per day

l CAUTIONS Abnormal liver function tests and/or signs or

symptoms of liver injury (further investigations may be

BNF 78 Growth hormone disorders 747

Endocrine system

6

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