6.5.1 Hypothalamic and anterior pituitary hormones and anti-oestrogens 409

BNF 57 6.5.1 Hypothalamic and anterior pituitary hormones and anti-oestrogens 409

FOLLITROPIN ALFA and BETA

Dose

(Recombinant human follicle stimulating . By deep intramuscular or subcutaneous injection , hormone)

according to patient’s response Indications see notes above

Menotrophin

Cautions

see under Human Menopausal Gonadotro- Purified extract of human post-menopausal urine con- phins; acute porphyria (section 9.8.2)

taining follicle-stimulating hormone (FSH) and lutein- Contra-indications see under Human Menopausal

ising hormone (LH) in a ratio of 1:1 Gonadotrophins Side-effects

see under Human Menopausal Gonado- c Merional (Pharmasure) A trophins

Injection , powder for reconstitution, menotrophin as Dose

follicle-stimulating hormone 75 units and luteinising or

hormone 75 units, net price per vial (with solvent) = . By subcutaneous intramuscular injection , according to patient’s response £13.95; follicle-stimulating hormone 150 units, lutein-

ising hormone 150 units, net price per vial (with solvent) = £27.90. For intramuscular injection

Gonal-F (Serono) A Menopur (Ferring) A Injection , powder for reconstitution, follitropin alfa.

Follitropin alfa c c

Injection , powder for reconstitution, menotrophin as Net price 75-unit amp = £22.31; 450 units/0.75 mL,

follicle-stimulating hormone 75 units and luteinising multidose vial = £133.86; 1050 units/1.75 mL, multi-

hormone 75 units, net price per vial (with solvent) = dose vial = £312.34 (all with solvent). For subcuta-

£13.65. For intramuscular or subcutaneous injection neous injection

Urofollitropin

Injection net price 0.5 mL (300 units) = £97.08, 0.75 mL

Purified extract of human post-menopausal urine con- (450 units) = £145.62, 1.5 mL (900 units) = £291.24.

, prefilled pen, follitropin alfa 600 units/mL,

taining follicle-stimulating hormone (FSH) For subcutaneous injection

Fostimon c (Pharmasure) A Injection , powder for reconstitution, urofollitropin as

Follitropin alfa with lutropin alfa follicle-stimulating hormone 75 units, net price per Pergoveris c (Serono) A vial (with solvent) = £13.95; follicle-stimulating

Injection , powder for reconstitution, follitropin alfa hormone 150 units, net price per vial (with solvent) = 150 units (11 micrograms), lutropin alfa 75 units

£27.90. For intramuscular or subcutaneous injection (3 micrograms), net price per vial (with solvent) =

£60.29. For subcutaneous injection

Electrolytes Na <1 mmol/vial

LUTROPIN ALFA Endocrine

Follitropin beta (Recombinant human luteinising hormone) Puregon c (Organon) A Indications see notes above

Injection , follitropin beta 100 units/mL, net price 0.5- Cautions rule out infertility caused by hypothyroidism, mL (50-unit) vial = £18.74; 200 units/mL, 0.5-mL

adrenocortical deficiency, hyperprolactinaemia,

syst

(100-unit) vial = £37.48; 300 units/mL, 0.5-mL (150- tumours of the pituitary or hypothalamus unit) vial = £50.62; 400 units/mL, 0.5-mL (200-unit)

Contra-indications ovarian enlargement or cyst

em

vial = £67.49; 0.36-mL (300-unit) cartridge = £101.23, (unless caused by polycystic ovarian disease); 0.72-mL (600-unit) cartridge = £202.47, 1.08-mL (900-

undiagnosed vaginal bleeding; tumours of hypotha- unit) cartridge = £303.66, (cartridges for use with Puregon c

lamus and pituitary; ovarian, uterine or mammary pen). For subcutaneous (cartridges and

carcinoma

vials) or intramuscular injection (vials) Excipients may include neomycin and streptomycin

Side-effects nausea, vomiting, abdominal and pelvic pain; headache, somnolence; injection-site reactions; ovarian hyperstimulation syndrome, ovarian cyst, breast pain, ectopic pregnancy; thromboembolism,

HUMAN MENOPAUSAL

adnexal torsion, and haemoperitoneum

GONADOTROPHINS

Dose

Indications . By subcutaneous injection

see notes above , in conjunction with

Cautions follicle-stimulating hormone, according to response

rule out infertility caused by hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, or c Luveris (Serono) A tumours of the pituitary or hypothalamus

Injection , powder for reconstitution, lutropin alfa, net Contra-indications ovarian cysts (not caused by

price 75-unit vial = £33.31 (with solvent) polycystic ovarian syndrome); tumours of pituitary,

hypothalamus, breast, uterus, ovaries, testes or prostate; vaginal bleeding of unknown cause;

Growth hormone

pregnancy and breast-feeding Growth hormone is used to treat deficiency of the Side-effects ovarian hyperstimulation, increased risk

hormone in children and in adults (see NICE guidance of multiple pregnancy and miscarriage, hypersensi-

below). In children it is used in Prader-Willi syndrome, tivity reactions, gastro-intestinal disturbances, head-

Turner’s syndrome and in chronic renal insufficiency; ache, joint pain, fever, injection site reactions, very

growth hormone has also recently been licensed for use rarely thromboembolism; gynaecomastia, acne, and

in short children considered small for gestational age at weight gain reported in men

birth.

6.5.1 Hypothalamic and anterior pituitary hormones and anti-oestrogens BNF 57 Growth hormone of human origin (HGH; somato-

recommend periodic thyroid function tests but limited trophin) has been replaced by a growth hormone of

evidence of clinical value), history of malignant dis- human sequence, somatropin, produced using recom-

ease, disorders of the epiphysis of the hip (monitor for binant DNA technology.

limping), resolved intracranial hypertension (monitor closely), initiation of treatment close to puberty not

NICE guidance recommended in child born small for gestational age; Somatropin in children with growth failure

Silver-Russell syndrome; rotate subcutaneous injec- (May 2002)

tion sites to prevent lipoatrophy; breast-feeding Treatment with somatropin is recommended for

(Appendix 5); interactions: Appendix 1 (somatropin) children with:

Contra-indications evidence of tumour activity .

proven growth-hormone deficiency; (complete antitumour therapy and ensure intracranial .

Turner’s syndrome; lesions inactive before starting); not to be used after .

Prader-Willi syndrome; renal transplantation or for growth promotion in .

chronic renal insufficiency before puberty. children with closed epiphyses (or near closure in Treatment should be initiated and monitored by a

Prader-Willi syndrome); severe obesity or severe paediatrician with expertise in managing growth-

respiratory impairment in Prader-Willi syndrome; hormone disorders; treatment can be continued

pregnancy (interrupt treatment if pregnancy occurs, under a shared-care protocol by a general practi-

Appendix 4)

tioner. Side-effects headache, funduscopy for papilloedema Treatment should be discontinued if the response is

recommended if severe or recurrent headache, visual poor (i.e. an increase in growth velocity of less than

problems, nausea and vomiting occur—if papilloede- 50% from baseline) in the first year of therapy.

ma confirmed consider benign intracranial hyper- In children with chronic renal insufficiency, treat-

tension (rare cases reported); fluid retention (periph- ment should be stopped after renal transplantation

eral oedema), arthralgia, myalgia, carpal tunnel and not restarted for at least a year

syndrome, paraesthesia, antibody formation, hypo-

tem

thyroidism, insulin resistance, hyperglycaemia, hypo-

sys glycaemia, reactions at injection site; leukaemia in

NICE guidance children with growth hormone deficiency also Somatropin for adults with growth hormone

reported

ocrine

deficiency (August 2003)

Dose

Somatropin is recommended in adults only if the . Gonadal dysgenesis (Turner’s syndrome), by subcu-

End

following 3 criteria are fulfilled: taneous injection , 45–50 micrograms/kg daily or

6 . Severe growth hormone deficiency, established

1.4 mg/m daily by an appropriate method,

. Deficiency of growth hormone in children, by sub- .

Impaired quality of life, measured by means of a cutaneous or intramuscular injection , 23–39 micr- specific questionnaire,

ograms/kg daily or 0.7–1 mg/m daily .

Already receiving treatment for another pitui- . Growth disturbance in short children born small for tary hormone deficiency.

gestational age whose growth has not caught up by 4 Somatropin treatment should be discontinued if the

years or later, by subcutaneous injection , 35 micr- quality of life has not improved sufficiently by 9

ograms/kg daily or 1 mg/m daily months.

. Prader-Willi syndrome, by subcutaneous injection in Severe growth hormone deficiency developing after

children with growth velocity greater than 1 cm/ linear growth is complete but before the age of 25

year, in combination with energy-restricted diet, years should be treated with growth hormone; treat-

35 micrograms/kg daily or 1 mg/m daily; max. ment should continue until adult peak bone mass

2.7 mg daily

has been achieved. Treatment for adult-onset . Chronic renal insufficiency in children (renal function growth hormone deficiency should be stopped

decreased to less than 50%), only when the patient and the patient’s physician

by subcutaneous consider it appropriate.

injection , 45–50 micrograms/kg daily or 1.4 mg/m Treatment with somatropin should be initiated and

daily (higher doses may be needed) adjusted if managed by a physician with expertise in growth

necessary after 6 months hormone disorders; maintenance treatment can be

. Adult growth hormone deficiency, by subcutaneous prescribed in the community under a shared-care

injection , initially 150–300 micrograms daily, gra- protocol.

dually increased if required to max. 1 mg daily; use minimum effective dose (requirements may

Mecasermin, a human insulin-like growth factor-I decrease with age)

Note Dose formerly expressed in units; somatropin 1 mg : (rhIGF-I), is licensed to treat growth failure in children

3 units

and adolescents with severe primary insulin-like growth factor-I deficiency (section 6.7.4).

Genotropin c (Pharmacia) A Injection , two-compartment cartridge containing