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