Somatropin (rbe) 12 mgHumatrope 12 mg powder and solvent for
solution for injection cartridges| 1 cartridgeP£ 216. 00 DT =
£ 208. 65 e
Somatropin (rbe) 24 mgHumatrope 24 mg powder and solvent for
solution for injection cartridges| 1 cartridgeP£ 432. 00 e
▶Saizen(Merck Serono Ltd)
Somatropin (rmc) 8 mgSaizen 8 mg click.easy powder and solvent
for solution for injection vials| 1 vialP£ 185. 44 DT =
£ 185. 44 e
▶Zomacton(Ferring Pharmaceuticals Ltd)
Somatropin (rbe) 4 mgZomacton 4 mg powder and solvent for
solution for injection vials| 1 vialP£ 68. 28 DT = £ 68. 28 e
Somatropin (rbe) 10 mgZomacton 10 mg powder and solvent for
solution for injection vials| 1 vialP£ 170. 70 DT = £ 170. 70 e6.4aInsulin-like growth factor-I
deficiency
PITUITARY AND HYPOTHALAMIC HORMONES
AND ANALOGUES›SOMATOMEDINS
Mecasermin
(Recombinant human insulin-like growth factor-I;
rhIGF-I)lDRUG ACTIONSomatomedins are a group of polypeptide
hormones structurally related to insulin and commonly
known as insulin-like growth factors (IGFs). Mecasermin, a
human insulin-like growth factor-I (rhIGF-I), is the
principal mediator of the somatotropic effects of human
growth hormone.
lINDICATIONS AND DOSE
Treatment of growth failure in children with severe
primary insulin-like growth factor-I deficiency
▶BY SUBCUTANEOUS INJECTION
▶Child 2–17 years:Initially 40 micrograms/kg twice daily
for 1 week, increased, if tolerated, in steps of
40 micrograms/kg (max. per dose 120 micrograms/kg
twice daily), discontinue if no response within 1 year,
reduce dose if hypoglycaemia occurs despite adequate
food intake; withhold injection if patient unable to eatlCONTRA-INDICATIONSEvidence of tumour activity
(discontinue treatment)
lCAUTIONSCorrect hypothyroidism before initiating
treatment.diabetes mellitus (adjustment of antidiabetic
therapy may be necessary).papilloedema
lSIDE-EFFECTS
▶Common or very commonAdenoidal hypertrophy.
arthralgia.dizziness.ear discomfort.gastrointestinal
discomfort.gynaecomastia.hair texture abnormal.
headache.hearing impairment.hyperglycaemia.
hypoglycaemia.injection site reaction (rotate site).
melanocytic naevus.myalgia.otitis media.pain in
extremity.papilloedema.scoliosis.seizures.skin
hypertrophy.sleep apnoea.snoring.tachycardia.thymus
enlargement.tonsillar hypertrophy.tremor.vomiting
▶UncommonCardiac hypertrophy.cardiac valve disorders.
depression.idiopathic intracranial hypertension.
lipohypertrophy.nervousness.weight increased
▶Frequency not knownAlopecia
SIDE-EFFECTS, FURTHER INFORMATIONFunduscopy for
papilloedema recommended regularly during treatment
and if severe or recurrent headache, visual problems,
nausea and vomiting occur—if papilloedema confirmed
consider benign intracranial hypertension.lCONCEPTION AND CONTRACEPTIONContraception advised
in women of child-bearing potential.
lPREGNANCYAvoid unless essential.
lBREAST FEEDINGAvoid.
lMONITORING REQUIREMENTS
▶Monitor ECG before and on termination of treatment (and
during treatment if ECG abnormal).
▶Monitor for disorders of the epiphysis of the hip (monitor
for limping).
▶Monitor for signs of tonsillar hypertrophy (snoring, sleep
apnoea, and chronic middle ear effusions).
lDIRECTIONS FOR ADMINISTRATIONDose should be
administered just before or after food.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer mecasermin injection.
Missed dosesPatients or carers should be advised not to
increase dose if a dose is missed.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
EXCIPIENTS:May contain Benzyl alcohol
▶Increlex(Ipsen Ltd)A
Mecasermin 10 mg per 1 mlIncrelex 40 mg/ 4 ml solution for
injection vials| 1 vialP£ 605. 007 Sex hormone responsive
conditions
Sex hormones
Hormone replacement therapy
Sex hormone replacement therapy is indicated in children
for the treatment of gonadotrophin deficiency, gonadal
disorders, or delayed puberty that interferes with quality of
life. Indications include constitutional delay in puberty,
congenital or acquired hypogonadotrophic hypogonadism,
hypergonadotrophic hypogonadism (Turner’s syndrome,
Klinefelter’s syndrome), endocrine disorders (Cushing’s
syndrome or hyperprolactinaemia), and chronic illnesses,
such as cysticfibrosis or sickle-cell disease, that may affect
the onset of puberty.
Replacement therapy is generally started at the
appropriate age for the development of puberty and should
be managed by a paediatric endocrinologist. Patients with
constitutional delay, chronic illness, or eating disorders may
need only small doses of hormone supplements for 4 to
6 months to induce puberty and endogenous sex hormone
production, which is then sustained. Patients with organic
causes of hormone deficiency will require life-long
replacement, adjusted to allow normal development.
Inadequate treatment may lead to poor bone
mineralisation, resulting in fractures and osteoporosis.Female sex hormones
Oestrogens
Oestrogens are necessary for the development of female
secondary sexual characteristics. If onset of puberty is
delayed because of organic pathology, puberty can be
induced with ethinylestradiol p. 478 in increasing doses,
guided by breast staging and uterine scans. Cyclical
progestogen replacement is added after 12 – 18 months of
oestrogen treatment. Once the adult dosage of oestrogen has
been reached, it may be more convenient to provide
replacement either as a low-dose oestrogen containing oral
contraceptive formulation [unlicensed indication] or as a
combined oestrogen and progestogen hormone replacement
therapy preparation [unlicensed indication]. There is limited
experience in the use of transdermal patches or gels inBNFC 2018 – 2019 Sex hormone responsive conditions 477
Endocrine system6