Somatropin (HGH) 6 IU/vial; 30 IU/kit

Basic Info

CAS Number	12629-01-5
Active Ingredient	Somatropin (recombinant human growth hormone, rhGH), a 22 kDa single-chain peptide of 191 amino acids
Dosage Form	Lyophilised powder for injection
Specification & Packaging	Strength: 6 IU/vial; 30 IU/kit Pack: 1 vial + 3 mL diluent Group: 03 Item No.: 41

Storage & Common Excipients

Storage Conditions	2–8 °C, protected from light; **do not freeze** (freezing denatures the protein). During use, pens and devices may be kept at room temperature for the period stated in the label (generally up to 28 days)
Common Excipients	Typical lyophilisate: mannitol, sucrose, buffer (L-histidine, phosphate), polysorbate 80/poloxamer, edetate disodium; vehicle is water for injection. Pens may contain preservatives such as m-cresol or benzyl alcohol — follow the label. Confirm against COA

Product Introduction

Recombinant human growth hormone produced by DNA recombination, identical in sequence to endogenous human GH. It is used for growth hormone deficiency, Turner syndrome, idiopathic short stature, small-for-gestational-age and growth failure in chronic kidney disease. It is the only growth-hormone product in this list with broadly approved human indications that may be lawfully obtained

Therapeutic Use

Children: growth hormone deficiency (GHD), Turner syndrome, idiopathic short stature, small-for-gestational-age short stature, growth failure in chronic kidney disease or after renal transplant; adults: replacement therapy for GHD. Anti-ageing and aesthetic use has no indication. Indications and follow-up requirements follow the locally approved label

Mode of Action

Identical to physiological GH induced by GHRH; acts via the GHR receptor and JAK2/STAT pathway, mainly through hepatic and local IGF-1 generation (the GH→IGF-1 axis); promotes protein synthesis, bone growth, lipolysis and has anti-insulin effects; pulsatile dosing most closely approximates physiology; it has no direct androgen-receptor activity and is therefore not an anabolic steroid

Administration & Monitoring

Subcutaneous injection at bedtime or at a fixed time each day; monitor IGF-1 and GH, height velocity and height age, bone age; during long-term therapy monitor HbA1c and fasting glucose (GH has anti-insulin action and can impair glucose tolerance), lipids, thyroid function, bone density, vertebral morphology (avascular necrosis), intraocular pressure (retinal detachment and glaucoma), and screen for tumour risk where there is a family history

Important Safety Information

Prescription medicine requiring specialist supervision. Long-term use carries increased insulin-resistance and diabetes risk. Raised intracranial pressure (headache, vomiting, blurred vision) requires immediate assessment. Contraindicated in active malignancy or during chemotherapy. Not for use in competitive sport. Preservative-containing formulations require special care in neonates and infants (e.g. benzyl alcohol). **Any growth-hormone use by an athlete is a violation** (see anti-doping)

Adverse Reactions

Injection-site reactions (erythema, bruising, pain); headache; oedema from sodium and water retention; arthralgia and myalgia; vitreous or retinal detachment and reduced visual acuity; intracranial hypertension; asymptomatic hypo- or hyperglycaemia and insulin resistance; hypothyroidism (sometimes with raised LT3); transient bone pain; scoliosis and slipped capital femoral epiphysis (features of untreated GHD); anti-GH antibodies (rare, may reduce efficacy)

Important Risks

Tumour risk (theoretical link to IGF-1/growth signalling; requires specialist judgement in craniopharyngioma residual tumour or post-remission patients); metabolic effects (impaired glucose tolerance, changes in liver function and lipids); orthopaedic complications (avascular necrosis, slipped capital femoral epiphysis); intracranial hypertension; visual impairment

Contraindications

Hypersensitivity to the product or excipients; known growth-hormone hypersensitivity; active malignancy or ongoing chemotherapy; diagnosed intracranial hypertension; pregnancy; acute upper-airway obstruction or severe respiratory infection in Prader-Willi syndrome; discontinue when final adult height has been reached

Special Populations

Contraindicated in pregnancy; hypoglycaemic regimens must be adjusted in significant diabetes or glucose intolerance; patients in tumour remission require joint endocrine and oncology decisions; dose adjustment for renal clearance in children with renal impairment; assess bone density and oedema risk in older women; use preservative-free presentations in infants

Usage Limitations

Prescription medicine and a **high-value, strongly regulated** product category (dedicated registries, prescription and quantity reporting are common); strict adherence to indications; no off-label use for aesthetics, anti-ageing or muscle building; prohibited for competitive athletes; single-use devices and correct sharps disposal; indication and efficacy reassessment typically every 6–12 months

Anti-Doping Testing

**Growth hormone is on the WADA Prohibited List S2.2** and is prohibited for performance enhancement. Testing uses a two-part strategy: (1) GH-200 detection combined with high IGF-1; (2) a confirmation test (OGTT or high-dose arginine). Genuine deficiency (therapeutic use) by an athlete requires a TUE and documentation through **ADAMS (Athlete Biological Passport and ADAMS reporting)**

Product Quality Testing

Identification (peptide mapping/MS), purity and assay (SEC-HPLC), specific activity, endotoxin, sterility, lyophilisate appearance and reconstitution time, in-use stability (do not store after reconstitution), fill volume, preservative content where applicable, bioactivity; pens also require mechanical and dose-accuracy testing; COA