Somatropin
GENOTROPIN
What it isRecombinant human growth hormone; growth hormone deficiency and several growth disorders.
Why this oneIt is direct replacement, effective where the pituitary cannot produce, unlike the secretagogues.
What limits itDaily injection, high cost, and it must be stopped once epiphyses fuse in growth indications. Intracranial hypertension, scoliosis and insulin resistance.
FDA-approved for
- growth hormone deficiency (~1985)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Pediatric growth hormone deficiency | Pediatric | 0.17–0.24 mg/kg/week SC (divided 6–7 days/wk) | 0.17–0.24 mg/kg/week | 0.24 mg/kg/week |
| Noonan syndrome | Pediatric | Up to 0.46 mg/kg/week SC | Up to 0.46 mg/kg/week | 0.46 mg/kg/week |
| Turner syndrome | Pediatric | Up to 0.47 mg/kg/week SC | Up to 0.47 mg/kg/week | 0.47 mg/kg/week |
| Small for gestational age (SGA) | Pediatric | Up to 0.47 mg/kg/week SC | Up to 0.47 mg/kg/week | 0.47 mg/kg/week |
| Idiopathic short stature (ISS) | Pediatric | Up to 0.47 mg/kg/week SC | Up to 0.47 mg/kg/week | 0.47 mg/kg/week |
| Prader-Willi syndrome | Pediatric | 0.24 mg/kg/week SC | 0.24 mg/kg/week | 0.24 mg/kg/week |
| Adult growth hormone deficiency | Adults | ~0.2 mg/day SC QD (range 0.15–0.3), or weight-based 0.004 mg/kg/day | Individualized | 0.016 mg/kg/day (weight-based) |
Titration Adult: increase every 1–2 months by ~0.1–0.2 mg/day per patient requirements
Renal Undefined
Hepatic Undefined
Instructions
- Administer by subcutaneous injection (back of upper arm, abdomen, buttock, thigh) with regular site rotation
- Divide the calculated weekly pediatric dose into equal doses given 6 or 7 days per week
- Perform fundoscopic exam before initiation and periodically
Contraindications
- Acute critical illness (post open-heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure)
- Pediatric Prader-Willi syndrome patients who are severely obese, have upper airway obstruction/sleep apnea, or severe respiratory impairment (risk of sudden death)
- Active malignancy
- Active proliferative or severe non-proliferative diabetic retinopathy
- Pediatric patients with closed epiphyses
Cautions
- Increased risk of neoplasms / second neoplasms
- Glucose intolerance and diabetes mellitus
- Intracranial hypertension
- Severe hypersensitivity
- Fluid retention
- Hypoadrenalism
- Hypothyroidism
- Slipped capital femoral epiphysis (pediatric)
- Progression of preexisting scoliosis (pediatric)
- Pancreatitis
Adverse reactions
- Upper respiratory infection
- Fever
- Pharyngitis
- Headache
- Otitis media
- Edema / peripheral edema
- Arthralgia
- Paresthesia
- Myalgia
- Flu syndrome
- Impaired glucose tolerance
Pregnancy Limited human data insufficient to determine drug-associated risk
Lactation No human data; exogenous somatropin does not increase breastmilk GH; no adverse effects on breastfed infants reported
NO BOXED WARNINGS
Principal riskIntracranial hypertension; insulin resistance
Cost, est. cash$100–$5,000/month
Generic entryLong generic
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Somatropin ballicule
