somatropin
Regulatory sources consulted
Approved indications
- Pediatric growth disorders due to growth-hormone deficiency, Turner syndrome, chronic renal impairment, short stature after being born small for gestational age, or Prader-Willi syndrome; replacement in adults with confirmed severe deficiency.
Contraindications
Absolute
- Active tumor; closed epiphyses for growth promotion; acute critical illness after major surgery, multiple trauma, or acute respiratory failure; hypersensitivity.
- In children with Prader-Willi syndrome: severe obesity, history of upper-airway obstruction or sleep apnea, or severe respiratory impairment.
Clinical warnings
- Major warning · Monitor IGF-I, growth, glucose, thyroid, and adrenal function. It may reduce insulin sensitivity and unmask diabetes, hypothyroidism, or central adrenal insufficiency. — CIMA/AEMPS, ficha técnica 60117
- Major warning · Do not start with active tumor; monitor recurrence, intracranial hypertension, scoliosis, and, in Prader-Willi syndrome, respiratory obstruction or apnea. — CIMA/AEMPS, ficha técnica 60117
- Major warning · Before starting in Prader-Willi syndrome, assess obesity, upper-airway obstruction, sleep apnea, and respiratory infection. Stop for new obstruction, increased snoring, or apnea; treat respiratory infections aggressively. — FDA/DailyMed, set_id 1058e17c-9261-459c-a3e6-fae38d196c14
Drug interactions
- ModerateGlucocorticoids
Mechanism: They may inhibit growth, and somatropin may reduce conversion of cortisone to cortisol.
Recommendation: Carefully adjust replacement and stress doses; monitor growth and adrenal function.
CIMA/AEMPS, ficha técnica 60117https://cima.aemps.es/cima/dochtml/ft/60117/FT_60117.html
- ModerateInsulin or antidiabetic medicines
Mechanism: Somatropin may reduce insulin sensitivity.
Recommendation: Monitor glucose and adjust antidiabetic treatment.
CIMA/AEMPS, ficha técnica 60117https://cima.aemps.es/cima/dochtml/ft/60117/FT_60117.html
Adverse events
Common (≥1%)
Peripheral or facial edema in adults · Arthralgia or myalgia · Paresthesia · Musculoskeletal stiffness · Injection-site reaction
Rare but serious
Benign intracranial hypertension · Type 2 diabetes mellitus · Tumor reactivation or progression · Severe hypersensitivity reaction
Pregnancy and lactation
No use recommendation is established during pregnancy. Use cautiously while breastfeeding; excretion into milk is unknown, although oral absorption of intact protein by the infant is unlikely.
Recent literature (PubMed)
Somatrogon is a long-acting recombinant human growth hormone (rhGH) in development for once-weekly treatment of children with growth hormone deficiency (GHD). We aimed to compare the efficacy and safety of once-weekly somatrogon with once-daily somatropin in prepubertal children with GHD. In this 12-month, open-label, randomized, active-controlled, parallel-group, phase 3 study, participants were randomized 1:1 to receive once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months. A total of 228 prepubertal children (boys aged 3-11 years, girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received ≥1 dose of study treatment (somatrogon: 109; somatropin: 115). The primary endpoint was annualized HV at month 12. HV at month 12 was 10.10 cm/year for somatrogon-treated subjects and 9.78 cm/year for somatropin-treated subjects, with a treatment difference (somatrogon-somatropin) of 0.33 (95% CI: -0.24, 0.89). The lower bound of the 2-sided 95% CI was higher than the prespecified noninferiority margin (-1.8 cm/year), demonstrating noninferiority of once-weekly somatrogon vs daily somatropin. HV at month 6 and change in height standard deviation score at months 6 and 12 were similar between both treatment groups. Both treatments were well tolerated, with a similar percentage of subjects experiencing mild to moderate treatment-emergent adverse events in both groups (somatrogon: 78.9%, somatropin: 79.1%). The efficacy of once-weekly somatrogon was noninferior to once-daily somatropin, with similar safety and tolerability profiles. (ClinicalTrials.gov no. NCT02968004). Limited data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone and that no adverse effects are experienced by the breastfed infants of mothers who receive somatropin. Growth hormone plasma concentration naturally increase in the first 3 days pos