somatropin
Genotropin · Humatrope · Norditropin
1 INDICATIONS AND USAGE NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome ( 1.1 ) • Adult : Replacement of endogenous GH in adults with growth hormone deficiency ( 1.2 ) 1.1 Pediatric Patients NORDITROPIN is indicated for the treatment of pediatric patients with: • growth failure due to inadequate secretion of endogenous growth hormone (GH), • short stature associated with Noonan syndrome, • short stature associated with Turner syndrome, • short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, • Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, • growth failure due to Prader-Willi syndrome (PWS). 1.2 Adult Patients NORDITROPIN is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)
Mechanism. 12.1 Mechanism of Action Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation hepatic glucose output, protein synthesis and lipolysis. Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis.
What stands out in the reports.
ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.
Somatropin shows disproportionately reported issues related to its delivery device, such as "DEVICE MECHANICAL ISSUE" (ROR 509.1) and "DEVICE DIFFICULT TO USE" (ROR 6.3). These are logical as somatropin is an injectable medication, making device-related problems a common concern. "INJECTION SITE BRUISING" (ROR 4.1) and "INJECTION SITE HAEMORRHAGE" (ROR 4.1) are also frequently reported, which is expected with injections. Remember, "frequently reported" is not the same as "frequently caused." This does not replace medical advice.
This does not replace medical advice.
No signals currently mapped to the label.
Report volume per quarter.
| Date | Class | Reason | Firm |
|---|---|---|---|
| Apr 27, 2016 | II | Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step | Novo Nordisk Inc |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm. Source: openFDA enforcement.