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Omnitrope (Somatropin)
Somatropin binds dimeric GH receptors on target cells, inducing intracellular signaling and GH-dependent protein synthesis including IGF-1.
NORDITROPIN (somatropin) is a recombinant human growth hormone indicated for pediatric growth failure from GH deficiency and multiple short stature conditions, as well as adult GH replacement therapy. The drug binds GH receptors to stimulate IGF-1 production and protein synthesis, with subcutaneous administration achieving peak levels in 3-5 hours and a 7-10 hour half-life. Major contraindications include acute critical illness, active malignancy, closed epiphyses in children, and severe diabetic retinopathy; glucocorticoid and CP450 drug interactions require monitoring. NORDITROPIN represents an established therapy for GH deficiency with well-characterized pharmacokinetics and defined safety parameters requiring careful patient selection and monitoring.
At a glance
| Generic name | Somatropin |
|---|---|
| Sponsor | Serono |
| Drug class | Recombinant human growth hormone |
| Target | Dimeric GH receptors on cell membranes of target tissues |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1976 |
| Annual revenue | 446 |
Mechanism of action
Somatropin binds to dimeric GH receptors located within cell membranes of target tissue cells, triggering intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3, and acid-labile subunit. The drug exerts direct tissue and metabolic effects or acts indirectly through IGF-1, including stimulation of chondrocyte differentiation and proliferation, stimulation of hepatic glucose output, protein synthesis, and lipolysis. In pediatric patients with GHD, somatropin stimulates skeletal growth through effects on the growth plates (epiphyses) of long bones, increasing linear growth rate (height velocity) in most treated patients through increased cellular protein synthesis.
Approved indications
- Growth retardation
- Pituitary dwarfism
- Prader-Willi syndrome
- Severe growth hormone deficiency in adulthood
- Turner syndrome
Common side effects
- Peripheral swelling
- Arthralgia
- Hypothyroidism
- Elevated HbA1c
- Eosinophilia
- Hematoma
- Headache
- Hypertriglyceridemia
- Leg pain
- Injection site reactions/rashes
- Lipoatrophy
Serious adverse events
- Benign intracranial hypertension
- Central precocious puberty
- Scoliosis aggravation
Drug interactions
- Glucocorticoids (cortisone acetate, prednisone)
- Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment
- Cytochrome P450-metabolized drugs
Primary sources
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| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| SEC EDGAR | Revenue + earnings |