Approved & therapeutic
Somatropin
Recombinant human growth hormone
Somatropin is recombinant human growth hormone, identical in amino acid sequence to the pituitary hormone. It is approved in the United States for several causes of growth failure in children and for growth hormone deficiency in adults, and is marketed under multiple brand names with product-specific indications.
- Status
- Somatropin is approved by the U.S. FDA and has official prescribing information.
- Evidence
- Approved labeling. Official prescribing information exists, based on clinical trials in people.
- Half-life
- Terminal half-life of approximately 3 hours after subcutaneous injection in adults with growth hormone deficiency, and approximately 0.4 hours after intravenous administration.
- How it's taken
- Subcutaneous injection
- Mechanism
- Anabolic (IGF-1 / myostatin)
- Pathways
- GH axis, IGF-1
How Somatropin works
Somatropin binds the growth hormone receptor on target cells and triggers intracellular signalling that stimulates chondrocyte activity at the epiphyseal plates and increases muscle cell number and size. Many of its effects are indirect and mediated by insulin-like growth factor 1 produced mainly in the liver. It also promotes protein synthesis, lipolysis and hepatic glucose output.
What research has looked at
- Increases linear growth velocity in children with growth hormone deficiency, Turner syndrome, Prader-Willi syndrome, short stature associated with being born small for gestational age, and idiopathic short stature, which are the labeled pediatric indications for Genotropin. Other products add further pediatric indications: Norditropin covers Noonan syndrome and Humatrope covers SHOX deficiency.
- Serum insulin-like growth factor 1 rises with treatment and is used by the label as a dose-titration and monitoring target rather than as a demonstrated clinical outcome.
- In adults with growth hormone deficiency, the six randomised placebo-controlled trials supporting the label (172 patients, six-month double-blind period) reported increased lean body mass and reduced total body fat mass and waist circumference. In the same trials bone mineral density declined after six months of treatment and returned to baseline by twelve months.
- Specific somatropin products are separately approved for HIV-associated wasting or cachexia (Serostim) and for short bowel syndrome in patients receiving specialised nutritional support (Zorbtive).
Evidence level: Approved labeling. Official prescribing information exists, based on clinical trials in people. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Contraindicated in acute critical illness following open heart surgery, abdominal surgery or multiple accidental trauma, or in acute respiratory failure, because of increased mortality observed in those settings.
- Contraindicated in known hypersensitivity to somatropin or to any excipient in the specific product; systemic hypersensitivity reactions have been reported in postmarketing use. Excipients differ by product, and some presentations contain m-cresol.
- Contraindicated in active malignancy. Any preexisting malignancy must be inactive and its treatment complete before starting. Because growth hormone deficiency can be an early sign of a pituitary or other brain tumor, such tumors must be ruled out before initiation, and somatropin must not be used in anyone with evidence of progression or recurrence of an underlying intracranial tumor.
- Contraindicated in active proliferative or severe non-proliferative diabetic retinopathy, and for growth promotion in children with closed epiphyses.
- Contraindicated in Prader-Willi syndrome with severe obesity, a history of upper airway obstruction or sleep apnea, or severe respiratory impairment; sudden deaths have been reported in such patients after starting treatment.
- Impaired glucose tolerance and new or worsened diabetes mellitus; intracranial hypertension presenting as headache, visual change, nausea or vomiting.
- Fluid retention with peripheral edema, arthralgia, myalgia and carpal tunnel syndrome, unmasking of hypoadrenalism, hypothyroidism, and pancreatitis.
- Slipped capital femoral epiphysis and progression of preexisting scoliosis in growing children; lipoatrophy at repeated injection sites; increased risk of a second neoplasm, most often an intracranial meningioma, in childhood cancer survivors treated with cranial radiation.
- In Turner syndrome, increased occurrence of otitis media and other ear and hearing disorders, and a need for close monitoring for cardiovascular disorders including stroke, aortic aneurysm or dissection, and hypertension.
- Non-medical use for anti-ageing, body composition or athletic performance is not an approved indication and is not supported by the label; efficacy and safety in people with normal growth hormone secretion are not established.
Sources
- PubMed research on Somatropin · NIH · National Library of Medicine
- DrugBank record for Somatropin · DrugBank
- Active clinical trials for Somatropin · U.S. National Library of Medicine
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Somatropin FAQ
What is Somatropin?
Somatropin is recombinant human growth hormone, identical in amino acid sequence to the pituitary hormone. It is approved in the United States for several causes of growth failure in children and for growth hormone deficiency in adults, and is marketed under multiple brand names with product-specific indications.
How does Somatropin work?
Somatropin binds the growth hormone receptor on target cells and triggers intracellular signalling that stimulates chondrocyte activity at the epiphyseal plates and increases muscle cell number and size. Many of its effects are indirect and mediated by insulin-like growth factor 1 produced mainly in the liver. It also promotes protein synthesis, lipolysis and hepatic glucose output.
Is Somatropin FDA approved?
Yes. Somatropin is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.
What is the half-life of Somatropin?
Reported half-life: Terminal half-life of approximately 3 hours after subcutaneous injection in adults with growth hormone deficiency, and approximately 0.4 hours after intravenous administration.
How is Somatropin taken?
Subcutaneous injection.
What side effects have been reported with Somatropin?
Reported in the sources: Contraindicated in acute critical illness following open heart surgery, abdominal surgery or multiple accidental trauma, or in acute respiratory failure, because of increased mortality observed in those settings; Contraindicated in known hypersensitivity to somatropin or to any excipient in the specific product; systemic hypersensitivity reactions have been reported in postmarketing use. Excipients differ by product, and some presentations contain m-cresol; Contraindicated in active malignancy. Any preexisting malignancy must be inactive and its treatment complete before starting. Because growth hormone deficiency can be an early sign of a pituitary or other brain tumor, such tumors must be ruled out before initiation, and somatropin must not be used in anyone with evidence of progression or recurrence of an underlying intracranial tumor; Contraindicated in active proliferative or severe non-proliferative diabetic retinopathy, and for growth promotion in children with closed epiphyses; Contraindicated in Prader-Willi syndrome with severe obesity, a history of upper airway obstruction or sleep apnea, or severe respiratory impairment; sudden deaths have been reported in such patients after starting treatment; Impaired glucose tolerance and new or worsened diabetes mellitus; intracranial hypertension presenting as headache, visual change, nausea or vomiting; Fluid retention with peripheral edema, arthralgia, myalgia and carpal tunnel syndrome, unmasking of hypoadrenalism, hypothyroidism, and pancreatitis; Slipped capital femoral epiphysis and progression of preexisting scoliosis in growing children; lipoatrophy at repeated injection sites; increased risk of a second neoplasm, most often an intracranial meningioma, in childhood cancer survivors treated with cranial radiation; In Turner syndrome, increased occurrence of otitis media and other ear and hearing disorders, and a need for close monitoring for cardiovascular disorders including stroke, aortic aneurysm or dissection, and hypertension; Non-medical use for anti-ageing, body composition or athletic performance is not an approved indication and is not supported by the label; efficacy and safety in people with normal growth hormone secretion are not established.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.