What is Somatropin?
Somatropin, commonly known as human growth hormone (hGH), is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration in humans and other animals. It is produced by the pituitary gland and plays a major role in human growth and development. It has an important anabolic effect in the body by increasing protein synthesis and bone growth and by inducing the production of insulin-like growth factor 1 (IGF-1).
Therapeutic Uses
It is approved for treatment of growth hormone deficiency in children and adults. It prevents short stature in childhood deficiency and replaces the hormone which the body is not producing enough of naturally. The hormone is also approved for treatment of idiopathic short stature in children. Other major therapeutic uses of it include treatment of Turner syndrome in girls, chronic kidney disease, Prader-Willi syndrome, and HIV/AIDS-related wasting. It is also prescribed off-label for anti-aging purposes.
Growth Hormone Deficiency in Children
Human growth hormone deficiency affects about 1 in 4000 children and leads to poor physical growth. Treatment with recombinant human growth hormone, Somatropin enables most GH-deficient children to catch up to their peers in growth rates. Improvement is seen within the first 6-12 months of starting treatment. Somatropin therapy must be followed throughout childhood and puberty to achieve normal growth and full adult height. If left untreated, childhood GH deficiency can lead to a permanently short stature.
Adult Growth Hormone Deficiency
Growth hormone deficiency that persists into adulthood is also treated with its replacement therapy. Deficiency in adults causes increased fat mass, decreased muscle mass and strength, osteopenia, lipid abnormalities and decreased quality of life. Long-term hormone therapy has been shown to reduce fat mass, increase lean body mass and muscle strength, improve lipid profiles, and enhance quality of life and sense of well-being. Treatment is lifelong and helps address the various impacts of adult growth hormone deficiency.
Off-Label Uses
While the therapeutic uses of it are well-established, it is also being increasingly used off-label for anti-aging, athletic performance enhancement and weight loss. Some perceived benefits of its treatment in non-FDA approved aging populations include increased muscle mass and strength, reduced fat mass, improved cardiovascular risk factors, and enhanced quality of life and sense of well-being. However, the long-term risks of these off-label uses are still unclear. The safety and efficacy of its therapy purely for anti-aging or cosmetic purposes still needs more evidence.
Side Effects of Therapy
Common side effects of its therapy include fluid retention leading to peripheral edema, carpal tunnel syndrome, joint and muscle pains. Rare but serious side effects include slipped capital femoral epiphysis in children and proliferation of malignant tumors in preexisting tumor conditions. Somatropin therapy requires lifelong monitoring by an endocrinologist to ensure the correct dosage and watch for side effects. Close monitoring of blood glucose levels is also important, especially in diabetics, due to the possibility of hypoglycemia or hyperglycemia. Overall, it is generally well-tolerated when administered as prescribed under medical guidance.
Production and Manufacturing of its Biologics
It is produced commercially by recombinant DNA technology and is biosimilar to natural human growth hormone. The global leaders in Somatropin drug manufacturing include Novo Nordisk, Merck, Eli Lilly, Pfizer and Sandoz. These companies have large-scale fermentation and purification facilities. Its production involves cloning and expression of the hGH gene in microorganisms like yeast followed by downstream processing to recover the active ingredient. The drug substance is then formulated into drug products available as injections in multi-dose vials and cartridges/pens for easy self-administration. Quality assurance and stringent regulatory standards are followed throughout the manufacturing process to ensure product safety, purity, potency and consistency. With biosimilar market entry by major generic drugmakers, Somatropin is expected to become more affordable and accessible to patients worldwide in the coming years.
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