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Somatotropin

Generic Name
Somatotropin
Brand Names
Genotropin, Humatrope, Norditropin, Norditropin Nordiflex, Nutropin, Nutropinaq, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive, NutropinAq
Drug Type
Biotech
CAS Number
12629-01-5
Unique Ingredient Identifier
NQX9KB6PCL

Overview

Human growth hormone (HGH), also known as somatotropin, is a peptide hormone that is synthesized and secreted by the somatotropic cells of the anterior pituitary gland. Growth hormone plays an essential role in growth regulation during childhood as well as other basal metabolic functions, muscle and fat mass regulation, blood glucose level regulation, and lipid regulation in both children and adults. Synthesized in a strain of Escherichia coli, recombinant HGH is a polypeptide hormone that contains 191 amino acid residues with a molecular weight of 22 kDa. It has an identical primary protein structure to endogenous human growth hormone. Recombinant HGH has been commercially available since 1985 after its development by Genentech. Somatrem was the first available recombinant HGH and was largely replaced by somatropin, another form of recombinant HGH. Growth hormone therapy is approved for various disorders of growth hormone deficiency, growth failure, or short stature including Turner syndrome, chronic renal insufficiency before transplantation, Prader-Willi syndrome, a history of fetal growth restriction, short stature homeobox (SHOX) haploinsufficiency, Noonan syndrome, idiopathic short stature, and adult- or childhood-onset growth hormone deficiency. Recombinant growth hormone is available as a subcutaneous injection for children and adults under a wide variety of brand names.

Background

Human growth hormone (HGH), also known as somatotropin, is a peptide hormone that is synthesized and secreted by the somatotropic cells of the anterior pituitary gland. Growth hormone plays an essential role in growth regulation during childhood as well as other basal metabolic functions, muscle and fat mass regulation, blood glucose level regulation, and lipid regulation in both children and adults. Synthesized in a strain of Escherichia coli, recombinant HGH is a polypeptide hormone that contains 191 amino acid residues with a molecular weight of 22 kDa. It has an identical primary protein structure to endogenous human growth hormone. Recombinant HGH has been commercially available since 1985 after its development by Genentech. Somatrem was the first available recombinant HGH and was largely replaced by somatropin, another form of recombinant HGH. Growth hormone therapy is approved for various disorders of growth hormone deficiency, growth failure, or short stature including Turner syndrome, chronic renal insufficiency before transplantation, Prader-Willi syndrome, a history of fetal growth restriction, short stature homeobox (SHOX) haploinsufficiency, Noonan syndrome, idiopathic short stature, and adult- or childhood-onset growth hormone deficiency. Recombinant growth hormone is available as a subcutaneous injection for children and adults under a wide variety of brand names.

Indication

Somatotropin is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone, short stature associated with Turner syndrome, Prader-Willi syndrome (PWS), idiopathic short stature (ISS), short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA). It is indicated for the treatment of growth failure in children associated with chronic kidney disease up to the time of renal transplantation. It is also indicated for adults with adult-onset growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma. It is also used to treat childhood-onset growth hormone deficiency in adults due to congenital, genetic, acquired, or idiopathic causes. Somatotropin is indicated for the treatment of wasting or cachexia in patients with human immunodeficiency virus (HIV) who are receiving antiretroviral therapy to increase lean body mass and body weight and improve physical endurance. Somatotropin is indicated for the treatment of short bowel syndrome in adult patients receiving specialized nutritional support.

Associated Conditions

  • Adult Onset Growth Hormone Deficiency
  • Cachexia
  • Childhood-onset Growth Hormone Deficiency
  • Growth Failure
  • HIV Wasting Syndrome
  • Short Bowel Syndrome (SBS)
  • Short Stature

FDA Approved Products

Norditropin
Manufacturer:Novo Nordisk
Route:SUBCUTANEOUS
Strength:5 mg in 1.5 mL
Approved: 2020/03/09
NDC:0169-7704
Nutropin AQ NuSpin 10
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:10 mg in 2 mL
Approved: 2016/12/22
NDC:50242-074
Norditropin
Manufacturer:Novo Nordisk
Route:SUBCUTANEOUS
Strength:15 mg in 1.5 mL
Approved: 2020/03/09
NDC:0169-7708
Nutropin AQ NuSpin 20
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:20 mg in 2 mL
Approved: 2016/12/22
NDC:50242-076
Nutropin AQ NuSpin 5
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:5 mg in 2 mL
Approved: 2016/12/22
NDC:50242-075

Singapore Approved Products

SciTropin A Solution for Injection 5 mg/1.5 ml
Manufacturer:Sandoz GmbH (Shaftenau Plant)
Form:INJECTION, SOLUTION
Strength:5mg/1.5mL
Online:Yes
Approved: 2009/03/06
Approval:SIN13607P
NORDITROPIN NORDIFLEX INJECTION 5 mg/1.5 ml
Manufacturer:Novo Nordisk A/S, Novo Nordisk A/S (Kalundborg)
Form:INJECTION
Strength:5 mg/1.5 ml
Online:Yes
Approved: 2003/03/05
Approval:SIN12219P
ZOMACTON Powder and Solvent for Solution for Injection 4 mg
Manufacturer:Wasserburger Arzneimittelwerk GmbH (Powder & Solvent), Ferring GmbH (Powder)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:4 mg
Online:Yes
Approved: 2013/06/10
Approval:SIN14362P
Saizen solution for injection 5.83mg/ml (6mg in 1.03ml)
Manufacturer:Merck Serono S.p.A
Form:INJECTION, SOLUTION
Strength:6 mg/1.03 ml
Online:Yes
Approved: 2013/11/06
Approval:SIN14432P
GENOTROPIN FOR INJECTION 16 iu (5.3 mg) /ml
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG, Pfizer Manufacturing Belgium N.V.
Form:INJECTION, POWDER, FOR SOLUTION
Strength:5.3 mg/ml
Online:Yes
Approved: 1990/12/24
Approval:SIN05273P

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