Accretropin (somatropin rDNA Original)
Company: Cangene Corp
Approval Status: Approved January 2008
Treatment for: growth failure in pediatrics
Areas: Endocrinology; Pediatrics/Neonatology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Accretropin is a sustained release formulation of recombinant human growth hormone product. This protein is produced by recombinant DNA technology during fermentation in E. coli, yielding a protein containing 192 amino acids. The N-terminal amino acid, methionine, is later removed to yield a protein that is chemically and physicochemically identical to pituitary derived human growth hormone, consisting of 191 amino acids in a single polypeptide chain.
Accretropin is specifically indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone and for the treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.
Accretropin is supplied as a solution designed for subcutaneous
administration. The recommended initial dose of the drug is as
follows:
Growth Hormone Deficiency
The recommended weekly dose is 0.18 mg/kg body weight to 0.3 mg/kg
(0.90 IU/kg) body weight. The dose should be divided into equal
daily doses given 6 or 7 times per week subcutaneously.
Turner Syndrome
The recommended weekly dose is 0.36 mg/kg of body weight. The dose
should be divided into equal daily doses given 6 or 7 times per
week subcutaneously.
Failure of Accretropin to increase growth rate, particularly during the first year of therapy, should prompt assessment of compliance and evaluation of other causes of growth failure such as hypothyroidism, under-nutrition and advanced bone age.
Clinical Results
FDA Approval
FDA approval of Accretropin was based on the results of two
clinical trials.
Growth Hormone Deficiency
This single-arm, open-label, multicenter trial enrolled 44
pediatric subjects who were treated for up to 3 years with an
Accretropin dose of 0.03 to 0.05 mg/kg/day (0.18 to 0.30
mg/kg/week) subcutaneously. Height SD score calculated relative to
population of normally growing children increased on Accretropin
treatment from -3.04 at baseline to -2.46 at one year, -2.12 at two
years, and -1.78 at three years.
Turner Syndrome
This single-arm, open-label, single-center trial enrolled 37
subjects who received an Accretropin dose of 0.06 mg/kg/day
subcutaneously (0.36 mg/kg/week). Height SD score calculated
relative to population of Turner Syndrome patients increased on
Accretropin treatment from -3.17 at baseline to -2.67 at one year,
-2.43 at two years, and -2.28 at three years.
Side Effects
Adverse events associated with the use of Accretropin for growth hormone deficiency may include, but are not limited to, the following:
- injection site reactions
- nausea
- headache
- fatigue
- scoliosis
Adverse events associated with the use of Accretropin for Turner Syndrome may include, but are not limited to, the following:
- injection site reactions, including erythema, edema, pain, pruritis
Mechanism of Action
Accretropin is a sustained release formulation of recombinant human growth hormone product. This protein is produced by recombinant DNA technology during fermentation in E. coli, yielding a protein containing 192 amino acids. The N-terminal amino acid, methionine, is later removed to yield a protein that is chemically and physicochemically identical to pituitary derived human growth hormone, consisting of 191 amino acids in a single polypeptide chain.
Literature References
Davenport ML, Crowe BJ, Travers SH, Rubin K, Ross JL, Fechner PY, Gunther DF, Liu C, Geffner ME, Thrailkill K, Huseman C, Zagar AJ, Quigley CA Growth hormone treatment of early growth failure in toddlers with Turner syndrome: a randomized, controlled, multicenter trial. The Journal of Clinical Endocrinology and Metabolism 2007 Sep;92(9):3406-16
Baxter L, Bryant J, Cave CB, Milne R Recombinant growth hormone for children and adolescents with Turner syndrome. Cochrane Database of Systematic Reviews 2007 Jan 24;(1):CD003887
Lanes R, Gunczler P, Esaa S, Weisinger JR The effect of short- and long-term growth hormone treatment on bone mineral density and bone metabolism of prepubertal children with idiopathic short stature: a 3-year study. Clinical Endocrinology 2002 Dec;57(6):725-30
Additional Information
For additional information regarding Accretropin or short stature in pediatrics due to growth hormone deficiencies or Turner Syndrome, please visit the Accretropin webpage.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
Medical Dictionary Searches
