NUTROPIN SUMMARY
Nutropin® [somatropin (rDNA origin) for
injection] is a human growth hormone (hGH) produced by recombinant DNA
technology. Nutropin has 191 amino acid residues and a
molecular weight of 22,125 daltons. The amino acid sequence of
the product is identical to that of pituitary-derived human
growth hormone.
Pediatric Patients
Nutropin® [somatropin (rDNA origin)
for injection] is indicated for the long?term
treatment of growth failure due to a lack of adequate endogenous
GH secretion.
Nutropin® [somatropin (rDNA origin)
for injection] is also indicated for the treatment of growth
failure associated with chronic renal insufficiency up to the
time of renal transplantation. Nutropin therapy should be used
in conjunction with optimal management of chronic renal
insufficiency.
Nutropin® [somatropin (rDNA origin)
for injection] is also indicated for the long?term
treatment of short stature associated with Turner syndrome.
Nutropin® [somatropin (rDNA origin)
for injection] is also indicated for the long?term
treatment of idiopathic short stature, also called
non?growth hormone?deficient short stature,
defined by height SDS ≤2.25, and associated
with growth rates unlikely to permit attainment of adult height
in the normal range, in pediatric patients whose epiphyses are
not closed and for whom diagnostic evaluation excludes other
causes associated with short stature that should be observed or
treated by other means.
Adult Patients
Nutropin® [somatropin (rDNA origin)
for injection] is indicated for the replacement of endogenous
growth hormone in adults with growth hormone deficiency who meet
either of the following two criteria:
Adult Onset: Patients who have adult 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; or
Childhood Onset: Patients who were growth hormone
deficient during childhood as a result of congenital, genetic,
acquired, or idiopathic causes.
In general, confirmation of the diagnosis of adult growth
hormone deficiency in both groups usually requires an appropriate growth
hormone stimulation test. However, confirmatory growth hormone
stimulation testing may not be required in patients with
congenital/genetic growth hormone deficiency or multiple
pituitary hormone deficiencies due to organic
disease.
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NEWS HIGHLIGHTS
Published Studies Related to Nutropin (Human Growth Hormone)
Pharmacokinetic and pharmacodynamic characteristics of a long-acting growth hormone (GH) preparation (nutropin depot) in GH-deficient children. [2004.07]
Long-term GH replacement therapy is indicated for children with growth failure due to GH deficiency (GHD). We evaluated the feasibility of administering a long-acting GH preparation [Nutropin Depot (somatropin, rDNA origin) for injectable suspension] to prepubertal children with GHD by examining pharmacokinetic and pharmacodynamic response parameters after single or multiple doses...
Clinical Trials Related to Nutropin (Human Growth Hormone)
Clinical Trial of Growth Hormone in MPS I, II, and VI [Terminated]
The purpose of this study is to determine whether growth hormone is a safe and effective
treatment for short stature in children with Mucopolysaccharidosis type I, II, and VI.
Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments [Recruiting]
We, the researchers, have found that growth hormone deficiency is very common in patients
with pseudohypoparathyroidism type 1a, which falls under the broader condition termed
Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically
are short and obese. Some of these patients are not short during childhood, but due to a
combination of factors, they end up short as adults. We are evaluating the effect of growth
hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to
be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute
to the short stature and obesity found in this condition. We are also evaluating the effect
of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth
hormone deficient (ie., growth hormone sufficient).
We are also evaluating neurocognitive and psychosocial functioning in participants with AHO
in order to determine the specific impairments that are most common in the condition and to
determine the best approach toward management.
Funding source - - FDA OOPD [R01 FD003409 (in no-cost extension year) and R01 FD002568 (which
has ended)]
Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study [Terminated]
To assess the immunogenicity of Saizen® solution for injection in adult subjects with
documented Growth Hormone Deficiency (GHD).
An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD) [Recruiting]
This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity
of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency
(AGHD), who are growth hormone (GH) treatment-naïve or who had prior GH treatment for GHD
which was stopped at least 1 month prior to Screening and have no contraindication to the
use of GH.
Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device [Completed]
The purpose of this strictly observational, prospective, longitudinal study is to evaluate
with sufficient precision the rate of overall treatment compliance from one year to 3 years
of follow-up of the patients.
Somatotropin is indicated in the long-term treatment of children with growth retardation
related to a deficiency in secretion of growth hormone and in the long-term treatment of
growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are
the two indications of Zomacton�® 4 mg and 10 mg injection solution.
The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the
administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved
for the administration of Zomacton® 10 mg), allows the product to be administered by
percutaneous transjection (needle-free) and can be used by the child directly or by the
family after an initial training.
In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a
follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the
compliance and duration of use of the device.
The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device
is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90
patients will be treated. In the cohort studied the patients will be followed-up for 1 year
at least and for 3 years at the maximum.
The rate of treatment compliance will be evaluated according to the ratio of the actual
duration of administration over the total duration recommended by the physician during the
observation period.
Reports of Suspected Nutropin (Human Growth Hormone) Side Effects
Headache (6),
Death (5),
Convulsion (5),
Grimacing (4),
Unevaluable Event (3),
Heart Valve Replacement (3),
Autoimmune Disorder (3),
Asthma (2),
Medical Device Implantation (2),
Nasopharyngitis (2), more >>
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Page last updated: 2006-01-31
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