NUTROPIN AQ SUMMARY
Nutropin AQ is a human growth hormone (hGH) produced by recombinant DNA technology.
Nutropin AQ® [somatropin (rDNA origin) injection] is indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.
Nutropin AQ® [somatropin (rDNA origin) injection] is also indicated for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin AQ therapy should be used in conjunction with optimal management of chronic renal insufficiency.
Nutropin AQ® [somatropin (rDNA origin) injection] is also indicated for the long-term treatment of short stature associated with Turner syndrome.
Nutropin AQ® [somatropin (rDNA origin) injection] is indicated for the replacement of endogenous GH in patients with adult GH deficiency who meet both of the following two criteria:
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Biochemical diagnosis of adult GH deficiency by means of a subnormal response to a standard growth hormone stimulation test (peak GH </=5 µg/L), and
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Adult-onset: Patients who have adult GH deficiency either alone or with multiple hormone deficiencies (hypopituitarism) as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood-onset: Patients who were GH deficient during childhood, confirmed as an adult before replacement therapy with Nutropin AQ is started.
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NEWS HIGHLIGHTS
Published Studies Related to Nutropin AQ (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 AQ (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 AQ (Human Growth Hormone) Side Effects
Convulsion (6),
Fatigue (5),
Hepatic Cirrhosis (4),
Vomiting (4),
Hypersensitivity (3),
Pyrexia (3),
Weight Increased (3),
Limb Operation (3),
Enamel Anomaly (3),
Completed Suicide (3), more >>
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Page last updated: 2006-01-31
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