HUMATROPE SUMMARY
HUMATROPE® SOMATROPIN (rDNA ORIGIN) FOR INJECTION VIALS and CARTRIDGES
Humatrope® (Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of recombinant DNA origin.
INDICATIONS AND USAGE
Pediatric Patients -- Humatrope is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone.
Humatrope is indicated for the treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed.
Humatrope is 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 -- Humatrope is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
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Adult Onset: Patients who have growth hormone 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 growth hormone-deficient during childhood who have growth hormone deficiency confirmed as an adult before replacement therapy with Humatrope is started.
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NEWS HIGHLIGHTS
Published Studies Related to Humatrope (Somatropin)
Cost-effectiveness of somatropin for the treatment of short children born small for gestational age. [2010.06] BACKGROUND: Short children born small for gestational age (SGA) may be at increased risk for long-term morbidity and reduced health-related quality of life (HRQoL) due to their short stature. Normalization of height in childhood and adolescence is possible in such children via the use of the recombinant human growth hormone somatropin. OBJECTIVE: The aim of this study was to determine whether somatropin was a cost-effective treatment option in short children born SGA... CONCLUSION: In this model, somatropin was a cost-effective treatment option for short children born SGA from the perspective of the UK NHS.
Relative bioavailability of two drug products of somatropin obtained from either the milk of transgenic cows or bacterial culture. [2010] BACKGROUND: Our objective was to assess the relative bioavailability of the first somatropin produced in transgenic cloned cows that carry the human growth hormone (GH) gene (Biohormon) and somatropin produced in Escherichia coli culture (HHT), the procedure most frequently used for the commercial production of the hormone... CONCLUSION: This study demonstrates that a single dose of Biohormon, the first product with somatropin obtained from milk of transgenic mammals, is bioequivalent to the reference product HHT according to standard criteria. Copyright (c) 2010 S. Karger AG, Basel.
Cost-effectiveness of somatropin for the treatment of short children born small
for gestational age. [2010] cost-effective treatment option in short children born SGA... CONCLUSION: In this model, somatropin was a cost-effective treatment option for
Effect of the inhaled corticosteroid mometasone on small airway patency in patients with asthma. [2009.05] The inflammation in asthma involves both the large and the small airways. This study was designed to examine whether mometasone delivered from a dry powder inhaler would improve those parameters thought to reflect patency and obstruction of the small airways (diameter <2 mm)... Mometasone delivered by a dry powder inhaler improved asthma control and pulmonary function in tests reflecting both large and small airways.
Exercise capacity and hormonal response in adults with childhood onset growth hormone deficiency during long-term somatropin treatment. [1998.10] Growth hormone (GH) deficiency in adults in associated with reduced muscular strength and peak oxygen uptake (peak Vo2). How these variables are influenced by long-term somatropin therapy in adults with childhood onset GH-deficiency has not been precisely defined...
Clinical Trials Related to Humatrope (Somatropin)
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).
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)]
Somatropin Treatment to Final Height in Turner Syndrome [Completed]
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and
younger than 13 at study entry, to determine the efficacy and safety of Humatrope
(somatropin) treatment in promoting linear growth to final height.
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 Humatrope (Somatropin) Side Effects
Hospitalisation (29),
Drug Dose Omission (17),
Malaise (13),
Incorrect Dose Administered (10),
Cerebrovascular Accident (10),
Death (9),
Fatigue (9),
Vomiting (7),
Cushing's Syndrome (7),
Cardiac Disorder (6), more >>
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Page last updated: 2013-02-10
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