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Norditropin (Somatropin) - Summary

 
 



NORDITROPIN SUMMARY

Norditropin is a registered trademark of Novo Nordisk Health Care AG for somatropin, a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone.

Pediatric Patients

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH).

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature associated with Noonan syndrome.

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature associated with Turner syndrome.

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature born small for gestational age (SGA) with no catch-up growth by age 2-4 years.

Adult Patients

Norditropin [somatropin (rDNA origin) injection] is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

  • Adult Onset (AO): Patients who have GHD, 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 (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with somatropin for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GHD adults. According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.


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NEWS HIGHLIGHTS

Published Studies Related to Norditropin (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.

Norditropin SimpleXx: a liquid human growth hormone formulation, a pen system and an auto-insertion device. [1999]
Patient compliance is of vital importance for the outcome of any medical therapy. Compliance is especially a problem in long-term treatment of non-life threatening diseases, such as growth retardation in children...

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Clinical Trials Related to Norditropin (Somatropin)

American Norditropin Studies - Registry of Growth Hormone (GH) Patients [Suspended]
The Norditropin National Registry is a post-marketing registry of patients using Norditropin therapy. A large body of data will be generated to meet the following Registry Objectives:

- To develop a pharmacodynamic model defining the relationship of Norditropin dose to IGF

changes, accounting for effects of known or suspected independent variables such as age, gender and puberty

- To develop a model defining the relationship of GH dose and IGF exposure to treatment

outcomes, accounting for effects of known or suspected independent variables such as age, gender and puberty

- To develop a safety model that related GH doses to adverse even occurrence, again

accounting for the effects of known or suspected independent variables

- To determine the relative predictive values of pre-treatment GH stimulation tests and

pre-treatment IGF-I and IGFBP-3 levels

Observational Prospective Study on Patients Treated With Norditropin« [Enrolling by invitation]
This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) [Completed]
This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. The order of dosing regimen within the groups and between the groups will be randomised. All patients will go through four different treatment sessions: A/B Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously

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)]

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Reports of Suspected Norditropin (Somatropin) Side Effects

Thyroid Cancer (8)Viith Nerve Paralysis (6)Osteochondrosis (6)Headache (5)Sleep Apnoea Syndrome (5)Tonsillar Hypertrophy (4)Neoplasm Progression (4)Oedema Peripheral (4)Condition Aggravated (4)Bone Sarcoma (4)more >>


Page last updated: 2013-02-10

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