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Omnitrope (Somatropin Subcutaneous) - Summary

 
 



OMNITROPE SUMMARY

OMNITROPE™ somatropin [rDNA origin] for injection is a polypeptide hormone of recombinant DNA origin.

OMNITROPE™ is indicated for:

  • Long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
  • Long-term replacement therapy in adults with growth hormone deficiency (GHD) of either childhood- or adult- onset etiology. GHD should be confirmed by an appropriate growth hormone stimulation test.

See all Omnitrope indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Omnitrope (Somatropin Subcutaneous)

Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis. [2010.11]
This article discusses the bioequivalence of Omnitrope (Sandoz's rhGH biosimilar) and Genotropin (reference rhGH product), assessed in the first 2 clinical phase 1 studies conducted during the development of Omnitrope. Both of these phase 1 studies were randomized, double-blind, crossover studies, each involving 24 healthy volunteers who underwent pituitary somatrope cell down-regulation using octreotide...

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.

Bioequivalence between novel ready-to-use liquid formulations of the recombinant human GH Omnitrope and the original lyophilized formulations for reconstitution of Omnitrope and Genotropin. [2010.06]
OBJECTIVE: Two strengths of a novel ready-to-use liquid preparation of the recombinant human GH (rhGH) Omnitrope were developed to increase the convenience for the patients. DESIGN: Omnitrope 3.3 mg/ml solution or Omnitrope 6.7 mg/ml solution was compared to Omnitrope 5 mg/ml powder and Genotropin 5 mg/ml powder in terms of pharmacokinetics, pharmacodynamics, safety, and local tolerance after a single s.c. dose of 5 mg... CONCLUSIONS: Omnitrope 3.3 mg/ml solution, 6.7 mg/ml solution, and 5 mg/ml powder, and Genotropin 5 mg/ml powder are bioequivalent, have similar pharmacokinetic and pharmacodynamic profiles, and are equally safe. Overall, the products can be considered to be therapeutically interchangeable.

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

more studies >>

Clinical Trials Related to Omnitrope (Somatropin Subcutaneous)

Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency [Completed]
To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-Onset Growth Hormone Deficiency [Completed]
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.

American Norditropin Studies - Registry of Growth Hormone (GH) Patients [Recruiting]
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

Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects [Recruiting]
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers [Recruiting]

more trials >>

Reports of Suspected Omnitrope (Somatropin Subcutaneous) Side Effects

Headache (4)Viith Nerve Paralysis (3)Rash (2)Convulsion (2)Syncope (2)Hypersensitivity (1)Haemorrhage (1)Eczema (1)Pyrexia (1)Drug Abuse (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Omnitrope has an overall score of 7. The effectiveness score is 6 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Omnitrope review by 46 year old male patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   HGH Deficiency & HIV
Dosage & duration:   .5 cc per day (dosage frequency: daily 5 days on , 2 days off) for the period of ongoing, been 6 months
Other conditions:   poor lipid profile
Other drugs taken:   testosterone, nandrolone ( Deca) and Noveral
  
Reported Results
Benefits:   skin seems to be producing more collagen and DEFINITELY has better texture and appearance. The low dose of HGH is something that needs to be considered as it really border a theraputic level. The bad side is the cost...500 per month at 1 cc per day. For men I cant tell you how happy I am with the low dose testosterone / Nandrolone (Deca) combination ( 100 mg per week). And generally speaking isnsurance companies DO cover injectable testosterone.
Side effects:   none
Comments:   see above

See all Omnitrope reviews / ratings >>

Page last updated: 2013-02-10

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