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Genotropin (Somatropin) - Summary

 
 



GENOTROPIN SUMMARY

GENOTROPIN Lyophilized Powder contains somatropin [rDNA origin], which is a polypeptide hormone of recombinant DNA origin.

GENOTROPIN Lyophilized Powder is indicated for:

  • Long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
  • Long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing (see CONTRAINDICATIONS).
  • Long-term treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2.
    Other causes of short stature in pediatric patients should be excluded.
  • 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 Genotropin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Genotropin (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.

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

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]
s.c. dose of 5 mg... CONCLUSIONS: Omnitrope 3.3 mg/ml solution, 6.7 mg/ml solution, and 5 mg/ml

more studies >>

Clinical Trials Related to Genotropin (Somatropin)

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

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.

Efficacy of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency [Completed]
Aim of this study is to define the possible benefits of growth hormone supplementation, in patients with heart failure due to left ventricular systolic dysfunction and coexisting growth hormone deficiency.

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

Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women [Completed]
The purpose of the study is to evaluate the effects of growth hormone replacement on women with growth hormone deficiency. Growth hormone deficiency means the body no longer produces growth hormone due to a tumor or some kind of disease of the brain in an area called the pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally produced. We, the researchers at Massachusetts General Hospital, will establish the effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is to see if this therapy:

- has effects on women's cardiovascular risk markers (special blood tests which indicate

how healthy the heart and arteries are)

- has effects on women's types and levels of various substances circulating in their

blood

- in women affects the stiffness of their arteries and heart rate variability in parallel

with changes in cardiovascular risk markers

- has different effects depending on whether women are pre or post menopausal.

Participation in this study is expected to last approximately 12 months.

more trials >>

Reports of Suspected Genotropin (Somatropin) Side Effects

Headache (82)Injection Site Pain (43)Vomiting (27)Injection Site Haemorrhage (25)Fatigue (25)Drug Ineffective (22)Nausea (22)Arthralgia (21)Pyrexia (19)Rash (19)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Genotropin has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Genotropin review by 48 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Myalgic Encephalomyelitis/CFS
Dosage & duration:   0.8mg taken varies for the period of 2 yrs and continuing
Other conditions:   severe insomnia (actually part of ME/CFS)
Other drugs taken:   A.M. Levothroxine, Wellbutrin, Adderall. P.M.clonozapem, trazadone, Detrol La, Gabapentin
  
Reported Results
Benefits:   Genotropin-aids in sleep cycle and helps counter the sagging skin & loss of muscle tone lost w/ this illness due to inactivity(see explain. below) also provides overall systemic support (deep sleep & activity stimulate release of hGH; both of which I've lost ability to do). Other P.M. meds address various stages of sleep; clonoapem=stage 1 or quieting down mind & trazadone helps me get deep sleep of which I was totally deprived (when hGH is suppose to be released) of as revealed in sleep study. I now actually fall asleep for more than 2 hr stretches (3-4 hrs now) and can get back to sleep (still need to refine regiment so I can get a normal nights sleep-of greatest importance for healing process). Detrol LA calms the hypersensitivity of the bladder was getting up 4-8 times each night to relieve very small amounts of urine (whole nervous system STUCK in over stimulated state) Gabapentin is a miracle for Restless Legs. A.M. meds. Adderall-some relief from "brain fog"(typical w/ illness) but find it helps keep my blood sugar level more stable and don't reach for as many "sugar fixes" (always suffered from Hypoglycemia but more severe w/ ME/CFS) which results in 20+ lb. weight gain due to inability to be active(another time hGH is released)(post exertional malaise is cornerstone of illness i.e. any exertion beyond minimal causes greater level of illness-leaves me bedridden/sofa-bound for days-weeks-months @ a time) Levothyroxine(spell?)is for Hasimoto's disease (form of hypothyroid) Wellbutrin (now Budipropion[spell?]keeps physiological depression at bay. That's all I can think of for now:(
Side effects:   The combo of sleep meds leave me in a very grogged out state sometimes for hours if I'm not able to get 10-11 hours of sleep/wake time-rather staying/resting in bed between sleeping & waking. hGH has the side effect of water retention but being stuck in a chronic dehydrated state (fluid goes right through me as opposed to into cells)I suppose part of the reason for sagging, old dehydrated skin-been ill since age 36 and am describing a state beyond normal for age.
Comments:   I think I summed this up when describing treatment benefits. But I'd like to add here that much of my daytime difficulties arise from how quickly exhaustion sets in from the mildest activity, sometimes just walking across the room. On the rare days I can get out a run local errands I come back so exhausted & in pain, it causes me to avoid doing so as much as possible. Another issue is low blood volume-which means low oxygen available so have sudden and very high lactic acid levels from climbing a few flights of stairs or anything that demands immediate demanding effort. Low O2 to brain leaves me faint and lose train of thought, confusion, high agitation from over sensory load-like the brain short circuits. Could write EVEN more this is such a horribly cruel "life-ending" curse. I am not dead but I lost my life back in 97.

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Page last updated: 2013-02-10

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