DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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)

Genotropin Study Assessing Use of Injection Pen [Completed]
Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire at baseline and 2 months.

Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects [Completed]
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.

SaizenŽ Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study [Terminated]
To assess the immunogenicity of SaizenŽ 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)]

Drug Use Investigation of Somatropin for GHD-ADULTS. [Completed]

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.

See all Genotropin reviews / ratings >>

Page last updated: 2013-02-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015