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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.


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NEWS HIGHLIGHTS

Published Studies Related to Genotropin (Somatropin)

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...

A low starting dose of genotropin in growth hormone-deficient adults. [1997.01]
We investigated the effect of 12 weeks of recombinant human GH therapy given in three different doses on serum insulin-like growth factor I (IGF-I) and IGF-binding protein-3 (IGFBP-3) in patients with GH deficiency (GHD). We used low doses of recombinant human GH (Genotropin), as we and others recently found a strong decrease in physiological GH production with age in healthy controls, especially in those older than 30 yr...

Outcome of a four-year randomized study of daily versus three times weekly somatropin treatment in prepubertal naive growth hormone-deficient children. Genentech Study Group. [1996.05]
A comparison was made of the growth responses of prepubertal naive GH-deficient children who were randomly assigned to receive 0.3 mg/kg.week recombinant human GH administered either daily (QD) or three times weekly (TIW) over 4 yr. The effects of the two regimens on annual growth velocity, change in height SD score, bone maturation, and age at onset of puberty are presented as the mean +/- SD.

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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

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.

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.

Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome [Recruiting]
This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome. The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.

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.

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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: 2009-10-20

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