Nutropin (Human Growth Hormone Recombinant) - Summary

NUTROPIN SUMMARY

Nutropin is a human growth hormone (hGH) produced by recombinant DNA technology.

Nutropin® [somatropin (rDNA origin) for injection] is indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.

Nutropin® [somatropin (rDNA origin) for injection] is also indicated for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin therapy should be used in conjunction with optimal management of chronic renal insufficiency.

Nutropin® [somatropin (rDNA origin) for injection] is also indicated for the long-term treatment of short stature associated with Turner syndrome.

Nutropin® [somatropin (rDNA origin) for injection] is indicated for the replacement of endogenous GH in patients with adult GH deficiency who meet both of the following two criteria:

1. Biochemical diagnosis of adult GH deficiency by means of a subnormal response to a standard growth hormone stimulation test (peak GH</=5 µg/L), and
2. Adult-onset: Patients who have adult GH deficiency either alone or with multiple hormone deficiencies (hypopituitarism) as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
   Childhood-onset: Patients who were GH deficient during childhood, confirmed as an adult before replacement therapy with Nutropin is started.

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NEWS HIGHLIGHTS

Media Articles Related to Nutropin (Human Growth Hormone)

Human Growth Hormone (hGH): Is it safe?
Source: MedicineNet Steroid Withdrawal Specialty [2007.02.06]
Title: Human Growth Hormone (hGH): Is it safe?
Category: Ask The Experts
Created: 2/6/2007 12:00:00 AM
Last Editorial Review: 2/6/2007 12:00:00 AM

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Published Studies Related to Nutropin (Human Growth Hormone)

Pharmacokinetic and pharmacodynamic characteristics of a long-acting growth hormone (GH) preparation (nutropin depot) in GH-deficient children. [2004.07]
Long-term GH replacement therapy is indicated for children with growth failure due to GH deficiency (GHD). We evaluated the feasibility of administering a long-acting GH preparation [Nutropin Depot (somatropin, rDNA origin) for injectable suspension] to prepubertal children with GHD by examining pharmacokinetic and pharmacodynamic response parameters after single or multiple doses...

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Clinical Trials Related to Nutropin (Human Growth Hormone)

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.

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

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.Clickâ„¢ 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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Reports of Suspected Nutropin (Human Growth Hormone) Side Effects

Headache (6),  Death (5),  Convulsion (5),  Grimacing (4),  Unevaluable Event (3),  Heart Valve Replacement (3),  Autoimmune Disorder (3),  Asthma (2),  Medical Device Implantation (2),  Nasopharyngitis (2), more >>