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:
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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
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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 HIGHLIGHTSMedia Articles Related to Nutropin (Human Growth Hormone)
PROLOR Biotech Reports Positive Top-Line Results From Phase I Study Of Its Longer-Acting Version Of Human Growth Hormone
Source: Clinical Trials / Drug Trials News From Medical News Today [2010.02.03]
PROLOR Biotech, Inc., (OTC Bulletin Board: PBTH) reported positive top-line results from a Phase I study of its longer-acting version of human growth hormone (hGH). The study was designed to measure the potential durability (half-life), overall drug exposure (AUC) and biological efficacy, as well as the safety and tolerability of PROLOR's longer-acting CTP-modified human growth hormone (hGH-CTP)...
Human Growth Hormone: Not A Life Extender After All?
Source: Endocrinology News From Medical News Today [2010.01.27]
People profoundly deficient in human growth hormone (HGH) due to a genetic mutation appear to live just as long as people who make normal amounts of the hormone, a new study shows. The findings suggest that HGH may not be the "fountain of youth" that some researchers have suggested...
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
Last Editorial Review: 2/6/2007
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...
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.
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.
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.
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