HUMATROPE SUMMARY
HUMATROPE®
SOMATROPIN (rDNA ORIGIN) FOR INJECTION
VIALS and CARTRIDGES
Humatrope® (Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of recombinant DNA origin.
INDICATIONS AND USAGE
Pediatric Patients -- Humatrope is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone.
Humatrope is indicated for the treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed.
Humatrope is indicated for the long-term treatment of idiopathic short stature, also called non-growth hormone-deficient short stature, defined by height SDS Adult Patients -- Humatrope is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
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Adult Onset: Patients who have growth hormone 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 growth hormone-deficient during childhood who have growth hormone deficiency confirmed as an adult before replacement therapy with Humatrope is started.
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NEWS HIGHLIGHTS
Published Studies Related to Humatrope (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.
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
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...
Clinical Trials Related to Humatrope (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.
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.
Reports of Suspected Humatrope (Somatropin) Side Effects
Hospitalisation (29),
Drug Dose Omission (17),
Malaise (13),
Incorrect Dose Administered (10),
Cerebrovascular Accident (10),
Death (9),
Fatigue (9),
Vomiting (7),
Cushing's Syndrome (7),
Cardiac Disorder (6), more >>
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