Introduction of a Novel GH Auto-Injector for Once-weekly Administration of TransCon hGH
Background: TransCon hGH is an investigational long-acting prodrug of growth hormone (hGH; somatropin) in development as a once-weekly therapy for pediatric growth hormone deficiency (GHD). We evaluated the usability of TransCon hGH in dual-chamber cartridges (DCCs) (Source: Journal of Pediatric Nursing)
Source: Journal of Pediatric Nursing - April 30, 2020 Category: Nursing Authors: Kimberly Walsh, Donna Campbell, Joe Permuy, Michael Henson, Larry Rodriguez, Brittany Machus, April Shiver, Katharine Smith Tags: Product-Based Research Source Type: research
Treatment Experience of Children with Growth Hormone Deficiency in the Phase 3 fliGHt Trial: Switching from Daily Growth Hormone to Once-weekly TransCon hGH
Background: Patients treated with daily growth hormone (hGH; somatropin) therapy have long requested the option of a treatment requiring fewer injections. Once-weekly TransCon hGH is an investigational long-acting prodrug in development for the treatment of growth hormone deficiency (GHD) designed to fulfill this unmet need. TransCon hGH consists of 3 components: unmodified hGH, an inert carrier that protects it, and a linker that temporarily binds the two. (Source: Journal of Pediatric Nursing)
Source: Journal of Pediatric Nursing - April 30, 2020 Category: Nursing Authors: Donna Campbell, Kimberly Walsh, Carlyn Herz, Linda Weber, Natalie Marlen, Karla Kummer, Liza Reys, Jill Gianettoni Source Type: research
Long-term efficacy and safety of two doses of Norditropin ® (somatropin) in Noonan syndrome: a 4-year randomized, double-blind, multicenter trial in Japanese patients.
In conclusion, treatment with 0.033 and 0.066 mg/kg/day GH for 208 weeks improved height SDS in Japanese children with short stature due to Noonan syndrome with a significantly greater increase with 0.066 vs. 0.033 mg/kg/day GH and was well tolerated, with no new safety concerns.
PMID: 32269181 [PubMed - as supplied by publisher] (Source: Endocrine Journal)
Source: Endocrine Journal - April 11, 2020 Category: Endocrinology Tags: Endocr J Source Type: research
No increased risk of glucose metabolism disorders in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope ®): data from an observational, longitudinal study
To evaluate the impact of treatment with recombinant human growth hormone (rhGH; Omnitrope ®) on the risk of diabetes mellitus in adults with growth hormone deficiency (GHD), using data from the ongoing PATRO A... (Source: BMC Endocrine Disorders)
Source: BMC Endocrine Disorders - December 11, 2019 Category: Endocrinology Authors: Paolo Beck-Peccoz, Charlotte H öybye, Robert D. Murray, Suat Simsek, Markus Zabransky, Hichem Zouater and Günter Stalla Tags: Research article Source Type: research
Transitions, Suicidality, and Underappreciated Autism Spectrum Disorder in a High School Student
CASE:
Alex is a 14-year-old Portuguese-American boy with a psychiatric history starting at age 5 who presents to your primary care practice after an insurance change.
He was delivered prematurely at 32 weeks and diagnosed with congenital hypothyroidism at the age of 6 weeks and growth hormone deficiency at the age of 2 years; he is in active treatment for both. He otherwise met developmental milestones on time yet continues to have significant fatigue despite adequate sleep and vitamin D supplementation.
His family history is remarkable for maternal anxiety, depression, suicidal thoughts, and previous attempted suicide...
Source: Journal of Developmental and Behavioral Pediatrics - September 1, 2019 Category: Child Development Tags: Challenging Case Source Type: research
Towards preventive pharmacovigilance through medicine misuse identification: an example with recombinant human growth hormone for aesthetic purposes
ConclusionsThis information was the basis to design interventions in order to reduce inappropriate utilisation of this expensive product. Analyses of how medicines are being used through pharmacovigilance databases are a way to identify its irrational utilisation, thus facilitating preventive actions to improve how medicines are used and reducing avoidable adverse effects. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - July 23, 2018 Category: Drugs & Pharmacology Source Type: research
Blood-brain barrier transport kinetics of NOTA-modified proteins: the somatropin case.
CONCLUSIONS: Our results show that modification of NOTA as well as gallium chelation onto proteins, in casu somatropin, does not lead to a significantly changed pharmacokinetic profile at the blood-brain barrier.
PMID: 29697217 [PubMed - as supplied by publisher] (Source: Quarterly Journal of Nuclear Medicine and Molecular Imaging)
Source: Quarterly Journal of Nuclear Medicine and Molecular Imaging - April 28, 2018 Category: Nuclear Medicine Tags: Q J Nucl Med Mol Imaging Source Type: research
Relative Bioavailability of a Single 4-mg Dose of Somatropin Administered by Subcutaneous Injection or by Needle-free Device and Coadministered With the Growth Hormone Inhibitor Octreotide Acetate in Healthy Adult Subjects.
This study evaluated the relative bioavailability of somatropin delivered with a needle-free device compared with traditional SC injection.
METHODS: In this randomized, single-dose, crossover study, healthy adults aged 18 to 35 years received single 4-mg doses of somatropin via a needle-free device or SC injection, along with octreotide to suppress endogenous growth hormone production. Blood samples were analyzed for serum somatropin and insulin-like growth factor-1 (IGF-1) concentrations over 24 hours after somatropin dosing. Pharmacokinetic and pharmacodynamic parameters were evaluated by using noncompartmental m...
Source: Clinical Therapeutics - April 23, 2018 Category: Drugs & Pharmacology Authors: Brimhall DB, Petri N, D'Angelo P Tags: Clin Ther Source Type: research
Pattern of Use of Biosimilar and Originator Somatropin in Italy: A Population-Based Multiple Databases Study During the Years 2009 –2014
Ilaria Marcian ò, Ylenia Ingrasciotta, Francesco Giorgianni, Valentina Ientile, Alessandro Chinellato, Daniele Ugo Tari, Rosa Gini, Salvatore Cannavò, Maurizio Pastorello, Salvatore Scondotto, Pasquale Cananzi, Giuseppe Traversa, Francesco Trotta, Valeria Belleudi, Antonio Addis, Gianluca Trifirò (Source: Frontiers in Endocrinology)
Source: Frontiers in Endocrinology - March 13, 2018 Category: Endocrinology Source Type: research
The Concept of Biosimilars: From Characterization to Evolution—A Narrative Review
This article highlights the importance of biosimilars, as a cost‐cutting strategy, in the delivery of state‐of‐the‐art health care in developing countries, at a fraction of what a reference biological agent would cost. (Source: The Oncologist)
Source: The Oncologist - March 9, 2018 Category: Cancer & Oncology Authors: Fadi Farhat, Alfredo Torres, Wungki Park, Gilberto de Lima Lopes, Raja Mudad, Chukwuemeka Ikpeazu, Simon Abi Aad Tags: New Drug Development and Clinical Pharmacology Source Type: research
The Concept of Biosimilars: From Characterization to Evolution-A Narrative Review.
This article highlights the importance of biosimilars, as a cost-cutting strategy, in the delivery of state-of-the-art health care in developing countries, at a fraction of what a reference biological agent would cost.
PMID: 29284760 [PubMed - as supplied by publisher] (Source: The Oncologist)
Source: The Oncologist - December 28, 2017 Category: Cancer & Oncology Authors: Farhat F, Torres A, Park W, de Lima Lopes G, Mudad R, Ikpeazu C, Abi Aad S Tags: Oncologist Source Type: research
Efficacy and safety of two doses of Norditropin ® (somatropin) in short stature due to Noonan syndrome: a 2-year randomized, double-blind, multicenter trial in Japanese patients.
Efficacy and safety of two doses of Norditropin® (somatropin) in short stature due to Noonan syndrome: a 2-year randomized, double-blind, multicenter trial in Japanese patients.
Endocr J. 2017 Nov 07;:
Authors: Ozono K, Ogata T, Horikawa R, Matsubara Y, Ogawa Y, Nishijima K, Yokoya S
Abstract
This randomized double-blind multicenter trial (NCT01927861) evaluated the growth-promoting effect and safety of Norditropin(®) (NN220; somatropin) in Japanese children with short stature due to Noonan syndrome. Prepubertal children aged 3-<11 years (boys) or 3-<10 years (girls) with ...
Source: Endocrine Journal - November 9, 2017 Category: Endocrinology Tags: Endocr J Source Type: research
Database analysis of a support program for pediatric patients using somatropin due to growth hormone deficiency (ghd)
Endocare is a pediatric patient support program for children treatment with somatropin for growth hormone deficiency (GHD) among other indications. Since its launching in 2009, a database was developed to gather epidemiological information and to identify treatment profile of these pediatric patients. Our goal is to analyze this information. (Source: Value in Health)
Source: Value in Health - October 1, 2017 Category: International Medicine & Public Health Authors: LV Biglia, P Seiler, PV Souza Source Type: research
Cost-Minimization of Somatropin for GH Deficiency and Turner Syndrome Treatment from SUS Perspective
The objective of the study was to analyze and compare the costs, waste and effects of adherence to the treatment of somatropin presentations made available in SUS in relation to other presentations of the drug registered in Brazil, but not reimbursed. (Source: Value in Health)
Source: Value in Health - October 1, 2017 Category: International Medicine & Public Health Authors: PV Souza, LV Biglia, FE Zanini Tags: DIABETES/ENDOCRINE DISORDERS - Cost Studies Source Type: research
Follow-up of pediatric patients under treatment with somatropin in brazil through a patient support program (psp)
Somatropin is indicated for pediatric patients with GH deficiency among other indications and usually presents low adherence. The aim was to carry out a survey with pediatric patients under treatment with somatropin to identify unmet needs of treatment and to understand how the Patient Support Program helps, through specialized monitoring a better treatment and monitoring of children patients included on the patient support program. (Source: Value in Health)
Source: Value in Health - October 1, 2017 Category: International Medicine & Public Health Authors: P Seiler, F Guimaraes, LV Biglia, PV Souza Source Type: research
