Somapacitan, sold under the brand name Sogroya, is a growth hormone medication.[3][10] Somapacitan is a human growth hormone analog.[3] Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology.[3]
The most common side effects include: back pain, joint paint, indigestion, a sleep disorder, dizziness, tonsillitis, swelling in the arms or lower legs, vomiting, adrenal insufficiency, hypertension, increase in blood creatine phosphokinase (a type of enzyme), weight increase, and anemia.[10][4]
It was approved for medical use in the United States in August 2020,[10][13][14][4] and in the European Union in March 2021.[11]
Somapacitan is the first human growth hormone (hGH) therapy that adults only take once a week by injection under the skin; other FDA-approved hGH formulations for adults with growth hormone deficiency must be administered daily.[10] It contains a small non-covalent moiety that reversibly binds to serum albumin which slows down elimination.[15]
^ ab"Sogroya APMDS". Therapeutic Goods Administration (TGA). 7 March 2022. Retrieved 23 March 2022.
^"Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Archived from the original on 3 April 2022. Retrieved 2 January 2023.
^ abcde"Sogroya- somapacitan-beco injection, solution". DailyMed. 1 October 2021. Archived from the original on 23 April 2022. Retrieved 23 April 2022.
^ abcCite error: The named reference FDA snapshot was invoked but never defined (see the help page).
^"Sogroya". Therapeutic Goods Administration (TGA). Retrieved 23 March 2022.[permanent dead link]
^Anvisa (15 September 2023). "RDC Nº 816 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 816 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 18 September 2023). Archived from the original on 19 October 2023. Retrieved 19 October 2023.
^"Details for: Sogroya". Health Canada. 27 November 2023. Retrieved 3 March 2024.
^"Summary Basis of Decision (SBD) for Sogroya". Health Canada. 1 September 2012. Retrieved 11 December 2023.
^"Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26]". Health Canada. 26 October 2023. Retrieved 3 January 2024.
^ abcde"FDA approves weekly therapy for adult growth hormone deficiency". U.S. Food and Drug Administration (FDA) (Press release). 1 September 2020. Archived from the original on 1 September 2020. Retrieved 1 September 2020. This article incorporates text from this source, which is in the public domain.
^ abCite error: The named reference Sogroya EPAR was invoked but never defined (see the help page).
^"Sogroya Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
^"FDA approves once-weekly Sogroya for the treatment of adult growth hormone deficiency". Novo Nordisk (Press release). 28 August 2020. Archived from the original on 1 September 2020. Retrieved 1 September 2020.
^"Sogroya: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 29 October 2020. Retrieved 2 September 2020.
^Yuen KC, Miller BS, Boguszewski CL, Hoffman AR (February 2022). Mancini A, Persani L, Arosio M, Kreitschmann-Andermahr I (eds.). "Usefulness and Potential Pitfalls of Long-Acting Growth Hormone Analogs". Front Endocrinol. 12. Frontiers Media SA: 32. doi:10.3389/fendo.2021.637209. ISBN 978-2-88974-443-5. PMC 7943875. PMID 33716988. Archived from the original on 30 September 2022. Retrieved 24 April 2022.
Somapacitan, sold under the brand name Sogroya, is a growth hormone medication. Somapacitan is a human growth hormone analog. Somapacitan-beco is produced...
approved a different sustained-release form of growth hormone, Sogroya® (somapacitan-beco) (Novo) for both pediatric patients (2.5 years and older) and adult...
primarily in the formulations and delivery devices.[citation needed] Somapacitan-beco (Sogroya) is first once-per week subcutaneous human growth hormone...