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Lonapegsomatropin

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Lonapegsomatropin
Names
Trade namesSkytrofa
Other namesLonapegsomatropin-tcgd; Lonapegsomatropin Ascendis Pharma; rhGH-PEG; ACP-011; ΤransConPEG hGh; WHO-10598
Clinical data
Drug classGrowth hormone receptor agonist
Main usesGrowth hormone deficiency[1]
Side effectsHeadache, joint pain, low thyroid, pain at the site of injection[2]
Routes of
use		Subcutaneous injection
Legal
License data
Legal status
Chemical and physical data
FormulaC1051H1627N269O317S9[C2H4O]4n

Lonapegsomatropin, sold under the brand name Skytrofa, is a medication used to treat growth hormone deficiency.[1] It may be used in children from the ages of 1 to 18 year.[1][2] It is given by injection under the skin once per week.[2]

Common side effects include headache, joint pain, low thyroid, and pain at the site of injection.[2] Other side effects may include allergic reactions, cancer, diabetes, intracranial hypertension, swelling, pancreatitis, and slipped capital femoral epiphysis.[1] It is a human growth hormone (somatropin) that has been developed to be long acting.[1][2]

Lonapegsomatropin was approved for medical use in the United States in 2021 and Europe in 2022.[1][2] In the United States it costs 2,800 to 12,300 USD per week, depending on the weight of the child.[4] As of 2022 it is not yet commercial available in Europe.[5]

Medical uses

Lonapegsomatropin is a growth hormone therapy indicated to treat growth hormone deficiency.[1][2] It is equivalent to somatropin but only needs to be given once per week.[2]

Dosage

The typical dose is 0.24 mg/kg by injection once per week.[1]

History

Timeline of daily GH and long-acting GH product[6]

The first treatment for growth hormone deficiency was reported in 1958.[7]

In terms of the history of Lonapegsomatropin in the United States in August 2021 it was approved, for growth failure due to inadequate secretion of endogenous growth hormone in those of at least 1 year of age [8]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 "Skytrofa- lonapegsomatropin-tcgd injection, powder, lyophilized, for solution". DailyMed. Archived from the original on 1 October 2021. Retrieved 30 September 2021.
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 "Lonapegsomatropin Ascendis Pharma EPAR". European Medicines Agency. 10 November 2021. Archived from the original on 16 March 2022. Retrieved 16 March 2022.
  3. ↑ "Skytrofa: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 26 August 2021. Retrieved 25 August 2021.
  4. ↑ "Skytrofa Prices, Coupons, Copay & Patient Assistance". Drugs.com. Retrieved 27 October 2022.
  5. ↑ "Lonapegsomatropin". SPS - Specialist Pharmacy Service. 7 March 2019. Archived from the original on 17 January 2022. Retrieved 27 October 2022.
  6. ↑ Miller, Bradley S.; Yuen, Kevin CJ (29 June 2022). "Spotlight on Lonapegsomatropin Once-Weekly Injection and Its Potential in the Treatment of Growth Hormone Deficiency in Pediatric Patients". Drug Design, Development and Therapy. 16: 2055–2066. doi:10.2147/DDDT.S336285.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  7. ↑ Ayyar, Vageesh S. (September 2011). "History of growth hormone therapy". Indian Journal of Endocrinology and Metabolism. 15 (Suppl3): S162 – S165. doi:10.4103/2230-8210.84852. ISSN 2230-8210. Archived from the original on 18 June 2024. Retrieved 19 June 2024.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  8. ↑ Lamb, Yvette N. (1 January 2022). "Lonapegsomatropin: Pediatric First Approval". Pediatric Drugs. 24 (1): 83–90. doi:10.1007/s40272-021-00478-8. ISSN 1179-2019. Archived from the original on 21 June 2024. Retrieved 19 June 2024.

Further reading

External links

External sites:
Identifiers:
  • Clinical trial number NCT02781727 for "A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)" at ClinicalTrials.gov

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