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Review

Somapacitan

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In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
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Review

Somapacitan

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Excerpt

Somapacitan is a long acting, recombinant growth hormone analog that is used to treat adults and children two years of age or older with growth hormone deficiency. Somapacitan has not been linked to elevations in serum aminotransferase levels or bilirubin levels during therapy or to instances of clinically apparent liver injury with symptoms or jaundice.

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References

    1. FDA. Clinical Review. 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761156Orig1s000M...(Summary of the data the safety and efficacy of somapacitan submitted in support of its approval as therapy of growth hormone deficiency, makes no specific mention of serum aminotransferase or bilirubin elevations, and after discussion of IGF-1 and glucose levels during treatment states “no other clinically relevant changes in other biochemistry parameters were observed”).
    1. Johannsson G, Feldt-Rasmussen U, Håkonsson IH, Biering H, Rodien P, Tahara S, Toogood A, et al.; REAL 2 Study Group. Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial. Eur J Endocrinol. 2018;178:491-499.(Among 92 adults with growth hormone deficiency on once daily growth hormone therapy who were randomized to receive weekly injections of somapacitan vs daily norditropin for 26 weeks, IGF-1 levels were maintained in the normal range with both agents, adverse events rates were similar, and there were “no clinically relevant changes…in clinical laboratory measurements”). - PMC - PubMed
    1. Sävendahl L, Battelino T, Brod M, Højby Rasmussen M, Horikawa R, Juul RV, Saenger P; REAL 3 study group. Once-weekly somapacitan vs daily GH in children with GH deficiency: results from a randomized phase 2 trial. J Clin Endocrinol Metab. 2020;105:e1847–61.(Among 59 previously untreated, pre-pubertal children with growth hormone deficiency treated with one of 3 doses of once weekly somapacitan or daily growth hormone, height velocity was greater with the highest dose of somapacitan [12.9 vs 11.4 cm per year], while adverse event rates were similar and there were “no clinically relevant findings” in laboratory measurements). - PMC - PubMed
    1. Johannsson G, Gordon MB, Højby Rasmussen M, Håkonsson IH, Karges W, Sværke C, Tahara S, et al. Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial. J Clin Endocrinol Metab. 2020;105:e1358–76.(Among 301 adults with growth hormone deficiency treated with somapacitan weekly vs recombinant growth hormone daily vs placebo for 34 weeks, improvements in truncal fat percentage and IGF-1 levels were similar with both forms of growth hormone in comparison to placebo, and both total and serious adverse event rates were similar in the three groups and there were no hepatic severe adverse events; no mention of ALT elevations or hepatotoxicity). - PMC - PubMed
    1. Miller BS, Blair JC, Rasmussen MH, Maniatis A, Kildemoes RJ, Mori J, Polak M, et al. Weekly somapacitan is effective and well tolerated in children With GH deficiency: the randomized phase 3 REAL4 trial. J Clin Endocrinol Metab. 2022;107:3378-3388.(Among 200 children with prepubertal growth hormone deficiency treated with somapacitan or daily recombinant growth hormone [somatropin] for 52 weeks followed by open-label somapacitan for up to 4 years, the increase in height velocity was similar with both forms of growth hormone and adverse events were largely mild-to-moderate and considered unrelated to therapy; there were no discontinuations or deaths attributed to therapy; no mention of ALT levels or hepatotoxicity). - PMC - PubMed

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