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Description

Indications and Usage Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg is indicated for the: treatment of pediatric patients aged 2.5 years and older with: Growth failure due to inadequate secretion of endogenous growth hormone (GH) Short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age Growth failure associated with Noonan Syndrome (NS) Idiopathic Short Stature (ISS) replacement of endogenous GH in adults with growth hormone deficiency (GHD) Indications and Usage Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg is indicated for the: treatment of pediatric patients aged 2.5 years and older with: Growth failure due to inadequate secretion of endogenous growth hormone (GH) Short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age Growth failure associated with Noonan Syndrome (NS) Idiopathic Short Stature (ISS) replacement of endogenous GH in adults with growth hormone deficiency (GHD) Important Safety Information for Sogroya Contraindications Sogroya is contraindicated in patients with: acute critical illness after open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure because of the risk of increased mortality with use of Sogroya hypersensitivity to Sogroya or any of its excipients

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Rare allergic reactions can occur with IV therapy, which is why a medical history check is mandatory

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The primary end point in the phase II is the BILAG-based Composite Lupus Assessment (BICLA) response at week 36

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