소그로야프리필드펜5mg/1.5mL(소마파시탄)

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). SOGROYA is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD). SOGROYA is a human growth hormone analog indicated for: Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). ( 1 ) • Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age. ( 1 ) • Growth failure associated with Noonan syndrome (NS). ( 1 ) • Idiopathic Short Stature (ISS). ( 1 ) Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). ( 1 )

is contraindicated in patients with: • Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity to SOGROYA or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin [see Warnings and Precautions ( 5.2 )] . • Pediatric patients with closed epiphyses. • Active malignancy [see Warnings and Precautions ( 5.3 )]. • Active proliferative or severe non-proliferative diabetic retinopathy. • Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to risk of sudden death [see Warnings and Precautions ( 5.13 )] . • Acute critical illness ( 4 ) • Active malignancy ( 4 ) • Hypersensitivity to somapacitan-beco or …

• Severe Hypersensitivity : Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, may occur. In the event of an allergic reaction, seek prompt medical attention. ( 5.2 ) • Increased Risk of Neoplasm : Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm. ( 5.3 ) • Glucose Intolerance and Diabetes Mellitus : SOGROYA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving SOGROYA, especially in patients with existing diabetes mellitus or at risk for its development. ( 5.4 ) • Intracranial Hypertension (IH) : Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating. If papilledema occurs with SOGROYA, stop treatment. ( 5.5 ) • Fluid Retention : Was observed and may be dose dependent. Reduce dose as necessary. ( 5.6 ) • Hypoadrenalism : Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. ( 5.7 ) • Hypothyroidism : Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of SOGROYA. ( 5.8 ) • Slipped Capital Femoral …

8.1 Pregnancy Risk Summary There are no available data on the use of SOGROYA during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week. No adverse developmental outcomes were observed in a pre- and post-natal development study with …