SOGROYA

2 DOSAGE AND ADMINISTRATION • SOGROYA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of patients with growth hormone deficiency, pediatric patients born SGA, pediatric patients with NS, and pediatric patients with ISS. ( 2.1 ) • SOGROYA should be administered by subcutaneous injection once weekly, any time of the day, in the upper arms, thigh, abdomen or buttocks with regular rotation of injection site to avoid lipohypertrophy/lipoatrophy. ( 2.1 ) • See Full Prescribing Information for complete dosage, titration, and monitoring recommendations for pediatric and adult patients, including those aged 65 years and older, patients with hepatic impairment, and women receiving oral estrogen. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ) For pediatric patients : • GH deficiency: Initiate SOGROYA with a dosage of 0.16 mg/kg body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (somatropin). ( 2.3 ) • SGA/NS/ISS: Initiate SOGROYA with a dosage of 0.24 mg/kg body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (somatropin). ( 2.3 ) • Individualize dosage for each patient based on the growth response. ( 2.3 ) • Patients switching from daily human growth hormone to once-weekly SOGROYA should choose the preferred day for the weekly dose and stop final dose of daily treatment the day before (or at least 8 hours before) taking the first dose of once-weekly somapacitan-beco. ( 2.3 ) For adult patients with GHD : • Initiate SOGROYA with a dosage of 1.5 mg once weekly for treatment naïve patients and patients switching from daily growth hormone. ( 2.4 ) • Increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg to 1.5 mg until the desired response has been achieved. ( 2.4 ) • Titrate the dosage based on clinical response and serum insulin-like growth factor-1 (IGF-1) concentrations. ( 2.4 ) • The maximum recommended dosage for adult GHD is 8 mg once weekly. ( 2.4 ) 2.1 Important Dosing and Administration Information • SOGROYA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients with growth failure due to GHD, pediatric patients born SGA, pediatric patients with NS, pediatric patients with ISS and/or adults with GHD [see Indications and Usage ( 1 )]. • SOGROYA should be administered by subcutaneous injection, once weekly, any time of the day, in the upper arms, thigh, abdomen or buttocks with weekly rotation of injection site. • Inspect visually for particulate matter and discoloration. SOGROYA should be a clear to slightly opalescent and colorless to slightly yellow solution. If the solution is cloudy or contains particulate matter do not use. • Advise patients to read the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the SOGROYA prefilled pen. • SOGROYA is available in 3 single-patient-use prefilled pens with 3 different dosing ranges ( Table 1 ). Table 1. Strength and Dosing Range of SOGROYA Prefilled Pens Strength Dose increments (mg) Dose Delivery Range (mg) 5 mg/1.5 mL (3.3 mg/mL) 0.025 0.025 to 2 10 mg/1.5 mL (6.7 mg/mL) 0.05 0.05 to 4 15 mg/1.5 mL (10 mg/mL) 0.1 0.1 to 8 2.2 Perform Fundoscopic Examination Prior to Initiation of SOGROYA • Perform fundoscopic examination before initiating treatment with SOGROYA to exclude preexisting papilledema. If papilledema is identified, evaluate the etiology and treat the underlying cause before initiating treatment with SOGROYA [see Warnings and Precautions ( 5.5 )]. 2.3 Recommended Dosage and Monitoring for Pediatric Patients • GH Deficiency: Recommended dosage of SOGROYA is 0.16 mg/kg based on actual body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (somatropin). • Small for Gestational Age (SGA), Noonan Syndrome (NS), and Idiopathic Short Stature (ISS): Recommended dosage of SOGROYA is 0.24 mg/kg based on actual body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (somatropin). • Individualize dosage for each patient based on the growth response. • When switching from daily human growth hormone to once-weekly SOGROYA, choose the preferred day for the weekly dose. Take the final dose of daily treatment on the day before (or at least 8 hours before) the first dose of SOGROYA. • When switching from a weekly human growth hormone to once-weekly SOGROYA, continue once weekly dosing schedule. • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment. • Patients who were treated with SOGROYA for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuing SOGROYA. 2.4 Recommended Dosage, Titration, and Monitoring for Adults with GHD • Initiate SOGROYA with a dosage of 1.5 mg once weekly for treatment naïve patients and patients switching from daily growth hormone (somatropin). • Increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg to 1.5 mg until the desired response is achieved. • Titrate the dosage based on clinical response and serum insulin-like growth factor-1 (IGF-1) concentrations. Draw IGF-1 samples 3 to 4 days after the prior dose. • Decrease the dosage as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and sex-specific normal range. • The maximum recommended dosage is 8 mg once weekly. 2.5 Recommended Dosage and Titration for Specific Populations Patients Aged 65 Years and Older Initiate SOGROYA with a dosage of 1 mg once weekly and use smaller dose increment increases when titrating the dosage [see Use in Specific Populations ( 8.5 )]. See above for monitoring recommendations and the maximum recommended dosage of SOGROYA [see Dosage and Administration ( 2.4 )]. Patients with Hepatic Impairment • SOGROYA is not recommended in adult and pediatric patients with severe hepatic impairment [see Hepatic Impairment ( 8.6 )] . • For adult patients with moderate hepatic impairment, initiate SOGROYA with a dosage of 1 mg once weekly and use smaller dose increment increases when titrating the dosage. See above for monitoring recommendations [see Dosage and Administration ( 2.4 ), Pharmacokinetics ( 12.3 )] . The maximum recommended dosage is 4 mg once weekly. • For pediatric patients with moderate hepatic impairment, SOGROYA is not recommended [see Hepatic Impairment ( 8.6 )] . • No dosage adjustment is recommended for adult and pediatric patients with mild hepatic impairment. Women Receiving Oral Estrogen Initiate SOGROYA with a dosage of 2 mg once weekly [see Drug Interactions ( 7 )]. See above for titration and monitoring recommendations and the maximum recommended dosage of SOGROYA [see Dosage and Administration ( 2.4 )]. 2.6 Missed Doses • If the dose is missed, SOGROYA can be taken within 3 days after the scheduled dosing day. Once-weekly dosing for the next dose could be resumed at the regularly scheduled dosing day. • If more than 3 days have passed since the missed dose, skip the dose and administer the next dose on the regularly scheduled dosing day.

See official label

1 INDICATIONS AND USAGE SOGROYA 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).