Sogroya

somapacitan-beco · Injection, Solution · Subcutaneous

Prescription (Rx)

Uses

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).
• 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 )

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 )].

Dosage forms and strengths

3 DOSAGE FORMS AND STRENGTHS SOGROYA is a clear to slightly opalescent and colorless to slightly yellow solution available as follows:
• Injection: 5 mg/1.5 mL (3.3 mg/mL) in a single-patient-use prefilled pen (teal)
• Injection: 10 mg/1.5 mL (6.7 mg/mL) in a single-patient-use prefilled pen (yellow)
• Injection: 15 mg/1.5 mL (10 mg/mL) in a single-patient-use prefilled pen (red) SOGROYA is a liquid solution available in a ready-to-use prefilled pen. Injection: 5 mg/1.5 mL (3.3 mg/mL) or 10 mg/1.5 mL (6.7 mg/mL) or 15 mg/1.5 mL (10 mg/mL) in a single-patient-use prefilled pen. ( 3 )

Contraindications

4 CONTRAINDICATIONS SOGROYA 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 excipients ( 4 )
• Active proliferative or severe non-proliferative diabetic retinopathy ( 4 )
• Closed epiphyses in children used for longitudinal growth promotion ( 4 )
• Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment due to risk of sudden death ( 4 )

Warnings and precautions

• 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 Epiphysis in Pediatric Patients : May develop. Evaluate children with the onset of a limp or persistent hip/knee pain. ( 5.9 )
• Progression of Preexisting Scoliosis in Pediatric Patients : May develop. ( 5.10 )
• Pancreatitis : Consider pancreatitis in patients with persistent severe abdominal pain. ( 5.11 )
• Lipohypertrophy/lipoatrophy : May occur if SOGROYA is administered in the same location over a long period of time. Rotate injection sites on a regular basis. ( 5.12 ) 5.1 Increased Mortality in Patients with Acute Critical Illness Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery and multiple accidental trauma, as well as patients with acute respiratory failure [see Contraindications ( 4 )] . The safety of continuing SOGROYA treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. SOGROYA is not indicated for the treatment of non-GH deficient adults. 5.2 Severe Hypersensitivity Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin. Inform patients and/or caregivers that such reactions are possible, and that prompt medical attention should be sought if an allergic reaction occurs. SOGROYA is contraindicated in patients with known hypersensitivity to somatropin or any excipients in SOGROYA [see Contraindications ( 4 )]. 5.3 Increased Risk of Neoplasms Active Malignancy There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy [see Contraindications ( 4 )] . Any preexisting malignancy should be inactive, and its treatment complete prior to instituting therapy with SOGROYA. Discontinue SOGROYA if there is evidence of recurrent activity. Risk of Second Neoplasm in Pediatric Patients In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent growth hormone deficiency (GHD) and were treated with somatropin, an increased risk of second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on somatropin therapy for progression or recurrence of the tumor. New Malignancy During Treatment Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting SOGROYA in these patients. If treatment with SOGROYA is initiated, carefully monitor these patients for development of neoplasms. There is risk of malignant changes of preexisting nevi with somatropin treatment in patients. Monitor patients on SOGROYA therapy carefully for increased growth or potential malignant changes of preexisting nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances, and/or changes in the appearance of preexisting nevi . 5.4 Glucose Intolerance and Diabetes Mellitus Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients taking somatropin. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving SOGROYA, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or pre-diabetes should be monitored closely. The doses of antidiabetic agents may require adjustment when SOGROYA is initiated. 5.5 Intracranial Hypertension Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in patients treated with somatropin. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, intracranial hypertension-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose.

Side effects

The following clinically significant adverse drug reactions are described elsewhere in the labeling:
• Increased mortality in patients with acute critical illness [see Warnings and Precautions ( 5.1 )]
• Severe hypersensitivity [see Warnings and Precautions ( 5.2 )]
• Increased risk of neoplasms [see Warnings and Precautions ( 5.3 )]
• Glucose intolerance and diabetes mellitus [see Warnings and Precautions ( 5.4 )]
• Intracranial hypertension [see Warnings and Precautions ( 5.5 )]
• Fluid retention [see Warnings and Precautions ( 5.6 )]
• Hypoadrenalism [see Warnings and Precautions ( 5.7 )]
• Hypothyroidism [see Warnings and Precautions ( 5.8 )]
• Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions ( 5.9 )]
• Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions ( 5.10 )]
• Pancreatitis [see Warnings and Precautions ( 5.11 )]
• Lipohypertrophy/Lipoatrophy [see Warnings and Precautions ( 5.12 )]
• Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions ( 5.13 )]
• Common adverse reactions reported in pediatric patients treated with SOGROYA include: cough, diarrhea, ear infection, headache, injection site reaction, nasopharyngitis, pain in extremity, pyrexia, respiratory tract infection, and vomiting. ( 6.1 )
• Adult patients with GHD: Adverse reactions reported in >2% of patients treated with SOGROYA are: back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, blood creatine phosphokinase increase, weight increase, anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Pediatric Patients with GHD SOGROYA 0.16 mg/kg/week was studied in a 52-week randomized, open-label, active-controlled, parallel-group clinical study in 200 treatment-naïve, prepubertal pediatric patients with growth hormone deficiency [see Clinical Studies ( 14.1 )] . Table 2 shows common adverse reactions that occurred in ≥ 5% of patients treated with either SOGROYA or somatropin in this trial. Table 2. Adverse Reactions Occurring ≥5% in SOGROYA or Somatropin-treated Pediatric Patients (52 Weeks of Treatment) Somatropin (N=68) SOGROYA (N=132) Adverse Reactions % % Nasopharyngitis a 16.2 16.7 Headache 8.8 12.1 Pyrexia b 11.8 9.1 Pain in extremity c 2.9 9.8 Injection site reaction d 5.9 6.1 Diarrhea e 5.9 4.5 Nausea/vomiting f 5.9 4.5 Bronchitis 7.4 3 a Nasopharyngitis in the SOGROYA treatment group included nasopharyngitis (11.4%), rhinitis (3.8%), pharyngitis streptococcal (0.8%), acute sinusitis (0.8%), nasal congestion (0.8%), pharyngitis (0.8%), and sinusitis (0.8%). b Pyrexia in the SOGROYA treatment group included pyrexia (8.3%) and hyperthermia (0.8%). c Pain in extremity in the SOGROYA treatment group included pain in extremity (9.1%) and growing pains (0.8%). d Injection site reaction in the SOGROYA treatment group included injection site bruising (1.5%), injection site pain (1.5%), injection site hematoma (1.5%), injection site reaction (0.8%), and injection site swelling (0.8%) e Diarrhea in the SOGROYA treatment group included diarrhea (2.3%), gastroenteritis viral (1.5%), and gastrointestinal viral infection (0.8%) f Nausea/vomiting in the SOGROYA treatment group included vomiting (4.5%) and nausea (1.5%) Pediatric Patients Born Small for Gestational Age and with no Catch-up Growth by 2 Years of Age SOGROYA 0.24 mg/kg/week was studied in a 52-week randomized, open-label, active-comparator, basket clinical study in GH treatment-naïve, pre-pubertal patients with short stature born small for gestational age (SGA), Noonan syndrome (NS) or idiopathic short stature (ISS) compared to somatropin [see Clinical Studies ( 14.2 )] . Table 3 shows the adverse reactions occurring at ≥10% in the SGA cohort with 141 pediatric patients. Table 3. Adverse Reactions Occurring ≥10% in SOGROYA or Somatropin-Treated Pediatric Patients with SGA at Week 52 Somatropin 0.035 mg/kg/day (N=37) Somatropin 0.067 mg/kg/day (N=35) SOGROYA 0.24 mg/kg/week (N=69) Adverse Reactions % % % Nasopharyngitis a 38 29 26 Respiratory Tract Infection b 30 20 26 Pyrexia 16 17 19 Cough c 16 9 16 Ear Infection d 16 17 13 Diarrhea e 8 6 10 Vomiting f 11 11 10 Bronchitis 11 11 7 a Nasopharyngitis in the SOGROYA treatment group included nasopharyngitis (15.9%), pharyngitis (2.9%), rhinitis (2.9%), pharyngitis streptococcal (1.4%), sinusitis (1.4%), and viral rhinitis (1.4%). b Respiratory tract infections in the SOGROYA treatment group included upper respiratory tract infection (20.3%), influenza (10.1%), metapneuomovirus infection (1.4%), mycoplasma infection (1.4%), pneumonia (1.4%), pneumonia bacterial (1.4%), pneumonia mycoplasmal (1.4%), respiratory syncytial virus infection (1.4%), and respiratory tract infection (1.4%). c Cough in the SOGROYA treatment group included cough (15.9%). d Ear infection in the SOGROYA treatment group included otitis media (7.2%), ear infection (2.9%), otitis externa (1.4%), and otitis media acute (1.4%). e Diarrhea in the SOGROYA treatment group included diarrhea (4.3%), gastroenteritis (4.3%), and gastrointestinal viral infection (1.4%) f Vomiting in the SOGROYA treatment group included vomiting (10.1%) Description of Select Adverse Reactions Adenoidal and tonsillar hypertrophy was reported in 1 (1%) subject with SGA in the first year of treatment with SOGROYA who received tonsillectomy and adenoidectomy. The adenoidal and tonsillar hypertrophy resolved after the procedure.

Drug interactions

Table 7 includes a list of drugs with clinically important drug interactions when administered concomitantly with SOGROYA and instructions for preventing or managing them. Table 7. Clinically Important Drug Interactions with SOGROYA Replacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of SOGROYA may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SOGROYA [see Warnings and Precautions ( 5.7 )]. Examples: Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. Cytochrome P450-Metabolized Drugs Clinical Impact: Limited published data indicate that GH treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. SOGROYA may alter the clearance of compounds known to be metabolized by CP450 liver enzymes. Intervention: Careful monitoring is advisable when SOGROYA is administered in combination with drugs metabolized by CP450 liver enzymes. Oral Estrogen Clinical Impact: Oral estrogens may reduce the serum IGF-1 response to SOGROYA. Intervention: Patients receiving oral estrogen replacement may require higher SOGROYA dosages [see Dosage and Administration (2.5 )] . Insulin and/or Other Hypoglycemic Agents Clinical Impact: Treatment with SOGROYA may decrease insulin sensitivity, particularly at higher doses. Intervention: Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents [see Warnings and Precautions ( 5.4 )].
• Replacement Glucocorticoid Treatment : Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SOGROYA. ( 7 )
• Cytochrome P450-Metabolized Drugs : SOGROYA may alter the clearance. Monitor carefully if used with SOGROYA. ( 7 )
• Oral Estrogen : Larger doses of SOGROYA may be required. ( 7 )
• Insulin and/or Other Antihyperglycemic Agents : Dose adjustment of insulin or antihyperglycemic agent may be required. ( 5.4 , 7 )

Use in specific populations

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 administration of somapacitan-beco to pregnant rats from organogenesis through lactation at approximately 275 times the clinical exposure at the MRHD (see Data) . The background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in rats, somapacitan-beco was administered by subcutaneous injection at doses of 2, 6, and 18 mg/kg/day during the period of organogenesis from gestation day 6 to 17. Fetal viability and development were not affected at doses up to 6 mg/kg/day (31 times the MRHD, based on AUC). Transient, fetal skeletal variations (short/bent/thickened long bones) were observed at 18 mg/kg/day (261 times the MRHD, based on AUC). In an embryo-fetal development study in rabbits, somapacitan-beco was administered by subcutaneous injection at doses of 1, 3, and 9 mg/kg every two days during the period of organogenesis from gestation day 6 to 18. Fetal viability and development were not adversely affected at somapacitan-beco dose of 1 mg/kg/every two days (12 times the MRHD, based on AUC). Reduced fetal growth was observed at doses ≥3 mg/kg/every two days (≥130 times the MRHD, based on C 12h ). In a pre- and post-natal development study in pregnant rats, somapacitan-beco was administered by subcutaneous injection at doses of 4, 9, and 18 mg/kg twice a week from gestation day 6 through lactation day 18. No adverse developmental effects were observed in the offspring at doses up to 9 mg/kg (275 times the MRHD, based on AUC). Increased incidence of renal pelvic dilatation was observed on post-natal day 21 at 18 mg/kg (630 times the MRHD, based on AUC), but was not observed in the adult F1 generation. 8.2 Lactation Risk Summary There is no information on the presence of somapacitan-beco in human milk, the effects on the breastfed infant, or the effects on milk production. Somapacitan-beco-related material was secreted into milk of lactating rats. When a substance is present in animal milk, it is likely that the substance will be present in human milk . Available published data describing administration of short-acting recombinant growth hormone (rhGH) to lactating women for 7 days reported that short-acting rhGH did not increase the normal breastmilk concentration of growth hormone and no adverse effects were reported in breastfed infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOGROYA and any potential adverse effects on the breastfed infant from SOGROYA or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of SOGROYA have been established in pediatric patients 2.5 years of age and older for the treatment of:
• Growth failure due to inadequate secretion of endogenous GH. The use of SOGROYA for this indication is supported by evidence from a 52-week randomized, multi-center, open-label, active-controlled, parallel-group phase 3 trial in 200 treatment-naïve, pediatric patients aged 2.5 to 11 years with GHD [see Clinical Studies (14.1)] . The safety profile from the pediatric trial was similar to that reported in adults [see Adverse Reactions (6.1)] .
• Short stature born SGA with no catch-up growth by 2 years of age. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 142 pediatric patients aged 2.6 to 10.7 years with short stature born SGA with no catch-up growth by 2 years of age [see Clinical Studies (14.2)] .
• Growth failure associated with NS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 77 pediatric patients aged 2 to 11.1 years with growth failure associated with NS [see Clinical Studies (14.3)].
• ISS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 88 pediatric patients aged 2.8 to 10.8 years with ISS [see Clinical Studies (14.4)]. The safety and effectiveness of SOGROYA have not been established in pediatric patients less than 2.5 years of age for the treatment of growth failure due to inadequate secretion of endogenous GH, short stature born SGA with no catch-up growth, growth failure associated with NS, or with ISS. Risks in pediatric patients associated with growth hormone use include:
• Sudden death in pediatric patients with Prader-Willi Syndrome. SOGROYA is not indicated for the treatment of pediatric patients with growth failure secondary to genetically confirmed Prader-Willi syndrome.

Pregnancy

Pediatric use

8.4 Pediatric Use The safety and effectiveness of SOGROYA have been established in pediatric patients 2.5 years of age and older for the treatment of:
• Growth failure due to inadequate secretion of endogenous GH. The use of SOGROYA for this indication is supported by evidence from a 52-week randomized, multi-center, open-label, active-controlled, parallel-group phase 3 trial in 200 treatment-naïve, pediatric patients aged 2.5 to 11 years with GHD [see Clinical Studies (14.1)] . The safety profile from the pediatric trial was similar to that reported in adults [see Adverse Reactions (6.1)] .
• Short stature born SGA with no catch-up growth by 2 years of age. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 142 pediatric patients aged 2.6 to 10.7 years with short stature born SGA with no catch-up growth by 2 years of age [see Clinical Studies (14.2)] .
• Growth failure associated with NS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 77 pediatric patients aged 2 to 11.1 years with growth failure associated with NS [see Clinical Studies (14.3)].
• ISS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 88 pediatric patients aged 2.8 to 10.8 years with ISS [see Clinical Studies (14.4)]. The safety and effectiveness of SOGROYA have not been established in pediatric patients less than 2.5 years of age for the treatment of growth failure due to inadequate secretion of endogenous GH, short stature born SGA with no catch-up growth, growth failure associated with NS, or with ISS. Risks in pediatric patients associated with growth hormone use include:
• Sudden death in pediatric patients with Prader-Willi Syndrome. SOGROYA is not indicated for the treatment of pediatric patients with growth failure secondary to genetically confirmed Prader-Willi syndrome. [see Warnings and Precautions (5.13)]
• Increased risk of second neoplasm in pediatric cancer survivors treated with radiation to the brain and/or head [see Warnings and Precautions (5.3)]
• Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.9)]
• Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.10)]
• Pancreatitis [see Warnings and Precautions (5.11)]

Geriatric use

8.5 Geriatric Use In clinical studies a total of 52 (15.6%) of the 333 SOGROYA-treated patients were 65 years or older and 3 (0.9%) were 75 years or older [see Clinical Studies ( 14 )] . Subjects older than 65 years appeared to have higher exposure than younger subjects at the same dose level. Elderly patients may be more sensitive to the action of somapacitan-beco and therefore may be at increased risk for adverse reactions. Initiate SOGROYA with a dose of 1 mg once weekly and use smaller increments when increasing the dose [see Dosage and Administration ( 2.5 )].

Overdosage

Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with SOGROYA is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess endogenous growth hormone.

Description

Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C 1038 H 1609 N 273 O 319 S 9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol. Structural Formula: SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL. Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. molecular-structure

Mechanism of action

12.1 Mechanism of Action Somapacitan-beco binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by insulin-like growth factor-1 (IGF-1) produced in the liver, while others are primarily a consequence of the direct effects of somapacitan-beco.

How supplied

How Supplied SOGROYA (somapacitan-beco) injection is a clear to slightly opalescent and colorless to slightly yellow solution available as one 1.5 mL single-patient-use prefilled pen per carton:
• SOGROYA 5 mg/1.5 mL (3.3 mg/mL) pen (teal) NDC 0169-2035-11
• SOGROYA 10 mg/1.5 mL (6.7 mg/mL) pen (yellow) NDC 0169-2030-11
• SOGROYA 15 mg/1.5 mL (10 mg/mL) pen (red) NDC 0169-2037-11 SOGROYA 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL pens are compatible with FlexPro ® PenMate ® . The FlexPro PenMate is an accessory device that is dispensed separately with its enclosed Instructions for Use. Storage and Handling Before and during use: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) with the cap on and in the original carton to protect from light. Do not freeze. Do not use SOGROYA if it has been frozen. Discard prefilled pen if kept above 30°C (86°F). Avoid direct or excessive heat. Avoid sunlight. Refer to storage conditions for SOGROYA ( Table 14 ). Write the date of first use in the space provided on the carton. Always remove and safely discard the needle after each injection and store the SOGROYA prefilled pen without an injection needle attached. Always use a new needle for each injection to prevent contamination. Table 14. Storage Conditions for SOGROYA Before first use (unopened) After first use (opened) Refrigerated 2°C to 8°C (36°F to 46°F) Room Temperature up to 25°C (77°F) Refrigerated 2°C to 8°C (36°F to 46°F) Room Temperature up to 25°C (77°F) SOGROYA Until expiration date Maximum 72 hours (3 days)* up to 6 weeks Maximum 72 hours (3 days)* *The total time allowed at room temperature (up to 25°C [77°F]) is 72 hours (3 days) regardless of whether the product is in-use (opened) or before first use (unopened). Must discard if kept above 30°C (86°F).

Patient information

Advise patients and/or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• Advise patients and/or caregivers to administer SOGROYA once weekly.
• Hypersensitivity - Advise patients and/or caregivers that severe and/or serious systemic hypersensitivity reactions (anaphylaxis and angioedema) have been reported, and to seek prompt medical attention should an allergic reaction occur [see Warnings and Precautions ( 5.2 )] .
• Neoplasms – Advise patients to report marked changes in skin pigmentation or changes in the appearance of preexisting nevi.
• Glucose Intolerance/ Diabetes Mellitus – Advise patients that new onset pre- /diabetes mellitus or exacerbation of preexisting diabetes mellitus can occur and monitoring of blood glucose during treatment with SOGROYA may be needed.
• Intracranial Hypertension - Advise patients to report to their healthcare provider any visual changes, headache, and nausea and/or vomiting.
• Fluid Retention - Advise patients that fluid retention during SOGROYA replacement therapy may frequently occur. Inform patients of the clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) and to report to their healthcare provider any of these signs or symptoms occur during treatment with SOGROYA.
• Hypoadrenalism - Advise patients who have or who are at risk for corticotropin deficiency that hypoadrenalism may develop and to report to their healthcare provider if they experience hyperpigmentation, extreme fatigue, dizziness, weakness, or weight loss.
• Hypothyroidism - Advise patients/caregivers that undiagnosed/untreated hypothyroidism may prevent an optimal response to SOGROYA. Advise patients/caregivers they may require periodic thyroid function tests.
• Pancreatitis - Advise patients that pancreatitis may develop and to report to their healthcare provider any new onset abdominal pain.
• Lipohypertrophy/ Lipoatrophy – Advise patients that lipohypertrophy or lipoatrophy can occur if SOGROYA is administered subcutaneously at the same site over a long period of time. Advise patients to rotate injection sites when administering SOGROYA to reduce this risk. Novo Nordisk ® and PenMate ® are registered trademarks of Novo Nordisk A/S. SOGROYA ® and FlexPro ® are registered trademarks of Novo Nordisk Health Care AG. © 2002-2026 Novo Nordisk Health Care AG Patent Information: http://novonordisk-us.com/products/product-patents.html For information about SOGROYA contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536 1-888-668-6444 Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 U.S. License No. 1261

Label text from the FDA structured product label by Novo Nordisk (revised Feb 25, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Somapacitan in 3 products

Sogroya NDC products (3)

NDC	Strength & form	Labeler	Type
0169-2030	Somapacitan 6.7 mg/mL Injection, Solution	Novo Nordisk	BLA
0169-2035	Somapacitan 3.3 mg/mL Injection, Solution	Novo Nordisk	BLA
0169-2037	Somapacitan 10 mg/mL Injection, Solution	Novo Nordisk	BLA

Frequently asked questions

What is Sogroya used for?

What are the side effects of Sogroya?

Who makes Sogroya?

Sogroya is listed by 1 labeler in the FDA NDC directory, including Novo Nordisk.