Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 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 36°F to 46°F (2°C to 8°C) 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 86°F (30°C). Avoid direct or excessive heat. Avoid sunlight. Refer to storage conditions for SOGROYA ( Table 8 ). 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 8. Storage conditions for SOGROYA Before first use (unopened) After first use (opened) Refrigerated 36°F to 46°F (2°C to 8°C) Room Temperature up to 77°F (25°C) Refrigerated 36°F to 46°F (2°C to 8°C) Room Temperature up to 77°F (25°C) 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 77°F [25°C]) is 72 hours (3 days) regardless of whether the product is in-use (opened) or before first use (unopened). Must discard if kept above 86°F (30°C).; PRINCIPAL DISPLAY PANEL – 5 mg Sogroya ® 5 mg pen NDC 0169-2035-11 (somapacitan-beco) injection List: 203511 5 mg / 1.5 mL (3.3 mg/mL) Prefilled Pen For subcutaneous Use Only 1x1.5 mL single-patient use prefilled pen Dials in 0.025 mg increments and contains 5 mg total Rx only once weekly 5mg-carton; PRINCIPAL DISPLAY PANEL – 10 mg Sogroya ® 10 mg pen NDC 0169-2030-11 (somapacitan-beco) injection List: 203011 10 mg / 1.5 mL (6.7 mg/mL) Prefilled Pen For subcutaneous Use Only 1x1.5 mL single-patient use prefilled pen Dials in 0.05 mg increments and contains 10 mg total Rx only once weekly 10mg-carton; PRINCIPAL DISPLAY PANEL – 15 mg Sogroya ® 15 mg pen NDC 0169-2037-11 (somapacitan-beco) injection List: 203711 15 mg / 1.5 mL (10 mg/mL) Prefilled Pen For subcutaneous Use Only 1x1.5 mL single-patient use prefilled pen Dials in 0.1 mg increments and contains 15 mg total Rx only once weekly 15mg-carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING 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 36°F to 46°F (2°C to 8°C) 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 86°F (30°C). Avoid direct or excessive heat. Avoid sunlight. Refer to storage conditions for SOGROYA ( Table 8 ). 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 8. Storage conditions for SOGROYA Before first use (unopened) After first use (opened) Refrigerated 36°F to 46°F (2°C to 8°C) Room Temperature up to 77°F (25°C) Refrigerated 36°F to 46°F (2°C to 8°C) Room Temperature up to 77°F (25°C) 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 77°F [25°C]) is 72 hours (3 days) regardless of whether the product is in-use (opened) or before first use (unopened). Must discard if kept above 86°F (30°C).
- PRINCIPAL DISPLAY PANEL – 5 mg Sogroya ® 5 mg pen NDC 0169-2035-11 (somapacitan-beco) injection List: 203511 5 mg / 1.5 mL (3.3 mg/mL) Prefilled Pen For subcutaneous Use Only 1x1.5 mL single-patient use prefilled pen Dials in 0.025 mg increments and contains 5 mg total Rx only once weekly 5mg-carton
- PRINCIPAL DISPLAY PANEL – 10 mg Sogroya ® 10 mg pen NDC 0169-2030-11 (somapacitan-beco) injection List: 203011 10 mg / 1.5 mL (6.7 mg/mL) Prefilled Pen For subcutaneous Use Only 1x1.5 mL single-patient use prefilled pen Dials in 0.05 mg increments and contains 10 mg total Rx only once weekly 10mg-carton
- PRINCIPAL DISPLAY PANEL – 15 mg Sogroya ® 15 mg pen NDC 0169-2037-11 (somapacitan-beco) injection List: 203711 15 mg / 1.5 mL (10 mg/mL) Prefilled Pen For subcutaneous Use Only 1x1.5 mL single-patient use prefilled pen Dials in 0.1 mg increments and contains 15 mg total Rx only once weekly 15mg-carton
Overview
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
Indications & Usage
SOGROYA is indicated for the: • Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH). • 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 who have growth failure due to inadequate secretion of endogenous growth hormone (GH) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency ( 1 ).
Dosage & Administration
• SOGROYA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of patients with growth hormone deficiency ( 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 with GHD: • 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 ). • 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 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 with GHD • 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). • 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 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 (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 ) and 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.
Warnings & 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: May occur 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. Perform fundoscopic examination before initiating treatment with SOGROYA to exclude preexisting papilledema and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating SOGROYA. If papilledema is observed by fundoscopy during SOGROYA treatment, treatment should be stopped. If intracranial hypertension is confirmed, treatment with SOGROYA can be restarted at a lower dose after intracranial hypertension-associated signs and symptoms have resolved. 5.6 Fluid Retention Fluid retention during SOGROYA replacement therapy may occur. Clinical manifestations of fluid retention (e.g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent. 5.7 Hypoadrenalism Patients receiving somatropin therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SOGROYA treatment. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases [see Drug Interactions ( 7 )]. 5.8 Hypothyroidism Undiagnosed/untreated hypothyroidism may prevent an optimal response to SOGROYA. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with somatropin therapy. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. 5.9 Slipped Capital Femoral Epiphysis in Pediatric Patients Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients receiving SOGROYA with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly. 5.10 Progression of Preexisting Scoliosis in Pediatric Patients Somatropin increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression. 5.11 Pancreatitis Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain. 5.12 Lipohypertrophy/Lipoatrophy When SOGROYA is administered subcutaneously at the same site over a long period of time, tissue lipohypertrophy or lipoatrophy may result. Rotate injection sites when administering SOGROYA to reduce this risk [see Dosage and Administration ( 2.1 )]. 5.13 Sudden Death in Pediatric Patients with Prader-Willi Syndrome There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. SOGROYA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. 5.14 Laboratory Tests Serum levels of inorganic phosphorus and alkaline phosphatase may increase after SOGROYA therapy. Serum levels of parathyroid hormone may increase with somatropin treatment.
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 )
Adverse Reactions
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 )] • Pediatric patients with GHD: Adverse reactions reported in ≥5% of patients treated with SOGROYA are: nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reaction ( 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 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%) Adult Patients with GHD SOGROYA was studied in adult patients with GHD in a 35-week, placebo-controlled, double-blind trial with an active-control arm [see Clinical Studies ( 14.2 )] . Adverse reactions occurring >2% with SOGROYA are presented in Table 3 . Table 3. Adverse Reactions occurring >2% in Adults with GHD Treated with SOGROYA and More Frequently # than in Placebo-Treated Patients for 34 Weeks Placebo (N=61) SOGROYA (N=120) Adverse Reactions % % Back pain 3.3 10 Arthralgia 1.6 6.7 Dyspepsia 3.3 5 Sleep disorder 1.6 4.2 Dizziness 1.6 4.2 Tonsillitis 1.6 3.3 Peripheral edema 1.6 3.3 Vomiting 1.6 3.3 Adrenal insufficiency 1.6 3.3 Hypertension 1.6 3.3 Blood creatine phosphokinase increase 0 3.3 Weight increased 0 3.3 Anemia 0 2.5 # Included adverse reactions reported with at least 1% greater incidence in SOGROYA group compared to the placebo group More SOGROYA treated patients shifted from normal baseline levels to elevated phosphate and creatine phosphokinase levels at the end of the trial compared to the placebo group (17.5% vs 4.9% and 9.2% vs. 6.6%, respectively); these laboratory changes occurred intermittently, and were non-progressive. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of somatropins. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Musculoskeletal and connective tissue disorders – osteonecrosis in pediatric patients.
Drug Interactions
Table 4 includes a list of drugs with clinically important drug interactions when administered concomitantly with SOGROYA and instructions for preventing or managing them. Table 4. 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 ).
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