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Somapacitan-Beco

FDA Drug Information • Also known as: Sogroya

Brand Names
Sogroya
Route
SUBCUTANEOUS
Dosage Form
INJECTION, SOLUTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 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

What Is Somapacitan-Beco Used For?

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

    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...

    • Side Effects (Adverse Reactions)

    6 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 )]
  • 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...

    • Drug Interactions

    7 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 )

    • 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 )

    • Pregnancy and Breastfeeding

    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...

    Overdosage

    10 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.

    How Supplied

    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 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).

    • About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.