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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, 15 mg logo

Sogroya® is indicated for pediatric patients aged 2.5 years and older with growth failure due to inadequate secretion of endogenous growth hormone (GH), and for replacement of endogenous GH in adults with growth hormone deficiency (GHD).

Prescribing Information
Important Safety Information | Patient Site

THREE YEARS OF LONG-TERM EFFICACY AND SAFETY DATA

for näive and switch patients1,2

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THREE YEARS OF LONG-TERM EFFICACY AND SAFETY DATA

for näive and switch patients1,2

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Pediatric patients showed sustained growth with once-weekly Sogroya® for up to 3 years2

Sogroya® demonstrated similar efficacy to daily somatropin with fewer injections1

Main Phase: Primary Endpoint AHV at Week 521

Primary endpoint data

ETD= –0.5 cm/year (95% CI: –1.1 to 0.2)

REAL4 is a multicenter, open-label, active-controlled, parallel-group phase 3 trial. A total of 200 treatment-naïve children aged 2.5 to 11 years with a confirmed diagnosis of GHD were randomized 2:1 to receive Sogroya® 0.16 mg/kg/week (n=132) or daily somatropin 0.034 mg/kg/day (n=68).1

AHV=annualized height velocity; CI=confidence interval; ETD=estimated treatment difference.

START and SWITCH patients continued to grow from Weeks 52 to 104 with Sogroya®4,a

Extension Phase: Observed Mean HV from Week 52 to Week 1042

Year 2 Observed Mean HV bar graph

ETD= –0.5 cm/year (95% CI: –1.1 to 0.2)

Limitations: No formal statistical analyses were done; however, descriptive statistics were used to report results.2

The REAL4 main trial phase (Week 0 to Week 52) was followed by an ongoing 3-year, single-group, safety extension phase (Week 52 to Week 208). The 2-year data presented here represent up to Week 104. A total of 199 patients rolled over into the safety extension where all patients received Sogroya® 0.16 mg/kg/week, either continuing Sogroya® treatment (START patients) or switching from daily GH treatment in main phase to once-weekly Sogroya® (SWITCH patients). 194 of 199 patients completed 104 weeks of treatment (127 START patients and 67 SWITCH patients). No statistical analyses of data were performed after 104 weeks of treatment. The observations after Week 104 are presented using descriptive statistics.2,4

aGrowth=observed annualized mean HV at Week 104.4

GH=growth hormone; GHD=growth hormone deficiency; HV=height velocity; SD=standard deviation.

Sogroya® demonstrated long-term, sustained growth in START and SWITCH patients2

Extension Phase: Observed Mean HV from Week 52 to Week 1562

Year 3 Observed Mean HV bar graph

ETD= –0.5 cm/year (95% CI: –1.1 to 0.2)

Limitations: No formal statistical analyses were done; however, descriptive statistics were used to report results.2

The REAL4 main trial phase (Week 0 to Week 52) was followed by an ongoing 3-year, single-group, safety extension phase (Week 52 to Week 208). The 3-year data presented here represent up to Week 156. A total of 194 patients continued in the safety extension where all patients received Sogroya® 0.16 mg/kg/week, either continuing Sogroya® treatment (START patients) or switching from daily GH treatment in main phase to once-weekly Sogroya® (SWITCH patients). 188 of 194 patients completed 156 weeks of treatment (125 START patients and 63 SWITCH patients). No statistical analyses of data were performed after 52 weeks of treatment. The observations after Week 156 are presented using descriptive statistics.2

aGrowth=observed annualized mean HV at Week 104.4

GH=growth hormone; GHD=growth hormone deficiency; HV=height velocity; SD=standard deviation.

In a dose-finding study, Sogroya® 0.16 mg/kg/wk demonstrated higher annualized mean HV vs other studied Sogroya® doses and daily somatropin3

Primary Endpoint (Week 26): Annualized Mean HV (observed values) with Sogroya® 0.16 mg/kg/wk was similar to that of daily somatropin3
Primary endpoint 26 weeks chart
Primary endpoint (Week 26) chart
REAL3 was a dose-finding trial. Sogroya® 0.04 mg/kg/wk and Sogroya® 0.08 mg/kg/wk have not been shown to be effective and are not approved doses of Sogroya®.

Data are mean, SD, observed values, FAS.

REAL4: A global phase 3 trial established the efficacy and safety of Sogroya® 0.16 mg/kg/wk in a large cohort of children with GHD.1

Study limitations: blinding of the once-weekly Sogroya® doses vs daily GH was not possible, and treatment group sizes were small but appropriate for a dose-finding trial in a rare disease such as GHD.3

REAL3 was a randomized, multinational, active-controlled, open-label, dose-finding, double-blind (Sogroya® doses only), 4-arm parallel-group, phase 2 trial investigating safety and efficacy of once-weekly Sogroya® vs somatropin in 59 GH-treatment-naïve, pre-pubertal children with GHD. A total of 58 patients completed both trial periods and 56 completed the treatment (3 patients discontinued treatment prematurely). The primary endpoint was annualized HV (cm/year) during the main phase (baseline to Week 26).3

FAS=full analysis set; GH=growth hormone; GHD=growth hormone deficiency; HV=height velocity; SD=standard deviation; wk=week.

A proven long-term safety profile

Main Phase: Adverse reactions occurring ≥5% in Sogroya®- or somatropin-treated pediatric patients (52 weeks)1

aNasopharyngitis 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%).

bPyrexia in the Sogroya® treatment group included pyrexia (8.3%) and hyperthermia (0.8%).

cPain in extremity in the Sogroya® treatment group included pain in extremity (9.1%) and growing pains (0.8%).

dInjection-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%).

eDiarrhea in the Sogroya® treatment group included diarrhea (2.3%), gastroenteritis viral (1.5%), and gastrointestinal viral infection (0.8%).

fNausea/vomiting in the Sogroya® treatment group included vomiting (4.5%) and nausea (1.5%).

AE=adverse event.

Safety profile for Sogroya®
No new safety signals occurred with Sogroya® in the extension phase
Extension Phase Week 104:
Safety experience in START and SWITCH patients

The most common AEs observed in ≥5% of the patients during the Week-52 to Week-104 period were: nasopharyngitis (8.4% START group and 7.4% SWITCH group), COVID-19 infection (4.6% START group and 7.4% SWITCH group), pyrexia (3.8% START group and 2.9% SWITCH group), and injection-site reactions without injection-site pain (2.3% START group and 2.9% SWITCH group)2,4

No subjects discontinued treatment due to AEs4

Extension Phase Week 156:
Long-term safety experience in START and SWITCH patients

The most common AEs observed in ≥5% of the patients during the Week-52 to Week-156 period were: COVID-19 infection (19.8% START group and 23.5% SWITCH group), nasopharyngitis (12.2% START group and 13.2% SWITCH group), headache (4.6% START group and 5.9% SWITCH group), pyrexia (7.6% START group and 8.8% SWITCH group), influenza (9.2% START group and 0% SWITCH group), upper respiratory tract infection (3.8% START group and 8.8% SWITCH group), vomiting (8.4% START group and 4.4% SWITCH group), bronchitis (6.1% START group and 5.9% SWITCH group), gastroenteritis (6.1% START group and 4.4% SWITCH group)2

No subjects discontinued treatment due to AEs2

Injection-site reactions (52 weeks)1
Sogroya®
(n=132)
Adverse reactions
%
Injection-site reactions
6.1

Bruising

1.5

Pain

1.5

Hematoma

1.5

Hypersensitivity

Reaction

0.8

Swelling

0.8
Injection icon
1.5% of patients experienced injection-site pain1
1.5% of patients experienced injection-site pain1

REAL4: A multicenter, open-label, parallel-group phase 3 trial1,2,4,5
Sogroya® 52 week study
REAL4 Study Design

a194 of 199 patients completed at Week 104.2,4
bA total of 188 of 194 patients completed at Week 156.2
GH=growth hormone; GHD=growth hormone deficiency.

Pediatric dosing

See dosing information for switch and treatment-naïve patients alike.

Injection pen with checkmark icon

See dosing information for switch and treatment-naïve patients alike.

Pediatric IGF-1 response

See the IGF-1 response from the REAL4 study showing mean IGF-1 standard deviation score (SDS) levels at Week 0 to Week 52.

Around the clock icon

See the IGF-1 response from the REAL4 study showing mean IGF-1 standard deviation score (SDS) levels at Week 0 to Week 52.

Important Safety Information for Sogroya®

Contraindications

Sogroya® is contraindicated in patients with:

  • acute critical illness after open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure because of the risk of increased mortality with use of Sogroya®
  • hypersensitivity to Sogroya® or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin
  • pediatric patients with closed epiphyses
  • active malignancy
  • 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

Warnings & Precautions

  • 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, multiple accidental trauma, and in patients with acute respiratory failure

Indications and Usage

Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg 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)

Important Safety Information

Contraindications

Sogroya® is contraindicated in patients with:

  • acute critical illness after open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure because of the risk of increased mortality with use of Sogroya®
  • hypersensitivity to Sogroya® or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin
  • pediatric patients with closed epiphyses
  • active malignancy
  • 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

Warnings & Precautions

  • 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, multiple accidental trauma, and in patients with acute respiratory failure
  • Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported postmarketing with 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
  • Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment complete prior to instituting Sogroya®. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression or recurrence of the tumor. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies and should be carefully monitored for development of neoplasms. Monitor patients for increased growth or potential malignant changes of preexisting nevi. Advise patients/caregivers to report changes in the appearance of preexisting nevi
  • Glucose Intolerance and Diabetes Mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes has been reported. Monitor glucose levels in all patients, especially in those with existing diabetes mellitus or with risk factors for diabetes mellitus, such as obesity, Turner syndrome or a family history of diabetes mellitus. The doses of antidiabetic agents may require adjustment when Sogroya® is initiated
  • Intracranial Hypertension: Has been reported usually within 8 weeks of treatment initiation. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is identified, evaluate the etiology, and treat the underlying cause before initiating Sogroya®. If papilledema is observed, stop treatment. If intracranial hypertension is confirmed, Sogroya® can be restarted at a lower dose after intracranial hypertension signs and symptoms have resolved
  • Fluid retention: May occur during Sogroya® therapy. Clinical manifestations of fluid retention (e.g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent
  • 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. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Sogroya®. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases
  • Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to Sogroya®. Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of Sogroya®
  • Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain
  • Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with a history of scoliosis for disease progression
  • Pancreatitis: Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared to adults. Consider pancreatitis in patients with persistent severe abdominal pain
  • Lipohypertrophy/Lipoatrophy: May occur if Sogroya® is administered at the same site over a long period of time. Rotate injection sites to reduce this risk
  • 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
  • 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

Adverse Reactions

  • Pediatric patients with GHD: Adverse reactions reported in ≥5% of patients are nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reaction
  • Adult patients with GHD: Adverse reactions reported in >2% of patients are back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, blood creatine phosphokinase increase, weight increase, and anemia

Drug Interactions

  • Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Sogroya®
  • Cytochrome P450-Metabolized Drugs: Sogroya® may alter the clearance. Monitor carefully if used with Sogroya®
  • Oral Estrogen: Patients receiving oral estrogen replacement may require higher Sogroya® dosages
  • Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required for patients with diabetes mellitus

Please click here for Sogroya® Prescribing Information.

References:

  1. Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk, Inc.
  2. Data on File. Novo Nordisk, Inc.; Plainsboro, NJ.
  3. Sävendahl L, Battelino T, Brod M, et al. Once-weekly somapacitan vs daily GH in children with GH deficiency: results from a randomized phase 2 trial. J Clin Endocrinol Metab. 2020;105(4):e1847-e1861. doi:10.1210/clinem/dgz310
  4. Miller BS, Blair JC, Rasmussen MH, et al. Effective GH replacement with somapacitan in children with GHD: REAL4 2-year results and after switch from daily GH. J Clin Endocrinol Metob. 2023;108(12):3090-3099.
  5. Miller BS, Blair JC, Rasmussen MS, et al. Weekly somapacitan is effective and well tolerated in children with GH deficiency: the randomized phase 3 REAL4 trial. J Clin Endocrinol Metab. 2022;107(12):3378-3388. doi:10.1210/clinem/dgac513