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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

IGF-1 RESPONSE

See the data about the IGF-1 response in adult and pediatric patients with growth hormone deficiency (GHD).

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IGF-1 RESPONSE

See the data about the IGF-1 response in adult and pediatric patients with growth hormone deficiency (GHD).

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Pediatric IGF-1 data

Pharmacodynamic endpoint: IGF-1 response over 52 weeks

Supportive secondary endpoint: Mean IGF-1 SDS levels at Weeks 0 to 522,3,a

Main Phase: IGF-1 SDS levels were –2.03 at baseline and the IGF-1 SDS level change from baseline was +2.362,3
IGF-1 response data
Year 1 IGF-1 Response Chart
~97 percent
of pediatric patients achieved an average IGF-1 SDS level within normal range after 52 weeks of treatment with Sogroya®, similar to daily somatropin2,3
Sogroya® produces a dose-linear IGF-1 response2
  • Average change of 0.02 mg/kg resulting in a change in IGF-1 standard deviation score (SDS) of 0.32

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).2  See study design.

aWeek 4 and 26 samples were collected in a window designed to characterize the peak between 1 and 4 days after dosing: mean sampling times after dosing were 45 and 44 hours (1.9 and 1.8 days), respectively. Trough samples at Weeks 13 and 39 were taken on Day 7. Week 52 samples taken 4 to 6 days after dosing captured expected weekly averages: mean sampling time after dosing was 113 hours (4.7 days). During the 52-week treatment period, 5 (3.8%) patients on Sogroya® and 2 (2.9%) patients on daily GH had an IGF-1 SDS above +2.0 at two or more consecutive visits. No safety issues were associated with IGF-1 SDS levels >+2.5 in 2 patients.3

GH=growth hormone; GHD=growth hormone deficiency; IGF-1=insulin-like growth factor-1; SDS=standard deviation score.

Pharmacodynamic endpoint: Weekly IGF-1 SDS profile1,3

Main Phase: Supportive secondary endpoint
Weekly IGF-1 SDS profile data
Year 1 Supportive secondary endpoint chart
Graph shows the weekly IGF-1 SDS profile (mean and 5th to 95th percentile) estimated from IGF-1 samples obtained in REAL4, derived by population PK/PD modeling, with a weekly average IGF-1 SDS in the normal range (SDS of –2 to +2) for 97% of patients.1,3

Limitations: It was assumed that missing data (dosing history, PK, and IGF-1) were missing at random. The structural model, interindividual variability model, and covariate model were assumed adequate for the analysis, and this was verified during model qualification. None of these assumptions and limitations were evaluated to affect the model validity.1

Model-based analysis of IGF-1 in children with GHD4,b

This table allows for calculation of estimated average weekly IGF-1 exposure from a single IGF-1 sample obtained at any time within the Sogroya® (0.16 mg/kg/week) dosing interval at steady state. In practice, this tool requires knowledge of Sogroya® injection timing relative to IGF-1 sample collection.4

Calculating

IGF-1avg SDS

Adjustment to measured IGF-1 SDS to approx IGF‑1avg SDS

90% PI of IGF-1 SDS adjustment value

25-48
hours after dose

IGF-1 SDS - 0.8

+/- 0.5

49-72
hours after dose

IGF-1 SDS - 1.0

+/- 0.6

73-96
hours after dose

IGF-1 SDS - 0.5

+/- 0.4

97-120
hours after dose

No adjustmentc

N/A

121-144
hours after dose

IGF-1 SDS + 0.7

+/- 0.4

145-168
hours after dose

IGF-1 SDS + 1.1

+/- 0.6

IGF-1avg conc (ng/mL)

Adjustment to measured IGF-1 (ng/mL) to approx IGF-1avg (ng/mL)

CV (%) of IGF-1 (ng/mL) adjustment value

25-48
hours after dose

IGF-1 (ng/mL) x 0.8

9.0

49-72
hours after dose

IGF-1 (ng/mL) x 0.7

8.3

73-96
hours after dose

IGF-1 (ng/mL) x 0.9

7.4

97-120
hours after dose

No adjustmentc

N/A

121-144
hours after dose

IGF-1 (ng/mL) x 1.3

10.0

145-168
hours after dose

IGF-1 (ng/mL) x 1.6

15.0

Calculating:

IGF-1avg SDS

IGF-1avg conc (ng/mL)

Interval
(hours after dose)

Adjustment to measured IGF-1 SDS to approx IGF‑1avg SDS

90% PI of IGF-1 SDS adjustment value

Adjustment to measured IGF-1 (ng/mL) to approx IGF-1avg (ng/mL)

CV (%) of IGF-1 (ng/mL) adjustment value

25-48

IGF-1 SDS - 0.8

+/- 0.5

IGF-1 (ng/mL) x 0.8

9.0

49-72

IGF-1 SDS - 1.0

+/- 0.6

IGF-1 (ng/mL) x 0.7

8.3

73-96

IGF-1 SDS - 0.5

+/- 0.4

IGF-1 (ng/mL) x 0.9

7.4

97-120

No adjustmentc

N/A

No adjustmentc

N/A

121-144

IGF-1 SDS + 0.7

+/- 0.4

IGF-1 (ng/mL) x 1.3

10.0

145-168

IGF-1 SDS + 1.1

+/- 0.6

IGF-1 (ng/mL) x 1.6

15.0

Checkmark icon

IGF-1 steady state reached within 1 to 2 doses after initiating Sogroya®4

bPK/PD modeling analyses included dosing information and 1473 PK samples from 210 Sogroya®-treated pediatric patients with GHD across 3 trials (phase1, phase 2 [REAL3], and phase 3 [REAL4]), as well as 1381 IGF-1 samples from 186 Sogroya®-treated pediatric patients with GHD in REAL3 and REAL4. Throughout REAL3 and REAL4, serial blood sampling was performed before first dose, 1 to 4 days and 4 to 6 days after dosing and before next dose to cover baseline, maximum (peak), estimated weekly average, and minimum (trough) PK as well as IGF-1 concentrations.

cAdjustment for values obtained 97 to 120 hrs after dose is considered not to be required as the predicted adjustments of IGF-1 SDS + 0.1 (PI 90% ± 0.3 SDS) and IGF-1 (ng/mL) x 1.1 (6.9 CV%) are not clinically relevant.

avg=average; approx=approximate; conc=concentration; CV=coefficient of variation; GHD=growth hormone deficiency; IGF-1=insulin-like growth factor-1; PD=pharmacodynamic; PK=pharmacokinetic; PI=prediction interval; SDS=standard deviation score.

Limitations: Results should always be interpreted in the context of individual clinical management.

If steady state has not been achieved at the time of sampling and/or if the Sogroya® dose is changed, this is not accounted for within the linear model, and subsequent predictions of IGF-1 values may be biased.

Analysis results may vary from 1 sample to another due to technical reasons, such as assay variability, pharmacological reasons, such as dose-to-dose variation in bioavailability, and temporal variations in physiology, which may affect the accuracy of IGF-1 sampling and limit the predictive power of the model.

For START and SWITCH groups, IGF-1 exposure was within normal range (–2 to +2) at 2 years1

Extension Phase: Mean IGF-1 SDS levels at Week 104 (supportive secondary endpoint)1,5,d
Year 2 Mean IGF-1 bar graph
  • Model-derived IGF-1 SDS suggests similar mean average IGF-1 SDS levels over the weekly dosing interval within normal range (–2 to +2 SDS) in Year 1 and for both groups (+0.72 and +0.75 for the START [Sogroya®/Sogroya®] and SWITCH [daily GH/Sogroya®] groups, respectively) in Year 25

  • Overall, IGF-1 levels greater than +2 SDS were measured in 28 (21.7%) and 10 (14.7%) patients in the START (Sogroya®/ Sogroya®) and SWITCH (daily GH/Sogroya®) groups, respectively, during the Week 52 to Week 104 period5

  • This surpassing of +2 SDS occurred on 2 consecutive visits in 1 (0.8%) and 2 (3.1%) of the patients in the START and SWITCH groups, respectively. This may be due to a discrepancy in the actual timing of IGF-1 SDS sampling between the groups5

  • No trend was seen in the amount or type of AEs reported in patients with IGF-1 levels greater than +2 SDS5

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 at 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.1,5

dBlood samples for IGF-1 measurements in patients treated with somapacitan up to Week 104 were taken at the following time points after dosing: Week 4, Week 26, and Week 78 (Days 1-4 after dosing; around peak level), Week 13, Week 39, and Week 104 (Day 7 after dosing; trough level) and at Week 52 (Days 4-6 after dosing; expected weekly average IGF-1 SDS). The number of patients that at some time during the second year had an IGF-1 SDS value exceeding +2.5 was 15 (11.6%) and 4 (5.9%) in the start and switch groups, respectively. None of these patients had a IGF-1 value exceeding +2.5 SDS at 2 consecutive visits.5

AE=adverse event; GH=growth hormone; GHD=growth hormone deficiency; IGF-1=insulin-like growth factor-1; SDS=standard deviation score.

IGF-1 exposure was maintained within normal range (–2 to +2) at 3 years1

Extension Phase: Mean IGF-1 SDS levels at Week 156 (supportive secondary endpoint)1,e
Year 3 Mean IGF-1 bar graph
  • Model-derived IGF-1 SDS suggests similar mean average IGF-1 SDS levels over the weekly dosing interval within normal range (–2 to +2 SDS) throughout 156 weeks for both groups with the mean (SD) IGF-1 SDS levels of –0.24 (1.10) for the START (Sogroya®/Sogroya®) and –0.34 (1.34) for the SWITCH (daily GH/Sogroya®) groups1

  • IGF-1 levels were taken at Week 156 on Day 7 (approximate trough level) and data were missing for 2 participants in the START group and 3 participants in the SWITCH groups1

  • No trend was seen in the amount or type of AEs reported in patients with IGF-1 levels greater than +2 SDS1

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 the 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.1

eBlood samples for IGF-1 measurements in subjects treated with somapacitan up to Week 156 were taken at the following time points: Week 4, Week 26, Week 78, and Week 130 (Days 1-4 after dosing; around peak IGF-1 level), Week 13, Week 39, Week 104, and Week 156 (Day 7 after dosing; around trough IGF-1 level) and at Week 52 (Days 4-6 after dosing; around average IGF-1 level). The number of participants that at some time during Year 3 had an IGF-1 value exceeding +2.5 SDS was 13 (10.4%) and 3 (4.7%) in the START and SWITCH groups, respectively, with participants exceeding +3.0 SDS were 1 (0.8%) and 0 (0%), respectively. One participant (0.8%) in the START group had an IGF-1 value exceeding +2.5 SDS at 2 consecutive visits.1

AE=adverse event; GH=growth hormone; GHD=growth hormone deficiency; IGF-1=insulin-like growth factor-1; SDS=standard deviation score.

Adults reached favorable IGF-1 levels

Sogroya® achieved serum IGF-1 increases that were comparable to daily treatment2

Secondary endpoint: IGF‑1 SDS values2,6
Baseline
Weekly IGF-1 SDS profile data
Secondary endpoint baseline data
Week 34
Weekly IGF-1 SDS profile data
Secondary endpoint week 34 data
Draw IGF-1 samples 3 to 4 days after the prior dose.2

In a 35-week, double-blind, placebo-controlled study, 300 treatment-naïve adult patients with GHD (full analysis set) were randomized (2:1:2) to once-weekly Sogroya® 10 mg/1.5 mL (n=120), once-weekly placebo (n=61), or daily somatropin 10 mg/1.5 mL (n=119) for a 34-week treatment period.2 See study design.

GHD=growth hormone deficiency; IGF-1=insulin-like growth factor-1; SDS=standard deviation score.
Sogroya ® IGF-1 Brochure

REAL1 phase 3 trial data
REAL4 phase 3 trial data
REAL4: A multicenter, open-label, parallel-group phase 3 trial1,2,3,4
Sogroya® 52 week study

a194 of 199 patients completed at Week 104.2,3

bA total of 188 of 194 patients completed at Week 156.3

GH=growth hormone; GHD=growth hormone deficiency.

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Questions about Sogroya®?

Dosing pediatric patients

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

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

Dosing adult patients

Take a look at the dosing guidance for adult patients—both switch and treatment-naïve.

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Take a look at the dosing guidance for adult patients—both switch and treatment-naïve.

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. Data on file. Novo Nordisk, Inc; Plainsboro, NJ.
  2. Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk, Inc.
  3. Miller BS, Blair JC, Rasmussen MH, 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.
  4. Kildemoes RJ, Backeljauw PF, Højby M, et al. Model-based analysis of IGF-1 response, dosing, and monitoring for once-weekly somapacitan in children with GH deficiency. J Endocr Soc. 2023;7(11):bvad115. Published 2023 Sep 11. doi:10.1210/jendso/bvad115
  5. 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 Metab. 2023;108(12):3090-3099. doi:10.1210/clinem/dgad394
  6. Johannsson G, Gordon MB, Rasmussen MH, et al. Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial. J Clin Endocrinol Metab. 2020;105(4):e1358-e1376.