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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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portrayal

Pharmacodynamic endpoint: IGF-1 response over 52 weeks

Supportive secondary endpoint: Mean IGF-1 SDS levels at Weeks 0 to 521,2,a

Chart: Mean IGF-1 SDS levels at Weeks 0-52
IGF-1 response data

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).1,2  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.2

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

≈97%

of pediatric patients achieved an average IGF-1 SDS level within normal range after 52 weeks of treatment with Sogroya®, similar to daily somatropin1,2
of pediatric patients achieved an average IGF-1 SDS level within normal range after 52 weeks of treatment with Sogroya®, similar to daily somatropin1,2
Sogroya® produces a dose-linear IGF-1 response1
  • Average change of 0.02 mg/kg resulting in a change in IGF-1 standard deviation score (SDS) of 0.32

Pharmacodynamic endpoint: Weekly IGF-1 SDS profile2,3

Chart: Estimate IGF-1 SDS profile over 7 days
Weekly IGF-1 SDS profile data

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.2,3

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.3

See study design.

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

In practice, this tool requires knowledge of Sogroya® injection timing relative to IGF-1 sample collection.4

Adjustment of IGF-I SDS values should be performed by either adding or subtracting the value provided in the table according to the time point when the sample was obtained. Adjustment of IGF-I (ng/mL) concentration values should be performed through multiplying by the factor provided in the table according to the time point when the sample was obtained.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

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
hours after dose

IGF-1 SDS - 0.8

+/- 0.5

IGF-1 (ng/mL) x 0.8

9.0

49-72
hours after dose

IGF-1 SDS - 1.0

+/- 0.6

IGF-1 (ng/mL) x 0.7

8.3

73-96
hours after dose

IGF-1 SDS - 0.5

+/- 0.4

IGF-1 (ng/mL) x 0.9

7.4

97-120
hours after dose

No adjustmentc

N/A

No adjustmentc

N/A

121-144
hours after dose

IGF-1 SDS + 0.7

+/- 0.4

IGF-1 (ng/mL) x 1.3

10.0

145-168
hours after dose

IGF-1 SDS + 1.1

+/- 0.6

IGF-1 (ng/mL) x 1.6

15.0

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.

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.

Adults reached favorable IGF-1 levels

Sogroya® achieved serum IGF-1 increases that were comparable to daily treatment1

Secondary endpoint: IGF‑1 SDS values1,5

Secondary endpoint baseline data
Secondary endpoint week 34 data

Draw IGF-1 samples 3 to 4 days after the prior dose.1

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.¹ 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
Sogroya® 52 week study
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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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portrayal

Actor portrayal

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. Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
  2. 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.
  3. Data on file. Novo Nordisk, Inc; Plainsboro, NJ.
  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. 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.