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Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, 15 mg logo
Important Safety Information | Patient Site
Prescribing Information
  • The Need for Once-Weekly
    • How It Works
    • Sogroya® Pen
    • Device Attribute Chart
    • Pediatric Growth Hormone Deficiency
    • Adult Growth Hormone Deficiency
    • IGF-1 Response
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    • Adult Dosing
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    • Formulary Coverage
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    • FAQ
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

Growing Together

Clinical Education Webinar Experience

Through three in-depth video chapters hosted on Medscape, experts in the field share their insights around the mechanism of action, efficacy of Sogroya®, dosing, administration and device for your growth hormone patients.

Go to Medscape webinar

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Growing Together

Clinical Education Webinar Experience

Through three in-depth video chapters hosted on Medscape, experts in the field share their insights around the mechanism of action, efficacy of Sogroya®, dosing, administration and device for your growth hormone patients.

Go to Medscape webinar

Actor Portrayal

Explore More Sogroya® Tools & Resources

We’ve gathered resources and tools tailored to further your understanding of Sogroya®.

See Sogroya® in action
(10:33)

Sogroya® Mechanism of Action and Key Insights From the Clinical Development

Discover more about the Sogroya® MOA in this detailed animation.

Watch video

Modeling-Based Insights for IGF-1 With Sogroya® in Children With GHD

Get at-your-fingertips resources for real-world use.

IGF-1 Calculation Table

Use this chart to help calculate the average weekly IGF-1 concentration.

Pediatric Dosing Guide

Download or order the Sogroya® dosing guide for quick reference in your office.

Three kids with backpacks and books

Actor portrayal

Sogroya® 5mg, 10mg, and 15mg pens

Key Features and Use of the Sogroya® Device

Find the right device or pen for your patients.

Device Comparison

Use this tool to consider your patients’ GH device options.

Pen Selector

Determine the appropriate amount of pens to prescribe.

Starting and Switching Your Patients

Get coverage information and cost support.

Formulary Look Up

Check Sogroya® coverage for your patients.

NovoCare®

Access patient support programs, savings offers, and more.

Father and son playing with blocks

Actor portrayal

Explore More Sogroya® Tools & Resources

We’ve gathered resources and tools tailored to further your understanding of Sogroya®.

See Sogroya® in action
(10:33)

Sogroya® Mechanism of Action and Key Insights From the Clinical Development

Discover more about the Sogroya® MOA in this detailed animation.

Watch now

Sogroya® Mechanism of Action and Key Insights from the Clinical Development

Discover more about the Sogroya® MOA in this detailed animation.

Watch video

Modeling-Based Insights for IGF-1 with Sogroya® in Children with GHD

Get at-your-fingertips resources for real-world use.

IGF-1 Calculation Table

Use this chart to help calculate IGF-1 concentration.

Pediatric Dosing Guide

Download or order the Sogroya® dosing guide for quick reference in your office.

Modeling-Based Insights for IGF-1 With Sogroya® in Children With GHD

Get at-your-fingertips resources for real-world use.

IGF-1 Calculation Table

Use this chart to help calculate the average weekly IGF-1 concentration.

Pediatric Dosing Guide

Download or order the Sogroya® dosing guide for quick reference in your office.

Key Features and Use of the Sogroya® Device

Find the right device or pen for your patients.

Device Comparison

Use this tool to consider your patients’ GH device options.

Pen Selector

Determine the appropriate amount of pens to prescribe.

Starting and Switching Your Patients

Get coverage information and cost support.

Formulary Look Up

Check Sogroya® coverage for your patients.

NovoCare®

Access patient support programs, savings offers, and more.

Meet the Sogroya® key opinion leaders

Aristides Maniatis, MD, FAAP smiling

Aristides Maniatis, MD, FAAP

In Sogroya® Mechanism of Action and Key Insights from the Clinical Development, Dr Maniatis discusses the Sogroya® MOA and results of the REAL4 clinical trial.

Philippe F. Backeljauw, MD looking off to the side

Philippe F. Backeljauw, MD

In Modeling-Based Insights for IGF-1 with Sogroya® in Children with GHD, Dr Backeljauw presents a calculation table for estimating average weekly IGF-1 exposure in pediatric patients.

Magnus Malmberg smiling

Magnus Malmberg

In Key Features and Use of the Sogroya® Device, Magnus spotlights features of the Sogroya® device as the lead engineer of FlexTouch® Platform Devices at Novo Nordisk.

Sarita A George, NP smiling

Sarita A George, NP

In Key Features and Use of the Sogroya® Device, Sarita demonstrates administration steps with the Sogroya® device.

Healthcare professionals received a fee from Novo Nordisk for their participation in this program.

Meet the Sogroya® key opinion leaders

Aristides Maniatis, MD, FAAP smiling

Aristides Maniatis, MD, FAAP

In Sogroya® Mechanism of Action and Key Insights from the Clinical Development, Dr Maniatis discusses the Sogroya® MOA and results of the REAL4 clinical trial.

Philippe F. Backeljauw, MD looking off to the side

Philippe F. Backeljauw, MD

In Modeling-Based Insights for IGF-1 with Sogroya® in Children with GHD, Dr Backeljauw presents a calculation table for estimating average weekly IGF-1 levels exposure in pediatric patients.

Magnus Malmberg smiling

Magnus Malmberg

In Key Features and Use of the Sogroya® Device, Magnus spotlights features of the Sogroya® device as the lead engineer of FlexTouch® Platform Devices at Novo Nordisk.

Sarita A George, NP smiling

Sarita A George, NP

In Key Features and Use of the Sogroya® Device, Sarita demonstrates administration steps with the Sogroya® device.

Healthcare professionals received a fee from Novo Nordisk for their participation in this program.

Medscape logo

View the Sogroya® Webinar

Watch now

To access the content, you will need to register with www.medscape.com (free registration).

Medscape logo

View the Sogroya® Webinar

Watch now

To access the content, you will need to register with www.medscape.com (free registration).

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Questions about Sogroya®?

Get a more personalized experience and relevant updates about Sogroya® by creating a novoMEDLINKTM account.

Create your account

Get a more personalized experience and relevant updates about Sogroya® by creating a novoMEDLINKTM account.

Create your account

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.

Growth-Related Disorders
Other Therapy Areas
Explore diabetes
Explore obesity
Explore growth-related disorders
Explore rare bleeding disorders
Explore rare renal disorders
Explore hormone replacement therapy
  • Growth-Related Disorders Home
  • Product Information
    Products
    • Treatments
    Professional Resources
    • Product Resources Library
      Contact Your Representative
      Growth Calculators
  • Professional Education
    Disease Education
    • Pediatric Growth-Related Disorders (Basics)
      Adult Growth Hormone Deficiency
    Treatment Guidelines
    • PES & AACE Guidelines
    Additional Resources
    • Organizations & Conferences
  • Patient Support
    Product Education
    • Product Education Materials
    Disease Education
    • Advocacy & Support Groups
      Disease Education Resources
    Access & Affordability
    • Insurance Support & Prescription Savings
      ICD-10 Codes for Growth-Related Disorders

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