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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). Please see full indications.

Prescribing Information
Important Safety Information | Patient Site

EASY TO LEARN TO USEa BASED ON THE FLEXPRO® YOU KNOW1

BASED ON THE FLEXPRO® YOU KNOW1,2

For your adult and pediatric patients, whether switching or treatment-naïve, the Sogroya® pen is designed to help them dose correctly.

Sogroya® 15 mg pen with stars

BASED ON THE FLEXPRO® YOU KNOW1,2

The Sogroya® (somapacitan-beco) injection pen is based on the familiar FlexPro® device.1,2

EASY TO LEARN TO USEa BASED ON THE FLEXPRO® YOU KNOW1

aBased on a human factors study of the safety and usability of the Norditropin® FlexPro® 30 mg pen in 94 participants (children ages 10-17 with growth-related disorders; adults with GHD; HCPs; and caregivers). Users performed injections using a foam cushion and then completed a device-specific questionnaire. Participants rated the device a 6.7 out of 7 (on a scale of 1 to 7, where 1 means "strongly disagree" and 7 means "strongly agree") for the statement, "FlexPro® was easy to learn to use". The FlexPro® used in this human factors study is similar to the Sogroya® pen.1

aBased on a human factors study of the safety and usability of the Norditropin® FlexPro® 30 mg pen in 94 participants (children ages 10-17 with growth-related disorders; adults with GHD; HCPs; and caregivers). Users performed injections using a foam cushion and then completed a device-specific questionnaire. Participants rated the device a 6.7 out of 7 (on a scale of 1 to 7, where 1 means “strongly disagree” and 7 means “strongly agree”) for the statement, "FlexPro® was easy to learn to use". The FlexPro® used in this human factors study is similar to the Sogroya® pen.1

Injection pen with checkmark icon

No mixing required

Prefilled, premixed, and preloaded.2

Thermometer with checkmark icon

Portable
 

Stable at room temperature (up to 77 °F) for up to 3 days (72 hours).2,b

Arrow on bullseye icon

Precise dosing
 

Over 100 dosing increments available across all pens.2

10 years inside shield icon

Familiar
 

Based on the FlexPro® you know with more than 10 years of patient experience.1

bThe pen should be refrigerated (36 °F-46 °F). If needed, it may be stored at room temperature (up to 77 °F) for no more than 72 hours total. The pen can be taken in and out of a refrigerator as needed. The pen must be discarded 6 weeks after first use, if it has been frozen, or if kept above 86 °F. See Prescribing Information for full storage and handling instructions.2

Dose counter lets patients view the dose prescribed2

Dose selector allows patients to choose the dose they need2

Dose button for patients to administer medication2

Dose counter lets patients view the dose prescribed2

Dose selector allows patients to choose the dose they need2

Dose button for patients to administer medication2

Use our tool to learn about select features across a range of daily and weekly growth hormone therapy devices.

This chart is not intended to be a comparison of safety or efficacy and is not based on any head-to-head data.

This chart does not display a complete list of available devices for GH treatment. Only select devices are shown.

This chart does not provide a comprehensive list of device attributes or storage information for the products. Please refer to each product's Prescribing Information for full details.

Please refer to the complete Prescribing Information for Sogroya® before use.
Please refer to the complete Prescribing Information for Norditropin® before use.

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.

Albumin-binding technology2

Sogroya® leverages the same albumin-binding prolongation technology developed by Novo Nordisk for other disease areas.2,3

Molecule icon

Sogroya® leverages the same albumin-binding prolongation technology developed by Novo Nordisk for other disease areas.2,3

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.

Selected Important Safety Information for Norditropin®

Contraindications

Norditropin® is contraindicated in patients with:

  • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin
  • 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 the risk of sudden death
  • Active Malignancy
  • Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Pediatric patients with closed epiphyses

Indications and Usage

Norditropin® (somatropin) injection is indicated for the treatment of pediatric patients with:

  • growth failure due to inadequate secretion of endogenous growth hormone (GH)
  • short stature associated with Noonan syndrome,
  • short stature associated with Turner syndrome,
  • short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age
  • Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range
  • growth failure due to Prader-Willi syndrome (PWS) 

Norditropin® is also indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)

Important Safety Information

Contraindications

Norditropin® is contraindicated in patients with:

  • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin
  • 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 the risk of sudden death
  • Active Malignancy
  • Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Pediatric patients with closed epiphyses

Warnings and Precautions

  • Increased mortality in patients with acute critical illness due to complications following open heart or abdominal surgery or multiple accidental trauma, or those with respiratory failure has been reported.
  • Sudden death in pediatric patients with Prader-Willi Syndrome has been reported after initiating treatment with somatropin with one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Evaluate patients for signs of upper airway obstruction and sleep apnea before initiation of treatment.
  • Increased risk of neoplasms: Monitor patients with preexisting tumors for progression or recurrence. In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm, in particular meningiomas, has been reported. Pediatric patients 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 carefully for increased growth, or potential malignant changes, of preexisting nevi.
  • Glucose intolerance and diabetes mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. Monitor glucose levels in all patients. Doses of concurrent antidiabetic drugs may require adjustment.
  • Intracranial hypertension has been reported in a small number of patients, usually within the first 8 weeks of somatropin treatment. Funduscopic examination should be performed before initiating treatment and periodically thereafter.
  • Severe hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products.
  • Fluid retention in adults (clinically manifesting as edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) may frequently occur and is usually transient and dose-dependent.
  • Hypoadrenalism: Patients who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Norditropin® treatment.
  • Hypothyroidism if undiagnosed/untreated, may prevent an optimal response to Norditropin®, in particular, the growth response in pediatric patients. In patients with GHD, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or adjusted when indicated.
  • Slipped capital femoral epiphysis in pediatric patients may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Pediatric patients with the onset of a limp or complaints of hip or knee pain should be evaluated.
  • Progression of preexisting scoliosis in pediatric patients can occur in patients who experience rapid growth. Patients with a history of scoliosis should be monitored for progression.
  • Pancreatitis: Cases of pancreatitis have been reported. Pancreatitis should be considered in any patient who develops persistent severe abdominal pain.
  • Lipoatrophy: Tissue atrophy may result when somatropin is administrated subcutaneously at the same site over a long period of time. Rotate injection sites when administering Norditropin® to reduce this risk.

Adverse Reactions

  • Other common adverse reactions in adults and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance

Drug Interactions

  • Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Norditropin®
  • Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatment to avoid both hypoadrenalism and an inhibitory effect on growth
  • Cytochrome P450-Metabolized Drugs: Norditropin® may alter the clearance. Monitor carefully if used with Norditropin®
  • Oral Estrogen: Larger doses of Norditropin® may be required
  • Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required

Use in Specific Populations

  • Pregnancy and Nursing Mothers: There are limited data with somatropin use in pregnant women and nursing mothers to inform a drug-associated risk for adverse developmental outcomes.
  • Geriatric Use: The safety and effectiveness in patients aged 65 and over has not been evaluated in clinical studies.

Please click here for Norditropin® Prescribing Information.

References:

  1. Data on File. Novo Nordisk, Inc; Plainsboro, NJ.
  2. Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2023.
  3. Johansson E, Nielsen AD, Demuth H, et al. Identification of binding sites on human serum albumin for somapacitan, a long-acting growth hormone derivative. Biochemistry. 2020;59(14):1410-1419.
  4. SKYTROFA [prescribing information]. Ascendis Pharma, Inc; 2022.
  5. NutropinAQ [prescribing information]. Genentech, Inc; 2016.
  6. Norditropin [prescribing information]. Novo Nordisk, Inc; 2020
  7. Omnitrope [prescribing information]. Sandoz, Inc; 2019.
  8. Genotropin [prescribing information]. Pharmacia & Upjohn Co; 2019.
  9. Humatrope [prescribing information]. Eli Lilly & Co; 2019.