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.
Could the flexibility of a once-weekly GH treatment impact your patient’s experience? Get informed.
THE #1 PRESCRIBED ONCE-WEEKLY GH TREATMENT1,a
3 years of long-term safety and efficacy data for naïve and switch patients1,2
Easy-to-use pen: most patients and caregivers said the Sogroya® pen was easy to use3,b
The first once-weekly treatment approved for both pediatric and adult patients with GHD2
Explore dosing to start and switch your patients2
View Sogroya®’s long-term safety profile in naïve and switch patients2
See users’ preferences between the Sogroya® pen and other LAGH devices3,4
Learn about the only LAGH preferred on CVS® and Aetna®, with increased coverage among more payers1,c,d
aBased on data from Komodo Sentinel as of February 2025.
bBased on a randomized, crossover device preference and handling study of the Sogroya® pen in 33 adolescents aged 10 to 17 years with growth-related disorders and 37 caregivers ≥18 years of age. After training, users performed simulated injections into a pad or mannequin and then completed the DHPAQ. 99% (69) of participants found the Sogroya® pen easy or very easy to use.3
cCoverage status does not imply product endorsement.
dBecause formularies do change and many health plans offer more than 1 formulary, please check directly with the health plan to confirm coverage for individual patients. Intended as a guide. The information provided is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with the plan’s respective policy and procedures. Multiple products within the same therapeutic class may be considered “preferred” and on the same tier.
GH=growth hormone, LAGH=long-acting growth hormone
THE #1 PRESCRIBED ONCE-WEEKLY GH TREATMENT1,a
3 years of long-term safety and efficacy data for naïve and switch patients1,2
Easy-to-use pen: most patients and caregivers said the Sogroya® pen was easy to use3,b
The first once-weekly treatment approved for both pediatric and adult patients with GHD2
Explore dosing to start and switch your patients2
View Sogroya®’s long-term safety profile in naïve and switch patients2
See users’ preferences between the Sogroya® pen and other LAGH devices3,4
Learn about the only LAGH preferred on CVS® and Aetna®, with increased coverage among more payers1,c,d
aBased on data from Komodo Sentinel as of February 2025.
bBased on a randomized, crossover device preference and handling study of the Sogroya® pen in 33 adolescents aged 10 to 17 years with growth-related disorders and 37 caregivers ≥18 years of age. After training, users performed simulated injections into a pad or mannequin and then completed the DHPAQ. 99% (69) of participants found the Sogroya® pen easy or very easy to use.3
cCoverage status does not imply product endorsement.
dBecause formularies do change and many health plans offer more than 1 formulary, please check directly with the health plan to confirm coverage for individual patients. Intended as a guide. The information provided is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with the plan’s respective policy and procedures. Multiple products within the same therapeutic class may be considered “preferred” and on the same tier.
GH=growth hormone, LAGH=long-acting growth hormone
Which pen should you prescribe?
Which pen should you prescribe?
The Sogroya® pen is based on the FlexPro® you know, with more than 15 years of patient experience. Over 150 dosing increments are available across all pens.1,2
No mixing, no charging, no cartridges2
Hypothetical pen device with push-button extension used for illustrative purposes only. Not intended to reflect any approved device.
No mixing, no charging, no cartridges2
How does the Sogroya® pen stand up to some of the other once-daily and once-weekly growth hormone therapy devices? When making your treatment decisions, think about the device’s attributes and how they can impact your patients.
Hypothetical pen device with push-button extension used for illustrative purposes only. Not intended to reflect any approved device.
We’re here to help you get patients started on Sogroya®
NovoCare® offers a variety of programs to help your patients access treatment.
Actor portrayal
We’re here to help you get patients started on Sogroya®
NovoCare® offers a variety of programs to help your patients access treatment.
Are you treating adult patients?
Sogroya® is the first once-weekly growth hormone treatment for adult growth hormone deficiency.2
Actor portrayal
Are you treating adult patients?
Sogroya® is the first once-weekly growth hormone treatment for adult growth hormone deficiency.2
Get a more personalized experience and relevant updates about Sogroya® by creating a novoMEDLINK™ account.
Get a more personalized experience and relevant updates about Sogroya® by creating a novoMEDLINK™ account.
Get a more personalized experience and relevant updates about Sogroya® by creating a novoMEDLINK™ account.
Get a more personalized experience and relevant updates about Sogroya® by creating a novoMEDLINK™ account.
Monitor your patients’ growth trajectory
Our growth calculators can help you calculate your patients' height velocity, target height, and body mass index.
Monitor your patients’ growth trajectory
Our growth calculators can help you calculate your patients' height velocity, target height, and body mass index.
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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
- 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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients receiving Sogroya® with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly
- 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.
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)
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 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
- 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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients receiving Sogroya® with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly
- 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.
Show More
Show Less
Show More
Show Less
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 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
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
- 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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients receiving Sogroya® with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly
- 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.
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
- 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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients receiving Sogroya® with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly
- 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.
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)
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 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
- 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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients receiving Sogroya® with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly
- 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:
- Data on file. Novo Nordisk Inc; Plainsboro, NJ.
- Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk, Inc.
- Akhtar S, Berg B, Medina J, et al. Patients with growth-related disorders and caregivers prefer the somapacitan device to the somatrogon device: results from a randomized crossover study assessing device preference and ease of use following simulated injections. Med Devices (Auckl). 2024;17:427-439. doi:10.2147/MDER.S484354
- Medina J, Ter-Borch G, Kelepouris N, et al. Usability and preference evaluation of the somapacitan pen-injector and lonapegsomatropin autoinjector: results of a US-based simulated-use study with adolescent patients and caregivers. Patient Prefer Adherence. 2025;19:1119-1131. doi:10.2147/PPA.S505952