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.

For Pediatric Patients For Adult Patients

Daily injections may present obstacles for patients and caregivers

Non-adherence to daily GH treatment is common and has been addressed in many studies^2,3

Repeated injections are one of the main causes of non-adherence in pediatric-aged patients⁴

Children, adolescents, and their caregivers may struggle with continual daily injections over the long term¹

GH=growth hormone; GHD=growth hormone deficiency

Missing

per week of daily
GH treatment

results in missing up to

of treatment
in a year

which equates to missing

of doses over a 7-year
treatment period

In a systematic literature review and meta-analysis of medication adherence with once-weekly vs once-daily therapy,

Once-weekly treatment adherence was ~2X better than once‑daily treatment^5,a

According to an LAGH Consensus Statement for pediatric GHD patients, developed independently by a panel of renowned pediatric endocrinology experts⁶:

LAGH formulations offer a potential advantage over daily GH injections for children with GH deficiency in terms of reduced injection frequency and treatment burden; this may also be associated with improved adherence and treatment outcomes over time. However, long-term data is needed
Parents/caregivers have shown a strong preference for the reduced frequency of LAGH preparations over daily GH formulations
It is likely that most if not all children could be considered for a weekly administration regimen, particularly children or their caregivers who experience challenges with injections, as well as those at increased risk of non-adherence, frequent travel schedules, and split households

^aMeta-analysis of observational studies which were conducted in patients with osteoporosis.⁵

GH=growth hormone; GHD=growth hormone deficiency; LAGH=long-acting growth hormone.

Adult GHD (AGHD) is most often acquired from^7,8:

A pituitary tumor^7,8

Including treatment with surgery and/or radiation⁸

Trauma to the brain⁷

Other patient subpopulations include subarachnoid hemorrhage, ischemic stroke, and infections in the central nervous system⁷

AGHD may also be idiopathic or due to other organic causes.^7,8

Reduced energy levels

Reduced muscle strength

Osteoporosis

Lipid abnormalities

Increased total body fat

Insulin resistance

Impaired cardiac function

Reduced energy levels

Reduced muscle strength

Osteoporosis

Lipid abnormalities

Increased total body fat

Insulin resistance

Impaired cardiac function

Per the American Association of Clinical Endocrinologists (AACE), identifying adult patients with GHD includes assessing⁸:

PATIENTS WITH CLINICAL FEATURES SUGGESTIVE OF AGHD

Patients with clinical features suggestive of AGHD, eg, patients with organic hypothalamic-pituitary disease and low-serum IGF-1 levels

PATIENTS WITH CLINICAL FEATURES SUGGESTIVE OF AGHD

eg, patients with organic hypothalamic-pituitary disease and low-serum IGF-1 levels

BIOCHEMICALLY PROVEN EVIDENCE OF AGHD

eg, GH stimulation testing

BIOCHEMICALLY PROVEN
EVIDENCE OF AGHD

eg, GH stimulation testing

With diagnosis confirmed, AACE recommends treating AGHD with growth hormone therapy⁸
While once-daily GH treatment is considered the standard of care, according to GRS consensus, a once-weekly GH option may also help¹

AGHD=adult growth hormone deficiency; GH=growth hormone; GHD=growth hormone deficiency; GRS=Growth Hormone Research Society; IGF-1=insulin-like growth factor-1.

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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

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:

Christiansen JS, Backeljauw PF, Bidlingmaier M, et al. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations. Eur J Endocrinol. 2016;174(6):C1–C8. doi:10.1530/EJE-16-0111
Graham S, Weinman J, Auyeung V. Identifying potentially modifiable factors associated with treatment non-adherence in paediatric growth hormone deficiency: a systematic review. Horm Res Paediatr. 2018;90(4):221-227. doi:10.1159/000493211
Bagnasco F, Di Iorgi N, Roveda A, Gallizia A, Haupt R, Maghnie M; Adherence Investigators Group. Prevalence and correlates of adherence in children and adolescents treated with growth hormone: a multicenter Italian study. Endocr Pract. 2017;23(8):929-941. doi:10.4158/EP171786.OR
Mameli C, Orso M, Calcaterra V, et al. Efficacy, safety, quality of life, adherence and cost-effectiveness of long-acting growth hormone replacement therapy compared to daily growth hormone in children with growth hormone deficiency: a systematic review and meta-analysis. Pharmacol Res. 2023;193:106805. doi:10.1016/j.phrs/2023.106805
Iglay K, Cao X, Mavros P, Joshi K, Yu S, Tuncell K. Systematic literature review and meta-analysis of medication adherence with once-weekly versus once-daily therapy. Clin Ther. 2015;37(8):1813-1821.e1. doi:10.1016/j.clinthera.2015.05.505
Maniatis A, Cutfield W, Dattani M, et al. Long-acting growth hormone therapy in pediatric growth hormone deficiency: a consensus statement. J Clin Endocrinol Metab. Published online December 3, 2024. doi:10.1210/clinem/dgae834
National Organization for Rare Disorders (NORD). Growth hormone deficiency. Updated 2016. Accessed November 17, 2022. https://rarediseases.org/rare-diseases/growth-hormone- deficiency
Yuen KCJ, Beverly MKB, Radovick S, et al. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of growth hormone deficiency in adults and patients transitioning from pediatric to adult care. Endocr Pract. 2019;25(11):1191-1232.

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WHY A ONCE-WEEKLY THERAPY?

WHY A ONCE-WEEKLY THERAPY?

Patients with GHD continue to face challenges with daily injections1

1 DAY

52 DAYS

~1 YEAR

Consider if the flexibility of a once-weekly GH treatment option may impact your patient’s persistence and treatment experience

GHD occurs in adults and has associated symptoms and conditions

Symptoms and associated conditions of adult GHD include7:

Symptoms and associated conditions of adult GHD include7:

Management of adult GHD

Treatment options1,8

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Important Safety Information for Sogroya®

Contraindications

Warnings & Precautions

Adverse Reactions

Drug Interactions

Indications and Usage

Indications and Usage

Important Safety Information for Sogroya®

Contraindications

Warnings & Precautions

Adverse Reactions

Drug Interactions

Indications and Usage

Indications and Usage

Important Safety Information for Sogroya®

Contraindications

Important Safety Information for Sogroya®

Contraindications

Warnings & Precautions

Adverse Reactions

Drug Interactions

Important Safety Information for Sogroya®

Contraindications

Warnings & Precautions

Adverse Reactions

Drug Interactions

Indications and Usage

Indications and Usage

Important Safety Information for Sogroya®

Contraindications

Warnings & Precautions

Adverse Reactions

Drug Interactions

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professional hub

Patients with GHD continue to face challenges with daily injections¹

Symptoms and associated conditions of adult GHD include⁷:

Symptoms and associated conditions of adult GHD include⁷:

Treatment options^1,8

Important Safety Information for Sogroya^®

Important Safety Information for Sogroya^®

Important Safety Information for Sogroya^®

Important Safety Information for Sogroya^®

Important Safety Information for Sogroya^®

Important Safety Information for Sogroya^®