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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
SOGROYA (BLA-761156)
(SOMAPACITAN-BECO)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
02/27/2026 (SUPPL-12)
5 Warnings and Precautions
5.6 Fluid Retention
Additions and/or revisions underlined:
Fluid retention was observed 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.
5.10 Progression of Preexisting Scoliosis in Pediatric Patients
Additions and/or revisions underlined:
Somatropin, including SOGROYA, increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression.
5.14 Laboratory Tests
Additions and/or revisions underlined:
Serum levels of inorganic phosphorus and alkaline phosphatase have increased after somatropin therapy, including SOGROYA. Serum levels of parathyroid hormone may increase with somatropin treatment.
6 Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label for complete information
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of SOGROYA have been established in pediatric patients 2.5 years of age and older for the treatment of:
Growth failure due to inadequate secretion of endogenous GH. The use of SOGROYA for this indication is supported by evidence from a 52-week randomized, multi-center, open-label, active-controlled, parallel-group phase 3 trial in 200 treatment-naïve, pediatric patients aged 2.5 to 11 years with GHD [see Clinical Studies (14.1)]. The safety profile from the pediatric trial was similar to that reported in adults [see Adverse Reactions (6.1)].
Short stature born SGA with no catch-up growth by 2 years of age. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 142 pediatric patients aged 2.6 to 10.7 years with short stature born SGA with no catch-up growth by 2 years of age [see Clinical Studies (14.2)].
Growth failure associated with NS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 77 pediatric patients aged 2 to 11.1 years with growth failure associated with NS [see Clinical Studies (14.3)].
- ISS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 88 pediatric patients aged 2.8 to 10.8 years with ISS [see Clinical Studies (14.4)].
The safety and effectiveness of SOGROYA have not been established in pediatric patients less than 2.5 years of age for the treatment of growth failure due to inadequate secretion of endogenous GH, short stature born SGA with no catch-up growth, growth failure associated with NS, or with ISS.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
What is SOGROYA?
SOGROYA is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body. SOGROYA is given by injection under the skin (subcutaneous).
SOGROYA is used to treat children 2.5 years of age and older who:
are not growing because of low or no growth hormone.
are short (in stature) and were born small (small for gestational age-SGA) and have not caught up in growth by age 2 years.
are not growing and have Noonan syndrome.
- have Idiopathic Short Stature (ISS).
SOGROYA is used to treat adults who do not make enough growth hormone.
…
The most common side effects of SOGROYA in children include:
cough
fever
common cold
pain in extremity
diarrhea
reaction to injection
ear infection
respiratory tract infection
headache
- vomiting
The most common side effects of SOGROYA in adults include:
back pain
vomiting
joint pain
low cortisol levels (adrenal insufficiency)
indigestion
high blood pressure
sleep problems
increase in the level of an enzyme in your blood called creatine phosphokinase
dizziness swelling of the tonsils (tonsillitis)
o weight gain
swelling in the feet and hands (peripheral edema)
- low red blood cells (anemia)
…
02/27/2026 (SUPPL-14)
5 Warnings and Precautions
5.6 Fluid Retention
Additions and/or revisions underlined:
Fluid retention was observed 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.
5.10 Progression of Preexisting Scoliosis in Pediatric Patients
Additions and/or revisions underlined:
Somatropin, including SOGROYA, increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression.
5.14 Laboratory Tests
Additions and/or revisions underlined:
Serum levels of inorganic phosphorus and alkaline phosphatase have increased after somatropin therapy, including SOGROYA. Serum levels of parathyroid hormone may increase with somatropin treatment.
6 Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label for complete information
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of SOGROYA have been established in pediatric patients 2.5 years of age and older for the treatment of:
Growth failure due to inadequate secretion of endogenous GH. The use of SOGROYA for this indication is supported by evidence from a 52-week randomized, multi-center, open-label, active-controlled, parallel-group phase 3 trial in 200 treatment-naïve, pediatric patients aged 2.5 to 11 years with GHD [see Clinical Studies (14.1)]. The safety profile from the pediatric trial was similar to that reported in adults [see Adverse Reactions (6.1)].
Short stature born SGA with no catch-up growth by 2 years of age. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 142 pediatric patients aged 2.6 to 10.7 years with short stature born SGA with no catch-up growth by 2 years of age [see Clinical Studies (14.2)].
Growth failure associated with NS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 77 pediatric patients aged 2 to 11.1 years with growth failure associated with NS [see Clinical Studies (14.3)].
- ISS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 88 pediatric patients aged 2.8 to 10.8 years with ISS [see Clinical Studies (14.4)].
The safety and effectiveness of SOGROYA have not been established in pediatric patients less than 2.5 years of age for the treatment of growth failure due to inadequate secretion of endogenous GH, short stature born SGA with no catch-up growth, growth failure associated with NS, or with ISS.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
What is SOGROYA?
SOGROYA is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body. SOGROYA is given by injection under the skin (subcutaneous).
SOGROYA is used to treat children 2.5 years of age and older who:
are not growing because of low or no growth hormone.
are short (in stature) and were born small (small for gestational age-SGA) and have not caught up in growth by age 2 years.
are not growing and have Noonan syndrome.
- have Idiopathic Short Stature (ISS).
SOGROYA is used to treat adults who do not make enough growth hormone.
…
The most common side effects of SOGROYA in children include:
cough
fever
common cold
pain in extremity
diarrhea
reaction to injection
ear infection
respiratory tract infection
headache
- vomiting
The most common side effects of SOGROYA in adults include:
back pain
vomiting
joint pain
low cortisol levels (adrenal insufficiency)
indigestion
high blood pressure
sleep problems
increase in the level of an enzyme in your blood called creatine phosphokinase
dizziness swelling of the tonsils (tonsillitis)
o weight gain
swelling in the feet and hands (peripheral edema)
- low red blood cells (anemia)
…
02/27/2026 (SUPPL-15)
5 Warnings and Precautions
5.6 Fluid Retention
Additions and/or revisions underlined:
Fluid retention was observed 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.
5.10 Progression of Preexisting Scoliosis in Pediatric Patients
Additions and/or revisions underlined:
Somatropin, including SOGROYA, increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression.
5.14 Laboratory Tests
Additions and/or revisions underlined:
Serum levels of inorganic phosphorus and alkaline phosphatase have increased after somatropin therapy, including SOGROYA. Serum levels of parathyroid hormone may increase with somatropin treatment.
6 Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label for complete information
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of SOGROYA have been established in pediatric patients 2.5 years of age and older for the treatment of:
Growth failure due to inadequate secretion of endogenous GH. The use of SOGROYA for this indication is supported by evidence from a 52-week randomized, multi-center, open-label, active-controlled, parallel-group phase 3 trial in 200 treatment-naïve, pediatric patients aged 2.5 to 11 years with GHD [see Clinical Studies (14.1)]. The safety profile from the pediatric trial was similar to that reported in adults [see Adverse Reactions (6.1)].
Short stature born SGA with no catch-up growth by 2 years of age. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 142 pediatric patients aged 2.6 to 10.7 years with short stature born SGA with no catch-up growth by 2 years of age [see Clinical Studies (14.2)].
Growth failure associated with NS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 77 pediatric patients aged 2 to 11.1 years with growth failure associated with NS [see Clinical Studies (14.3)].
- ISS. The use of SOGROYA for this indication is supported by evidence from a multi-center, randomized open-label, active-comparator, phase 3 basket study in 88 pediatric patients aged 2.8 to 10.8 years with ISS [see Clinical Studies (14.4)].
The safety and effectiveness of SOGROYA have not been established in pediatric patients less than 2.5 years of age for the treatment of growth failure due to inadequate secretion of endogenous GH, short stature born SGA with no catch-up growth, growth failure associated with NS, or with ISS.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
What is SOGROYA?
SOGROYA is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body. SOGROYA is given by injection under the skin (subcutaneous).
SOGROYA is used to treat children 2.5 years of age and older who:
are not growing because of low or no growth hormone.
are short (in stature) and were born small (small for gestational age-SGA) and have not caught up in growth by age 2 years.
are not growing and have Noonan syndrome.
- have Idiopathic Short Stature (ISS).
SOGROYA is used to treat adults who do not make enough growth hormone.
…
The most common side effects of SOGROYA in children include:
cough
fever
common cold
pain in extremity
diarrhea
reaction to injection
ear infection
respiratory tract infection
headache
- vomiting
The most common side effects of SOGROYA in adults include:
back pain
vomiting
joint pain
low cortisol levels (adrenal insufficiency)
indigestion
high blood pressure
sleep problems
increase in the level of an enzyme in your blood called creatine phosphokinase
dizziness swelling of the tonsils (tonsillitis)
o weight gain
swelling in the feet and hands (peripheral edema)
- low red blood cells (anemia)
…
07/09/2025 (SUPPL-13)
5 Warnings and Precautions
5.9 Slipped Capital Femoral Epiphysis in Pediatric Patients
Additions and/or revisions underlined:
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.
6 Adverse Reactions
6.2 Postmarketing Experience
Newly added subsection
The following adverse reactions have been identified during post-approval use of somatropins. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Musculoskeletal and connective tissue disorders – osteonecrosis in pediatric patients.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
. . .
What are the possible side effects of SOGROYA? SOGROYA may cause serious side effects, including:
. . .
- hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help right away if you or your child develops a limp or has hip or knee pain.
. . .
04/28/2023 (SUPPL-5)
4 Contraindications
Additions and/or revisions underlined:
SOGROYA is contraindicated in patients with:
Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA [see Warnings and Precautions (5.1)].
Hypersensitivity to SOGROYA or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin [see Warnings and Precautions (5.2)].
Pediatric patients with closed epiphyses.
Active malignancy [see Warnings and Precautions (5.3)].
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 [see Warnings and Precautions (5.13)].
5 Warnings and Precautions
6 Adverse Reactions
Additions and/or revisions underlined:
The following clinically significant adverse drug reactions are described elsewhere in the labeling:
Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1)]
Severe hypersensitivity [see Warnings and Precautions (5.2)]
Increased risk of neoplasms [see Warnings and Precautions (5.3)]
Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)]
Intracranial hypertension [see Warnings and Precautions (5.5)]
Fluid retention [see Warnings and Precautions (5.6)]
Hypoadrenalism [see Warnings and Precautions (5.7)]
Hypothyroidism [see Warnings and Precautions (5.8)]
Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.9)]
Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.10)]
Pancreatitis [see Warnings and Precautions (5.11)]
Lipohypertrophy/Lipoatrophy [see Warnings and Precautions (5.12)]
Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions (5.13)]
6.1 Clinical Trials Experience
Extensive changes; please refer to label for complete information
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of SOGROYA have been established for the treatment of growth failure due to inadequate secretion of endogenous growth hormone (GH) in pediatric patients 2.5 years of age and older. The use of SOGROYA for this indication is supported by evidence from a 52 week randomized, multi-center, open-label, active-controlled, parallel- group phase 3 trial in 200 treatment-naïve, pediatric patients with GHD. The safety profile from the pediatric trial was similar to that reported in adults [see Adverse Reactions (6.1) and Clinical Studies (14.1)].
Risks in pediatric patients associated with growth hormone use include:
- Sudden death in pediatric patients with Prader-Willi Syndrome. SOGROYA is not indicated for the treatment of pediatric patients with growth failure secondary to genetically confirmed Prader-Willi syndrome.[see Warnings and Precautions (5.13)]
- Increased risk of second neoplasm in pediatric cancer survivors treated with radiation to the brain and/or head [see Warnings and Precautions (5.3)]
- Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.9)]
- Progression of pre-existing scoliosis in pediatric patients [see Warnings and Precautions (5.10)]
- Pancreatitis [see Warnings and Precautions (5.11)]
The safety and effectivness of SOGROYA for the treatment of growth failure due to inadequate secretion of endogenous growth hormone have not been established in pediatric patients less than 2.5 years of age.
8.6Hepatic Impairment
Additions and/or revisions underlined:
Adult patients: No dose adjustment of SOGROYA is required for patients with mild hepatic impairment. Higher somapacitan-beco exposure was observed in patients with moderate hepatic impairment. In patients with moderate hepatic impairment, initiate SOGROYA with a dose of 1 mg once weekly and use smaller increments when increasing the dose. The maximum dose should not exceed 4 mg once weekly. Somapacitan-beco was not studied in patients with severe hepatic impairment. Therefore, use of SOGROYA is not recommended in patients with severe hepatic impairment. [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].
Pediatric patients: Based on the hepatic impairment study in adults, no dose adjustment of SOGROYA is recommended for patients with mild hepatic impairment. Higher systemic exposure of SOGROYA is expected in pediatric patients with moderate and severe hepatic impairment; therefore, SOGROYA is not recommended in these pediatric patients [see Dosage and Administration (2.5)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
Advise patients and/or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
- Advise patients and/or caregivers to administer SOGROYA once weekly.
- Hypersensitivity - Advise patients and/or caregivers that severe and/or serious systemic hypersensitivity reactions (anaphylaxis and angioedema) have been reported, and to seek prompt medical attention should an allergic reaction occur [see Warnings and Precautions (5.2)].
…
PATIENT INFORMATION
Additions and/or revisions underlined:
What is SOGROYA?
…
SOGROYA is given by injection under the skin (subcutaneous) and is used to treat adults and children 2.5 years and older who do not make enough growth hormone.
Do not use SOGROYA if:
…
you are a child with closed bone growth plates.
you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stop breathing during sleep).
Before taking SOGROYA, tell your healthcare provider about all of your medical conditions, including if you:
…
are a child with a history of worsening of curvature of the spine (scoliosis).
How should I use SOGROYA?
…
SOGROYA comes in 3 strengths: 5 mg/1.5 mL (3.3 mg/mL) pen, 10 mg/1.5 mL (6.7 mg/mL) pen, and 15 mg/1.5 mL (10 mg/mL) pen. Your healthcare provider will prescribe the dose that is right for you.
…
If you miss a dose of SOGROYA, the missed dose can be taken within 3 days (72 hours) after the scheduled dosing day. One-time weekly dosing for the next dose can be started again on the regularly scheduled dosing day.
- If more than 3 days (72 hours) have passed, skip the missed dose and take your next dose on the regularly scheduled dosing day.
…
SOGROYA may cause serious side effects, including:
…
increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child’s skin.
new or worsening high blood sugar (hyperglycemia) or diabetes. You or your child’s blood sugar may need to be monitored during treatment with SOGROYA.
increase in pressure in the skull (intracranial hypertension). If you or your child have headaches, eye problems, nausea or vomiting, contact the healthcare provider.
- serious allergic reactions. Get medical help right away if you or your child have the following symptoms:
…
your or your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your or your child’s joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Tell your or your child’s healthcare provider if you or your child have any of these signs or symptoms of fluid retention.
decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss.
decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well SOGROYA works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels.
severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain.
loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your or your child’s healthcare provider about rotating the areas where you or your child inject SOGROYA.
worsening of curvature of the spine in children (scoliosis).
hip and knee pain or a limp in children (slipped capital femoral epiphysis).
high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea. See “Do not use SOGROYA if”.
- increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. Your or your child’s healthcare provider will do blood tests to check this.
The most common side effects of SOGROYA in children include:
common cold
pain in extremity
headache
reaction to injection
- fever
The most common side effects of SOGROYA in adults include:
…
10/01/2021 (SUPPL-1)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATIONHow should I use SOGROYA?
SOGROYA comes in 2 strengths: 5 mg/1.5mL (3.3 mg/mL) pen and 10 mg/1.5mL (6.7 mg/mL) pen. Your healthcare provider will prescribe the dose that is right for you.