Sogroya® (somapacitan-beco) injection Sogroya® (somapacitan-beco) injection

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Results and safety for children taking Sogroya®

Kids these days are on-the-go and kids with growth hormone deficiency (GHD) are no exception. Ask your doctor if once-weekly Sogroya® could be the right choice for your family. Keep reading to learn about the efficacy and safety of Sogroya®.

Jump to safety information

Let’s get growing…with Sogroya®

Sogroya® promotes growth with 1 injection per week.

In a 1-year (52-week) study of 200 children who had never been treated for growth hormone deficiency (GHD), Sogroya® was compared with a daily GH treatment (somatropin).a

The main goal of this study, REAL4, was to see if children who took Sogroya® once per week grew at the same rate as children who took the daily GH treatment.

From year 0 to year 1:

Children taking Sogroya® grew 4.4 inches (11.2 cm), on average, at 1 year.

Children taking daily GH grew 4.6 inches (11.7 cm), on average, at 1 year.

Following that initial 1-year study period, a 3-year extension phase study began. 199 patients from the first study remained part of the study either by continuing to take Sogroya® or switching to once-weekly Sogroya® from daily GH treatment.

From year 1 to year 2:

Children continuing on Sogroya® grew ~3.3 inches per year (8.4 cm), on average, at 2 years.

Children switching to Sogroya® grew ~3.4 inches per year (8.7 cm), on average, at 2 years.

These results are from the REAL4 main trial phase (Week 0 to Week 52), which was followed by an ongoing 3-year, single-group, safety extension phase (Week 52 to Week 208). The 3-year data presented here represent up to Week 156. A total of 194 patients continued in the safety extension where all patients received Sogroya® 0.16 mg/kg/week, either continuing Sogroya® treatment (START patients) or switching from daily GH treatment in main phase to once-weekly Sogroya® (SWITCH patients). 188 of 194 patients completed 156 weeks of treatment (125 START patients and 63 SWITCH patients).

Then the study continued—and Sogroya® continued to show sustained growth for kids who were new to treatment and kids who switched to a once-weekly treatment.

From year 1 to year 3:

Children continuing on Sogroya® grew ~2.9 inches per year (7.4 cm), on average, at 3 years.

Children switching to Sogroya® grew ~3 inches per year (7.8 cm), on average, at 3 years.

Limitations: No statistical analyses of data were performed after 52 weeks of treatment. The observations after Week 52 are presented using descriptive statistics.

Sogroya® has a proven long-term safety profile

The most common side effects of Sogroya® in children include:

  • common cold
  • headache
  • fever
  • pain in extremity
  • reaction to injection

With three years of growth data now available from the extension phase, Sogroya® showed no additional side effects or injection-site reactions.

6.1% of children taking Sogroya® experienced injection-site reactions, which included:

 Injection icon

1.5% injection-site pain

1.5% injection-site bruising

1.5% injection-site hematoma

0.8% injection-site reaction

0.8% injection-site swelling

Talk to your child's doctor for medical advice about these and other possible side effects.

How to use Sogroya® for children

Use our helpful tools for learning how to take Sogroya®.

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Find out about support programs as you start your GH journey.

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Important Safety Information

Do not use Sogroya® if:

  • you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
  • you have cancer or other tumors
  • you are allergic to somapacitan-beco or any of the ingredients in Sogroya®
  • your healthcare provider tells you that you have certain types of eye problems caused by diabetes
  • 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 stopping breathing during sleep)

Before taking Sogroya®, tell your healthcare provider about all of your medical conditions, including if you:

  • have had heart or stomach surgery, trauma, or serious breathing problems
  • are taking replacement therapy with glucocorticoids
  • have had cancer or any tumor
  • have thyroid gland problems
  • have diabetes
  • have liver problems
  • have adrenal gland problems
  • are a child with a history of worsening of curvature of the spine (scoliosis)
  • are pregnant or plan to become pregnant. It is not known if Sogroya® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if Sogroya® passes into your breast milk. You and your healthcare provider should decide if you will take Sogroya® while you breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sogroya® may affect the way some medicines work, and some medicines may affect how Sogroya® works.

How should I use Sogroya®?

  • Use Sogroya® exactly as your healthcare provider tells you to
  • Use Sogroya® 1 time each week
  • 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® pens are for use by 1 person only
  • Do not share your Sogroya® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them

What are the possible side effects of Sogroya®?

Sogroya® may cause serious side effects, including:

  • high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing problems
  • 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. You 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 or diabetes. You or your child’s blood sugar may need to be monitored during treatment with Sogroya®
  • increase in pressure in the skull. 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: swelling of your face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness, or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, sweating
  • 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 have 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 you 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). This may lead to a serious condition where bone tissue dies due to lack of blood supply (osteonecrosis). Get medical help right away if your child develops a limp or has hip or knee pain
  • high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
  • increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. You 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, headache, fever, pain in extremity, and reaction to injection

The most common side effects of Sogroya® in adults include: back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils (tonsillitis), vomiting, high blood pressure, increase in the level of an enzyme in your blood called creatine phosphokinase, weight gain, and low red blood cells (anemia)

Please click here for Sogroya® Prescribing Information.

Sogroya® is a prescription medication. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is Sogroya®?

  • Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body.
  • It 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.

What is Sogroya®?

  • Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body.
  • It 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.

Show more Show less
Show more Show less

What is Sogroya®?

  • Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body.
  • It 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.

What is Sogroya®?

  • Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body.
  • It 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.

Important Safety Information

Do not use Sogroya® if:

  • you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
  • you have cancer or other tumors
  • you are allergic to somapacitan-beco or any of the ingredients in Sogroya®
  • your healthcare provider tells you that you have certain types of eye problems caused by diabetes
  • 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 stopping breathing during sleep)

Important Safety Information

Do not use Sogroya® if:

  • you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
  • you have cancer or other tumors
  • you are allergic to somapacitan-beco or any of the ingredients in Sogroya®
  • your healthcare provider tells you that you have certain types of eye problems caused by diabetes
  • 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 stopping breathing during sleep)

Before taking Sogroya®, tell your healthcare provider about all of your medical conditions, including if you:

  • have had heart or stomach surgery, trauma, or serious breathing problems
  • are taking replacement therapy with glucocorticoids
  • have had cancer or any tumor
  • have thyroid gland problems
  • have diabetes
  • have liver problems
  • have adrenal gland problems
  • are a child with a history of worsening of curvature of the spine (scoliosis)
  • are pregnant or plan to become pregnant. It is not known if Sogroya® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if Sogroya® passes into your breast milk. You and your healthcare provider should decide if you will take Sogroya® while you breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sogroya® may affect the way some medicines work, and some medicines may affect how Sogroya® works.

How should I use Sogroya®?

  • Use Sogroya® exactly as your healthcare provider tells you to
  • Use Sogroya® 1 time each week
  • 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® pens are for use by 1 person only
  • Do not share your Sogroya® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them

What are the possible side effects of Sogroya®?

Sogroya® may cause serious side effects, including:

  • high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing problems
  • 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. You 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 or diabetes. You or your child’s blood sugar may need to be monitored during treatment with Sogroya®
  • increase in pressure in the skull. 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: swelling of your face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness, or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, sweating
  • 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 have 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 you 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). This may lead to a serious condition where bone tissue dies due to lack of blood supply (osteonecrosis). Get medical help right away if your child develops a limp or has hip or knee pain
  • high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
  • increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. You 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, headache, fever, pain in extremity, and reaction to injection

The most common side effects of Sogroya® in adults include: back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils (tonsillitis), vomiting, high blood pressure, increase in the level of an enzyme in your blood called creatine phosphokinase, weight gain, and low red blood cells (anemia)

Please click here for Sogroya® Prescribing Information.

Sogroya® is a prescription medication. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information

Do not use Sogroya® if:

  • you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
  • you have cancer or other tumors
  • you are allergic to somapacitan-beco or any of the ingredients in Sogroya®
  • your healthcare provider tells you that you have certain types of eye problems caused by diabetes
  • 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 stopping breathing during sleep)

Before taking Sogroya®, tell your healthcare provider about all of your medical conditions, including if you:

  • have had heart or stomach surgery, trauma, or serious breathing problems
  • are taking replacement therapy with glucocorticoids
  • have had cancer or any tumor
  • have thyroid gland problems
  • have diabetes
  • have liver problems
  • have adrenal gland problems
  • are a child with a history of worsening of curvature of the spine (scoliosis)
  • are pregnant or plan to become pregnant. It is not known if Sogroya® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if Sogroya® passes into your breast milk. You and your healthcare provider should decide if you will take Sogroya® while you breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sogroya® may affect the way some medicines work, and some medicines may affect how Sogroya® works.

How should I use Sogroya®?

  • Use Sogroya® exactly as your healthcare provider tells you to
  • Use Sogroya® 1 time each week
  • 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® pens are for use by 1 person only
  • Do not share your Sogroya® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them

What are the possible side effects of Sogroya®?

Sogroya® may cause serious side effects, including:

  • high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing problems
  • 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. You 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 or diabetes. You or your child’s blood sugar may need to be monitored during treatment with Sogroya®
  • increase in pressure in the skull. 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: swelling of your face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness, or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, sweating
  • 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 have 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 you 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). This may lead to a serious condition where bone tissue dies due to lack of blood supply (osteonecrosis). Get medical help right away if your child develops a limp or has hip or knee pain
  • high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
  • increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. You 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, headache, fever, pain in extremity, and reaction to injection

The most common side effects of Sogroya® in adults include: back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils (tonsillitis), vomiting, high blood pressure, increase in the level of an enzyme in your blood called creatine phosphokinase, weight gain, and low red blood cells (anemia)

Please click here for Sogroya® Prescribing Information.

Sogroya® is a prescription medication. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is Sogroya®?

  • Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body.
  • It 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.

What is Sogroya®?

  • Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body.
  • It 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.

Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A.
Sogroya® is a registered trademark of Novo Nordisk Health Care AG.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
All other trademarks, registered or unregistered, are the property of their respective owners.

© 2025 Novo Nordisk All rights reserved. US25SOM00022 August 2025

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