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Overview: Sogroya is an injection that is used to replace growth hormone when your body does not make enough. It works by producing the same effects as human growth hormone, which promotes normal growth and development in children and also helps regulate metabolism. Common side effects may include common cold symptoms, joint pain, upset stomach, and pain, itching, swelling, or redness near the injection site. Though less common, more serious side effects include fluid retention, high blood sugar, and hormone changes.

Uses

What is Sogroya used for?

Sogroya (somapacitan-beco) is commonly used for children who are not growing as expected (growth failure) due to their bodies not making enough growth hormone. This is also called growth hormone deficiency (GHD). 

Sogroya is also commonly used to treat growth hormone deficiency in adults.

Sogroya may also be used for other conditions as determined by your health care provider.

How does Sogroya work (mechanism of action)?

Sogroya acts like a natural hormone in your body called growth hormone. Children with growth hormone deficiency (GHD) do not make enough growth hormone. Sogroya acts similarly to the body's natural growth hormone to stimulate growth and promote normal development. In adults with GHD, Sogroya helps regulate metabolism and keep the bones, muscles, and tissues healthy.

How is Sogroya supplied (dosage forms)?

Brands and other names

  • Sogroya

Dosage forms and strengths

  • 5 mg/1.5 mL (3.3 mg/mL) prefilled pens
  • 10 mg/1.5 mL (6.7 mg/mL) prefilled pens
  • 15 mg/1.5 mL (10 mg/mL) prefilled pens

How should I store Sogroya?

Sogroya should be stored in a refrigerator, between 36 F and 46 F (2 C and 8 C). After you open it, Sogroya should be stored in the refrigerator for up to six weeks. Sogroya may be stored at room temperature, up to 77 F (25 C), for no more than three days. Do not use Sogroya that has been frozen or exposed to temperatures above 86 F (30 C). Store Sogroya in the original carton to protect it from light.

Side Effects

What are the most common side effects of Sogroya?

The most common side effects of Sogroya are listed below. These side effects may vary depending on your age. Tell your health care provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Headache
  • Fever
  • Pain, itching, swelling, or redness near the injection site 
  • Pain in your arms, legs, joints, or back
  • Upset stomach or vomiting
  • Sleep problems
  • Dizziness
  • Inflamed tonsils
  • Fluid retention (see below)
  • Reduced adrenal function (see below)
  • High blood pressure
  • Weight gain
  • Low levels of red blood cells (anemia)
  • Other changes in blood test results

There may be other side effects of Sogroya that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Sogroya?

While less common, the most serious side effects of Sogroya are described below, along with what to do if they happen.

Severe Allergic Reactions. Sogroya may cause allergic reactions, which can be serious. Stop using Sogroya and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Cancer. Sogroya may cause a new cancer to develop or cause a previously treated cancer to return, especially if you got radiation therapy to your brain or head. Tell your health care provider about any new symptoms that you may get, including any of the following.

  • New headaches
  • Vision changes
  • Skin color changes or changes in how moles or birthmarks look
  • Behavior changes

Fluid Retention (Edema). Sogroya can cause fluid retention, also called edema. The extra fluid commonly causes swelling in your arms, legs, feet, or ankles. Fluid retention can also cause serious issues in people with certain conditions, such as heart failure or kidney problems. Call your health care provider right away if you have any of the following symptoms.

  • Shortness of breath
  • Stretched or shiny skin
  • Stiffness or swollen body parts, such as the belly or ankles
  • Muscle or joint pain
  • Nerve pain
  • Wrist pain or swelling

High Blood Sugar. Sogroya may affect the way your body uses sugar. This can increase your blood sugar levels and may lead to or worsen diabetes. Talk to your health care provider about how to maintain healthy blood sugar levels. Keep all appointments to check your blood work. Call your health care provider if you have the following symptoms of high blood sugar.

  • More thirsty or hungry than usual
  • Peeing more than usual
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Increased Pressure Around the Brain. Sogroya may increase pressure around the brain, which can be serious and lead to brain damage. Stop using Sogroya and call your health care provider right away if you have any of the following symptoms.

  • Blurry vision or other vision changes
  • Dizziness
  • Nausea and vomiting
  • Headache

Low Thyroid Hormones (Hypothyroidism). Sogroya can cause the function of your thyroid gland to change, which can lead to low thyroid levels. Keep all appointments for blood work. Tell your health care provider if you have any of the following signs of low thyroid hormones.

  • Weight gain
  • Feeling cold 
  • Tiredness that does not go away or continues to worsen
  • Constipation

Reduced Adrenal Function. Sogroya can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency, and it can get worse if your body is under stress because of fever, surgery, or trauma. Tell your health care provider if you have any of the following symptoms.

  • Weakness, tiredness, or lack of energy
  • Low blood pressure or dizziness
  • Nausea, vomiting, or weight loss

Inflamed Pancreas (Pancreatitis). Sogroya may cause inflammation of the pancreas, which is called pancreatitis. This risk may be higher in children. Stop using Sogroya and call your health care provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.

Hip Socket Problem (Children). Sogroya is used to help certain children grow. Growing very quickly can weaken the growth plate (the area of a bone that is still growing) in your thigh bone, which can lead to a problem called slipped capital femoral epiphysis. Call your health care provider right away if you have pain in your hip or knee, trouble walking, or are limping.

Warnings & Precautions

Who should not use Sogroya?

Allergies to Ingredients. People who are allergic to any of the following should not use Sogroya.

  • Sogroya
  • Somapacitan
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Sogroya.

Diabetic Retinopathy. People who have certain types of diabetic retinopathy, which is an eye problem caused by diabetes, should not use Sogroya. The medicine could make this eye problem worse. 

Closed Bone Growth Plates. Sogroya should not be used to increase height in children who have closed bone growth plates, also known as closed epiphyses. This means their bones have stopped growing. 

Certain Children With Prader-Willi Syndrome. Children with an inherited disorder called Prader-Willi syndrome should not use Sogroya if they also have obesity or breathing problems, such as asthma or sleep apnea.

Cancer. People who have cancer or a tumor should not use Sogroya. This medicine could make the cancer grow or spread faster. Tell your health care provider about any current or previous cancers you have had.

Critical Illness. Sogroya should not be used by people who have a critical illness due to breathing problems, severe injuries, or certain surgeries, such as open heart surgery or stomach surgery.

What should I know about Sogroya before using it?

Do not use Sogroya unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Sogroya with other people, even if they have the same condition as you. It may harm them. Do not share needles, syringes, or devices, as this can spread infections.

Keep Sogroya out of the reach of children. Since this medicine should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Keep all appointments for blood work and other tests. Your health care provider needs these results to help you use this medicine safely.

This medicine is injected under the skin (subcutaneously). Make sure that you or a caregiver understands how to properly prepare, use, and throw away Sogroya. Read and follow the instructions for the product before using it. If you have any questions, talk to your health care provider.

Do not inject your medicine in the same spot each time. You should rotate the spots where you use this medicine. If you inject it in the same spot every time, you may get a condition called lipoatrophy. This is where you lose fat under the skin and your skin may look sunken in this spot. Consider writing down or taking a picture of the exact spot where you injected your last dose to help you remember. 

What should I tell my health care provider before using Sogroya?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Sogroya is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Cancer or a tumor
  • High blood sugar, diabetes, or a family history of diabetes
  • Severe illness or injury
  • Liver problems
  • Heart, stomach, or breathing problems
  • Problems with your adrenal glands
  • Thyroid problems
  • A curved spine (scoliosis)

Surgery. Using Sogroya may raise the risk of serious problems during or after certain surgeries, such as heart or stomach surgery. Tell your health care provider if you recently had surgery or are planning to have surgery. They may recommend that you wait until after the surgery is over to start Sogroya treatment.

Other Medicines and Supplements. Sogroya may interact with other medicines and supplements. Before using Sogroya, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Sogroya could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Sogroya passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Sogroya while breastfeeding.

How can I get more information about Sogroya?

For more information about Sogroya, you can visit the drugmaker’s website at www.sogroya.com or call them at 800-727-6500.

Interactions

Does Sogroya interact with foods or drinks?

There are no known interactions between Sogroya and foods or drinks.

It is unknown if drinking alcohol will affect Sogroya.

Does Sogroya interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Sogroya.

  • A corticosteroid, such as cortisone or prednisone, which is a medicine for adrenal gland problems or certain inflammatory conditions
  • A medicine that you take by mouth that contains estrogen, such as certain birth control pills
  • Any medicine for diabetes

Sogroya may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently used.

This may not be a complete list of medicines that can interact with Sogroya. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Sogroya?

If you or someone else has used too much Sogroya, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Sogroya?

If you miss a dose, use it as soon as possible as long as it is within three days (72 hours) of your scheduled dose. Then continue your regular dosage schedule. If it has been more than three days, skip the missed dose and only use the next dose at the regularly scheduled time. Do not use double or extra doses.

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