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Overview: Ngenla is an injection that is used to treat growth hormone deficiency in children. It acts like a natural hormone in your body that promotes growth and development. Common side effects include pain, swelling, or other side effects where it is injected, common cold symptoms, and headache. Though less common, more serious side effects may include fluid retention, high blood sugar, or hormone changes.

Uses

What is Ngenla used for?

Ngenla (somatrogon-ghla) is commonly used for children who are not growing as expected (growth failure) due to their bodies not making enough growth hormone. This condition is called growth hormone deficiency (GHD). 

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

How does Ngenla work (mechanism of action)?

Ngenla acts like a natural hormone in your body called growth hormone. Children with growth hormone deficiency (GHD) do not make enough growth hormone. Ngenla acts similarly to the body's natural growth hormone to stimulate growth and development.

How is Ngenla supplied (dosage forms)?

Brands and other names

  • Ngenla

Dosage forms and strengths

  • 24 mg/1.2 mL (20 mg/mL) prefilled pens
  • 60 mg/1.2 mL (50 mg/mL) prefilled pens

How should I store Ngenla?

Ngenla should be stored in a refrigerator, between 36 F and 46 F (2 C and 8 C). After you open it, Ngenla should be stored in the refrigerator for up to 28 days. Before using a dose, Ngenla may be stored at room temperature for up to 30 minutes to make the injection more comfortable. Do not use Ngenla that has been frozen, exposed to heat or direct sunlight, or has been open for more than 28 days.

Side Effects

What are the most common side effects of Ngenla?

The most common side effects of Ngenla are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, or redness near the injection site 
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Headache
  • Fever
  • Low levels of red blood cells (anemia)
  • Cough
  • Vomiting or stomach pain
  • Low thyroid hormones (see below)
  • Rash

There may be other side effects of Ngenla 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 Ngenla?

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

Severe Allergic Reactions. Ngenla may cause allergic reactions, which can be serious. Stop using Ngenla 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. Ngenla 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). Ngenla 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, or numbness in your hands 

High Blood Sugar. Ngenla 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. Ngenla may increase pressure around the brain, which can be serious and lead to brain damage. Stop using Ngenla 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). Ngenla 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. Ngenla 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). Ngenla may cause inflammation of the pancreas, which is called pancreatitis. This risk may be higher in children. Stop using Ngenla 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. Ngenla 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 Ngenla?

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

  • Somatrogon
  • Ngenla
  • Any of the ingredients in the specific product dispensed

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

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

Closed Bone Growth Plates. Ngenla 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 Ngenla if they also have obesity or breathing problems, such as asthma or sleep apnea.

Cancer. People who currently have cancer or a tumor should not use Ngenla. 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. Ngenla 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 Ngenla before using it?

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

Do not share Ngenla 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 Ngenla 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 Ngenla. Read and follow the instructions for the product before using it. If you have any questions, talk to your health care provider.

Rotate the site for each injection of Ngenla. Do not inject it in the same spot each time because this may lead to 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.

Ngenla may affect the results of certain lab tests. Tell all of your health care providers that you are taking this medicine before any lab tests.

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

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 Ngenla 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 or kidney problems
  • A curved spine (scoliosis)
  • Breathing problems, such as sleep apnea
  • Problems with your adrenal glands
  • Thyroid problems

Surgery. Using Ngenla 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 have recently had surgery are planning to have surgery. They may recommend that you wait until after the surgery is over to start Ngenla treatment.

Other Medicines and Supplements. Ngenla may interact with other medicines and supplements. Before using Ngenla, 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 Ngenla 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 Ngenla 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 Ngenla while breastfeeding.

How can I get more information about Ngenla?

For more information about Ngenla, you can visit the drugmaker’s website at www.ngenla.com or call them at 800-879-3477.

Interactions

Does Ngenla interact with foods or drinks?

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

It is unknown if drinking alcohol will affect Ngenla.

Does Ngenla 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 Ngenla.

  • 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

Ngenla 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 Ngenla. 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 Ngenla?

If you or someone else has used too much Ngenla, 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 Ngenla?

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