(soe ma′ troe gon)

Brand Name(s): Ngenla^®

WHY is this medicine prescribed?

Somatrogon-ghla injection is used to replace growth hormone (a natural hormone produced by your body) and to increase growth in children 3 years of age or older with growth hormone deficiency. Somatrogon-ghla is a human growth hormone (hGH) analog. It works by replacing growth hormones that are normally produced in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Somatrogon-ghla comes as a solution (liquid) in a prefilled injection pen to be injected subcutaneously (under the skin). It is usually injected once a week, on the same day of the week, and at any time of the day. Follow the directions on the prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use somatrogon-ghla injection exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

The first dose of somatrogon-ghla injection may be given in a doctor's office. Your doctor may allow you or a caregiver to perform the injections at home. Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of somatrogon-ghla. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication. To help you remember to use somatrogon-ghla injection, mark a calendar to keep track of when you are to receive a dose.

You can inject somatrogon-ghla anywhere on the front of the thighs (upper leg), buttocks, upper arms, or on the stomach except around the navel (belly button) and the area 2 inches (5 centimeters) around it. Choose a different spot each time you inject your medication. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars.

Do not stop using somatrogon-ghla injection without talking to your doctor.

Always look at somatrogon-ghla solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless to slightly yellow. The liquid should not contain visible particles. Do not use a pen if it is expired or if the liquid is cloudy or contains particles.

Do not share pens and needles. Dispose of used pens and needles in a puncture resistant container that is out of the reach of children. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using somatrogon-ghla injection,

• tell your doctor and pharmacist if you are allergic to somatrogon-ghla, any other medications, or any of the ingredients in somatrogon-ghla injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have recently had heart or stomach surgery, an accident or trauma, or serious breathing problems, sleep apnea (stopping breathing for short periods of time during sleep), or if you have cancer, diabetic retinopathy (damage to the eyes caused by diabetes), or Prader-Willi syndrome (a genetic condition that can cause physical, mental and behavioral problems). Your doctor may tell you not to use somatrogon-ghla injection. Somatrogon-ghla should not be used in children whose growth plate has closed and whose bones are no longer growing (usually after puberty).

• tell your doctor if you have ever had cancer or if you have ever been treated with radiation therapy to the head or brain; or if you have or have ever had diabetes; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); pancreatitis (swelling of the pancreas); papilledema (swelling of the optic nerve caused by increased pressure in the brain); scoliosis (curving of the spine); high blood levels of phosphate; or thyroid or parathyroid problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using somatrogon-ghla injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Give the missed dose as soon as you remember it. However, if it is more than 3 days after the time you were supposed to use the dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

You may use a dose of somatrogon-ghla 3 days before or 3 days after your scheduled dosing day and then continue your regular dosing schedule; make sure that there are at least 3 days between doses.

What SIDE EFFECTS can this medicine cause?

Somatrogon-ghla injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• skin thickening at injection site
• injection site pain, redness, swelling, bleeding, or itching
• headache
• vomiting
• sore throat, cough, runny nose, fever, or other signs of infection
• ear pain
• stomach pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• vision changes, headache, nausea, and vomiting
• hives; rash; itching; difficulty breathing or swallowing; sweating; swelling of the eyes, face, mouth, lips, tongue or throat; hoarseness; lightheadedness; fainting; or chest pain
• ongoing pain that begins in the stomach area but may spread to the back nausea, vomiting, or loss of appetite
• fast heartbeat
• shortness of breath
• pale skin
• excessive tiredness, muscle or joint pain, weakness, or lightheadedness
• swelling of the hands, feet, ankles, or lower legs
• numbness, burning, tingling, or tingling in the hands, fingers, arms, legs, or feet
• fatigue, dizziness, weakness, vomiting, dehydration or weight loss
• new or persistent knee or hip pain, limping

Somatrogon-ghla may increase the risk of developing certain types of cancer, including brain or skin cancer. Call your doctor right away if you have any of the following symptoms: changes in behavior or vision; headaches; or changes in moles, birthmarks, or skin color.

Somatrogon-ghla may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store somatrogon-ghla pens in the refrigerator and protect from light. Do not freeze. Dispose of any medication that has been frozen. Make a note of the date you first use a somatrogon-ghla pen, and dispose of the pen after 28 days, even if there is some solution left in the pen.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• swelling of the hands, feet, ankles, or lower legs
• excessive sweating and body odor
• enlarged hands, feet, lips, nose, and tongue
• joint or muscle weakness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check the body's response to somatrogon-ghla injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using somatrogon-ghla injection. Somatrogon-ghla injection may interfere with the results of home pregnancy tests.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2023.