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This document provides essential safety information and warnings associated with the use of Ngenla (somatrogon). Please review the details carefully and consult your healthcare provider if you have any questions or concerns.

• Increased Mortality Risk with Critical Illness: Patients with serious conditions like recent open heart or stomach surgery, significant injuries, or severe respiratory issues may experience a heightened risk of death when using growth hormone treatments similar to Ngenla. It is crucial to discuss any concerns with your child’s endocrinologist.

• Severe Allergic Reactions: Growth hormone treatments like Ngenla have been linked to severe allergic responses, potentially life-threatening ones such as anaphylaxis. If your child experiences symptoms such as dizziness, a choking sensation, nausea, swelling around the eyes, lips or tongue, or difficulty breathing, seek medical help immediately.

• Cancer Risk: Ngenla should not be administered to individuals with active tumors or cancer. Those with a history of cancer should inform their endocrinologist, as growth hormone therapy may increase cancer risk. Continuous monitoring will be conducted to detect any signs of cancer development.

• Hyperglycemia: Ngenla may decrease insulin sensitivity, potentially leading to elevated blood sugar levels and an increased risk of diabetes. Be vigilant for signs of high blood sugar, including excessive thirst, frequent urination, and fatigue. Contact your healthcare provider if these symptoms arise.

• Intracranial Hypertension: Rarely, medications like Ngenla can cause high blood pressure within the brain’s blood vessels, leading to vision changes, headaches, nausea, and vomiting. These symptoms generally appear within two months of starting treatment. Regular examinations will be scheduled to monitor this risk.

• Fluid Retention and Swelling: Ngenla may cause fluid accumulation in the body, resulting in swelling, joint and muscle pain, and nerve compression issues such as carpal tunnel syndrome. Notify your endocrinologist if symptoms such as swelling in the limbs, shortness of breath, or rapid weight gain occur.

• Low Cortisol Levels: This medication may reduce cortisol levels, impacting blood sugar, blood pressure, and inflammation control. Report symptoms like weakness, fatigue, appetite loss, dizziness, or mood changes to your child’s endocrinologist.

• Bone Issues: In children, Ngenla may cause slipped capital femoral epiphysis, a condition where the thigh bone slips out of the hip socket. Watch for limping or hip and knee pain, and contact your healthcare provider if these symptoms develop.

• Pancreatitis: Rare occurrences of pancreatitis, or inflammation of the pancreas, have been associated with similar medications. Children may be at a higher risk. Seek medical advice if sudden, severe abdominal pain arises.

• Sudden Death in Prader-Willi Syndrome: Ngenla should not be used in children with Prader-Willi syndrome who also have obesity, obstructed airways, sleep apnea, or unidentified respiratory infections due to the risk of sudden death.

Contraindications: Ngenla should not be used in individuals with the following conditions:

• Short-term critical illness due to surgery, severe injuries, or respiratory problems.
• Children who have completed growth (closed growth plates).
• Current cancer diagnosis.
• Severe diabetic eye disease (diabetic retinopathy).
• Prader-Willi syndrome with obesity or severe respiratory issues, including sleep apnea.

If any of these conditions apply, consult your healthcare provider before using Ngenla.

When using this medication, you might experience some common side effects, which are usually mild and manageable. These include reactions at the injection site such as pain, redness, itching, swelling, or thickening of the skin. In addition, you might notice symptoms similar to a common cold, such as cough, runny or stuffy nose, and sore throat. Headaches, fever, nausea, vomiting, joint or muscle pain, and low red blood cell count are also possible. Some users report low thyroid hormone levels, stomach pain, rash, and mouth or throat pain. If these effects persist or worsen, it is advisable to consult with a healthcare provider.

There are other side effects that, while less common, should be monitored. These include joint pain, ear infections, swollen tonsils, and bronchitis. If you notice any of these, particularly if they are severe, it's important to reach out to a healthcare professional for advice.

Serious side effects, although rare, require immediate medical attention. These include signs of a serious allergic reaction such as rash, itching, swelling (particularly of the face, tongue, or throat), severe dizziness, and trouble breathing. High blood pressure in the brain can manifest as changes in vision, severe headaches, nausea, and vomiting. Additionally, swelling of the pancreas may cause severe abdominal pain that radiates to the back. There is also a risk of developing new tumors or cancer, especially in children who have undergone brain or head radiation treatments. If you experience unusual behavior changes, vision problems, severe headache, changes in skin color, or alterations in the appearance or size of a mole, seek urgent medical care.