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The following safety information outlines important risks and warnings associated with the use of somatropin injections, such as Omnitrope. Review these details carefully and consult with your healthcare provider if you have any questions or concerns.

• Increased Risk of Death in Critical Illness: Avoid using somatropin injections in individuals experiencing short-term critical illnesses due to open heart or abdominal surgery, severe injuries, or significant respiratory issues, as the medication can elevate the risk of death in these situations.

• Sudden Death in Children with Prader-Willi Syndrome: Somatropin injections should not be administered to children with Prader-Willi syndrome who are obese, have a history of airway obstruction, or an unknown respiratory infection, as there have been reports of sudden death in these cases. Children without these risk factors may use the medication but should maintain proper weight control, and caregivers should monitor for respiratory symptoms. Report any breathing difficulties or increased snoring to the healthcare provider immediately.

• Severe Allergic Reactions: There is a possibility of experiencing severe allergic reactions, including life-threatening anaphylaxis. Seek immediate medical attention if you experience dizziness, throat constriction, breathing difficulties, nausea, or swelling around the eyes, lips, or tongue after using the medication.

• Cancer Risks: Individuals with active tumors or cancer should not use somatropin injections. If you have a cancer history, your healthcare provider may closely monitor your condition, as the medication may increase the risk of new cancers. Report any behavioral changes, headaches, vision issues, or skin changes to your provider.

• High Blood Sugar and Diabetes Risk: Somatropin can increase blood sugar levels and the risk of developing diabetes, especially in those who are obese, have Turner syndrome, or a family history of diabetes. Regularly monitor your blood sugar if you are using this medication and consult your provider for any necessary adjustments to diabetes medications.

• Intracranial Hypertension: Some users may experience high blood pressure in the brain, leading to vision changes, headaches, nausea, and vomiting. These symptoms often occur within the first eight weeks of treatment. Contact your healthcare provider if you notice these symptoms, as they usually resolve upon discontinuation or dose adjustment of the medication.

• Fluid Retention and Swelling: The medication may cause fluid retention, leading to swelling in the arms and legs, muscle pain, or carpal tunnel syndrome. Inform your provider if you experience these symptoms; dose adjustments may be necessary.

• Low Cortisol Levels: Somatropin can reduce cortisol levels, particularly in individuals taking specific steroid hormones like prednisone. Monitor for symptoms of low cortisol and report concerns to your healthcare provider.

• Bone Issues in Children: The medication may cause a condition where the thigh bone slips out of position, particularly in rapidly growing children. Report any knee or hip pain or limping to your healthcare provider.

• Pancreatitis: Though rare, somatropin may cause pancreatitis, which involves painful inflammation of the pancreas. Symptoms include nausea, vomiting, and abdominal pain radiating to the back. Discontinue use and seek immediate medical help if you experience these symptoms.

Contraindications:

• Avoid use in cases of short-term critical illness due to surgery, serious injuries, or severe breathing problems.
• Do not use with active cancer or severe diabetic eye damage (retinopathy).
• Not suitable for children with Prader-Willi syndrome who are severely obese or have significant breathing issues.
• Not recommended for children who have completed their growth phase (closed epiphyses).

This medication may lead to a variety of side effects, ranging from mild to serious. Common side effects include headaches, nausea, vomiting, tiredness, muscle pain, and weakness. These symptoms are typically mild and may not require medical attention unless they persist or worsen. Additionally, some individuals may experience bruising, leg pain, or joint pain. Swelling in the arms and legs, and upper respiratory infections are also possible and should be monitored.

In some cases, more serious side effects can occur, necessitating prompt medical attention. These include persistent nausea or vomiting, unusual tiredness, unexplained weight gain, cold intolerance, irregular heartbeat, ear pain, hearing issues, or severe stomach/abdominal pain. Some users may also experience increased thirst or urination, swelling in the hands, ankles, or feet, and changes in moles. Symptoms like a tingling sensation, stiffness, and back pain should also be noted.

Particularly concerning are rare but severe side effects such as vision changes, seizures, and severe headaches, which require immediate medical intervention. In children with Prader-Willi syndrome, the drug may cause serious lung or breathing problems, which are especially concerning for those with sleep apnea or lung infections. Heavy snoring or irregular breathing during sleep should be reported immediately. Additionally, there is a risk of developing tumors or cancer, and any signs of lung infection, such as fever or cough, warrant prompt attention.

While a very serious allergic reaction to this medication is rare, symptoms such as rash, severe swelling, dizziness, or trouble breathing demand urgent medical care. This summary does not cover all possible side effects, so any new or worrying symptoms should be discussed with a healthcare provider.