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The following safety information outlines important warnings and precautions associated with the use of Lyumjev (insulin lispro). Please read carefully and discuss any concerns with your healthcare provider.

• Infection Risk from Shared Injection Supplies: Never share Lyumjev pens, syringes, needles, or cartridges. Sharing can lead to the transmission of serious infections.

• Blood Sugar Level Fluctuations: Changes in your insulin regimen, such as altering the injection site or switching insulin types, may result in high or low blood sugar levels. Repeated injections into areas with skin abnormalities can also cause elevated blood sugar. Risk factors include dietary or exercise modifications, transitioning from other insulin types, alcohol consumption, concurrent diabetes medications, and liver or kidney issues.

• Hypoglycemia (Low Blood Sugar): Using Lyumjev alone or with other diabetes medications may significantly lower blood sugar, posing life-threatening risks. It is crucial to verify all medication labels to ensure correct dosing, particularly when using multiple insulin types. Risk factors include dietary or exercise changes, alcohol use, and other diabetes medications.

• Hypokalemia (Low Blood Potassium): Lyumjev may reduce potassium levels, which can be hazardous. This risk is heightened if you are on potassium-lowering medications like certain diuretics. Regular monitoring of potassium levels is necessary, and symptoms such as weakness or abnormal heartbeats should be reported to your healthcare provider.

• Fluid Retention and Heart Failure Risk: Combining Lyumjev with glitazones (e.g., pioglitazone) can result in fluid retention, exacerbating or leading to heart failure. Notify your healthcare provider of sudden weight gain or heart failure symptoms like difficulty breathing or fatigue.

• High Blood Sugar and Ketoacidosis with Insulin Pump Use: If using an insulin pump, ensure it functions correctly to prevent dangerously high blood sugar or ketoacidosis. Seek immediate medical advice if the pump malfunctions and alternative administration methods may be necessary. Symptoms of ketoacidosis include fatigue, fruity breath, or vomiting.

Contraindications: Avoid using Lyumjev if you have symptoms of low blood sugar (hypoglycemia) as it can present significant health risks. Always consult with your healthcare provider if you suspect this condition or any other concerns arise.

When using this medication, some individuals may experience common side effects such as a runny nose or common cold, upper respiratory tract infections, and urinary tract infections. These side effects are generally mild, but if they persist or worsen, it's important to consult your healthcare provider. Additionally, low blood sugar can occur, particularly if meals are skipped or during intense physical activity. Symptoms of low blood sugar include sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling of the hands and feet. To manage these symptoms, consuming a fast source of sugar is recommended.

Injection site reactions, such as pain, redness, and irritation, are also common and typically not severe. However, if you notice lumps or thickened skin at the injection site, contact your healthcare provider. Weight gain has been reported by some users and should be monitored.

Serious side effects, though rare, require immediate medical attention. These include signs of low potassium, such as muscle cramps, weakness, and irregular heartbeat, or symptoms of high blood sugar, like increased thirst and urination. Severe allergic reactions are also rare but warrant urgent care if symptoms like rash, itching, swelling, severe dizziness, or difficulty breathing occur. Always discuss any side effects you experience with your healthcare provider for further guidance.