Insulin Overdose

10 OVERDOSAGE Hypoglycemia (from insulin and liraglutide) and gastrointestinal adverse reactions (from liraglutide) may develop if a patient is dosed with more XULTOPHY 100/3.6 than required.

An excess of insulin-containing products like XULTOPHY 100/3.6 relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.6 , 5.10 )] .

Mild episodes of hypoglycemia usually can be treated with oral glucose.

Lowering the drug dosage, and adjustments in meal patterns, or exercise may be needed.

More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon for emergency use or concentrated intravenous glucose.

After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia.

Hypokalemia must be corrected appropriately.

Overdoses have been reported in clinical trials and postmarketing use of liraglutide, one of the components of XULTOPHY 100/3.6.

Effects have included severe nausea and severe vomiting.

In the event of overdosage, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Initiate appropriate supportive treatment according to the patient’s clinical signs and symptoms.