SymlinPen

BOXED WARNING

Quoted from the FDA label

Quoted in full from the FDA product label.

WARNING: SEVERE HYPOGLYCEMIA SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk. WARNING: SEVERE HYPOGLYCEMIA See full prescribing information for complete boxed warning. • SYMLIN use with insulin has been associated with an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes. • Hypoglycemia risk may be reduced by appropriate patient selection, careful patient instruction, and insulin dose reduction (5.1 , 5.2) .

INDICATIONS AND USAGE

Quoted from the FDA label

1 INDICATIONS AND USAGE SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy (1) .

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