What is the generic name?

(INSULIN DEGLUDEC AND LIRAGLUTIDE)

What is the Trade Name for (INSULIN DEGLUDEC AND LIRAGLUTIDE)?

Xultophy 100/3.6

What are the Indications for (INSULIN DEGLUDEC AND LIRAGLUTIDE)?

• 1 INDICATIONS AND USAGE XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: ‚Ä¢ XULTOPHY 100/3.6 is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans [see Warnings and Precautions ( 5.1 )] . ‚Ä¢ XULTOPHY 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor agonist [see Warnings and Precautions ( 5.5 )]. ‚Ä¢ XULTOPHY 100/3.6 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. ‚Ä¢ XULTOPHY 100/3.6 has not been studied in combination with prandial insulin. XULTOPHY 100/3.6 is a combination of insulin degludec, a long-acting human insulin analog, and liraglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ( 1 ): ‚Ä¢ Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. ‚Ä¢ Not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor agonist. ‚Ä¢ Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ‚Ä¢ Has not been studied in combination with prandial insulin.

References: https://open.fda.gov/