The FDA has approved Xultophy 100/3.6 (insulin degludec and liraglutide injection) (Novo Nordisk, Plainsboro, NJ), a new combination therapy for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin or liraglutide.

Indications: 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 inadequately controlled on basal insulin (<50 units daily) or liraglutide (≤1.8 mg daily).

Dosage and administration:

• Discontinue therapy with liraglutide or basal insulin prior to initiation of Xultophy 100/3.6.

• Recommended starting dosage is 16 units (16 units of insulin degludec and 0.58 mg of liraglutide) given subcutaneously once daily.

• Administer once daily at same time each day with or without food.

• Maximum daily dosage is 50 units (50 units of insulin degludec and 1.8 mg of liraglutide).

• Xultophy 100/3.6 pen delivers doses from 10 to 50 units with each injection; each Xultophy 100/3.6 dosage unit contains 1 unit of insulin degludec and 0.036 mg of liraglutide.

Adverse reactions: Adverse reactions associated with Xultophy 100/3.6 include hypoglycemia, allergic reactions, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.

Citation: Novo Nordisk receives FDA approval for Xultophy® 100/3.6 (insulin degludec and liraglutide injection). [news release]. Plainsboro, NJ: Novo Nordisk; November 21, 2016: http://press.novonordisk-us.com/2016-11-21-Novo-Nordisk-Receives-FDA-Approval-for-Xultophy-100-3-6-insulin-degludec-and-liraglutide-injection. Accessed November 22, 2016.