The FDA has approved once-daily Soliqua 100/33 (insulin glargine and lixisenatide injection) (Sanofi, Paris, France), a new combination therapy for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin or lixisenatide.

Indications: Soliqua 100/33 is a combination of a long-acting human insulin analog with 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 (<60 units daily) or lixisenatide.

Dosage and administration:

• Discontinue therapy with lixisenatide or basal insulin prior to initiation of Soliqua 100/33.

• In patients inadequately controlled on <30 units of basal insulin or on lixisenatide, the starting dosage is 15 units (15 units insulin glargine/5 mcg lixisenatide) given subcutaneously once daily.

• In patients inadequately controlled on 30 to 60 units of basal insulin, the starting dosage is 30 units (30 units insulin glargine/10 mcg lixisenatide) given subcutaneously once daily.

• Inject once a day within the hour prior to the first meal of the day.

• Maximum daily dosage is 60 units (60 units of insulin glargine and 20 mcg of lixisenatide).

• Soliqua 100/33 pen delivers doses from 15 to 60 units with each injection.

Adverse reactions: Adverse reactions associated with Soliqua 100/33 include hypoglycemia, allergic reactions, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.

Citation: Sanofi receives FDA approval of Soliqua 100/33 for the treatment of adults with type 2 diabetes. [news release]. Paris, France: Sanofi; November 21, 2016: http://mediaroom.sanofi.com/sanofi-receives-fda-approval-of-soliqua-10033-for-the-treatment-of-adults-with-type-2-diabetes/. Accessed November 22, 2016.