Liquid Soliqua 100/33 Insulin Glargine And Lixisenatide Pen Injection

Adverse effects associated with the use of Soliqua 100/33 may include, but are not limited to, the following:

hypoglycemia
allergic reactions
nausea
nasopharyngitis
diarrhea
upper respiratory tract infection
headache
Dosing/Administration

Soliqua 100/33 is supplied as an injection for subcutaneous administration into the thigh, upper arm or abdomen. Lixisenatide or basal insulin should be discontinued prior to initiation of Soliqua 100/33. In patients inadequately controlled on less than 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. Soliqua 100/33 should be Injected once a day within the hour prior to the first meal of the day. The 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. Use alternative antidiabetic products if patients require a Soliqua 100/33 daily dosage below 15 units or over 60 units. Please see full prescribing information for titration recommendations.

Clinical Trial Results

The FDA approval of Soliqua was based on an insulin intensification study. Soliqua 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus with a majority of the 736 patients (55 percent versus 30 percent) achieving the American Diabetes Association target of less than 7 percent at 30 weeks. Subjects treated with Soliqua 100/33 experienced similar rates of documented (<70 mg/dL) hypoglycemia compared to Lantus-treated subjects.