Important Dosage Information

• SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide.
• Administer SOLIQUA 100/33 subcutaneously once a day within the hour prior to the first meal of the day.
• The SOLIQUA 100/33 pen delivers doses from 15 to 60 units in a single injection. Table 1 presents the units of insulin glargine and the micrograms of lixisenatide in each dosage of SOLIQUA 100/33 [see Dosage and Administration (2.2)].
• The maximum dose of SOLIQUA 100/33 is 60 units daily (60 units insulin glargine and 20 mcg lixisenatide) [see Warnings and Precautions (5.5)].

Recommended Starting Dose

In patients naive to basal insulin or to a GLP-1 receptor agonist, currently on a GLP-1 receptor agonist or currently on less than 30 units of basal insulin daily:

• Discontinue therapy with basal insulin or a GLP-1 receptor agonist prior to initiation of SOLIQUA 100/33.
• The recommended starting dosage of SOLIQUA 100/33 is 15 units (15 units insulin glargine and 5 mcg lixisenatide) given subcutaneously once daily.

In patients currently on 30 to 60 units of basal insulin daily, with or without a GLP-1 receptor agonist:

• Discontinue therapy with basal insulin or GLP-1 receptor agonist prior to initiation of SOLIQUA 100/33.
• The recommended starting dosage of SOLIQUA 100/33 is 30 units (30 units insulin glargine and 10 mcg lixisenatide) given subcutaneously once daily.

Titration of SOLIQUA 100/33

• After starting with the recommended dosage of SOLIQUA 100/33, [see Dosage and Administration (2.2)], titrate the dosage upwards or downwards by two to four units (see Table 2) every week based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal until the desired fasting plasma glucose is achieved.
• To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be needed with changes in physical activity, meal patterns (i.e., macronutrient content or timing of food intake), or renal or hepatic function; during acute illness; or when used with other medications [see Warnings and Precautions (5.4) and Drug Interactions (7)].

Missed Doses

Instruct patients who miss a dose of SOLIQUA 100/33 to resume the once-daily regimen as prescribed with the next scheduled dose. Do not administer an extra dose or increase the dose to make up for the missed dose.

Important Administration Instructions

• The SOLIQUA 100/33 prefilled pen is for single-patient-use only [see Warnings and Precautions (5.3)].
• Train patients on proper use and injection technique before initiating SOLIQUA 100/33.
• Always check the SOLIQUA 100/33 label before administration [see Warnings and Precautions (5.5)].
• Visually inspect for particulate matter and discoloration prior to administration. Only use SOLIQUA 100/33 if the solution is clear and colorless to almost colorless.
• Inject SOLIQUA 100/33 subcutaneously into the abdominal area, thigh, or upper arm.
• Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2), Adverse Reactions (6)].
• During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.4)].
• Do not administer intravenously or via an insulin pump.
• Use SOLIQUA 100/33 with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
• The SOLIQUA 100/33 pen dials in 1-unit increments.
• Do not dilute or mix SOLIQUA 100/33 with any other insulin or solution.
• Do not split the dose of SOLIQUA 100/33.