2 DOSAGE AND ADMINISTRATION

2.1 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)].

2.2 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.

Table 1: Units of Insulin Glargine and Micrograms of Lixisenatide in Each Dosage of SOLIQUA 100/33
SOLIQUA 100/33 (dose window display)*	Insulin glargine component dose	Lixisenatide component dose	Comment
* The dose window on the SOLIQUA 100/33 pen displays numbers for the even units and displays lines for the odd units.
2	---	---	Safety test dose – not for injection

15	15 units	5 mcg	Recommended starting dosage for patients naive to basal insulin or GLP-1 receptor agonist, currently on GLP-1 receptor agonist, or currently on less than 30 units of basal insulin daily
16	16 units	5.3 mcg
17	17 units	5.7 mcg
18	18 units	6 mcg
19	19 units	6.3 mcg
20	20 units	6.7 mcg
21	21 units	7 mcg
22	22 units	7.3 mcg
23	23 units	7.7 mcg
24	24 units	8 mcg
25	25 units	8.3 mcg
26	26 units	8.7 mcg
27	27 units	9 mcg
28	28 units	9.3 mcg
29	29 units	9.7 mcg
30	30 units	10 mcg	Recommended starting dosage for patients currently on 30 to 60 units of basal insulin daily, with or without a GLP-1 receptor agonist:
31	31 units	10.3 mcg
32	32 units	10.7 mcg
33	33 units	11 mcg
34	34 units	11.3 mcg
35	35 units	11.7 mcg
36	36 units	12 mcg
37	37 units	12.3 mcg
38	38 units	12.7 mcg
39	39 units	13 mcg
40	40 units	13.3 mcg
41	41 units	13.7 mcg
42	42 units	14 mcg
43	43 units	14.3 mcg
44	44 units	14.7 mcg
45	45 units	15 mcg
46	46 units	15.3 mcg
47	47 units	15.7 mcg
48	48 units	16 mcg
49	49 units	16.3 mcg
50	50 units	16.7 mcg
51	51 units	17 mcg
52	52 units	17.3 mcg
53	53 units	17.7 mcg
54	54 units	18 mcg
55	55 units	18.3 mcg
56	56 units	18.7 mcg
57	57 units	19 mcg
58	58 units	19.3 mcg
59	59 units	19.7 mcg
60	60 units	20 mcg	Maximum daily dosage [see Warnings and Precautions (5.5)]

2.3 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)].

Table 2: Recommended Titration of SOLIQUA 100/33 (Every Week)*
Self-Monitored Fasting Plasma Glucose	SOLIQUA 100/33 Dosage Adjustment
* The recommended SOLIQUA 100/33 dosage is between 15 to 60 units (see Table 1).
Above target range	+2 units (2 units of insulin glargine and 0.66 mcg of lixisenatide) to +4 units (4 units of insulin glargine and 1.32 mcg of lixisenatide)
Within target range	0 units
Below target range	-2 units (2 units of insulin glargine and 0.66 mcg of lixisenatide) to -4 units (4 units of insulin glargine and 1.32 mcg of lixisenatide)

2.4 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.

2.5 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.