Maximum Dose for Soliqua 100-33 Pen
The Soliqua (insulin glargine/lixisenatide) 100-33 pen has a maximum single injection dose of 60 units of insulin glargine (which corresponds to 20 mcg of lixisenatide), as this is the standard maximum for this fixed-ratio combination pen device. 1
Understanding the 100-33 Formulation
The 100-33 designation means:
- 100 units/mL of insulin glargine
- 33 mcg/mL of lixisenatide
- This creates a 3:1 fixed ratio (every 3 units of insulin glargine delivers 1 mcg of lixisenatide) 1
Maximum Dosing Specifications
The pen delivers doses from 10 to 60 units of insulin glargine in single-unit increments, which translates to 3.3 to 20 mcg of lixisenatide per injection. 1
- If a patient requires more than 60 units of basal insulin daily, the Soliqua 100-33 formulation is not appropriate 1
- For patients requiring higher insulin doses (above 60 units), alternative treatment strategies must be considered, such as switching to basal insulin alone or using a basal-bolus regimen 1, 2
Clinical Context for Dosing
The maximum 60-unit dose was established in clinical trials where:
- Patients were titrated to achieve fasting plasma glucose <100 mg/dL (<5.6 mmol/L) 3
- Mean final insulin doses in the LixiLan-O trial reached approximately 40 units daily 3
- The 60-unit maximum provides adequate dosing range for most patients with type 2 diabetes inadequately controlled on oral agents 3
Important Safety Considerations
Never attempt to extract insulin from the pen with a syringe or split doses between multiple pens, as this would disrupt the fixed ratio and lead to incorrect dosing of both components. 4
- The pen must be primed before each injection to ensure proper flow (observe at least one drop at needle tip) 4
- Each pen contains 300 units total of insulin glargine, allowing for multiple injections until depleted 4
- Doses are selected by turning the dose selector; the maximum it will allow is 80 units on the dial, but for the 100-33 formulation specifically, clinical guidelines limit use to 60 units maximum 1, 4
When Maximum Dose is Insufficient
If glycemic targets are not met at the 60-unit maximum:
- Consider switching to separate basal insulin (which can be titrated higher) plus a GLP-1 RA 1, 2
- Alternatively, advance to a basal-bolus insulin regimen, though this increases injection burden and hypoglycemia risk 2
- The fixed-ratio combination becomes impractical when insulin requirements exceed the lixisenatide dose that would be co-administered 1