Usual Adult Dose for Diabetes Type 1

Dose should be individualized: Must be used concomitantly with shorter acting (i.e., prandial/bolus) insulin

Insulin glargine 100 units/mL (U-100):

• Initial dose: Approximately one-third total daily insulin requirement subcutaneously once a day
• Maintenance dose: Individualize and adjust dose according to metabolic needs, blood glucose measurements, and glycemic goals

Insulin glargine 300 units/mL (U-300):

• Initial dose: Approximately one-third to one-half total daily insulin requirement subcutaneously once a day; maximum glucose lowering effect may take 5 days to fully manifest and the first dose may be insufficient to cover metabolic needs during the first 24 hour; monitor closely
• Maintenance dose: Individualize and adjust dose according to metabolic needs, blood glucose measurements, and glycemic goals; dose titration should occur no more frequently than every 3 to 4 days due to the longer time to achieve steady-state

DOSE-CONVERSION Between U-100 and U-300:

• Switching from U-100 to U-300: Initiate U-300 at same dose; expect a higher daily dose of U-300 will be needed to maintain same level of glycemic control
• Switching from U-300 to U-100: Initial U-100 dose should be 80% of the U-300 dose to reduce the risk of hypoglycemia

DOSE-CONVERSIONS From Intermediate or Long-Acting Insulins to Insulin Glargine:

• Switching from a once-daily intermediate or long-acting insulin to U-100: The U-100 dose may need to be adjusted; the amount and timing of the shorter-acting insulins may need to be adjusted
• Switching from a once-daily intermediate or long-acting insulin to U-300: Initiate U-300 dose at same dose
• Switching from twice-daily long or intermediate-acting insulin (e.g., insulin detemir, NPH): Initiate U-300 at 80% of the total daily twice-daily long or intermediate-acting insulin
• Switching from once-daily NPH to U-100: Initiate U-100 dose at same dose
• Switching from twice-daily NPH to U-100: Initiate U-100 dose at 80% of total NPH dose

Maintenance doses: Once the switch is made, doses should be adjusted as described above for maintenance doses

Comments:

• Dose adjustments may be needed with changes in physical activity, changes in meal patterns, during acute illness, or with changes in renal or hepatic function.
• In a basal-bolus regimen, insulin glargine (basal insulin) provides approximately one-third to one-half of the total daily insulin requirement while pre-meal insulin (i.e., short-acting [bolus] insulin) should be used to satisfy the remainder of the daily insulin requirement.
• Changing insulin, insulin concentrations, and regimens should be done cautiously while closely monitoring blood glucose; dose adjustments to short-acting insulin may be needed during transition periods.
• During clinical trials, patients receiving insulin glargine U-300 required 17.5% greater dose than patients treated with insulin glargine U-100.

Use: To improve glycemic control in patients with type 1 diabetes mellitus.

Usual Adult Dose for Diabetes Type 2

Dose should be individualized based on clinical response

Insulin-naive:

• Initial dose U-100 (100 units/mL): 0.2 units/kg (up to 10 units) subcutaneously once a day
• Initial dose U-300 (300 units/mL): 0.2 units/kg subcutaneously once a day
• Maintenance dose: Dose should be adjusted according to metabolic needs, blood glucose measurements, and glycemic goals

Special considerations for insulin glargine U-300 insulin:

• Maximum glucose lowering effect may take 5 days to fully manifest and the first dose may be insufficient to cover metabolic needs during the first 24 hour; monitor closely
• Dose titration should occur no more frequently than every 3 to 4 days due to the longer time for U-300 to achieve steady-state

DOSE-CONVERSION Between U-100 and U-300:

• Switching from U-100 to U-300: Initiate U-300 at same dose; expect a higher daily dose of U-300 will be needed to maintain same level of glycemic control
• Switching from U-300 to U-100: Initial U-100 dose should be 80% of the U-300 dose to reduce the risk of hypoglycemia

DOSE-CONVERSIONS From Intermediate or Long-Acting Insulins to Insulin Glargine:

• Switching from a once-daily intermediate or long-acting insulin to U-100: The U-100 dose may need to be adjusted; the amount and timing of the shorter-acting insulins may need to be adjusted
• Switching from a once-daily intermediate or long-acting insulin to U-300: Initiate U-300 dose at same dose
• Switching from twice-daily long or intermediate-acting insulin (e.g., insulin detemir, NPH): Initiate U-300 at 80% of the total daily twice-daily long or intermediate-acting insulin
• Switching from once-daily NPH to U-100: Initiate U-100 dose at same dose
• Switching from twice-daily NPH to U-100: Initiate U-100 dose at 80% of total NPH dose

Maintenance doses: Once the switch is made, doses should be adjusted as described above for maintenance doses

Comments:

• When changing treatment regimens, the dose and frequency of short-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.
• To minimize hypoglycemia, closely monitor blood glucose, especially with changing regimens.
• During clinical trials, patients receiving insulin glargine U-300 required 11% to 15% more basal insulin than patients receiving U-100 insulin glargine.

Use: To improve glycemic control in patients with type 2 diabetes mellitus.

Usual Geriatric Dose for Diabetes Type 2

Initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions.

Usual Geriatric Dose for Diabetes Type 1

Initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions.

Usual Pediatric Dose for Diabetes Type 1

Age: 6 years or older:
Dose should be individualized: Must be used concomitantly with shorter acting (i.e., prandial/bolus) insulin

Insulin glargine 100 units/mL (U-100):

• Initial dose: Approximately one-third total daily insulin requirement subcutaneously once a day
• Maintenance dose: Individualize and adjust dose according to metabolic needs, blood glucose measurements, and glycemic goals

Insulin glargine 300 units/mL (U-300):

• Initial dose: Approximately one-third to one-half total daily insulin requirement subcutaneously once a day; maximum glucose lowering effect may take 5 days to fully manifest and the first dose may be insufficient to cover metabolic needs during the first 24 hour; monitor closely
• Maintenance dose: Individualize and adjust dose according to metabolic needs, blood glucose measurements, and glycemic goals; dose titration should occur no more frequently than every 3 to 4 days due to the longer time to achieve steady-state

DOSE-CONVERSION Between U-100 and U-300:

• Switching from U-100 to U-300: Initiate U-300 at same dose; expect a higher daily dose of U-300 will be needed to maintain same level of glycemic control
• Switching from U-300 to U-100: Initial U-100 dose should be 80% of the U-300 dose to reduce the risk of hypoglycemia

DOSE-CONVERSIONS From Intermediate or Long-Acting Insulins to Insulin Glargine:

• Switching from a once-daily intermediate or long-acting insulin to U-100: The U-100 dose may need to be adjusted; the amount and timing of the shorter-acting insulins may need to be adjusted
• Switching from a once-daily intermediate or long-acting insulin to U-300: Initiate U-300 dose at same dose
• Switching from twice-daily long or intermediate-acting insulin (e.g., insulin detemir, NPH): Initiate U-300 at 80% of the total daily twice-daily long or intermediate-acting insulin
• Switching from once-daily NPH to U-100: Initiate U-100 dose at same dose
• Switching from twice-daily NPH to U-100: Initiate U-100 dose at 80% of total NPH dose

Maintenance doses: Once the switch is made, doses should be adjusted as described above for maintenance doses

Comments:

• The initial total daily insulin requirement in insulin naive patients is generally 0.2 to 0.4 units of insulin per kilogram of body weight.
• In a basal-bolus regimen, insulin glargine (basal insulin) provides approximately one-third to one-half of the total daily insulin requirement while pre-meal insulin (i.e., short-acting [bolus] insulin) should be used to satisfy the remainder of the daily insulin requirement.
• Changing insulin, insulin concentrations, and regimens should be done cautiously while closely monitoring blood glucose; dose adjustments to short-acting insulin may be needed during transition periods.
• During clinical trials, patients receiving insulin glargine U-300 required 17.5% greater dose than patients treated with insulin glargine U-100.

Use: To improve glycemic control in pediatric patients 6 years or older with type 1 diabetes mellitus.

Usual Pediatric Dose for Diabetes Type 2

Age: 6 years or older:

Insulin-naive:

• Initial dose U-300 (300 units/mL): 0.2 units/kg subcutaneously once a day
• Maintenance dose: Dose should be adjusted according to metabolic needs, blood glucose measurements, and glycemic goals

Special considerations for insulin glargine U-300 insulin:

• Maximum glucose lowering effect may take 5 days to fully manifest and the first dose may be insufficient to cover metabolic needs during the first 24 hour; monitor closely
• Dose titration should occur no more frequently than every 3 to 4 days due to the longer time for U-300 to achieve steady-state

DOSE-CONVERSIONS From Intermediate or Long-Acting Insulins to Insulin Glargine:

• Switching from a once-daily intermediate or long-acting insulin to U-300: Initiate U-300 dose at same dose
• Switching from twice-daily long or intermediate-acting insulin (e.g., insulin detemir, NPH): Initiate U-300 at 80% of the total daily twice-daily long or intermediate-acting insulin

Maintenance doses: Once the switch is made, doses should be adjusted as described above for maintenance doses

Comments:

• Insulin glargine 100 units/mL (Lantus) is not FDA-approved for use in pediatric patients.
• When changing treatment regimens, the dose and frequency of short-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.
• To minimize hypoglycemia, closely monitor blood glucose, especially with changing regimens.

Use: To improve glycemic control in patients with type 2 diabetes mellitus.

Renal Dose Adjustments

Use with caution; frequent glucose monitoring and insulin dose reduction may be required

Liver Dose Adjustments

Use with caution; frequent glucose monitoring and insulin dose reduction may be required

Dose Adjustments

Daily insulin requirements may be higher during illness, stress, pregnancy, in obese patients, trauma, during concurrent use with medications having hyperglycemic effects, or after surgery

Daily insulin requirements may be lower with exercise, weight loss, calorie restricted diets, or during concurrent use of medications having hypoglycemic effects

Supplemental doses may be prescribed during illness; patients with type 2 diabetes receiving oral medications may be switched to insulin therapy temporarily

Dosage adjustments may be required when the brand, type, or species of insulin is changed; oral antidiabetic treatment may need to be adjusted as well

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to insulin glargine or any of the product components
• During episodes of hypoglycemia

• Safety and efficacy of insulin glargine 100 units/mL (U-100) have not been established in patients with type 1 diabetes younger than 6 years or pediatric patients with type 2 diabetes.
• Safety and efficacy of insulin glargine 300 units/mL (U-300) have not been established in pediatric patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Always check insulin labels before administration
• Administer subcutaneously once a day at any time of day, but at the same time every day
• Rotate injection sites within the same region (abdomen, thigh, or deltoid) to reduce the risk of lipodystrophy
• Due to the risk for transmission of blood-borne pathogens, insulin pens (even if the needle is changed), syringes, needles, and vials, should not be re-used or shared between patients
• Ensure patients have been educated as to proper injection technique
• The dose counter shows the number of units to be delivered
• Patients should be aware that there are 2 strengths of insulin glargine (U-100 and U-300) and that they are not interchangeable
• Patients with visual impairment should use caution with insulin pens; counting clicks to dial the dose is not recommended

Insulin Glargine is available in 2 concentrations: 100 units/mL (U-100) and 300 units/mL (U-300)

• Lantus(R) U-100: Available 10 mL vials and 3 mL SoloStar pens; pen delivers doses in 1 unit increments from 1 to 80 units; doses greater than 80 units should be given as 2 or more injections.
• Basalglar(R) U-100: Available as 3 mL KwikPens(R); pen delivers doses in 1 unit increments from 1 to 80 units; doses greater than 80 units should be given as 2 or more injections.
• Toujeo(R) U-300: Available as 1.5 mL Solostar and 3 mL Max SoloStar pens:
• Toujeo(R) SolarStar pen delivers doses in 1 unit increments from 1 to 80 units
• Toujeo(R) Max SolarStar pen delivers doses in 2 unit increments from 2 to 160 units; this pen is recommended for patients requiring at least 20 units per day

Preparation and Instructions for Use:

• Do not use if the solution does not appear clear and colorless.
• Do not dilute or mix with any other insulins or solutions; mixing or diluting can change the time/action profile and cause precipitation.
• Do not administer via an insulin pump; do not administer IV or IM
• Do not transfer insulin from insulin pens into syringes, especially U-300; patients should generally not remove insulin from insulin pens and administer in a separate syringe as this increases risk for error and may result in severe hypoglycemia.
• Consult manufacturer product labeling for specific instructions for use.

Storage requirements: Do not freeze; discard if frozen

• Unopened insulin pens and vials should be kept refrigerated 2C to 8C (36F to 46F) until use
• Unopened insulin pens and vials that are stored at room temperature (below 86F [30C]) should be discarded after 28 days
• In-use vials: May be refrigerated or unrefrigerated for up to 28 days after opening; keep away from direct heat and light; temperature should not exceed 30C (86F); discard after 28 days
• In-use U-100 insulin pens: Should be kept at room temperature (do not refrigerate) after opening; discard after 28 days
• In-use U-300 insulin pens: Should be kept at room temperature (do not refrigerate) after opening; discard after 56 days

General:

• This drug is not recommended for the treatment of diabetic ketoacidosis; IV short-acting insulin is the preferred treatment for this condition.
• Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
• Hypoglycemia is the most common adverse reaction of insulin therapy; the timing generally reflects the time-action profile of the administered insulin.

Monitoring:

• Blood glucose monitoring is essential for all patients receiving insulin therapy, more frequent monitoring is recommended when insulin regimens are being adjusted.
• Monitor potassium levels in patients at risk for hypokalemia.
• Monitor for signs and symptoms of heart failure in patients receiving concomitant thiazolidinediones.
• Urine ketone testing is recommended for patients with type I diabetes if they develop symptoms of colds, influenza, nausea, vomiting, or other illnesses, polyuria, or if blood glucose levels are unexpectedly high or inconsistent.
• Glycosylated hemoglobin measurements are recommended every 3 months.

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients should be advised to never share an insulin pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens.
• Patients should be reminded to always check insulin labels before injection, especially if they are using more than 1 type of insulin.
• Patients should be instructed on glucose monitoring, proper injection technique, and the management of hypoglycemia and hyperglycemia.
• Patients should be instructed on how to handle situations which may affect their insulin requirements.
• Patients should check blood sugar prior to driving a car or operating machinery.
• Advise patient to speak to physician or health care professional if pregnant or if they intend to become pregnant.

Frequently asked questions

• How and where should I inject insulin?
• What are the different types of insulin?
• When is the best time to take Toujeo?
• How long can Toujeo stay out of the refrigerator?
• Soliqua vs Lantus: What’s the difference between them?
• Can Toujeo be given twice a day?
• How many pens are in a box of Toujeo?
• What is the difference between Soliqua and Xultophy?
• Is Toujeo a fast or long-acting insulin?