Generic name: Insulin glargine 100[iU] in 1mL
Dosage form: injection, solution
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Important Administration Instructions
- Always check insulin labels before administration [see Warnings and Precautions (5.4)].
- Train patients on proper use and injection technique before initiating BASAGLAR.
- Visually inspect BASAGLAR KwikPen for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
- Inject between 1 and 80 units per injection.
- Administer BASAGLAR subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)].
- Do not dilute or mix BASAGLAR with any other insulin or solution as the onset of action or time to peak effect of BASAGLAR and the mixed insulin may be altered in an unpredictable manner.
- Do not administer intravenously or via an insulin pump because this could result in severe hypoglycemia.
General Dosing Instructions
- In patients with type 1 diabetes, BASAGLAR must be used concomitantly with short-acting insulin.
- Inject BASAGLAR subcutaneously once daily at any time of day but at the same time every day.
- Individualize and titrate the dosage of BASAGLAR based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal.
- Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), during acute illness, or changes in renal or hepatic function and should be made under medical supervision with appropriate glucose monitoring [see Warnings and Precautions (5.2)].
Initiation of BASAGLAR Therapy
- The recommended starting dose of BASAGLAR in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short- or rapid-acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements.
- The recommended starting dose of BASAGLAR in patients with type 2 diabetes is 0.2 units/kg or up to 10 units once daily. One may need to adjust the amount and timing of short- or rapid-acting insulins and dosages of any anti-diabetic drugs.
Changing to BASAGLAR from Other Insulin Therapies
- If changing patients from another insulin glargine product, 100 units/mL, to BASAGLAR, the dose of BASAGLAR should be the same as the other insulin glargine product, 100 units/mL, and the time of day for administration should be determined by the physician.
- If changing patients from a once-daily insulin glargine product, 300 units/mL, to once-daily BASAGLAR, the recommended initial BASAGLAR dosage is 80% of the insulin glargine product, 300 units/mL, dose that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia [see Warnings and Precautions (5.2)].
- If changing from a treatment regimen with an intermediate- or long-acting insulin (other than an insulin glargine product, 100 units/mL) to a regimen with BASAGLAR, a change in the dose of the basal insulin may be required and the amount and timing of shorter-acting insulins and doses of any anti-diabetic drugs may need to be adjusted.
- If changing patients from twice-daily NPH insulin to once-daily BASAGLAR, the recommended initial BASAGLAR dosage is 80% of the total NPH dosage that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia [see Warnings and Precautions (5.2)].