BASAGLAR Solution for injection Kwikpen / Tempo pen Ref.[10756] Active ingredients: Insulin glargine

2.1 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 prefilled pens 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 and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2) and Adverse Reactions (6)].
• During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].
• Use BASAGLAR with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
• 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.

2.2 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)].
• The BASAGLAR prefilled pens each dials in 1 unit increments and delivers a maximum dose of 80 units per injection.

2.3 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.

2.4 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)].

Excess insulin administration relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Dispense in the original sealed carton with the enclosed Instructions for Use.

Do not freeze BASAGLAR. Do not use BASAGLAR if it has been frozen.

BASAGLAR must be protected from direct heat and light.

Do not use after the expiration date. In-use BASAGLAR prefilled pens must be used within 28 days or be discarded, even if they still contain BASAGLAR.

Storage conditions are summarized in the following table: