SEMGLEE Solution for injection Ref.[27592] Active ingredients: Insulin glargine

2.1 Important Administration Instructions

• Always check insulin labels before administration [see Warnings and Precautions (5.4)].
• Visually inspect SEMGLEE vials and prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
• Prior to initiation of SEMGLEE, train patients on proper use and injection technique.
• Administer SEMGLEE subcutaneously once daily at any time of day but at the same time every day.
• Administer SEMGLEE subcutaneously into the abdominal area, thigh, buttocks or upper arms, 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)].
• The SEMGLEE prefilled pen dials in 1-unit increments.
• Use SEMGLEE prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
• Do not administer intravenously or via an insulin pump.
• Do not dilute or mix SEMGLEE with any other insulin or solution.

2.2 General Dosing Instructions

• Individualize and adjust the dosage of SEMGLEE 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. Dosage adjustments should only be made under medical supervision with appropriate glucose monitoring [see Warnings and Precautions (5.2)].

2.3 Initiation of SEMGLEE Therapy

Type 1 Diabetes:

• In patients with type 1 diabetes, SEMGLEE must be used concomitantly with short-acting insulin. The recommended starting dose of SEMGLEE in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.

Type 2 Diabetes:

• The recommended starting dose of SEMGLEE in patients with type 2 diabetes who are not currently treated with insulin 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 other antidiabetic drugs.

2.4 Changing to SEMGLEE from Other Insulin Therapies

• If changing patients from once-daily insulin glargine injection 300 units/mL to once-daily SEMGLEE, the recommended initial SEMGLEE dose is 80% of the insulin glargine injection 300 units/mL dose that is being discontinued. This dose reduction will lower the likelihood of hypoglycemia [see Warnings and Precautions (5.3)].
• If changing from a treatment regimen with an intermediate or long-acting insulin (other than an insulin glargine injection 100 units/mL) to a regimen with SEMGLEE, a change in the dose of the basal insulin may be required and the amount and timing of the shorter-acting insulins and doses of other antidiabetic drugs may need to be adjusted.
• In patients changing from once-daily NPH insulin to once daily dose of SEMGLEE, the recommended initial SEMGLEE dose is the same as the dose of NPH that is being discontinued.
• If changing patients from twice-daily NPH insulin to once-daily SEMGLEE, the recommended initial SEMGLEE dosage is 80% of the total NPH dose that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia [see Warnings and Precautions (5.3)].

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia can usually be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes of hypoglycemia 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 store SEMGLEE in the freezer and do not allow to freeze. Discard SEMGLEE if it has been frozen. Protect SEMGLEE from direct heat and light.

Storage conditions are summarized in the following table: