Insulindosage

Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use.

Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day.

Do not dilute or mix with any other insulin or solution.

Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.

See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes and how to change to Insulin Glargine-yfgn from other insulins.

Closely monitor glucose when switching to Insulin Glargine-yfgn and during initial weeks thereafter.

2.1 Important

Administration Instructions

Always check insulin labels before administration. This product is SEMGLEE (insulin glargine-yfgn).

Visually inspect Insulin Glargine-yfgn 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.

Administer Insulin Glargine-yfgn 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.

During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring.

Do not administer intravenously or via an insulin pump.

Do not dilute or mix Insulin Glargine-yfgn with any other insulin or solution.

The Insulin Glargine-yfgn prefilled pen dials in 1-unit increments.

Use the Insulin Glargine-yfgn prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

2.2 General

Dosing Instructions

Administer Insulin Glargine-yfgn subcutaneously once daily at any time of day but at the same time every day.

Individualize and adjust the dosage of Insulin Glargine-yfgn based on the patient’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.

In patients with type 1 diabetes, Insulin Glargine-yfgn must be used concomitantly with short-acting insulin.

2.3 Initiation of

Insulin Glargine-yfgn Therapy Recommended Starting Dosage in Patients with Type 1 Diabetes The recommended starting dosage of Insulin Glargine-yfgn in patients with type 1 diabetes is approximately one-third of the total daily insulin requirements. Use short-acting, premeal insulin to satisfy the remainder of the daily insulin requirements. Recommended Starting Dosage in Patients with Type 2 Diabetes The recommended starting dosage of Insulin Glargine-yfgn 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.

2.4 Switching to

Insulin Glargine-yfgn from Other Insulin Therapies Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Insulin Glargine-yfgn from other insulin therapies. When switching from:

Once-daily insulin glargine 300 units/mL to once-daily Insulin Glargine-yfgn (100 units/mL), the recommended starting Insulin Glargine-yfgn dosage is 80% of the insulin glargine, 300 units/mL dosage that is being discontinued.

Once-daily NPH insulin to once-daily Insulin Glargine-yfgn, the recommended starting Insulin Glargine-yfgn dosage is the same as the dosage of NPH that is being discontinued.

Twice-daily NPH insulin to once-daily Insulin Glargine-yfgn, the recommended starting Insulin Glargine-yfgn dosage is 80% of the total NPH dosage that is being discontinued.