Important Administration Instructions

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Always check insulin labels before administration [see Warnings and Precautions (5.4)]

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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.

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Administer SEMGLEE 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)].

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During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].

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Do not administer intravenously or via an insulin pump.

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

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The SEMGLEE prefilled pen dials in 1-unit increments.

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Use SEMGLEE prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

General Dosing Instructions

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Administer SEMGLEE subcutaneously once daily at any time of day but at the same time every day.

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Individualize and adjust the dosage of SEMGLEE based on the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal.

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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)].

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

Initiation of SEMGLEE Therapy

Recommended Starting Dosage in Patients with Type 1 Diabetes

The recommended starting dosage of SEMGLEE 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 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.

Switching to SEMGLEE from Other Insulin Therapies

Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to SEMGLEE from other insulin therapies [see Warnings and Precautions (5.3)].

When switching from:

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

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

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