Insulindosage

See Full Prescribing Information for important preparation and administration instructions. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.

Subcutaneous injection: Administer ADMELOG by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Continuous subcutaneous infusion (Insulin Pump): Refer to the insulin infusion pump user manual to see if ADMELOG can be used. Use in accordance with the insulin pump instructions for use. Administer ADMELOG by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Do not mix with other insulins or diluents in the pump.

Intravenous Infusion: Administer ADMELOG by intravenous infusion ONLY after dilution and under medical supervision. The dosage of ADMELOG must be individualized based on the route of administration and the patient's metabolic needs, blood glucose monitoring results and glycemic control goal.

2.1 Important

Preparation and Administration Instructions Always check insulin labels before administration. Inspect ADMELOG visually before use. It should appear clear and colorless. Do not use ADMELOG if particulate matter or coloration is seen. Use ADMELOG SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose. Do NOT mix ADMELOG with other insulins when administering using a continuous subcutaneous infusion pump.

2.2 Preparation and

Administration Instructions for the Approved Routes of Administration Subcutaneous Injection Administer the dose of ADMELOG subcutaneously within fifteen minutes before a meal or immediately after a meal into the abdominal wall, thigh, upper arm, or buttocks. Rotate injection site 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. ADMELOG administered by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin. The ADMELOG SoloStar prefilled pen dials in 1-unit increments. Prior to subcutaneous use, ADMELOG may be diluted with sterile 0.9% Sodium Chloride Injection. Dilute one-part ADMELOG to one-part 0.9% Sodium Chloride Injection to yield a concentration one-half that of ADMELOG (equivalent to U-50). If diluted ADMELOG is not used immediately, refrigerate at 2°C to 8°C (36°F to 46°F) for no more than 24 hours or store at room temperature up to 30°C (86°F) for 4 hours. Discard the unused diluted ADEMLOG after 24 hours if refrigerated or after 4 hours if stored at room temperature. Continuous Subcutaneous Infusion (Insulin Pump) Refer to the continuous subcutaneous insulin infusion pump user manual to see if ADMELOG can be used with the insulin pump. Use ADMELOG in accordance with the insulin pump system's instructions for use. Administer ADMELOG by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. Train patients using continuous subcutaneous insulin infusion therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure. During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring. Change ADMELOG in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter. Change the infusion sets and the infusion set insertion site according to the manufacturer's user manual. Do NOT dilute or mix ADMELOG when administering by continuous subcutaneous infusion. Do NOT expose ADMELOG in the pump reservoir to temperatures greater than 98.6°F (37°C). Intravenous Administration Administer ADMELOG intravenously ONLY under medical supervision. Dilute ADMELOG to concentrations from 0.1 unit/mL to 1 unit/mL using 0.9% Sodium Chloride Injection, USP. Closely monitor of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.

2.3 Dosage Recommendations

Individualize and adjust the dosage of ADMELOG based on the route of administration, the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal. Dosage modifications may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function, or during acute illness. When switching from another insulin lispro product to ADMELOG, the dose of ADMELOG should be the same as the other insulin lispro product. When switching from other insulins to ADMELOG, the ADMELOG dosage may need to be adjusted.

2.4 Dosage Adjustment for

Drug Interactions Dosage modification may be needed when ADMELOG is coadministered with certain drugs. Do NOT mix ADMELOG with any other insulin.