General Information

Humalog is a rapid acting human insulin analog.

Humalog is specifically indicated to improve glycemic control in adults and children with diabetes mellitus.

Humalog is supplied as the following:

HUMALOG- insulin lispro injection, solution
HUMALOG KWIKPEN - insulin lispro injection, solution
HUMALOG JUNIOR KWIKPEN - insulin lispro injection, solution
HUMALOG TEMPO PEN - insulin lispro injection, solution

Individualize and adjust the dosage of HUMALOG based on route of administration, 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), changes in renal or hepatic function or during acute illness. Do NOT perform dose conversion when using any HUMALOG U-100 or U-200 prefilled pens. The dose window shows the number of insulin units to be delivered and no conversion is needed.

Subcutaneous Injection: HUMALOG U-100 or U-200

Administer the dose of HUMALOG U-100 or HUMALOG U-200 within fifteen minutes before a meal or immediately after a meal by injection into the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. To reduce the risk of lipodystrophy and localized cutaneous amyloidosis, rotate the injection site within the same region from one injection to the next. 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

HUMALOG administered by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.

The HUMALOG U-100 KwikPen, HUMALOG U-100 Tempo Pen and HUMALOG U-200 KwikPen each dial in 1 unit increments and delivers a maximum dose of 60 units per injection.

The HUMALOG U-100 Junior KwikPen dials in 0.5 unit increments and delivers a maximum does of 30 units per injection.

Continuous Subcutaneous Infusion (Insulin Pump): HUMALOG U-100 ONLY

Do NOT administer HUMALOG U-200 using a continuous subcutaneous infusion pump.

Administer HUMALOG U-100 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

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

Follow healthcare professional recommendations when setting basal and meal time infusion rate.

Do NOT dilute or mix HUMALOG U-100 when administering by continuous subcutaneous infusion.

Change HUMALOG U-100 in the pump reservoir at least every 7 days.

Change the infusion sets and the infusion set insertion site at least every 3 days.

Do NOT expose HUMALOG U-100 in the pump reservoir to temperatures greater than 98.6°F (37°C).

Intravenous Administration: HUMALOG U-100 ONLY

Do NOT administer HUMALOG U-200 intravenously.

Dilute HUMALOG U-100 to concentrations from 0.1 unit/mL to 1.0 unit/mL using 0.9% Sodium Chloride Injection, USP.

Administer HUMALOG U-100 intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia

Mechanism of Action

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis. HUMALOG has been shown to be equipotent to human insulin on a molar basis. One unit of HUMALOG has the same glucose-lowering effect as one unit of regular human insulin. Studies in normal volunteers and patients with diabetes demonstrated that HUMALOG has a more rapid onset of action and a shorter duration of activity than regular human insulin when given subcutaneously.

Clinical Trial Results

The approval of Humalog was based on data from worldwide clinical studies that included approximately 3,000 subjects who were evaluated over three years. Diabetics who participated in clinical trials injected Humalog within 15 minutes of eating a meal instead of injecting regular human insulin between 20 and 45 minutes before. Clinical trial evidence showed that Humalog acted faster than regular human insulin to control blood-glucose levels after a meal.