General Information

Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL) is a rapid-acting human insulin analog.

Lyumjev is specifically indicated to improve glycemic control in adults with diabetes mellitus.

Lyumjev is supplied as an injection for subcutaneous or intravenous administration. The recommended dose is as follows:

Subcutaneous Injection

Administer Lyumjev at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks.

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

Lyumjev given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin.

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

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

Intravenous Administration for Lyumjev U-100 Only

Do not administer Lyumjev U-200 intravenously.

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

Dilute Lyumjev U-100 to a concentration of 1 unit/mL using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP infusion solutions. Dilutions to concentrations below 1 unit/mL are not recommended.

Diluted Lyumjev may be stored for up to 4 days when refrigerated at 36°F to 46°F (2°C to 8°C) until time of use. The same solution may be stored for up to 12 hours at room temperature at 68°F to 77°F (20°C to 25°C).

Mechanism of Action

Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL) is a rapid-acting human insulin analog. The primary activity of Lyumjev is the regulation of glucose metabolism. Insulins, including insulin lispro-aabc, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers 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.

Clinical Trial Results

The FDA approval of Lyumjev was based on data from the Phase 3 studies PRONTO-T1D and PRONTO-T2D, which were randomized, active controlled, treat-to-target comparisons of Lyumjev and Humalog (insulin lispro injection, 100 units/mL) in adults with type 1 and type 2 diabetes, respectively. The studies were designed as treat-to-target trials in which each arm was treated to achieve the same level of blood glucose control and evaluated other important treatment effects, such as rates of hypoglycemia and post-meal glucose control. A subset of patients randomized to PRONTO-T1D participated in an evaluation of 24-hour ambulatory glucose profiles captured with blinded continuous glucose monitoring (CGM) over a two-week period. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime. Key endpoints were adjusted for multiple testing, including the comparisons of one- and two-hour postprandial glucose. In both studies, Lyumjev demonstrated superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Additionally, in studies evaluating the time action profile of this new insulin, Lyumjev appeared in the blood stream approximately one minute after injection.