LYUMJEV

AbsorptionAbsorption of insulin lispro-aabc was evaluated in healthy subjects (see Figure 2 ) and patients with diabetes following subcutaneous injection of LYUMJEV. Insulin lispro-aabc appeared in circulation approximately 1 minute after injection of LYUMJEV. Time to 50% maximum insulin lispro-aabc concentration was 13 minutes. Time to maximum insulin lispro-aabc concentration was achieved at 57 minutes. In healthy subjects, the day-to-day variability [CV%] within subjects of LYUMJEV was 10% f...

14.1 Overview of Clinical Studies The effectiveness of LYUMJEV was evaluated in: Two randomized, active controlled trials of 26 weeks in adults with type 1 diabetes (N=780) or type 2 diabetes (N=336) (PRONTO-T1D and PRONTO-T2D, respectively) [see Clinical Studies ( 14.2 , 14.3 )]. A randomized, active controlled 16-week trial in adults with type 1 diabetes using continuous subcutaneous insulin infusion (N=432) (PRONTO-Pump-2) [see Clinical Studies ( 14.4 )]. A randomized, active controlled 26-week trial in pediatric patients with type 1 diabetes (N=716) (PRONTO-Peds) [see Clinical Studies ( 14...

The following adverse reactions are also discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.3 )] . Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] . Adverse reactions observed with LYUMJEV include hypoglycemia, injection/infusion site reactions, allergic reactions, rash, pruritus, lipodystrophy, and weight gain. ( 6.1 ) To report SUS...

LYUMJEV is contraindicated: during episodes of hypoglycemia. in patients with hypersensitivity to insulin lispro-aabc or any of the excipients in LYUMJEV. During episodes of hypoglycemia. ( 4 ) Hypersensitivity to insulin lispro-aabc or any of the excipients in LYUMJEV. ( 4 )

Never share a LYUMJEV prefilled pen or cartridge between patients, even if the needle is changed. ( 5.1 ) Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosag...

7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with LYUMJEV. Table 6. Clinically Significant Drug Interactions with LYUMJEV Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, som...