Lyumjev

• See Full Prescribing Information for important administration instructions.
• Subcutaneous Injection :
  • Administer LYUMJEV U-100 or U-200 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 to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
  • Should generally be used in regimens with an intermediate or long-acting insulin.
• Continuous subcutaneous infusion (Insulin Pump) :
  • Refer to the insulin infusion pump user manual to see if LYUMJEV can be used. Use in accordance with the insulin pump instructions for use.
  • Administer LYUMJEV U-100 by continuous subcutaneous infusion using an insulin pump 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 administer LYUMJEV U-200 by continuous subcutaneous infusion.
• Intravenous Infusion :
  • Administer LYUMJEV U-100 intravenously only under medical supervision. DO NOT administer LYUMJEV U-200 by intravenous infusion.
  • Dilute LYUMJEV U-100 to a concentration of 1 unit/mL.
• Individualize and adjust the dosage of LYUMJEV based on the patient's metabolic needs, glucose monitoring results, and glycemic control goal.
• Dose adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or hepatic function, or during acute illness.

Injection: 100 units/mL (U-100) clear and colorless solution available as:

• 10 mL multiple-dose vial
• 3 mL single-patient-use LYUMJEV KwikPen
• 3 mL single-patient-use LYUMJEV Junior KwikPen
• 3 mL single-patient-use LYUMJEV Tempo Pen
• 3 mL single-patient-use cartridges

Injection: 200 units/mL (U-200) clear and colorless solution available as:

• 3 mL single-patient-use LYUMJEV KwikPen

Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes

The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA_1c>7 and has been reported to be as high as 20% to 25% in women with a HbA_1c>10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.