Humalog

HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

• See Full Prescribing Information for important administration instructions.
• Subcutaneous injection :
  • Administer HUMALOG^® U-100 or U-200 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 HUMALOG can be used. Use in accordance with the insulin pump instructions for use.
  • Administer HUMALOG U-100 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 administer HUMALOG U-200 by continuous subcutaneous infusion.
• Intravenous Infusion :
  • Administer HUMALOG U-100 by intravenous infusion ONLY after dilution and under medical supervision. DO NOT administer HUMALOG U-200 by intravenous infusion.
• The dosage of HUMALOG must be individualized based on the route of administration and the individual's metabolic needs, blood glucose monitoring results and glycemic control goal.
• Do not perform dose conversion when using the 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.
• Do not mix HUMALOG U-200 with any other insulin.

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

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

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

• 3 mL single-patient-use KwikPen prefilled pen
• 3 mL single-patient-use Tempo Pen prefilled pen

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

Pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. No adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. No adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day

The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >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 2-4% and 15-20%, respectively.