Humalog (Diluent)

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

• See Full Prescribing Information for important administration instructions. (
  2.1 Important Administration Instructions

  • Always check insulin labels before administration
    [see Warnings and Precautions ]
    .
  • Inspect HUMALOG visually before use. It should appear clear and colorless. Do not use HUMALOG if particulate matter or coloration is seen.
  • Use HUMALOG prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
  • Do NOT mix HUMALOG U-100 with other insulins when using a continuous subcutaneous infusion pump.
  • Do NOT transfer HUMALOG U-200 from the prefilled pen to a syringe for administration
    [see Warnings and Precautions ]
    .
  • 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.
  ,
  2.2 Administration Instructions for the Approved Routes of Administration

  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.
  • Rotate the injection site within the same region from one injection to the next (abdominal wall, thigh, upper arm, or buttocks) to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis
    [see Warnings and Precautions and Adverse Reactions ]
    .
  • During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring
    [see Warnings and Precautions ]
    .
  • 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, HUMALOG U-200 KwikPen, and HUMALOG U-200 Tempo Pen 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 dose of 30 units per injection.

  Subcutaneous Injection: Diluted HUMALOG U-100

  • HUMALOG U-100 may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection ONLY under medical supervision. Dilute one part HUMALOG U-100 to:
    • Nine parts diluent to yield a concentration one-tenth that of HUMALOG U-100 (equivalent to U-10).
    • One part diluent to yield a concentration one-half that of HUMALOG U-100 (equivalent to U-50).
  • Diluted HUMALOG for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and for 14 days at room temperature up to 86°F (30°C).

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

  • Do NOT administer HUMALOG U-200 using a continuous subcutaneous infusion pump.
  • Refer to the continuous subcutaneous insulin infusion pump user manual to see if HUMALOG can be used with the insulin pump. Use HUMALOG in accordance with the insulin pump system's instructions for use.
  • 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
    [see Warnings and Precautions and Adverse Reactions ]
    .
  • Train patients using continuous subcutaneous insulin infusion therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure
    [see Warnings and Precautions ].
  • During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring
    [see Warnings and Precautions ]
    .
  • Change HUMALOG U-100 in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter.
  • Change the infusion set and the infusion set insertion site according to the manufacturer's user manual.
  • Do NOT dilute or mix HUMALOG U-100 when administering by continuous subcutaneous infusion.
  • 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.
  • Administer HUMALOG U-100 intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia
    [see Warnings and Precautions ]
    .
  • Dilute HUMALOG U-100 to concentrations from 0.1 unit/mL to 1.0 unit/mL using 0.9% Sodium Chloride Injection, USP.
  • Infusion bags prepared with HUMALOG U-100 are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours.
  ,
  2.3 Dosage Recommendations

  • 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.
  • When switching from another insulin to HUMALOG, a different dosage of HUMALOG may be needed
    [see Warnings and Precautions ]
    .
  • Dosage modifications 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
    [see Warnings and Precautions and Use in Specific Populations ]
    .
  • 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.
  ,
  2.4 Dosage Modifications for Drug Interactions

  Dosage modification may be needed when HUMALOG is used concomitantly with certain drugs

  [see Drug Interactions ]

  .
  )
• Subcutaneous injection (
  2.2 Administration Instructions for the Approved Routes of Administration

  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.
  • Rotate the injection site within the same region from one injection to the next (abdominal wall, thigh, upper arm, or buttocks) to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis
    [see Warnings and Precautions and Adverse Reactions ]
    .
  • During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring
    [see Warnings and Precautions ]
    .
  • 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, HUMALOG U-200 KwikPen, and HUMALOG U-200 Tempo Pen 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 dose of 30 units per injection.

  Subcutaneous Injection: Diluted HUMALOG U-100

  • HUMALOG U-100 may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection ONLY under medical supervision. Dilute one part HUMALOG U-100 to:
    • Nine parts diluent to yield a concentration one-tenth that of HUMALOG U-100 (equivalent to U-10).
    • One part diluent to yield a concentration one-half that of HUMALOG U-100 (equivalent to U-50).
  • Diluted HUMALOG for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and for 14 days at room temperature up to 86°F (30°C).

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

  • Do NOT administer HUMALOG U-200 using a continuous subcutaneous infusion pump.
  • Refer to the continuous subcutaneous insulin infusion pump user manual to see if HUMALOG can be used with the insulin pump. Use HUMALOG in accordance with the insulin pump system's instructions for use.
  • 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
    [see Warnings and Precautions and Adverse Reactions ]
    .
  • Train patients using continuous subcutaneous insulin infusion therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure
    [see Warnings and Precautions ].
  • During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring
    [see Warnings and Precautions ]
    .
  • Change HUMALOG U-100 in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter.
  • Change the infusion set and the infusion set insertion site according to the manufacturer's user manual.
  • Do NOT dilute or mix HUMALOG U-100 when administering by continuous subcutaneous infusion.
  • 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.
  • Administer HUMALOG U-100 intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia
    [see Warnings and Precautions ]
    .
  • Dilute HUMALOG U-100 to concentrations from 0.1 unit/mL to 1.0 unit/mL using 0.9% Sodium Chloride Injection, USP.
  • Infusion bags prepared with HUMALOG U-100 are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours.
  ):
  • 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) (
  2.2 Administration Instructions for the Approved Routes of Administration

  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.
  • Rotate the injection site within the same region from one injection to the next (abdominal wall, thigh, upper arm, or buttocks) to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis
    [see Warnings and Precautions and Adverse Reactions ]
    .
  • During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring
    [see Warnings and Precautions ]
    .
  • 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, HUMALOG U-200 KwikPen, and HUMALOG U-200 Tempo Pen 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 dose of 30 units per injection.

  Subcutaneous Injection: Diluted HUMALOG U-100

  • HUMALOG U-100 may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection ONLY under medical supervision. Dilute one part HUMALOG U-100 to:
    • Nine parts diluent to yield a concentration one-tenth that of HUMALOG U-100 (equivalent to U-10).
    • One part diluent to yield a concentration one-half that of HUMALOG U-100 (equivalent to U-50).
  • Diluted HUMALOG for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and for 14 days at room temperature up to 86°F (30°C).

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

  • Do NOT administer HUMALOG U-200 using a continuous subcutaneous infusion pump.
  • Refer to the continuous subcutaneous insulin infusion pump user manual to see if HUMALOG can be used with the insulin pump. Use HUMALOG in accordance with the insulin pump system's instructions for use.
  • 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
    [see Warnings and Precautions and Adverse Reactions ]
    .
  • Train patients using continuous subcutaneous insulin infusion therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure
    [see Warnings and Precautions ].
  • During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring
    [see Warnings and Precautions ]
    .
  • Change HUMALOG U-100 in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter.
  • Change the infusion set and the infusion set insertion site according to the manufacturer's user manual.
  • Do NOT dilute or mix HUMALOG U-100 when administering by continuous subcutaneous infusion.
  • 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.
  • Administer HUMALOG U-100 intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia
    [see Warnings and Precautions ]
    .
  • Dilute HUMALOG U-100 to concentrations from 0.1 unit/mL to 1.0 unit/mL using 0.9% Sodium Chloride Injection, USP.
  • Infusion bags prepared with HUMALOG U-100 are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours.
  ):
  • 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 (
  2.2 Administration Instructions for the Approved Routes of Administration

  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.
  • Rotate the injection site within the same region from one injection to the next (abdominal wall, thigh, upper arm, or buttocks) to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis
    [see Warnings and Precautions and Adverse Reactions ]
    .
  • During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring
    [see Warnings and Precautions ]
    .
  • 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, HUMALOG U-200 KwikPen, and HUMALOG U-200 Tempo Pen 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 dose of 30 units per injection.

  Subcutaneous Injection: Diluted HUMALOG U-100

  • HUMALOG U-100 may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection ONLY under medical supervision. Dilute one part HUMALOG U-100 to:
    • Nine parts diluent to yield a concentration one-tenth that of HUMALOG U-100 (equivalent to U-10).
    • One part diluent to yield a concentration one-half that of HUMALOG U-100 (equivalent to U-50).
  • Diluted HUMALOG for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and for 14 days at room temperature up to 86°F (30°C).

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

  • Do NOT administer HUMALOG U-200 using a continuous subcutaneous infusion pump.
  • Refer to the continuous subcutaneous insulin infusion pump user manual to see if HUMALOG can be used with the insulin pump. Use HUMALOG in accordance with the insulin pump system's instructions for use.
  • 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
    [see Warnings and Precautions and Adverse Reactions ]
    .
  • Train patients using continuous subcutaneous insulin infusion therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure
    [see Warnings and Precautions ].
  • During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring
    [see Warnings and Precautions ]
    .
  • Change HUMALOG U-100 in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter.
  • Change the infusion set and the infusion set insertion site according to the manufacturer's user manual.
  • Do NOT dilute or mix HUMALOG U-100 when administering by continuous subcutaneous infusion.
  • 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.
  • Administer HUMALOG U-100 intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia
    [see Warnings and Precautions ]
    .
  • Dilute HUMALOG U-100 to concentrations from 0.1 unit/mL to 1.0 unit/mL using 0.9% Sodium Chloride Injection, USP.
  • Infusion bags prepared with HUMALOG U-100 are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours.
  ):
  • 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. (
  2.3 Dosage Recommendations

  • 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.
  • When switching from another insulin to HUMALOG, a different dosage of HUMALOG may be needed
    [see Warnings and Precautions ]
    .
  • Dosage modifications 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
    [see Warnings and Precautions and Use in Specific Populations ]
    .
  • 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.
  )
• 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. (
  2.1 Important Administration Instructions

  • Always check insulin labels before administration
    [see Warnings and Precautions ]
    .
  • Inspect HUMALOG visually before use. It should appear clear and colorless. Do not use HUMALOG if particulate matter or coloration is seen.
  • Use HUMALOG prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
  • Do NOT mix HUMALOG U-100 with other insulins when using a continuous subcutaneous infusion pump.
  • Do NOT transfer HUMALOG U-200 from the prefilled pen to a syringe for administration
    [see Warnings and Precautions ]
    .
  • 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.
  ,
  2.3 Dosage Recommendations

  • 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.
  • When switching from another insulin to HUMALOG, a different dosage of HUMALOG may be needed
    [see Warnings and Precautions ]
    .
  • Dosage modifications 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
    [see Warnings and Precautions and Use in Specific Populations ]
    .
  • 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.
  )
• Do not mix HUMALOG U-200 with any other insulin. (
  2.4 Dosage Modifications for Drug Interactions

  Dosage modification may be needed when HUMALOG is used concomitantly with certain drugs

  [see Drug Interactions ]

  .
  )

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.