Novolog (Water Injection)

Check Drug InteractionsCheck known drug interactions.

Dosage & administration

See Full Prescribing Information for important preparation, administration, and dosage instructions (

2.1 Important Preparation and Administration Instructions

* •Always check insulin labels before administration

[see

Warnings and Precautions ]

.
* •Inspect NOVOLOG visually before use. It should appear clear and colorless. Do not use NOVOLOG if particulate matter or coloration is seen.
* •In patients with visual impairment, use:
* oNOVOLOG FlexPen and NOVOLOG FlexTouch with caution in those who may rely on audible clicks to dial their dose.
* oPenFill cartridges with caution.

* •Do

not

mix NOVOLOG with other insulins when administering using a continuous subcutaneous infusion pump.

* •

Subcutaneous injection (

2.2 Preparation and Administration Instructions for the Approved Routes of Administration

Subcutaneous Injection

* •Inject NOVOLOG subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
* •

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 [see Warnings and Precautions and Adverse Reactions].

* •Dial the NOVOLOG FlexPen and FlexTouch in 1-unit increments.

* •Generally use NOVOLOG (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin.
* •May dilute NOVOLOG with Insulin Diluting Medium for NOVOLOG for subcutaneous injection. Diluting one part NOVOLOG to:
* oNine parts diluent will yield a concentration one-tenth that of NOVOLOG (equivalent to U-10).
* oOne part diluent will yield a concentration one-half that of NOVOLOG (equivalent to U-50).

Continuous Subcutaneous Infusion (Insulin Pump)

* •Can use this NOVOLOG product with the continuous subcutaneous insulin infusion pumps labeled for use with NOVOLOG (insulin aspart). Refer to the insulin pump user manual to see if NOVOLOG can be used. Use NOVOLOG in accordance with the insulin pump system’s instructions for use.
* •Train patients using continuous subcutaneous insulin infusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
* •Administer NOVOLOG 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 or localized cutaneous amyloidosis

[see Warnings and Precautions and Adverse Reactions].

* •Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.
* •Change the NOVOLOG in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter. Follow the NOVOLOG-specific information for in-use time because NOVOLOG-specific information may differ from general pump manual instructions.
* •Change the infusion set and the infusion set insertion site according to the manufacturer’s user manual.
* •Do

not

dilute or mix NOVOLOG when administering by continuous subcutaneous infusion.
* •Do

not

expose NOVOLOG in the pump reservoir to temperatures greater than 98.6°F (37°C).

Intravenous Administration

* •Dilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. NOVOLOG is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP.
* •Administer NOVOLOG intravenously

only

under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia

[see Warnings and Precautions and How Supplied/Storage and Handling ]

* oInject subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
* oRotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
* oShould generally be used in regimens with an intermediate- or long-acting insulin.
* •

Continuous Subcutaneous Infusion (Insulin Pump) (

2.2 Preparation and Administration Instructions for the Approved Routes of Administration

Subcutaneous Injection

* •Inject NOVOLOG subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
* •

* •Dial the NOVOLOG FlexPen and FlexTouch in 1-unit increments.

Continuous Subcutaneous Infusion (Insulin Pump)

[see Warnings and Precautions and Adverse Reactions].

not

dilute or mix NOVOLOG when administering by continuous subcutaneous infusion.
* •Do

not

expose NOVOLOG in the pump reservoir to temperatures greater than 98.6°F (37°C).

Intravenous Administration

only

under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia

[see Warnings and Precautions and How Supplied/Storage and Handling ]

* oRefer to the insulin infusion pump user manual to see if NOVOLOG can be used. Use in accordance with the insulin pump instructions for use.
* oAdminister by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer.
* oRotate the injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.

* oDo not mix with other insulins or diluents in the pump.
* •

Intravenous Administration (

2.2 Preparation and Administration Instructions for the Approved Routes of Administration

Subcutaneous Injection

* •Inject NOVOLOG subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
* •

* •Dial the NOVOLOG FlexPen and FlexTouch in 1-unit increments.

Continuous Subcutaneous Infusion (Insulin Pump)

[see Warnings and Precautions and Adverse Reactions].

not

dilute or mix NOVOLOG when administering by continuous subcutaneous infusion.
* •Do

not

expose NOVOLOG in the pump reservoir to temperatures greater than 98.6°F (37°C).

Intravenous Administration

only

under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia

[see Warnings and Precautions and How Supplied/Storage and Handling ]

)

:
* oDilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags.
* oNOVOLOG is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP.
* •Individualize and adjust the dosage of NOVOLOG based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal (

2.4 Dosage Modifications for Drug Interactions

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

[see Drug Interactions ]

).
* •Dosage adjustments 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 (

2.4 Dosage Modifications for Drug Interactions

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

[see Drug Interactions ]

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Novolog prescribing information

See Full Prescribing Information for important preparation, administration, and dosage instructions (

2.1 Important Preparation and Administration Instructions

•Always check insulin labels before administration
[see
Warnings and Precautions ]
.
•Inspect NOVOLOG visually before use. It should appear clear and colorless. Do not use NOVOLOG if particulate matter or coloration is seen.
•In patients with visual impairment, use:
- oNOVOLOG FlexPen and NOVOLOG FlexTouch with caution in those who may rely on audible clicks to dial their dose.
- oPenFill cartridges with caution.
•Do
not
mix NOVOLOG with other insulins when administering using a continuous subcutaneous infusion pump.

•
Subcutaneous injection (
2.2 Preparation and Administration Instructions for the Approved Routes of Administration
Subcutaneous Injection
•Inject NOVOLOG subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
•
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 [see Warnings and Precautions and Adverse Reactions].
•Dial the NOVOLOG FlexPen and FlexTouch in 1-unit increments.
•Generally use NOVOLOG (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin.
•May dilute NOVOLOG with Insulin Diluting Medium for NOVOLOG for subcutaneous injection. Diluting one part NOVOLOG to:
oNine parts diluent will yield a concentration one-tenth that of NOVOLOG (equivalent to U-10).
oOne part diluent will yield a concentration one-half that of NOVOLOG (equivalent to U-50).
Continuous Subcutaneous Infusion (Insulin Pump)
•Can use this NOVOLOG product with the continuous subcutaneous insulin infusion pumps labeled for use with NOVOLOG (insulin aspart). Refer to the insulin pump user manual to see if NOVOLOG can be used. Use NOVOLOG in accordance with the insulin pump system’s instructions for use.
•Train patients using continuous subcutaneous insulin infusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
•Administer NOVOLOG 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 or localized cutaneous amyloidosis
[see Warnings and Precautions and Adverse Reactions].
•Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.
•Change the NOVOLOG in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter. Follow the NOVOLOG-specific information for in-use time because NOVOLOG-specific information may differ from general pump manual instructions.
•Change the infusion set and the infusion set insertion site according to the manufacturer’s user manual.
•Do
not
dilute or mix NOVOLOG when administering by continuous subcutaneous infusion.
•Do
not
expose NOVOLOG in the pump reservoir to temperatures greater than 98.6°F (37°C).
Intravenous Administration
•Dilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. NOVOLOG is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP.
•Administer NOVOLOG intravenously
only
under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia
[see Warnings and Precautions and How Supplied/Storage and Handling ]
.
):
oInject subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
oRotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
oShould generally be used in regimens with an intermediate- or long-acting insulin.
•
Continuous Subcutaneous Infusion (Insulin Pump) (
2.2 Preparation and Administration Instructions for the Approved Routes of Administration
Subcutaneous Injection
•Inject NOVOLOG subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
•
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 [see Warnings and Precautions and Adverse Reactions].
•Dial the NOVOLOG FlexPen and FlexTouch in 1-unit increments.
•Generally use NOVOLOG (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin.
•May dilute NOVOLOG with Insulin Diluting Medium for NOVOLOG for subcutaneous injection. Diluting one part NOVOLOG to:
oNine parts diluent will yield a concentration one-tenth that of NOVOLOG (equivalent to U-10).
oOne part diluent will yield a concentration one-half that of NOVOLOG (equivalent to U-50).
Continuous Subcutaneous Infusion (Insulin Pump)
•Can use this NOVOLOG product with the continuous subcutaneous insulin infusion pumps labeled for use with NOVOLOG (insulin aspart). Refer to the insulin pump user manual to see if NOVOLOG can be used. Use NOVOLOG in accordance with the insulin pump system’s instructions for use.
•Train patients using continuous subcutaneous insulin infusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
•Administer NOVOLOG 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 or localized cutaneous amyloidosis
[see Warnings and Precautions and Adverse Reactions].
•Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.
•Change the NOVOLOG in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter. Follow the NOVOLOG-specific information for in-use time because NOVOLOG-specific information may differ from general pump manual instructions.
•Change the infusion set and the infusion set insertion site according to the manufacturer’s user manual.
•Do
not
dilute or mix NOVOLOG when administering by continuous subcutaneous infusion.
•Do
not
expose NOVOLOG in the pump reservoir to temperatures greater than 98.6°F (37°C).
Intravenous Administration
•Dilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. NOVOLOG is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP.
•Administer NOVOLOG intravenously
only
under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia
[see Warnings and Precautions and How Supplied/Storage and Handling ]
.
):
oRefer to the insulin infusion pump user manual to see if NOVOLOG can be used. Use in accordance with the insulin pump instructions for use.
- oAdminister by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer.
- oRotate the injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
oDo not mix with other insulins or diluents in the pump.
•
Intravenous Administration (
2.2 Preparation and Administration Instructions for the Approved Routes of Administration
Subcutaneous Injection
•Inject NOVOLOG subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
•
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 [see Warnings and Precautions and Adverse Reactions].
•Dial the NOVOLOG FlexPen and FlexTouch in 1-unit increments.
•Generally use NOVOLOG (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin.
•May dilute NOVOLOG with Insulin Diluting Medium for NOVOLOG for subcutaneous injection. Diluting one part NOVOLOG to:
oNine parts diluent will yield a concentration one-tenth that of NOVOLOG (equivalent to U-10).
oOne part diluent will yield a concentration one-half that of NOVOLOG (equivalent to U-50).
Continuous Subcutaneous Infusion (Insulin Pump)
•Can use this NOVOLOG product with the continuous subcutaneous insulin infusion pumps labeled for use with NOVOLOG (insulin aspart). Refer to the insulin pump user manual to see if NOVOLOG can be used. Use NOVOLOG in accordance with the insulin pump system’s instructions for use.
•Train patients using continuous subcutaneous insulin infusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
•Administer NOVOLOG 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 or localized cutaneous amyloidosis
[see Warnings and Precautions and Adverse Reactions].
•Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.
•Change the NOVOLOG in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter. Follow the NOVOLOG-specific information for in-use time because NOVOLOG-specific information may differ from general pump manual instructions.
•Change the infusion set and the infusion set insertion site according to the manufacturer’s user manual.
•Do
not
dilute or mix NOVOLOG when administering by continuous subcutaneous infusion.
•Do
not
expose NOVOLOG in the pump reservoir to temperatures greater than 98.6°F (37°C).
Intravenous Administration
•Dilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. NOVOLOG is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP.
•Administer NOVOLOG intravenously
only
under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia
[see Warnings and Precautions and How Supplied/Storage and Handling ]
.
)
:
oDilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags.
oNOVOLOG is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP.
•Individualize and adjust the dosage of NOVOLOG based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal (
2.4 Dosage Modifications for Drug Interactions
Dosage modification may be needed when NOVOLOG is used concomitantly with certain drugs
[see Drug Interactions ]
.
).
•Dosage adjustments 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 (
2.4 Dosage Modifications for Drug Interactions
Dosage modification may be needed when NOVOLOG is used concomitantly with certain drugs
[see Drug Interactions ]
.
).

Risk Summary

Available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes

[see Data]

. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy

[see Clinical Considerations]

In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. Pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. These effects were similar to those observed in rats administered regular human insulin

[see Data]

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. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a periconceptional HbA_1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptional HbA_1c >10%. The estimated background risk of miscarriage for the indicated population is unknown.

Clinical Considerations

Disease-Associated Maternal and/or Embryo-Fetal Risk

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

Data

Human Data

Published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart during the late 2^nd trimester of pregnancy did not identify an association of insulin aspart with major birth defects or adverse maternal or fetal outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials.

Animal Data

Fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. In a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. Further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats. In an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. The effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. Insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents). No significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. The effects are considered secondary to maternal hypoglycemia.

NOVOLOG is contraindicated:

•During episodes of hypoglycemia
[see
5 WARNINGS AND PRECAUTIONS
•
Never share
a NOVOLOG FlexPen or a NOVOLOG FlexTouch, PenFill cartridge or PenFill cartridge device between patients, even if the needle is changed .
•
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 blood glucose monitoring .
•
Hypoglycemia:
May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness .
•
Hypokalemia:
May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated .
•
Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction:
Monitor glucose and administer NOVOLOG by subcutaneous injection if pump malfunction occurs .
5.1 Never Share a NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill Cartridge, or PenFill Cartridge Device between Patients
NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill cartridge, and PenFill cartridge devices should never be shared between patients, even if the needle is changed. Patients using NOVOLOG vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia
[see Warnings and Precautions]
or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia
[see Adverse Reactions(
6.1
, 6.3)].
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
5.3 Hypoglycemia
Hypoglycemia is the most common adverse reaction of all insulins, including NOVOLOG. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers)
[see Drug Interactions (7)]
, or in patients who experience recurrent hypoglycemia.
Risk Factors for Hypoglycemia
The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of NOVOLOG may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature
[see Clinical Pharmacology]
. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitantly administered medication [
see Drug Interactions (7)]
. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia
[see Use in Specific Populations].
Risk Mitigation Strategies for Hypoglycemia
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia; increased frequency of blood glucose monitoring is recommended. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia; increased frequency of blood glucose monitoring is recommended.
5.4 Hypoglycemia Due to Medication Errors
Accidental mix-ups between insulin products have been reported. To avoid medication errors between NOVOLOG and other insulins, instruct patients to always check the insulin label before each injection.
5.5 Hypersensitivity Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including NOVOLOG. If hypersensitivity reactions occur, discontinue NOVOLOG; treat per standard of care and monitor until symptoms and signs resolve
[see Adverse Reactions (6)].
NOVOLOG is contraindicated in patients who have had hypersensitivity reactions to insulin aspart or one of the excipients
[see Contraindications (4)].
5.6 Hypokalemia
All insulins, including NOVOLOG, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration).
5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including NOVOLOG, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
5.8 Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction
Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim subcutaneous injections with NOVOLOG may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure
[see How Supplied/Storage and Handling and Patient Counseling Information]
.
(
5.3 Hypoglycemia
Hypoglycemia is the most common adverse reaction of all insulins, including NOVOLOG. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers)
[see Drug Interactions (7)]
, or in patients who experience recurrent hypoglycemia.
Risk Factors for Hypoglycemia
The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of NOVOLOG may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature
[see Clinical Pharmacology]
. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitantly administered medication [
see Drug Interactions (7)]
. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia
[see Use in Specific Populations].
Risk Mitigation Strategies for Hypoglycemia
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia; increased frequency of blood glucose monitoring is recommended. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia; increased frequency of blood glucose monitoring is recommended.
)]
•In patients with hypersensitivity to NOVOLOG or one of its excipients,
[see
5 WARNINGS AND PRECAUTIONS
•
Never share
a NOVOLOG FlexPen or a NOVOLOG FlexTouch, PenFill cartridge or PenFill cartridge device between patients, even if the needle is changed .
•
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 blood glucose monitoring .
•
Hypoglycemia:
May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness .
•
Hypokalemia:
May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated .
•
Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction:
Monitor glucose and administer NOVOLOG by subcutaneous injection if pump malfunction occurs .
5.1 Never Share a NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill Cartridge, or PenFill Cartridge Device between Patients
NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill cartridge, and PenFill cartridge devices should never be shared between patients, even if the needle is changed. Patients using NOVOLOG vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia
[see Warnings and Precautions]
or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia
[see Adverse Reactions(
6.1
, 6.3)].
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
5.3 Hypoglycemia
Hypoglycemia is the most common adverse reaction of all insulins, including NOVOLOG. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers)
[see Drug Interactions (7)]
, or in patients who experience recurrent hypoglycemia.
Risk Factors for Hypoglycemia
The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of NOVOLOG may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature
[see Clinical Pharmacology]
. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitantly administered medication [
see Drug Interactions (7)]
. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia
[see Use in Specific Populations].
Risk Mitigation Strategies for Hypoglycemia
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia; increased frequency of blood glucose monitoring is recommended. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia; increased frequency of blood glucose monitoring is recommended.
5.4 Hypoglycemia Due to Medication Errors
Accidental mix-ups between insulin products have been reported. To avoid medication errors between NOVOLOG and other insulins, instruct patients to always check the insulin label before each injection.
5.5 Hypersensitivity Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including NOVOLOG. If hypersensitivity reactions occur, discontinue NOVOLOG; treat per standard of care and monitor until symptoms and signs resolve
[see Adverse Reactions (6)].
NOVOLOG is contraindicated in patients who have had hypersensitivity reactions to insulin aspart or one of the excipients
[see Contraindications (4)].
5.6 Hypokalemia
All insulins, including NOVOLOG, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration).
5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including NOVOLOG, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
5.8 Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction
Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim subcutaneous injections with NOVOLOG may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure
[see How Supplied/Storage and Handling and Patient Counseling Information]
.
(
5.5 Hypersensitivity Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including NOVOLOG. If hypersensitivity reactions occur, discontinue NOVOLOG; treat per standard of care and monitor until symptoms and signs resolve
[see Adverse Reactions (6)].
NOVOLOG is contraindicated in patients who have had hypersensitivity reactions to insulin aspart or one of the excipients
[see Contraindications (4)].
)]

•
Never share
a NOVOLOG FlexPen or a NOVOLOG FlexTouch, PenFill cartridge or PenFill cartridge device between patients, even if the needle is changed (
5.1 Never Share a NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill Cartridge, or PenFill Cartridge Device between Patients
NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill cartridge, and PenFill cartridge devices should never be shared between patients, even if the needle is changed. Patients using NOVOLOG vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
).
•
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 blood glucose monitoring (
5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia
[see Warnings and Precautions]
or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia
[see Adverse Reactions(
6.1
, 6.3)].
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
).
•
Hypoglycemia:
May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness (
5.4 Hypoglycemia Due to Medication Errors
Accidental mix-ups between insulin products have been reported. To avoid medication errors between NOVOLOG and other insulins, instruct patients to always check the insulin label before each injection.
3).
•
Medication Errors:
Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection (
5.5 Hypersensitivity Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including NOVOLOG. If hypersensitivity reactions occur, discontinue NOVOLOG; treat per standard of care and monitor until symptoms and signs resolve
[see Adverse Reactions (6)].
NOVOLOG is contraindicated in patients who have had hypersensitivity reactions to insulin aspart or one of the excipients
[see Contraindications (4)].
4).
•
Hypersensitivity reactions:
Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. Discontinue NOVOLOG, treat, and monitor, if indicated (
5.5 Hypersensitivity Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including NOVOLOG. If hypersensitivity reactions occur, discontinue NOVOLOG; treat per standard of care and monitor until symptoms and signs resolve
[see Adverse Reactions (6)].
NOVOLOG is contraindicated in patients who have had hypersensitivity reactions to insulin aspart or one of the excipients
[see Contraindications (4)].
).
•
Hypokalemia:
May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated and Patient Counseling Information]

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