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Insulin Aspart

INSULIN ASPART

Standard Dose

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important preparation, administration, and dosage instructions ( 2.1, 2.2, 2.3, 2.4, 2.5 ). Subcutaneous injection ( 2.2 ): Inject 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 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) ( 2.2 ): Refer to the insulin infusion pump user manual to see if NovoLog (insulin aspart) can be used. Use in accordance with the insulin pump instructions for use. Administer by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate the injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not mix with other insulins or diluents in the pump. Intravenous Administration ( 2.2 ) : Dilute Insulin Aspart to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. Insulin Aspart is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP. Individualize and adjust the dosage of Insulin Aspart based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.4 ). 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 ). 2.1 Important Preparation and Administration Instructions Always check insulin labels before administration. This product is NovoLog (insulin aspart) [see Warnings and Precautions ( 5.4 )] . Inspect Insulin Aspart visually before use. It should appear clear and colorless. Do not use Insulin Aspart if particulate matter or coloration is seen. In patients with visual impairment, use: Insulin Aspart FlexPen with caution in those who may rely on audible clicks to dial their dose. PenFill cartridges with caution. Do not mix Insulin Aspart with other insulins when administering using a continuous subcutaneous infusion pump. 2.2 Preparation and Administration Instructions for the Approved Routes of Administration Subcutaneous Injection Inject Insulin Aspart 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 ( 5.2 ) and Adverse Reactions ( 6.1 , 6.3 )]. Dial the Insulin Aspart FlexPen dials in 1-unit increments. Generally use Insulin Aspart (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin. May dilute this Insulin Aspart product with Insulin Diluting Medium for NovoLog for subcutaneous injection. Diluting one part Insulin Aspart to: Nine parts diluent will yield a concentration one-tenth that of Insulin Aspart (equivalent to U-10). One part diluent will yield a concentration one-half that of Insulin Aspart (equivalent to U-50). Continuous Subcutaneous Infusion (Insulin Pump) Can use this Insulin Aspart 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 Insulin Aspart 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 Insulin Aspart 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 (5.2) and Adverse Reactions (6.1, 6.3)]. Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate. Change the Insulin Aspart 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 Insulin Aspart when administering by continuous subcutaneous infusion. Do not expose Insulin Aspart in the pump reservoir to temperatures greater than 98.6°F (37°C). Intravenous Administration Administer Insulin Aspart intravenously only under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6) and How Supplied/Storage and Handling (16.2)]. Dilute Insulin Aspart to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. Insulin Aspart is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP. 2.3 Dosage Recommendations Individualize the dosage of Insulin Aspart based on the route of administration, the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal. 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 [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.6 , 8.7 )] . When switching from another insulin to Insulin Aspart, a different dosage of Insulin Aspart may be needed [see Warnings and Precautions ( 5.2 )] . During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)]. 2.4 Dosage Modifications for Drug Interactions Dosage modification may be needed when Insulin Aspart is used concomitantly with certain drugs [see Drug Interactions (7)] . 2.5 Instructions for Mixing Insulin Aspart with Other Insulins The table below includes instructions regarding mixing Insulin Aspart with other insulins. Subcutaneous injection route Insulin Aspart may only be mixed with NPH insulin preparations. • If Insulin Aspart is mixed with NPH insulin, withdraw Insulin Aspart into the syringe first and inject immediately after mixing. Continuous subcutaneous infusion route (Insulin Pump) Do not mix Insulin Aspart with any other insulin.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Insulin Aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Summary

Indications and usage 1 INDICATIONS AND USAGE Insulin Aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Insulin Aspart is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Insulin Aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Insulin Aspart is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ). Dosage and administration 2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important preparation, administration, and dosage instructions ( 2.1, 2.2, 2.3, 2.4, 2.5 ). Subcutaneous injection ( 2.2 ): Inject 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 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) ( 2.2 ): Refer to the insulin infusion pump user manual to see if NovoLog (insulin aspart) can be used. Use in accordance with the insulin pump instructions for use. Administer by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate the injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not mix with other insulins or diluents in the pump. Intravenous Administration ( 2.2 ) : Dilute Insulin Aspart to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. Insulin Aspart is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP. Individualize and adjust the dosage of Insulin Aspart based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.4 ). 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 ). 2.1 Important Preparation and Administration Instructions Always check insulin labels before administration. This product is NovoLog (insulin aspart) [see Warnings and Precautions ( 5.4 )] . Inspect Insulin Aspart visually before use. It should appear clear and colorless. Do not use Insulin Aspart if particulate matter or coloration is seen. In patients with visual impairment, use: Insulin Aspart FlexPen with caution in those who may rely on audible clicks to dial their dose. PenFill cartridges with caution. Do not mix Insulin Aspart with other insulins when administering using a continuous subcutaneous infusion pump. 2.2 Preparation and Administration Instructions for the Approved Routes of Administration Subcutaneous Injection Inject Insulin Aspart 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 ( 5.2 ) and Adverse Reactions ( 6.1 , 6.3 )]. Dial the Insulin Aspart FlexPen dials in 1-unit increments. Generally use Insulin Aspart (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin. May dilute this Insulin Aspart product with Insulin Diluting Medium for NovoLog for subcutaneous injection. Diluting one part Insulin Aspart to: Nine parts diluent will yield a concentration one-tenth that of Insulin Aspart (equivalent to U-10). One part diluent will yield a concentration one-half that of Insulin Aspart (equivalent to U-50). Continuous Subcutaneous Infusion (Insulin Pump) Can use this Insulin Aspart 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 Insulin Aspart 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 Insulin Aspart 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 (5.2) and Adverse Reactions (6.1, 6.3)]. Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate. Change the Insulin Aspart 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 ge

Monitoring

• 5 WARNINGS AND PRECAUTIONS Never share a Insulin Aspart FlexPen, PenFill cartridge or PenFill cartridge device 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 blood glucose monitoring ( 5.2 ).
• 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.

Interaction Notes

• 7 DRUG INTERACTIONS The table below presents clinically significant drug interactions with Insulin Aspart.
• 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, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics.
• Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Insulin Aspart is concomitantly administered with these drugs.
• Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Aspart Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.