Drug Detail:Novolog flexpen (Insulin aspart [ in-su-lin-as-part ])
Drug Class: Insulin
Usual Adult Dose for Diabetes Type 1
Individualize dose based on metabolic needs, blood glucose monitoring results, and glycemic goal
- Total daily insulin requirement is generally between 0.4 to 1 unit/kg/day with approximately 50% provided as prandial insulin (e.g., mealtime or bolus) to control blood glucose after meals and the other half as basal insulin to control glycemia in the periods between meal absorption:
Multiple-daily injection (MDI):
- Use insulin aspart in combination with an intermediate-acting or long-acting basal insulin
ADMINISTRATION:
- Insulin aspart (Novolog): Administer subcutaneously within 5 to 10 minutes before a meal
- Insulin aspart with nicotinamide (Fiasp): Administer at the start of a meal or within 20 minutes after starting a meal
Continuous Subcutaneous Infusion (Insulin Pump):
- Initial pump programming (e.g. basal rates and bolus dosing) should be based on the patients total daily insulin dose requirement
- The basal rate is programmed to deliver approximately 50% of the daily insulin requirement; many pumps allow for multiple basal rates to be stored and the patient can adjust or choose their basal rate depending on daily activities, medical illness, or other factors
- Meal time bolus doses and correction doses are calculated and delivered by the patient to cover carbohydrate intake and correct high blood glucose levels, respectively
- Basal and bolus programming is adjusted as needed
- Patients using insulin pump therapy should have alternate insulin therapy available in case of pump failure
Intravenous Administration: To be Administered Under Medical Supervision:
- Insulin aspart (Novolog): Dilute to a concentration of 0.05 to 1 unit/mL in an infusion system using polypropylene infusion bags
- Insulin aspart with nicotinamide (Fiasp): Dilute to a concentration of 0.5 to 1 unit/mL in infusion system using polypropylene infusion bags
- Closely monitor blood glucose and serum potassium during administration
Comments:
- Most patients with type 1 diabetes are treated with intensive insulin regimens via multiple daily subcutaneous injections or continuous subcutaneous insulin infusions, insulin requirements can be estimated based on weight, however, higher amounts are required during puberty, pregnancy, and medical illness.
- As with all insulins, the effect of this insulin may vary in different individuals or at different times in the same individual; many factors influence insulin's effects such as injection site, content or timing of meals, changes in level of physical activity, or changes to co-administered medication.
- The difference between insulin aspart (Novolog) and insulin aspart with nicotinamide (Fiasp) is their time-action profile; dosing is the same, but administration time in relation to meals is different.
- The addition of nicotinamide to insulin aspart results in faster initial absorption which is evidenced by greater glucose-lowering, particularly in the first 30 minutes compared to insulin aspart.
- Frequent blood glucose monitoring is necessary to avoid hyper and hypoglycemia; HbA1c values are necessary to guide therapy; consult current guidelines for optimal target ranges.
Use: To improve glycemic control in adult patients with diabetes mellitus.
Usual Adult Dose for Diabetes Type 2
Individualize dose based on metabolic needs, blood glucose monitoring results, and glycemic goal
Prandial Insulin:
Initial dose: 4 units (or 10% of basal dose) subcutaneously with largest meal of the day (or meal with greatest post prandial glucose excursion)
- Titrate with additional injections of prandial insulin (i.e., 2, then 3) with meals; titrate dose based on glycemic goals
- Insulin aspart (Novolog): Administer subcutaneously within 5 to 10 minutes before a meal
- Insulin aspart with nicotinamide (Fiasp): Administer subcutaneously at the start of a meal or within 20 minutes after starting a meal
Continuous Subcutaneous Infusion (Insulin Pump):
- Initial pump programming (e.g. basal rates and bolus dosing) should be based on the patients total daily insulin dose requirement
- The basal rate is programmed to deliver approximately 50% of the daily insulin requirement; many pumps allow for multiple basal rates to be stored and the patient can adjust or chose their basal rate depending on daily activities, medical illness, or other factors
- Meal time bolus doses and correction doses are calculated and delivered by the patient to cover carbohydrate intake and correct high blood glucose levels, respectively
- Basal and bolus programming is adjusted as needed
- Patients using insulin pump therapy should have alternate insulin therapy available in case of pump failure
Intravenous Administration: To be Administered Under Medical Supervision:
- Insulin aspart (Novolog): Dilute to a concentration of 0.05 to 1 unit/mL in an infusion system using polypropylene infusion bags
- Insulin aspart with nicotinamide (Fiasp): Dilute to a concentration of 0.5 to 1 unit/mL in infusion system using polypropylene infusion bags
- Closely monitor blood glucose and serum potassium during administration
Comments:
- For treating type 2 diabetes, the major diabetes organizations recommend a patient-centered approach to choosing appropriate pharmacologic treatment; specifically, the early introduction of insulin is recommended when there is evidence of ongoing catabolism (weight loss), symptoms of hyperglycemia, or very high HbA1c or blood glucose levels (i.e., 10% or greater or 300 mg/dL or greater, respectively).
- The stepwise introduction of prandial insulin appears to lower the risk of hypoglycemia and increases patient's satisfaction compared with the immediate introduction of a full basal-bolus regimen.
- As with all insulins, the effect of this insulin may vary in different individuals or at different times in the same individual; many factors influence insulin's effects such as injection site, content or timing of meals, changes in level of physical activity, or changes to co-administered medication.
- The difference between insulin aspart (Novolog) and insulin aspart with nicotinamide (Fiasp) is their time-action profile; dosing is the same, but administration time in relation to meals is different.
- The addition of nicotinamide to insulin aspart results in faster initial absorption which is evidenced by greater glucose-lowering, particularly in the first 30 minutes compared to insulin aspart.
- Frequent blood glucose monitoring is necessary to avoid hyper and hypoglycemia; HbA1c values are necessary to guide therapy; consult current guidelines for optimal target ranges
Use: To improve glycemic control in patients with diabetes mellitus.
Usual Adult Dose for Diabetic Ketoacidosis
Successful treatment of hyperglycemic emergencies such as diabetic ketoacidosis (DKA) and hyperosmolar state (HHS) requires frequent monitoring of clinical and laboratory parameters while carefully correcting volume deficits, managing electrolytes, and normalizing blood glucose.
Insulin therapy is used to slowly correct high glucose levels; consult current treatment protocols for specific guidance on fluid and electrolyte management.
Intravenous:
- IV insulin infusion is generally started 1 to 2 hours after initiating fluid replacement therapy
- Dose: 0.14 unit/kg/hour IV; alternatively, a bolus of 0.1 unit/kg followed by an infusion of 0.1 unit/kg/hr has been used
- If blood glucose has not fallen by 10% in first hour, give bolus of 0.14 units/kg while continuing insulin infusion
DKA: When blood glucose concentration reaches 200 mg/dL, decrease the insulin infusion to 0.02 to 0.05 unit/kg/hr; dextrose should be added to the IV fluids to maintain a blood glucose between 150 and 200 mg/dL until resolution of DKA (serum bicarbonate level 15 mEq/L or greater, venous pH greater than 7.3, and a calculated anion gap in the normal range)
HHS: When blood glucose concentration reaches 300 mg/dL or less, decrease the insulin infusion to 0.02 to 0.05 unit/kg/hr; dextrose should be added to the IV fluids to maintain blood glucose between 250 and 300 mg/dL until resolution of HHS
Subcutaneous:
- Rapid acting insulin analogs (lispro, aspart, and glulisine) have been used in studies for the treatment of uncomplicated mild to moderate DKA
- Initial dose of 0.2 unit/kg followed by 0.1 unit/kg every hour subcutaneously until blood glucose decreased below 250 mg/dL, then 0.05 unit/kg every hour until DKA resolved
- Initial dose of 0.3 units/kg followed by 0.2 unit/kg every 2 hours until blood glucose decreased below 250 mg/dL, then 0.1 unit/kg every 2 hours until DKA resolved
Comments:
- An endocrinologist or critical care specialist with training and expertise in the management of DKA or HHS should direct care; frequent monitoring of clinical and laboratory parameter is necessary as well as identification and correction of precipitating event.
- Starting insulin therapy before IV fluid replacement may precipitate shock, and increase the risk of hypokalemia and cerebral edema.
- To prevent rebound hyperglycemia, initiate subcutaneous insulin 15 to 30 minutes (rapid-acting) or 1 to 2 hours (regular insulin) before stopping the insulin infusion; alternatively, basal insulin may be administered in the evening and the insulin infusion stopped the next morning.
Use: Treatment of hyperglycemic emergencies.
Usual Adult Dose for Nonketotic Hyperosmolar Syndrome
Successful treatment of hyperglycemic emergencies such as diabetic ketoacidosis (DKA) and hyperosmolar state (HHS) requires frequent monitoring of clinical and laboratory parameters while carefully correcting volume deficits, managing electrolytes, and normalizing blood glucose.
Insulin therapy is used to slowly correct high glucose levels; consult current treatment protocols for specific guidance on fluid and electrolyte management.
Intravenous:
- IV insulin infusion is generally started 1 to 2 hours after initiating fluid replacement therapy
- Dose: 0.14 unit/kg/hour IV; alternatively, a bolus of 0.1 unit/kg followed by an infusion of 0.1 unit/kg/hr has been used
- If blood glucose has not fallen by 10% in first hour, give bolus of 0.14 units/kg while continuing insulin infusion
DKA: When blood glucose concentration reaches 200 mg/dL, decrease the insulin infusion to 0.02 to 0.05 unit/kg/hr; dextrose should be added to the IV fluids to maintain a blood glucose between 150 and 200 mg/dL until resolution of DKA (serum bicarbonate level 15 mEq/L or greater, venous pH greater than 7.3, and a calculated anion gap in the normal range)
HHS: When blood glucose concentration reaches 300 mg/dL or less, decrease the insulin infusion to 0.02 to 0.05 unit/kg/hr; dextrose should be added to the IV fluids to maintain blood glucose between 250 and 300 mg/dL until resolution of HHS
Subcutaneous:
- Rapid acting insulin analogs (lispro, aspart, and glulisine) have been used in studies for the treatment of uncomplicated mild to moderate DKA
- Initial dose of 0.2 unit/kg followed by 0.1 unit/kg every hour subcutaneously until blood glucose decreased below 250 mg/dL, then 0.05 unit/kg every hour until DKA resolved
- Initial dose of 0.3 units/kg followed by 0.2 unit/kg every 2 hours until blood glucose decreased below 250 mg/dL, then 0.1 unit/kg every 2 hours until DKA resolved
Comments:
- An endocrinologist or critical care specialist with training and expertise in the management of DKA or HHS should direct care; frequent monitoring of clinical and laboratory parameter is necessary as well as identification and correction of precipitating event.
- Starting insulin therapy before IV fluid replacement may precipitate shock, and increase the risk of hypokalemia and cerebral edema.
- To prevent rebound hyperglycemia, initiate subcutaneous insulin 15 to 30 minutes (rapid-acting) or 1 to 2 hours (regular insulin) before stopping the insulin infusion; alternatively, basal insulin may be administered in the evening and the insulin infusion stopped the next morning.
Use: Treatment of hyperglycemic emergencies.
Usual Adult Dose for Hyperkalemia
10 units IV bolus
Comments:
- Due to the urgency of treatment and risks associated with potential errors in insulin administration, standard hyperkalemia protocols should be available and followed.
- Protocols should specify insulin type, dose, and route of administration, how to flush IV line or access site (to ensure small volume has been fully administered); concomitant dextrose concentration, volume, and route of administration; and specific doses and administration for all other pharmacological interventions.
- Following insulin administration, adequate glucose monitoring will be necessary for several hours.
Use: For the treatment of hyperkalemia.
Usual Pediatric Dose for Diabetes Type 1
Individualize dose based on metabolic needs and frequent monitoring of blood glucose
2 years and older:
Total daily insulin requirement is generally between 0.4 to 1 unit/kg/day with approximately 50% provided as prandial insulin (e.g., mealtime or bolus) to control blood glucose after meals and the other half as basal insulin to control glycemia in the periods between meal absorption:
Multiple-daily injection (MDI):
- Use insulin aspart in combination with an intermediate-acting or long-acting basal insulin
ADMINISTRATION:
- Insulin aspart (Novolog): Administer subcutaneously within 5 to 10 minutes before a meal
- Insulin aspart with nicotinamide (Fiasp): Administer at the start of a meal or within 20 minutes after starting a meal
Continuous Subcutaneous Infusion (Insulin Pump):
- Initial pump programming (e.g. basal rates and bolus dosing) should be based on the patients total daily insulin dose requirement
- The basal rate is programmed to deliver approximately 50% of the daily insulin requirement; many pumps allow for multiple basal rates to be stored and the patient can adjust or choose their basal rate depending on daily activities, medical illness, or other factors
- Meal time bolus doses and correction doses are calculated and delivered by the patient to cover carbohydrate intake and correct high blood glucose levels, respectively
- Basal and bolus programming is adjusted as needed
- Patients using insulin pump therapy should have alternate insulin therapy available in case of pump failure
Intravenous Administration: To be Administered Under Medical Supervision:
- Insulin aspart (Novolog): Dilute to a concentration of 0.05 to 1 unit/mL in an infusion system using polypropylene infusion bags
- Insulin aspart with nicotinamide (Fiasp): Dilute to a concentration of 0.5 to 1 unit/mL in infusion system using polypropylene infusion bags
- Closely monitor blood glucose and serum potassium during administration
Comments:
- Most patients with type 1 diabetes are treated with intensive insulin regimens via multiple daily subcutaneous injections or continuous subcutaneous insulin infusions, insulin requirements can be estimated based on weight, however, higher amounts are required during puberty, pregnancy, and medical illness.
- As with all insulins, the effect of this insulin may vary in different individuals or at different times in the same individual; many factors influence insulin's effects such as injection site, content or timing of meals, changes in level of physical activity, or changes to co-administered medication.
- The difference between insulin aspart (Novolog) and insulin aspart with nicotinamide (Fiasp) is the time-action profile; dosing is the same, but administration time in relation to meals is different.
- The addition of nicotinamide to insulin aspart results in faster initial absorption which is evidenced by greater glucose-lowering, particularly in the first 30 minutes compared to insulin aspart.
- Frequent blood glucose monitoring is necessary to avoid hyper and hypoglycemia; HbA1c values are necessary to guide therapy; consult current guidelines for optimal target ranges.
Use: To improve glycemic control in pediatric patients 2 years or older with type 1 diabetes mellitus.
Renal Dose Adjustments
Use with caution; frequent glucose monitoring and insulin dose adjustments may be required
Liver Dose Adjustments
Use with caution; frequent glucose monitoring and insulin dose adjustments may be required
Dose Adjustments
Additional monitoring is recommended when brand, type, or species of insulin is changed; insulin doses and/or oral antidiabetic treatment may need to be adjusted
- Daily insulin requirements may be higher during illness, stress, pregnancy, in obese patients, trauma, during concurrent use with medications having hyperglycemic effects, or after surgery
- Daily insulin requirements may be lower with exercise, weight loss, calorie restricted diets, or during concurrent use of medications having hypoglycemic effects.
Supplemental doses may be prescribed during illness
Patients with type 2 diabetes receiving oral medications may be switched to insulin therapy temporarily.
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to insulin aspart or any of the product excipients
- During episodes of hypoglycemia
Safety and efficacy of insulin aspart have not been established in patients younger than 2 years.
Safety and efficacy of insulin aspart have not been established in patients younger than 18 years with type 2 diabetes mellitus.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- May be administered IV or subcutaneously
- Never share an insulin pen between patients (even if the needle is changed) and do not reuse or share needles or syringes between patients when using vials as this presents a risk for transmission of blood-borne pathogens
Multiple-daily injections:
- Administer subcutaneously into the abdomen, buttocks, thigh, or upper arm
- Novolog should be administered within 5 to 10 minutes before a meal
- Fiasp should be administered at the start of a meal or within 20 minutes after starting a meal
- Rotate injection sites within same region to reduce the risk of lipodystrophy
- Ensure patients/caregivers have been trained on proper injection technique
- Use prefilled pens with caution in patients with visual impairment, especially those that may rely on audible clicks to dial dose
Missed doses: For patients on basal-bolus treatment who miss a mealtime dose, monitor blood glucose levels to determine if an insulin dose is needed; resume usual dosing at next meal
Reconstitution/preparation techniques:
- If needed, Novolog may be diluted with Insulin Diluting Medium for NovoLog to provide concentrations of U-10 or U-50; a dilution of 1 part Novolog to 9 parts diluent results in a U-10 concentration, a dilution of 1 part NovoLog to 1 part diluent results in a U-50 concentration
- NovoLog may be mixed with NPH insulin; draw NovoLog into syringe first and administer immediately after mixing
- Insulin Pens and Cartridge Systems: The manufacturer product information should be consulted.
- To avoid contamination, pens should be used by a single patient only: always remove needle from delivery device after use and store pens without a needle attached; always use a new needle for each injection
Continuous Subcutaneous Infusion (Insulin pump):
- Infusion sets should be inserted into the subcutaneous fat layer of the abdominal wall; rotate sites to avoid lipodystrophy
- Do not use diluted, intermediate-acting, long-acting, or mixed insulins in insulin pumps
- Check pump labeling to ensure this insulin may be used in pump; use in accordance with insulin pump instructions
- Change insulin in pump reservoir at least every 6 days; infusion sets and insertion site should be changed according to pump manufacturer's instructions
- Patients on insulin pump therapy should be trained to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure
Intravenous:
- Novolog: Administer by IV infusion at a concentration of 0.05 to 1 unit/mL
- Fiasp: Administer by IV infusion at a concentration of 0.5 to 1 unit/mL
- Administer under close medical supervision with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia
- Use polypropylene infusion bags and compatible infusion fluids
- Insulin mixtures should never be administered IV
Storage requirements:
Vials/Cartridge Systems/Pens: Protect from light; do not freeze, discard if frozen
- Unopened: Store in refrigerator (36F to 46F [2C to 8C])
- Open (in-use) Vials: Use within 28 days; store below 86F (30C), may refrigerate after opening
- Open (in-use) Novolog PenFill Cartridges, Novolog FlexPen, and Novolog FlexTouch: Use within 28 days; store below 86F (30C); do not refrigerate after opening
- Open (in-use) Fiasp PenFill Cartridges: Use within 28 days; store below 86F (30C); do not refrigerate after opening
- Open (in-use) Fiasp FlexTouch Pens: Use within 28 days; store below 86F (30C), may refrigerate after opening
Diluted Novolog:
- Concentrations of U-10 or U-50 when prepared with insulin diluting medium may be used for up to 28 days when stored below 30C (86F)
Infusion Fluids:
- If prepared as indicated, stable at room temperature for 24 hours.
Pump:
- Discard insulin in pump reservoir after 6 days or if exposed to temperatures that exceed 37C (98.6F)
General:
- Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs; duration of action of this insulin will vary according to dose, injection site, blood flow, temperature, and level of physical activity.
- Insulin aspart is a rapid-acting insulin analog that is equipotent to human insulin when administered IV; when administered subcutaneously, it has a more rapid onset of action and a shorter duration of action.
- At equivalent doses, the extent of blood glucose lowering is similar for insulin aspart (Novolog) and insulin aspart with nicotinamide (Fiasp), however, the addition of nicotinamide results in faster initial absorption which is evidenced by greater glucose-lowering, particularly in the first 30 minutes compared to insulin aspart.
- Rapid acting insulin analogs are superior to regular insulin when administered subcutaneously because they are more predictable.
- Hypoglycemia is the most common adverse reaction of insulin therapy; the timing generally reflects the time-action profile of the administered insulin.
Monitoring:
- Blood glucose monitoring is essential for patients receiving insulin therapy
- Closely monitor blood glucose and potassium in patients receiving IV insulin
- Urine ketone testing is recommended for patients with type I diabetes with high blood glucose levels or expected high blood glucose levels (e.g., colds, influenza, nausea/vomiting, stress)
- Glycosylated hemoglobin measurements are recommended every 3 months
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
- Patients should be advised to never share an insulin pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens.
- Patients should be instructed on glucose monitoring, proper injection technique, and the management of hypoglycemia and hyperglycemia.
- Patients should understand that insulins have different time action profiles, and they should understand the time action profile of the insulins they are using; additionally they should be aware that there are 2 formulations of insulin aspart to ensure they are prescribed and using the correct formulation.
- Patients should be instructed on how to handle situations which may affect their insulin requirements, including missed doses, stress, infections, and illness.
- Patients should be reminded to check insulin labels before injection to avoid medication errors.
- Patients should be instructed to check blood sugar prior to driving a car or operating machinery.
- Advise patient to speak to physician or health care professional if pregnant or if they intend to become pregnant.
Frequently asked questions
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