insulin aspart (NovoLog, NovoLog FlexPen, NovoPen Echo, NovoLog FlexTouch)

Dosing and uses of NovoLog (insulin aspart)

• Adult
• Pediatric

 

Adult dosage forms and strengths

injectable solution

• 100 units/mL

prefilled syringe

• 100units/mL (3mL NovoLog FlexPen or FlexTouch)

 

Type 1 Diabetes Mellitus

Improvement of glycemic control in adults and children with diabetes mellitus

May administer 0.2-0.6 unit/kg/day in divided doses; conservative doses of 0.2-0.4 unit/kg/day often recommended to reduce risk of hypoglycemia

Total maintenance daily insulin requirement may vary; it is usually between 0.5 and 1 unit/kg/day; nonobese may require 0.4-0.6 unit/kg/day; obese may require 0.6-1.2 units/kg/day

 

Type 2 Diabetes Mellitus

Diabetes inadequately controlled by diet, weight reduction, exercise, or oral medication

10 units/day SC (or 0.1-0.2 units/kg/day) in evening or divided q12hr of an intermediate (eg, NPH) or long-acting insulin at bedtime recommended; conversely, regular insulin or rapid-acting insulin (aspart insulin) before meals also recommended

 

Dosing Considerations

When used in a meal-related SC injection treatment regimen, 50-75% of total insulin requirements may be provided by an intermediate-acting or long-acting insulin; the remainder is divided and provided before or at mealtimes as a rapid-acting insulin, such as insulin aspart

Because of insulin aspart’s comparatively rapid onset and short duration of glucose-lowering activity, some patients may require more basal insulin and more total insulin to prevent premeal hyperglycemia than they would need when using human regular insulin

Dosage must be individualized; blood and urine glucose monitoring is essential in all patients receiving insulin therapy

Insulin requirements may be altered during stress or major illness or with changes in exercise, meal patterns, or coadministered drugs

SC injection

• Administer within 5-10 minutes before a meal
• When administered by SC injection, insulin aspart should generally be used in regimens with an intermediate- or long-acting insulin
• Injection sites should be rotated within the same region to reduce the risk of lipodystrophy
• As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature, and level of physical activity

Continuous SC injection (insulin pump)

• Divide the number of units by 24 to obtain the basal rate in units/hr
• Change the NovoLog in the reservoir at least every 6 days
• Change the infusion set and the infusion set insertion site at least every 3 days
• Do not mix with other insulins or with a diluent when it is used in the pump

IV administration

• IV use is at concentrations of 0.05-1 unit/mL in infusion systems using PVC infusion bags
• Stable in infusion fluids such as 0.9% NaCl

 

Pediatric dosage forms and strengths

injectable solution

• 100 units/mL

prefilled syringe

• 100units/mL (3mL NovoLog FlexPen or FlexTouch)

 

Type 1 Diabetes Mellitus

Improvement of glycemic control in adults and children with diabetes mellitus

>2 years: May require 0.8-1.2 units/kg/day SC during growth spurts; adolescents may require ≤1.2 units/kg/day; otherwise, may use 0.5-1 unit/kg/day

Dosing considerations

• Insulin pens specifically designed for children and adolescents allow for 0.5 unit dosage increments (eg, NovoPen Echo, NovoPen Junior)
• Dosage of human insulin, which is always expressed in USP units, must be based on the results of blood and urine glucose tests and must be carefully individualized to optimal effect
• NovoLog approved for children >2 years for SC daily injections and for children >4 years for continuous SC infusion
• 50-75% of daily insulin requirement may be supplied by intermediate- to long-acting insulin; the remainder is divided and provided before or at mealtimes as a rapid-acting insulin, such as insulin aspart

 

NovoLog (insulin aspart) adverse (side) effects

Frequency not defined

Hypoglycemia

Lipodystrophy

Lipohypertrophy

Local allergic reaction

Hypokalemia

Paresthesia

Itching

Tremor

Hunger

Nausea

Urticaria

Redness

Diaphoresis

Hypothermia

Mental confusion

Loss of consciousness

Muscle weakness

 

Warnings

Contraindications

During episodes of hypoglycemia

Documented hypersensitivity

 

Cautions

Decreased insulin requirements: Diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, and hepatic impairment

Increased insulin requirements: Fever, hyperthyroidism, trauma, infection, and surgery

Hypoglycemia is the most common adverse reaction

May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; when given intravenously or in settings of poor glycemic control, can cause hypokalemia; use caution in patients predisposed to hypokalemia; caution when coadministered with potassium-lowering drugs or in conditions that may decrease potassium

Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment

Do not mix SC injection with insulin preparations other than NPH insulin

Do not mix IV or continuous SC infusions with any other insulins

Pregnancy

Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure; monitor for signs and symptoms of heart failure, treat accordingly, and consider discontinuing thiazolidinediones

Never share pen between patients even if needle is changed

 

Pregnancy and lactation

Pregnancy category: B; Open-label, randomized trial (n=322) observed insulin aspart reduced Hgb A1C similarly to regular insulin in pregnant women

Lactation: Considered safe for use while breastfeeding

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of NovoLog (insulin aspart)

Mechanism of action

Regulates glucose metabolism

Insulin and its analogues lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production; insulin inhibits lipolysis and proteolysis, and enhances protein synthesis; targets include skeletal muscle, liver, and adipose tissue

 

Absorption

Bioavailability: SC, well absorbed (2-3 times faster than regular insulin)

Onset: 0.2-0.3 hr; 1-3 hr (peak effect)

Duration of action: 3-5 hr

Peak plasma time: 40-50 minutes

Peak plasma concentration: 82 microunits/L

 

Distribution

Protein bound: <10%, similar to regular insulin (not bound to serum binding-protein, but present as a monomer in plasma)

Vd: 0.26-0.36 L/kg

 

Metabolism

Liver (>50%); kidney (30%); adipose tissue/muscle (20%)

 

Elimination

Half-life: 81 min (SC)

Excretion: Urine