insulin aspart (Rx)

Brand and Other Names:NovoLog, NovoLog FlexPen, more...NovoPen Echo, NovoLog FlexTouch, Fiasp
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 100 units/mL (Novolog or Fiasp)

prefilled syringe

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

Fiasp only

  • If converting to Fiasp from another mealtime insulins, the change can be done on a unit-to-unit basis

Dosage Modifications

Patients with hepatic and renal impairment may be at increased risk of hypoglycemia and may require more frequent dose adjustment and more frequent blood glucose monitoring

Dosage Forms & Strengths

injectable solution

  • 100 units/mL

prefilled syringe

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

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
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Interactions

Interaction Checker

and insulin aspart

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            Adverse Effects

            >10%

            Nasopharyngitis, postmeal Fiasp with insulin detemir (23.9%)

            Nasopharyngitis, mealtime Fiasp with insulin detemir (20.2%)

            1-10%

            Fiasp with insulin glargine

            • Urinary tract infection (5.9%)
            • Severe hypoglycemia (3.2%)

            Mealtime Fiasp with insulin detemir

            • Upper respiratory tract infection (9.1%)
            • Severe hypoglycemia (6.7%)
            • Diarrhea (5.4%)
            • Back pain (5.2%)
            • Nausea (4.9%)

            Post meal Fiasp with insulin detemir

            • Severe hypoglycemia (8%)
            • Upper respiratory tract infection (7.4%)
            • Diarrhea (5%)
            • Back pain (4%)
            • Nausea (3.2%)

            Frequency Not Defined

            Novolog

            • Hypoglycemia
            • Lipodystrophy
            • Lipohypertrophy
            • Local allergic reaction
            • Hypokalemia
            • Paresthesia
            • Itching
            • Tremor
            • Hunger
            • Nausea
            • Urticaria
            • Redness
            • Diaphoresis
            • Hypothermia
            • Mental confusion
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            Warnings

            Contraindications

            During episodes of hypoglycemia

            Documented hypersensitivity

            Cautions

            Decreased insulin requirements: Diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, and hepatic impairment; monitor therapy closely

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

            Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia; these changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased.

            All insulin products 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 (eg, patients using potassium-lowering medications, patients taking medications sensitive to potassium concentrations)

            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; patients using vials must never share needles or syringes with another person

            To avoid accidental mix-ups between insulin products, instruct patients to always check insulin label before each injection

            If hypersensitivity reactions occur, discontinue therapy; treat per standard of care and monitor until symptoms and signs resolve

            Malfunction of insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis; 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

            Insulin products may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy

            Hypoglycemia

            • Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death; hypoglycemia can impair concentration ability and reaction time
            • Risk of hypoglycemia after injection is related to duration of action of insulin and, in general, is highest when glucose lowering effect of insulin is maximal; as with all insulin preparations, glucose lowering effect time course of insulins may vary in different individuals or at different times in the same individual and depends on many conditions, including area of injection as well as injection site blood supply and temperature; other factors which may increase risk of hypoglycemia include changes in meal pattern (eg, macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication; patients with renal or hepatic impairment may be at higher risk of hypoglycemia
            • In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, and increased frequency of blood glucose monitoring is recommended

            Drug Interactions Overview

            • Drugs may increase the risk of hypoglycemia
              • Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (eg, octreotide), and sulfonamide antibiotics
              • Reduce dose and monitor glucose levels when insulin aspart is coadministered with these drugs
            • Drugs may decrease the blood glucose lowering effect of the insulin aspart
              • Atypical antipsychotics (eg, olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (eg, in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (eg, albuterol, epinephrine, terbutaline), and thyroid hormones
              • Increase dose and monitor glucose levels when insulin aspart is coadministered with these drugs
            • Drugs may increase or decrease the blood glucose lowering effect of the insulin aspart
              • Alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
              • Adjust dose and monitor glucose levels when insulin aspart is coadministered with these drugs
            • Drugs may blunt signs and symptoms of hypoglycemia
              • Beta-blockers, clonidine, guanethidine, and reserpine
              • Monitor glucose levels when insulin aspart is coadministered with these drugs
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            Pregnancy & Lactation

            Pregnancy

            There are no available data with insulina aspart in pregnant women to inform a drug-associated risk for major birth defects and miscarriage

            Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications

            Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity

            Lactation

            Endogenous insulin is present in human milk; it is unknown whether insulin aspart is excreted in human milk

            Because many drugs, including human insulin, are excreted in human milk caution should be exercised when therapy is administered to a nursing woman

            Use of insulin is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses

            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.

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            Pharmacology

            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

            Novolog

            • 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

            Fiasp

            • Peak plasma time: 91 minutes (0.1 unit/kg); 122 minutes (0.2 unit/kg); 133 minutes (0.4 unit/kg)
            • AUC (infusion rate): 697mg/kg (0.1 unit/kg); 1406 mg/kg (0.2 unit/kg); 2427 mg/kg (0.4 unit/kg)

            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 (Novolog SC); 1.1 hr (Fiasp)

            Excretion: Urine

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            Administration

            SC Administration

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

            Fiasp

            • Administer within 20 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
            • Instruct patients on basal-bolus treatment who forget a mealtime dose to monitor blood glucose level to determine if a dose is necessary, and to resume their usual dosing schedule at the next meal

            Novolog

            • 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 administration (insulin pump)

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

            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

            Storage

            Unused vials, pens, and cartridge

            • Store at room temperature below 30°C (86°F) for up to 28 days
            • If refrigerated 2-8°C (36-46°F); stable until expiration date; do not freeze

            Used vials, pens and cartridges

            • Store at room temperature below 30°C (86°F) for up to 28 days
            • If refrigerated 2-8°C (36-46°F), stable for 28 days; do not freeze

            Diluted solutions

            • Store at room temperature below 30°C (86°F); stable for 24 hr

            External insulin pump

            • Store at room temperature, not to exceed 37°C (98.6°F); discard after 6 days
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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