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Effective for insulin use in pediatric patients

If you have pediatric patients with type 1 or type 2 diabetes, consider prescribing NovoLog® as part of their care plan.

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NovoLog® is effective and well tolerated in pediatric patients with type 1 diabetes reach age-specific A1C goals1

Studied in children aged 4 to 18 years. Age-specific A1C goals were defined as <8.5% for patients aged <6 years and <8% for patients aged 6 to 18 years, in alignment with the 2006 American Diabetes Association guidelines.

Percentage of patients who achieved their A1C goal1

Clinical study results showing the percentage of patients who achieved their A1C goal

P=0.040

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Significantly lower daily dosing with NovoLog® at the end of the study1

Text: double click to edit.

Mean weight-adjusted
daily dose at Week 161

Clinical study results indicating the mean weight-adjusted daily dose at week 16 of study

P=0.018

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Safety results1

  • Rates of minor, major, and nocturnal hypoglycemic events were similar with NovoLog® and insulin lispro
  • The number of infusion site reactions also was similar, with 17% of NovoLog® patients and 21% of lispro patients reporting an infusion site reaction as an adverse event (P=0.43)
    • Injection site reactions were defined to include catheter-site—related reaction, infusion site erythema, induration, irritation, pruritus, rash, reaction, swelling, and vesicles

Study design
A 16-week, open-label, multicenter, parallel-group study enrolling 298 patients with type 1 diabetes, aged 3 to 18 years. The efficacy and safety of NovoLog® continuous subcutaneous insulin infusion (CSII) therapy were compared with those of insulin lispro. Although patients as young as 3 years were eligible for inclusion, the youngest child included in the study was aged 4 years. The primary endpoint was change in A1C from baseline to the end of the study.1

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Consider NovoPen Echo® for your pediatric patients

Insulin Diluting Medium for NovoLog®

  • NovoLog® may be diluted with Insulin Diluting Medium for NovoLog® to a concentration equivalent to U-10 or U-50.
  • Insulin Diluting Medium for NovoLog® is designed for use by healthcare professionals for the dilution of NovoLog® for subcutaneous injection only.
  • Prior to use, Insulin Diluting Medium for NovoLog® should be stored at 2ºC–8ºC (36º–46ºF) and protected from light and heat until the expiration date; do not freeze. Once mixed with NovoLog® the sterile vial containing the mixture may be stored at temperatures below 30°C (86°F) for 28 days.2
  • When diluting NovoLog® with Insulin Diluting Medium, the products should be combined in a sterile vial and the dilution should be performed under aseptic conditions.

How to Order Insulin Diluting Medium for NovoLog®

  • Please complete the form and email it to NNIdiluent@novonordisk.com.  
  • Please note: diluent can only be shipped to healthcare providers licensed to prescribe or dispense medications (ie MD, RPH, PharmD, NP, PA)
  • All fields on the form are required

NovoLog® (insulin aspart) injection 100 U/mL Indications and Usage

NovoLog® (insulin aspart) injection 100 U/mL is an insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Important Safety Information

Contraindications

  • NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients.

Warnings and Precautions

  • Never Share a NovoLog® FlexPen, NovoLog® FlexTouch, PenFill® Cartridge, or PenFill® Cartridge Device 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: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia 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. 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. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia: Hypoglycemia is the most common adverse effect 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), 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. Other factors which may increase the risk of hypoglycemia include changes in meal pattern, 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. Patients and caregivers must be educated to recognize and manage hypoglycemia. 
  • Hypoglycemia Due to Medication Errors: To avoid medication errors and accidental mix-ups between NovoLog® and other insulin products, instruct patients to always check the insulin label before injection.
  • Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog®.
  • 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).
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including NovoLog®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.
  • 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. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

NovoLog® continuous subcutaneous infusion route (insulin pump): Do not mix NovoLog® with any other insulin or diluent.

Adverse Reactions

  • Adverse reactions observed with NovoLog® include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.

Drug Interactions

  • Drugs that 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 analog (e.g., octreotide), and sulfonamide antibiotics.
  • Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics, 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.
  • Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine.
  • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.

Please click here for Prescribing Information.

 

Reference:

  1. Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008;31(2):210-215.
  2. NovoLog [package insert]. Plainsboro, NJ: Novo Nordisk Inc; October 2021