NovoLog®— safe for pump use in children 2 years and older1

Data from a study of NovoLog® (insulin aspart [rDNA origin] injection) vs insulin lispro for pump use in pediatric patients with type 1 diabetes, supported NovoLog® as a safe option for pediatric patients. 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.)

 

Number of infusion site reactions was similar1

rate of infusion site reactions NovoLog® vs insulin lispro
  • Rates of minor, major and nocturnal hypoglycemic events were similar for both treatment groups
  • Mean weight-adjusted daily dose at study enda


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.1

a 0.86 units/kg/day for Novolog® vs 0.94 units/kg/day for insulin lispro

Adapted from Weinzimer et al, 2008.1
 



NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes who are younger than 2 years of age.

 



 

Efficacy and pump use

The same study also examined A1C levels in children


 


Related Safety Topics:

Selected 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. Sharing poses a risk for transmission of blood-borne pathogens.
  • Administration: NovoLog® should generally be given immediately (within 5-10 minutes) prior to the start of a meal. Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. As with all insulin preparations, the time course of action of NovoLog® may vary in different individuals or at different times in the same individual and is dependent on many conditions, including injection site, local blood supply, temperature, and level of physical activity. NovoLog® should be used with a longer-acting insulin.

NovoLog® (insulin aspart [rDNA origin] injection) Indications and Usage

  • NovoLog® (insulin aspart [rDNA origin] injection) is an insulin analog indicated to improve glycemic control in adults and children 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. Sharing poses a risk for transmission of blood-borne pathogens.
  • Administration: NovoLog® should generally be given immediately (within 5-10 minutes) prior to the start of a meal. Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. As with all insulin preparations, the time course of action of NovoLog® may vary in different individuals or at different times in the same individual and is dependent on many conditions, including injection site, local blood supply, temperature, and level of physical activity. NovoLog® should be used with a longer-acting insulin.
  • Hypoglycemia: Hypoglycemia is the most common adverse effect of insulin therapy. The timing of hypoglycemia may reflect the time-action profile of the insulin formulation. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy. Any change of insulin dose should be made cautiously and only under medical supervision.
  • Hypokalemia: Insulin, particularly when given intravenously or in settings of poor glycemic control, can cause hypokalemia. Use caution in patients predisposed to hypokalemia.
  • Renal and Hepatic Impairment: Like all insulins, NovoLog® requirements may be reduced in patients with renal impairment or hepatic impairment.
  • Hypersensitivity and Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog®
  • Continuous Subcutaneous Insulin Infusion by External Pump: When used in an external subcutaneous insulin infusion pump, NovoLog® should not be mixed with any other insulin or diluent.
  • 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.

Adverse Reactions

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

Use in Specific Populations

  • NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes who are younger than 2 years of age.
  • The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia.

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References

  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.