In patients with type 2 diabetes: 


a
Results from patients who completed the IMPROVE™ study who were previously treated with human premix ± oral antidiabetic drug (OAD) therapy and had A1C values available at baseline and final visit. The IMPROVE™ study was a multinational, open-label, nonrandomized, 26-week, observational study that evaluated the safety and efficacy of NovoLog® Mix 70/30 in patients with type 2 diabetes; n=3856.

bNovoLog® Mix 70/30 has a flexible dosing approach that allows type 2 patients to dose within 15 minutes before or after meal initiation vs 30 minutes before meals required with human premix insulin.

 



 

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cRestrictions apply.

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Selected Important Safety Information

  • NovoLog® Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® Mix 70/30 or one of its excipients.
  • Never Share a NovoLog® Mix 70/30 FlexPen® Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
  • NovoLog® Mix 70/30 should not be mixed with any other insulin product, administered intravenously, or used in insulin infusion pumps. NovoLog® Mix 70/30 has a faster onset of action than human insulin premix 70/30 and should be dosed within 15 minutes before meal initiation for patients with type 1 diabetes. For patients with type 2 diabetes, dosing should occur within 15 minutes before or after meal initiation. 

NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) Indications and Usage

  • NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.

Important Limitations of Use

  • In premix insulins, such as NovoLog® Mix 70/30, the proportions of rapid-acting and long-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. 

Important Safety Information

Contraindications

  • NovoLog® Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® Mix 70/30 or one of its excipients. 

Warnings and Precautions

  • Never Share a NovoLog® Mix 70/30 FlexPen® Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
  • Administration: NovoLog® Mix 70/30 should not be mixed with any other insulin product, administered intravenously, or used in insulin infusion pumps. NovoLog® Mix 70/30 has a faster onset of action than human insulin premix 70/30 and should be dosed within 15 minutes before meal initiation for patients with type 1 diabetes. For patients with type 2 diabetes, dosing should occur within 15 minutes before or after meal initiation.
  • 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. Any change of insulin dose should be made cautiously and only under medical supervision.
  • Hypokalemia: Insulin, particularly when given in settings of poor glycemic control, can cause hypokalemia. Use caution in patients predisposed to hypokalemia.
  • Renal and Hepatic Impairment: Like all insulins, NovoLog® Mix 70/30 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® Mix 70/30.
  • Fluid retention and heart failure can occur 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® Mix 70/30.

Adverse Reactions

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

Use in Specific Populations

  • The safety and effectiveness of NovoLog® Mix 70/30 have not been established in pediatric patients. Clinical studies of NovoLog® Mix 70/30 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. 

The significance, with respect to the long-term clinical sequelae of diabetes, of the differences in postprandial hyperglycemia between treatment groups has not been established.

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