- NovoLog® Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® Mix 70/30 or one of its excipients.
Please read the Important Safety Information below
NovoLog® Mix 70/30 Selected Important Safety Information
Warnings and Precautions
- Never Share a NovoLog® Mix 70/30 FlexPen®, Needle, or Syringe Between Patients, even if the needle is changed. Patients using NovoLog® Mix 70/30 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.
NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart injectable suspension) 100 U/mL Indications and Usage
- NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart injectable suspension) 100 U/mL is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in patients with diabetes mellitus.
Important Limitations of Use
- NovoLog® Mix 70/30 is not recommended for the treatment of diabetic ketoacidosis.
- The proportions of rapid-acting and long-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.
NovoLog® Mix 70/30 Important Safety Information
Warnings and Precautions (cont'd)
- 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. Increase monitoring with changes to: insulin dose, co- administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
- To avoid medication errors and accidental mix-ups between NovoLog® Mix 70/30 and other insulin products, instruct patients to always check the insulin label before injection.
- Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog® Mix 70/30.
- As with all insulins, NovoLog® Mix 70/30 use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
- 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. 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 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.
- Like all insulins, NovoLog® Mix 70/30 requirements may be reduced in patients with renal impairment or hepatic impairment. These patients may require more frequent blood glucose monitoring and dose adjustments.
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