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Levemir® (insulin detemir [rDNA origin] injection) Indications and Usage
Levemir® is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
Levemir® Important Safety Information
Levemir® is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.
Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir®. As with other insulins, the timing of hypoglycemic events may differ among various insulin preparations. Glucose monitoring is recommended for all patients with diabetes. Levemir® is not to be used in insulin infusion pumps. Any change of insulin dose should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may require adjustment.
Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. Levemir® should not be diluted or mixed with any other insulin preparations. Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia in patients being switched to Levemir® from other intermediate or long-acting insulin preparations. The dose of Levemir® may need to be adjusted in patients with renal or hepatic impairment.
Other adverse events commonly associated with insulin therapy may include injection site reactions (on average, 3% to 4% of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, and inflammation.
Please see Prescribing Information.
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NovoLog® (insulin aspart [rDNA origin] injection) Indications and Usage
NovoLog® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
NovoLog® Important Safety Information
NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients.
NovoLog® has a more rapid onset and shorter duration of action than regular human insulin. An injection of NovoLog® should be immediately followed by a meal within 5 to 10 minutes. Because of the short duration of action of NovoLog®, a longer-acting insulin also should be used in patients with type 1 diabetes and may be needed in patients with type 2 diabetes. When used in an external subcutaneous insulin infusion pump, NovoLog® should not be mixed with any other insulin or diluent. Hypoglycemia is the most common adverse effect of all insulin therapies, including NovoLog®. The timing of hypoglycemia usually reflects the time-action profile of the administered insulins.
Any change of insulin dose should be made cautiously and only under medical supervision. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy. 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.
Severe, life-threatening generalized allergy, including anaphylactic reaction, may occur with any insulin product, including NovoLog®. Adverse reactions observed with NovoLog® include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. Insulin, particularly when given intravenously or in settings of poor glycemic control, may cause hypokalemia. Like all insulins, NovoLog® requirements may be reduced in patients with renal impairment or hepatic impairment.
Please see Prescribing Information.
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NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) Indications and Usage
NovoLog® Mix 70/30 is indicated for the treatment of patients with diabetes mellitus for the control of hyperglycemia.
NovoLog® Mix 70/30 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.
Because NovoLog® Mix 70/30 has peak pharmacodynamic activity 1 hour after injection, it should be administered with meals. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog® Mix 70/30. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, species, or method of manufacture may result in the need for a change in dosage. Potential side effects associated with the use of all insulins include hypoglycemia, hypokalemia, lipodystrophy, and allergic reactions.
Because of differences in the action of NovoLog® Mix 70/30 and other insulins, care should be taken in patients in whom these conditions may be clinically relevant (eg, patients who are fasting, have autonomic neuropathy, are using potassium-lowering drugs, or are taking drugs sensitive to serum potassium level). Do not mix NovoLog® Mix 70/30 with any other insulin product.
As with other insulin therapy, erythema, swelling, and pruritus at the injection site have been observed with NovoLog® Mix 70/30. Less common but more serious are severe cases of generalized allergy, including anaphylactic reaction, which may be life threatening. NovoLog® Mix 70/30 dose requirements may be reduced in the presence of renal impairment or impaired hepatic function. Changes in cross-reactive antibodies were more common after NovoLog® Mix 70/30 than with human premixed 70/30, but the clinical significance of these antibodies has not been established. Frequency of adverse events comparable with that of human 70/30. Local injection site reactions comparable with those of human 70/30.
Please see Prescribing Information.
