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Victoza® (liraglutide [rDNA origin] injection) Indications and Usage
Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. It has not been studied sufficiently in patients with a history of pancreatitis. Victoza® should not be used to treat type 1 diabetes mellitus or diabetic ketoacidosis. It has not been studied in combination with insulin.
Victoza® Important Safety Information
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.
In clinical trials, there were more cases of pancreatitis among Victoza®-treated patients than among comparator-treated patients. If pancreatitis is suspected, Victoza® should be discontinued. Victoza® should not be re-initiated if pancreatitis is confirmed. Use with caution in patients with a history of pancreatitis.
When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia.
There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.
The most common adverse reactions reported in patients treated with Victoza® are headache, nausea, diarrhea, and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients than among comparator-treated patients in clinical trials.
Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.
Victoza® should be used with caution in patients with renal impairment and in patients with hepatic impairment.
Please see Prescribing InformationPrescribing Information.
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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.
Levemir® should not be diluted or mixed with any other insulin preparations.
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.
Needles and Levemir® FlexPen® must not be shared.
Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis.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. Less common but more serious are severe cases of generalized allergy, including anaphylactic reaction, which may be life threatening.
*Whether these observed differences represent true differences in the effects of Levemir®, NPH insulin, and insulin glargine is not known, since these trials were not blinded and the protocols (eg, diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences in weight has not been established.
Please see Prescribing InformationPrescribing 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.
Needles and NovoLog® FlexPen® must not be shared.
NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes under the age of two.
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.
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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 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) 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 theneed for a change in dosage.
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 (e.g. patients who are fasting, have autonomicneuropathy, 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.
Needles and NovoLog® Mix 70/30 FlexPen® must not be shared.
Potential side effects associated with the use of all insulins include hypoglycemia, hypokalemia, lipodystrophy and allergic reactions. As with other insulin therapy, erythema, swelling and pruritis 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 hepaticfunction.
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