Indications and Usage
Levemir® (insulin detemir [rDNA origin] injection) is indicated to improve glycemic control in adults and children with diabetes mellitus.
Important Limitations of Use
Levemir® is not recommended for the treatment of diabetic ketoacidosis. Intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition.
Important Safety Information
Levemir® is contraindicated in patients with hypersensitivity to Levemir® or any of its excipients.
Glucose monitoring is essential for all patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision.
Do not dilute or mix Levemir® with any other insulin or solution or use in insulin infusion pumps. Do not administer Levemir® intravenously or intramuscularly because severe hypoglycemia could occur. Needles and Levemir® FlexPen® should never be shared.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Levemir®. When a GLP-1 receptor agonist is used in combination with Levemir®, the Levemir® dose may need to be lowered or more conservatively titrated to minimize the risk of hypoglycemia. Careful glucose monitoring and dose adjustments of insulin, including Levemir®, may be necessary in patients with renal or hepatic impairment.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Levemir®. Adverse reactions associated with Levemir® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash and pruritus.
Levemir® has not been studied in children with type 2 diabetes or in children with type 1 diabetes younger than two years of age.
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 (e.g., 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 has not been established.
Whether these observed changes in weight represent true effects of Levemir® are not known since the trial was not blinded and the protocol (e.g., diet and exercise instructions and monitoring) was not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences has not been established.
The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia. Female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking Levemir®.
In a 26-week randomized study (n=323) of Levemir® add-on to liraglutide 1.8 mg + metformin, diarrhea was the only adverse reaction reported in ≥5% of the patients treated with liraglutide 1.8 mg + metformin + Levemir® (11.7%) and greater than in patients treated with liraglutide 1.8 mg and metformin alone (6.9%).
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Victoza® (liraglutide [rDNA origin] injection)
Indications and Usage
Victoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
In clinical trials of Victoza®, there were more cases of pancreatitis with Victoza® than with comparators. Victoza® has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza®. Use with caution in patients with a history of pancreatitis.
Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Victoza® has not been studied in combination with prandial insulin.
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.
Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.
If pancreatitis is suspected, Victoza® should be discontinued. Victoza® should not be re-initiated if pancreatitis is confirmed.
When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Renal impairment has been reported post-marketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.
Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during post marketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly.
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 ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) 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.
There is limited data in patients with renal or hepatic impairment.
Victoza® is not indicated for the management of obesity, and weight change was a secondary end point in clinical trials.
In a 26-week study (n=323) of Victoza® 1.8 mg and intensification with insulin detemir, the only adverse reaction reported in ≥5% of the patients treated with Victoza® 1.8 mg + metformin + insulin detemir and greater than in patients treated with Victoza 1.8 mg + metformin alone was diarrhea (11.7% vs 6.9%, respectively).
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