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Levemir

Generic Name: Insulin Detemir [rDNA origin] Injection
Drug Category: Human Insulin Analog
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 2 years old for a maximum duration of 2 years.

Approved Uses

Indicated to improve glycemic control in adults and children with diabetes mellitus.

LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. Intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition.

LEVEMIR has not been studied in children with type 2 diabetes and has not been studied in children with type 1 diabetes under 2 years of age.

In patients with type 1 diabetes, LEVEMIR must be used in a regimen with rapid-acting or short-acting insulin.

LEVEMIR should only be administered subcutaneously. Do not administer LEVEMIR intravenously or intramuscularly. The intended duration of activity of LEVEMIR is dependent on injection into subcutaneous tissue. Intravenous or intramuscular administration of the usual subcutaneous dose could result in severe hypoglycemia. Do not use LEVEMIR in insulin infusion pumps. Do not dilute or mix LEVEMIR with any other insulin or solution.

Medication errors have been reported during post-approval use of LEVEMIR in which other insulins, particularly rapid-acting or short-acting insulins, have been accidentally administered instead of LEVEMIR. To avoid medication errors between LEVEMIR and other insulins, patients should be instructed always to verify the insulin label before each injection.

Severe hypoglycemia requiring the assistance of another person or parenteral glucose infusion, or glucagon administration has been observed in clinical trials with insulin, including trials with LEVEMIR.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including LEVEMIR.

Careful glucose monitoring and dose adjustments of insulin, including LEVEMIR, may be necessary in patients with renal or hepatic impairment.

All insulin products can elicit the formation of insulin antibodies. These insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose.

Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Weight gain can occur with insulin therapy, including LEVEMIR.

Insulin, including LEVEMIR, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Long-term use of insulin, including LEVEMIR, can cause lipodystrophy at the site of repeated insulin injections. 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.

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.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure.

The following are examples of medications that may increase the blood-glucose lowering effect of insulins including LEVEMIR and, therefore, increase the susceptibility to hypoglycemia: oral antidiabetic medications, pramlintide acetate, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, pentoxifylline, salicylates, somatostatin analogs, and sulfonamide antibiotics.

The following are examples of medications that may reduce the blood-glucose lowering effect of insulins including LEVEMIR: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors and atypical antipsychotic medications (e.g. olanzapine and clozapine).

Beta-blockers, clonidine, lithium salts, and alcohol may either increase or decrease the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

The signs of hypoglycemia may be reduced or absent in patients taking anti adrenergic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.

A randomized controlled clinical trial of pregnant women with type I diabetes using LEVEMIR during pregnancy did not show an increase in the risk of fetal abnormalities.

It is unknown whether LEVEMIR is excreted in human milk.

GoToSource 

Off-label Uses

• Use in patients under the age of 18 with type 2 diabetes. GoToSource

• Use in patients under the age of 2 with type 1 diabetes. GoToSource

• Gestational diabetes. GoToSource

Adverse Events

Increased risk of cancer. GoToSource

Injection site reactions, urticaria (hives), angioedema (swelling in deep layers of skin) and anaphylaxis (life-threatening allergic reaction). GoToSource

Worsening of diabetic retinopathy (damage to blood vessels in retina). GoToSource

Lipoatrophy (loss of localized fat tissue). GoToSource

Hypoglycemia (low blood sugar). GoToSource

Litigation

No major injury lawsuits reported.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024