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Lantus

Generic Name: Insulin Glargine [rDNA origin] Injection
Drug Category: Human Insulin Analog
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 5 years.

Approved Uses

Indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Not recommended for treating diabetic ketoacidosis.

Do not administer intravenously or via an insulin pump.

In patients with type 1 diabetes, LANTUS must be used concomitantly with short acting insulin. The recommended starting dose of LANTUS in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.

The recommended starting dose of LANTUS in patients with type 2 diabetes who are not currently treated with insulin is 0.2 units/kg or up to 10 units once daily.

LANTUS is contraindicated during episodes of hypoglycemia.

Hypoglycemia is the most common adverse reaction associated with insulin, including LANTUS. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including LANTUS and may be life threatening. 

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 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.

All insulin products, including LANTUS, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death.

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.

Weight gain has occurred with some insulin therapies including LANTUS and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Caution should be exercised when LANTUS is administered to geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly.

As with all therapeutic proteins, there is potential for immunogenicity. All insulin products can elicit the formation of insulin antibodies. The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose.

Accidental mix-ups among insulin products, particularly between long-acting insulins and rapid-acting insulins, have been reported. To avoid medication errors between LANTUS and other insulins, instruct patients to always check the insulin label before each injection.

Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics may increase the risk of hypoglycemia. Dose reductions and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.

Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones may decrease the risk of hypoglycemia. Dose increases and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.

Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

There are no well-controlled clinical studies of the use of LANTUS in pregnant women. Animal studies: dilation of the cerebral ventricles.

Endogenous insulin is present in human milk; it is unknown whether insulin glargine is excreted in human milk.

GoToSource

Off-label Uses

• Type 1 diabetes in patients under the age of 6. GoToSource

• Type 2 diabetes in patients under the age of 18. GoToSource

Adverse Events

Increased risk of breast cancer. GoToSource

Weight gain and retinopathy. GoToSource

Fluid retention. GoToSource

Stroke. GoToSource

Anaphylaxis (potentially life-threatening allergic reaction). GoToSource

Lipoatrophy (depression in the skin) and lipohypertrophy (enlargement or thickening of tissue). GoToSource

Immunogenicity (immune response). GoToSource

Hypoglycemia (low blood sugar). GoToSource

Litigation

Lawsuits filed for cancer. 

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 28, 2024