Brand Name: Lantus
Generic Name: insulin Glargine (rDNA Origin) Injection (vials and SoloStar)
Medication Class: Long-Acting Insulin
Manufacturer: Sanofi Aventis US
FDA Approval Date: April 20, 2000
What is Lantus and its mechanism of action?
Lantus (Insulin Glargine) is a long-acting type of insulin used for treating diabetes. Lantus is a biologic drug made by using recombinant DNA (rDNA) technology. Insulin is a hormone produced and released by beta cells in the pancreas. Insulin is released to help the body regulate blood glucose. Insulin release is triggered by an increase in blood glucose from food consumption. Lantus is a basal insulin analogue and it is equivalent to human insulin but it has a slower onset, no pronounced peak, and longer duration of action. Like other types of insulin Lantus regulates the use of glucose by the body. It lowers blood glucose by stimulating glucose uptake by skeletal muscle and adipose tissue, and also reducing glucose production in the liver. Insulin enhances protein production and reduces the breakdown of protein into smaller protein molecules (polypeptides) and breakdown of fats to release fatty acids.
What is Lantus used for treating?
Lantus is used to lower blood glucose and improve diabetes control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
How effective is Lantus?
In multiple studies in adults and pediatric patients with type 1 or type 2 diabetes the effect of Lantus given once daily at bedtime on reducing glycated hemoglobin (HbA1C) was measured and compared against NPH once daily and twice daily.
In two of the clinical studies, adult patients with type 1 diabetes were given Lantus or NPH insulin for 28 weeks. Regular insulin was administered before each meal. Baseline HbA1C were 8.0% and by the end of the trial the group that received Lantus had 0.2% reduction in their HbA1C and the group on NPH had 0.1% reduction in their HbA1C. Hypoglycemia occurred in 10% of patients in the Lantus group compared to 15% in the NPH group.
In another clinical study, 513 adult patients with type 2 diabetes were given Lantus or NPH insulin for 5 years. Patients who recently started insulin treatment were given 10 units daily. Patients who were already on NPH started on the same NPH dose or were given Lantus at a dose that was 80% of their previous NPH dose. Baseline HbA1C was 8.4% and by the end of the trial HbA1C dropped by 0.6% in the Lantus group and 0.8% in the NPH. Hypoglycemia occurred in 11.9% of the NPH group compared to 7.8% in the Lantus group.
Another study in type 1 diabetes patients compared the administration of Lantus at bedtime, pre-breakfast, or pre-dinner. Overall, the reduction in HbA1C was the same regardless of the time Lantus was administered.
Interesting Facts about Lantus
Lantus should not be recommended for the treatment of diabetic ketoacidosis. Short acting insulin such as Humulin R or Novolin R is preferred to treat this condition.
Lantus vial should be clear and colorless before use.
Lantus must not be diluted or mixed with any other insulin.
Lantus has an onset of 4-5 hours and duration of 22-24 hours compare to short-acting insulin (Humulin R) which has an onset of 30-60 minutes and duration of 4-6 hours.
What are side effects of Lantus?
Side effects of Lantus are similar to side effects from other insulins. Severe Hypoglycemia is the most common side effect observed in diabetes patients. Symptoms of hypoglycemia include blurry vision, rapid heart beat, pale skin, headache, fatigue, tremor, and hunger. Allergic reactions such as redness, rash, itching, inflammation, pain, and urticaria also occur. Weight gain occurs with all insulins. Lipodystrophy, which is an abnormal deposit of fat tissue that happens at the site of injection from long-term use of insulin can also occur.
What is the dosage of Lantus and how is it administered and stored?
Lantus solution is available in vials of 100 units per mL for injection; 10 mL vial (100 units/10 mL) and 3 mL SoloStar Pen disposable insulin device (300 Units/3 mL). Lantus should not be administered intravenously or via insulin pump due to severe hypoglycemia. It can only be administered subcutaneously.
Dosing is based on the patient's blood glucose control goals and the dose is adjusted according to response.
Lantus should NOT be stored in freezer. Unopened Lantus if stored in a refrigerator at 36 to 46 F (20 C to 80 C) is good until the expiration date but if stored at room temperature it is good for only 28 days. Opened Lantus vials must be discarded after 28 days.
Opened Lantus SoloStar should NOT be refrigerated and should be kept at room temperature. It must be discarded 28 days after being opened.
What are Lantus drug interactions?
Drugs that should not be combined with Lantus:
Pramlintide: The exact mechanism is unknown. Must be administered separately and not in combination.
Drugs that have a serious interaction with Lantus:
Alcohol can either decrease or increase the effect of insulin in lowering blood glucose. Alcohol can decrease glucose production in the liver, increasing the risk of hypoglycemia.
GLP-1 Agonists (exenatide, liraglutide), sulfonylureas (e.g., glyburide) and other drugs that reduce blood glucose may increase the risk of hypoglycemia when combined with insulin. Dose modifications are needed when these drugs are given in combination.
Somatropin may reduce the hypoglycemic effect of antidiabetic agents.
Atypical antipsychotics (e.g., aripiprazole, clozapine, risperidone) can cause hyperglycemia and alter blood glucose control.
Protease Inhibitors (e.g., atazanavir, ritonavir) decrease the effect of insulin and cause hyperglycemia due to insulin resistance.
Quinolone antibiotics (levofloxacin, ciprofloxacin) can increase or decrease blood glucose and lead to hypoglycemia or hyperglycemia.
Non-Selective beta blockers (e.g., propranolol, timolol, pindolol) mask symptoms of hypoglycemia, and delay recovery from hypoglycemia. They also reduce insulin secretion, increasing the risk of developing diabetes.
Androgens (e.g., testosterone) may decrease blood glucose and increase the risk of hypoglycemia.
What are warnings and precautions for Lantus?
Hypersensitivity and Allergic reactions
Renal Impairment: Lantus is not recommended when renal function is declining rapidly
Hepatic Impairment: Lantus is not recommended when liver function is declining rapidly due to the risk of prolong hypoglycemia.
Patients on Lantus and thiazolidinediones (TZDs) should be monitored for signs and symptoms of heart failure due to dose-related fluid retention caused by TZDs.
Pregnancy Category C.
Nursing Mother: It is unknown if Lantus is excreted in human milk, caution should be exercised when Lantus is given to nursing mothers.
What is the cost of Lantus?
The wholesale price of one vial of Lantus 100 Units/mL is $222.08 and the retail price is approximately $239.56.
How to obtain prescription cost assistance for Lantus?
RedBook Online. Lantus. Truven Health Analytics, Inc.;2014