Lantaus Uses

How do you administer this medicine?
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What is Lantaus?

Lantaus (Lantaus) is a man-made form of a hormone that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Lantaus is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

The Lantaus SoloStar injection pen is used to improve blood sugar control in adults with diabetes mellitus.

Lantaus is used to treat type 1 diabetes or type 2 diabetes in adults.

It is not known if Lantaus is safe and effective in children.

Lantaus indications

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Lantaus injection is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Limitations of Use

Lantaus injection is not recommended for the treatment of diabetic ketoacidosis.

How should I use Lantaus?

Use Lantaus cartridge systems as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Lantaus cartridge systems.

Uses of Lantaus in details

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Lantaus is used to reduce high blood sugar (glucose) levels in people with diabetes mellitus.

Lantaus description

Each mL contains 100 IU Lantaus, 0.27% w/v m-cresol as preservative and water for injection.

Lantaus injection [ribosomal deoxyribonucleic acid (rDNA)] is a recombinant human insulin analogue produced by recombinant DNA technology. Lantaus differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and 2 arginines are added to the C-terminus of B-chain.

Chemically, it is 21A-Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6,063.

Lantaus is an insulin analogue, equipotent to human insulin, with a peakless glucose lowering profile and a prolonged duration of action that permits once daily dosing.

Lantaus dosage

Lantaus Dosage

Generic name: Lantaus 100[iU] in 1mL

Dosage form: injection, solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Important Administration Instructions

General Dosing Instructions

Initiation of Lantaus Therapy

Changing to Lantaus from Other Insulin Therapies

More about Lantaus (Lantaus)

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Professional resources

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Lantaus interactions

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What other drugs will affect Lantaus?

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Drugs That May Increase The Risk Of Hypoglycemia

The risk of hypoglycemia associated with Lantaus use may be increased with 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. Dose adjustment and increased frequency of glucose monitoring may be required when Lantaus is co-administered with these drugs.

Drugs That May Decrease The Blood Glucose Lowering Effect Of Lantaus

The glucose lowering effect of Lantaus may be decreased when co-administered with atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isonazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when Lantaus is co-administered with these drugs.

Drugs That May Increase Or Decrease The Blood Glucose Lowering Effect Of Lantaus

The glucose lowering effect of Lantaus may be increased or decreased when co-administered with alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when Lantaus is co-administered with these drugs.

Drugs That May Affect Signs And Symptoms Of Hypoglycemia

The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with Lantaus.

Lantaus side effects

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What are the possible side effects of Lantaus?

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The following adverse reactions are discussed elsewhere:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Two clinical trials with Lantaus were conducted: one in type 1 diabetes and one in type 2 diabetes.

The type 1 diabetes population had the following characteristics: Mean age was 41 years and mean duration of diabetes was 16 years. 58% were male. 75% were Caucasian, 2% Black or African American and 4% American Indian or Alaskan native. 4% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m². 73.5 percent of patients had eGFR > 90 mL/min/1.73m². The mean BMI was approximately 26 kg/m². HbA1c at baseline was 7.8%. The data in Table 1 reflect exposure of 268 patients to Lantaus with a mean exposure duration of 49 weeks.

The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 11 years. 50% were male. 78% were Caucasian, 8% Black or African American and 5% American Indian or Alaskan native. 28% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m². 67.5 percent of patients had eGFR > 90 mL/min/1.73m². The mean BMI was approximately 32 kg/m². HbA1c at baseline was 8.3%. The data in Table 2 reflect exposure of 376 patients to Lantaus with a mean exposure duration of 22 weeks.

Common adverse reactions were defined as reactions occurring in ≥ 5% of the population studied. Common adverse reactions during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively.

Table 1: Adverse reactions occurring in ≥ 5% of adult patients with type 1 diabetes treated with Lantaus in a 52-week trial

Lantaus + Insulin Lispro, %

(n=268)

Infection Infections other than nasopharyngitis or upper respiratory tract infection.

The frequencies of adverse reactions during a clinical trial of 5 years duration with another Lantaus product, 100 units/mL, in patients with type 2 diabetes mellitus are listed in Table 3.

Table 3: Common adverse reactions in 5-year trial of adult patients with type 2 diabetes (adverse reactions with incidence ≥ 10% and higher with another Lantaus product, 100 units/mL, than comparator)

Another Lantaus Product, %

(n=514)

NPH, %

(n=503)

Hypertension 20 19
Sinusitis 19 18
Cataract 18 16
Bronchitis 15 14
Back pain 13 12
Cough 12 7
Urinary tract infection 11 10
Diarrhea 11 10
Depression 11 10
Headache 10 9

The frequencies of adverse reactions during clinical trials with another Lantaus product, 100 units/mL, in children and adolescents with type 1 diabetes mellitus are listed in Table 4.

Table 4: Adverse reactions in a 28-week clinical trial of children and adolescents with type 1 diabetes (adverse reactions with frequency ≥ 5% and the same or higher with another Lantaus product, 100 units/mL, than comparator)

Another Lantaus Product, %

(n=174)

NPH, %

(n=175)

Rhinitis 5 5

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Lantaus. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for Lantaus with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.

Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL ( ≤ 56 mg/dL in the 5-year trial and ≤ 36 mg/dL in the ORIGIN trial) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.

The incidence of severe symptomatic hypoglycemia in patients receiving Lantaus with type 1 diabetes mellitus and type 2 diabetes mellitus was 4% at 52 weeks and 1% at 24 weeks, respectively.

The incidence of severe symptomatic hypoglycemia in a clinical trial with another Lantaus product, 100 units/mL, in children and adolescents age 6 to 15 years with type 1 diabetes was 23% at 26 weeks.

Table 5 displays the proportion of patients experiencing severe symptomatic hypoglycemia in another Lantaus product, 100 units/mL, and Standard Care groups in the ORIGIN Trial.

Table 5: Severe Symptomatic Hypoglycemia in the ORIGIN Trial

ORIGIN Trial Median duration of follow-up: 6.2 years
Another Lantaus Product, 100 units/mL

(N=6231)

Standard Care

(N=6273)

Percent of patients 6 2

Allergic Reactions

Some patients taking insulin therapy, including Lantaus have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported.

Peripheral Edema

Some patients taking Lantaus have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Lipodystrophy

Administration of insulin subcutaneously, including Lantaus, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.

Weight Gain

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

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity.

In a 52-week study of type 1 diabetes patients, 42% of patients who received Lantaus once daily were positive for anti-drug antibodies (ADA) at least once during the study, including 17% that were positive at baseline and 25% of patients who developed ADA during the study. Sixty-five percent of the ADA positive patients on Lantaus with antibody testing at week 52 remained ADA positive at week 52.

In a 24-week study of type 2 diabetes patients, 17% of patients who received Lantaus once daily were positive for ADA at least once during the study. Among the subjects who were positive, 5% had ADA at baseline and 12% developed antibodies during the study. The percent binding of patients positive at baseline on Lantaus did not increase significantly during the study. Fifty-one percent of the ADA positive patients on Lantaus with antibody testing at week 24 remained ADA positive at week 24. There was no evidence that these antibodies had an impact on efficacy and safety outcomes.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to Lantaus with the incidence of antibodies in other studies or to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of another Lantaus product, 100 units/mL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which other insulin products, particularly rapid-acting insulins, have been accidentally administered instead of an Lantaus product. To avoid medication errors between Lantaus products and other insulin products, patients should be instructed to always verify the insulin label before each injection.

Lantaus contraindications

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What is the most important information I should know about Lantaus?

Lantaus injection is contraindicated:

during episodes of hypoglycemia.
in patients with hypersensitivity to Lantaus products or any of the excipients in Lantaus injection.

Active ingredient matches for Lantaus:

Insulin Glargine in Bangladesh.


List of Lantaus substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Injectable; Injection; Insulin Glargine 100 IU / ml
Injectable; Injection; Insulin Glargine 100 IU / ml
Injectable; Injection; Insulin Glargine 100 IU / ml
100 IU x 1 mL x 1's (Aventis Pasteur)$ 28.92
Lantus Autopen 10 IU x 1mL INJ / 3ml (Aventis Pasteur)$ 28.92
LANTUS AUTOPEN inj 100 IU x 1 mL x 3ml (Aventis Pasteur)$ 28.92
Lantus Autopen 10 IU x 1mL INJ / 3ml (Aventis Pasteur)$ 28.92
100 IU x 1 mL x 3ml (Aventis Pasteur)$ 5.82
Lantus Cartridge 100 IU x 1mL INJ / 3ml (Aventis Pasteur)$ 5.82
LANTUS CARTRIDGE inj 100 IU x 1 mL x 3ml (Aventis Pasteur)$ 5.82
Lantus Cartridge 100 IU x 1mL INJ / 3ml (Aventis Pasteur)$ 5.82
Injectable; Injection; Insulin Glargine 100 IU / ml (Sanofi - aventis)
Injectable; Injection; Insulin Glargine 100 IU / ml (Dr. Reddy's)
OPTISULIN Capsule/ Tablet /   / 15 units (Dr. Reddy's)$ 0.31
OPTISULIN Capsule/ Tablet /   / 30 units (Dr. Reddy's)$ 0.51
15's (Dr. Reddy's)$ 0.11
OPTISULIN cap 15's (Dr. Reddy's)$ 0.31

References

  1. PubChem. "Insulin glargine". https://pubchem.ncbi.nlm.nih.gov/sub... (accessed September 17, 2018).
  2. DrugBank. "Insulin Glargine - DrugBank". http://www.drugbank.ca/drugs/DB00047 (accessed September 17, 2018).

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