Lantus AUTOPEN Uses

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What is Lantus AUTOPEN?

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

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

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

It is not known if Lantus AUTOPEN is safe and effective in children.

Lantus AUTOPEN indications

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Lantus AUTOPEN 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

Lantus AUTOPEN injection is not recommended for the treatment of diabetic ketoacidosis.

How should I use Lantus AUTOPEN?

Use Lantus AUTOPEN 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 Lantus AUTOPEN cartridge systems.

Uses of Lantus AUTOPEN in details

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

Lantus AUTOPEN description

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

Lantus AUTOPEN injection [ribosomal deoxyribonucleic acid (rDNA)] is a recombinant human Lantus AUTOPEN analogue produced by recombinant DNA technology. Lantus AUTOPEN differs from human Lantus AUTOPEN 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 Lantus AUTOPEN and has the empirical formula C267H404N72O78S6 and a molecular weight of 6,063.

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

Lantus AUTOPEN dosage

Lantus AUTOPEN Dosage

Generic name: Lantus AUTOPEN 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 Lantus AUTOPEN Therapy

Changing to Lantus AUTOPEN from Other Lantus AUTOPEN Therapies

More about Lantus AUTOPEN (Lantus AUTOPEN)

Consumer resources

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Lantus AUTOPEN interactions

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What other drugs will affect Lantus AUTOPEN?

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Drugs That May Increase The Risk Of Hypoglycemia

The risk of hypoglycemia associated with Lantus AUTOPEN 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 Lantus AUTOPEN is co-administered with these drugs.

Drugs That May Decrease The Blood Glucose Lowering Effect Of Lantus AUTOPEN

The glucose lowering effect of Lantus AUTOPEN 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 Lantus AUTOPEN is co-administered with these drugs.

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

The glucose lowering effect of Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN.

Lantus AUTOPEN side effects

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What are the possible side effects of Lantus AUTOPEN?

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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 Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN in a 52-week trial

Lantus AUTOPEN + Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN product, 100 units/mL, than comparator)

Another Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN product, 100 units/mL, than comparator)

Another Lantus AUTOPEN Product, %

(n=174)

NPH, %

(n=175)

Rhinitis 5 5

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using Lantus AUTOPEN, including Lantus AUTOPEN. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN Product, 100 units/mL

(N=6231)

Standard Care

(N=6273)

Percent of patients 6 2

Allergic Reactions

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

Lipodystrophy

Administration of Lantus AUTOPEN subcutaneously, including Lantus AUTOPEN, 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 Lantus AUTOPEN therapies including Lantus AUTOPEN and has been attributed to the anabolic effects of Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN did not increase significantly during the study. Fifty-one percent of the ADA positive patients on Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN 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 Lantus AUTOPEN products, particularly rapid-acting insulins, have been accidentally administered instead of an Lantus AUTOPEN product. To avoid medication errors between Lantus AUTOPEN products and other Lantus AUTOPEN products, patients should be instructed to always verify the Lantus AUTOPEN label before each injection.

Lantus AUTOPEN contraindications

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What is the most important information I should know about Lantus AUTOPEN?

Lantus AUTOPEN injection is contraindicated:

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

Active ingredient matches for Lantus AUTOPEN:

Insulin glargine in India.

Insulin


Unit description / dosage (Manufacturer)Price, USD
100 IU x 1 mL x 1's$ 28.92
Lantus Autopen 10 IU x 1mL INJ / 3ml$ 28.92
LANTUS AUTOPEN inj 100 IU x 1 mL x 3ml (Aventis Pasteur)$ 28.92
Lantus Autopen 10 IU x 1mL INJ / 3ml$ 28.92

List of Lantus AUTOPEN substitutes (brand and generic names):

Lentard 40 40iu/ml VIAL / 10ml$ 1.56
Injectable; Injection; Insulin 100 units / ml
Lentisulin CPI Porcine Insulin Zn suspension400iu INJ / 10ml$ 0.95
Lentisulin HPI Insulin Zn suspension 40iu, Zn 0.096mg, Methylparaben1mg/1ml INJ / 10ml$ 1.14
Lentisulin HPI Insulin Zn suspension 40iu, Zn 0.096mg, Methylparaben1mg/1ml INJ / 10ml$ 1.14
Lentisulin HPI 400 400IU VIAL / 10ml$ 1.33
Lupisulin-M 30 40 IU VIAL / 10ml (Lupin)$ 1.71
Lupisulin-M 30 100 IU CATRIDGE / 3ml (Lupin)$ 1.83
Lupisulin-M 50 40 IU VIAL / 10ml
Mixtard HM Penfill 40iu/10ml INJ / 5x3ml$ 12.59
Mixtard-30 30% insulin , 70% insulin, isophane100IU x 1mL PENFILL / 3.5mlx5 (Novo Nordisk)$ 12.52
Mixtard-30 30% insulin , 70% insulin, isophane 100IU x 1mL PENFILL / 3.5mlx5 (Novo Nordisk)$ 12.52
MIXTARD-30 FlexPen 100 IU x 1 mL x 3ml (Novo Nordisk)$ 3.95
Mixtard-30 Novolet 30% Soluble insulin , 70%Insulin, Isophane100IU x 1mL INJ / 3ml (Novo Nordisk)$ 3.43
100 IU x 1 mL x 3ml (Novo Nordisk)$ 3.43
Mixtard-30 Novolet 30% Soluble insulin , 70%Insulin, Isophane 100IU x 1mL INJ / 3ml (Novo Nordisk)$ 3.43
MIXTARD-30 NOVOLET Novolet 100 IU x 1 mL x 3ml (Novo Nordisk)$ 3.43
Mixulin HPI Porcine Insulin premix 100iu INJ / 10ml$ 3.43
MIXULIN HPI 40IU INJECTION 1 vial / 10 ML injection each (Cadila Pharmaceuticals Ltd)$ 1.14
Mixulin Hpi 40IU Injection (Cadila Pharmaceuticals Ltd)$ 0.11
Mixulin HPI 30/70 Porcine Insulin 30%, IsophaneInsulin 70%, 40iu INJ / 10ml$ 1.14
NovoFine insulin needles 1's (Novo Nordisk)
Novomix-30 300iu FLEXPEN / 1 (Novo Nordisk)$ 6.33
Novomix-30 Insulin Aspart 300iu PENFILL / 5x3ml (Novo Nordisk)$ 23.67
100 IU x 1 mL x 3ml (Novo Nordisk)$ 2.50
Novomix-30 Soluble insulin aspart 30 %, insulin aspart protamine 70 %.100 IU x 1mL FLEXPEN / 3ml (Novo Nordisk)$ 6.83
Novomix-30 Soluble insulin aspart 30 %, insulin aspart protamine 70 %.100 IU x 1mL PENFILL / 3ml (Novo Nordisk)$ 2.50
NOVOMIX-30 FlexPen 100 IU x 1 mL x 3ml (Novo Nordisk)$ 6.70
NOVOMIX-30 penfill 100 IU x 1 mL x 3mlx5 (Novo Nordisk)$ 26.65
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
Rapisulin HPI neutral insulin soluble 40iu INJ / 10ml (Cadila)$ 1.14
40 IU x 10ml (Cadila)$ 1.14
RAPISULIN HPI 400IU INJECTION 1 vial / 10 ML injection each (Cadila)$ 1.33

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).

Reviews

The results of a survey conducted on ndrugs.com for Lantus AUTOPEN are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Lantus AUTOPEN. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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2 consumers reported age

Users%
30-451
50.0%
> 601
50.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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