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Lantus OptiSet

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Lantus OptiSet uses


1. INDICATIONS AND USAGE

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

Lantus OptiSet is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. (1)

Limitations of Use:


Limitations of Use

Lantus OptiSet is not recommended for the treatment of diabetic ketoacidosis.

2. DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 General Dosing Instructions

2.3 Initiation of Lantus OptiSet Therapy

Type 1 Diabetes:


Type 2 Diabetes:

2.4 Changing to Lantus OptiSet from Other Insulin Therapies

3. DOSAGE FORMS AND STRENGTHS

Injection: 100 units per mL of Lantus OptiSet. Lantus OptiSet is available as:


Injection: 100 units/mL Lantus OptiSet is available as:

4. CONTRAINDICATIONS

Lantus OptiSet is contraindicated

5. WARNINGS AND PRECAUTIONS

5.1 Never Share a Lantus OptiSet SoloStar Prefilled Pen, Syringe, or Needle between Patients

Lantus OptiSet SoloStar prefilled pens must never be shared between patients, even if the needle is changed. Patients using Lantus OptiSet vials must never reuse or share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant oral and anti-diabetic products may be needed.

5.3 Hypoglycemia

Hypoglycemia is the most common adverse reaction associated with insulin, including Lantus OptiSet. 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).

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) , or in patients who experience recurrent hypoglycemia.

Risk Factors for Hypoglycemia

The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulin preparations, the glucose lowering effect time course of Lantus OptiSet may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature . Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication . Patients with renal or hepatic impairment may be at higher risk of hypoglycemia .

Risk Mitigation Strategies for Hypoglycemia

Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

The long-acting effect of Lantus OptiSet may delay recovery from hypoglycemia.

5.4 Medication Errors

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

5.5 Hypersensitivity and Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Lantus OptiSet. If hypersensitivity reactions occur, discontinue Lantus OptiSet; treat per standard of care and monitor until symptoms and signs resolve . Lantus OptiSet is contraindicated in patients who have had hypersensitivity reactions to Lantus OptiSet or one of the excipients [see Contraindications (4)].

5.6 Hypokalemia

All insulin products, including Lantus OptiSet, 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. Monitor potassium levels in patients at risk for hypokalemia if indicated.

5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists

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. Patients treated with insulin, including Lantus OptiSet, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

6. ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere:


Adverse reactions commonly associated with Lantus OptiSet include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact sanofi- aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trial Experience

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

The data in Table 1 reflect the exposure of 2327 patients with type 1 diabetes to Lantus OptiSet or NPH. The type 1 diabetes population had the following characteristics: Mean age was 38.5 years. Fifty four percent were male, 96.9% were Caucasian, 1.8 % were Black or African American and 2.7 % were Hispanic. The mean BMI was 25.1 kg/m2.

The data in Table 2 reflect the exposure of 1563 patients with type 2 diabetes to Lantus OptiSet or NPH. The type 2 diabetes population had the following characteristics: Mean age was 59.3 years. Fifty eight percent were male, 86.7% were Caucasian, 7.8 % were Black or African American and 9 % were Hispanic. The mean BMI was 29.2 kg/m2.

The frequencies of adverse events during Lantus OptiSet clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Lantus OptiSet, %

(n=1257)

 NPH, %

(n=1070)
Upper respiratory tract infection 22.4 23.1
Infection Body System not Specified 9.4 10.3
Accidental injury 5.7 6.4
Headache 5.5 4.7
Lantus OptiSet, %

(n=849)

 NPH, %

(n=714)
Upper respiratory tract infection 11.4 13.3
Infection Body System not Specified 10.4 11.6
Retinal vascular disorder 5.8 7.4
Lantus OptiSet, %

(n=514)

 NPH, %

(n=503)
Upper respiratory tract infection 29.0 33.6
Edema peripheral 20.0 22.7
Hypertension 19.6 18.9
Influenza 18.7 19.5
Sinusitis 18.5 17.9
Cataract 18.1 15.9
Bronchitis 15.2 14.1
Arthralgia 14.2 16.1
Pain in extremity 13.0 13.1
Back pain 12.8 12.3
Cough 12.1 7.4
Urinary tract infection 10.7 10.1
Diarrhea 10.7 10.3
Depression 10.5 9.7
Headache 10.3 9.3
Lantus OptiSet, %

(n=174)

 NPH, %

(n=175)
Infection Body System not Specified 13.8 17.7
Upper respiratory tract infection 13.8 16.0
Pharyngitis 7.5 8.6
Rhinitis 5.2 5.1

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Lantus OptiSet . Tables 5, and 6 and 7 summarize the incidence of severe hypoglycemia in the Lantus OptiSet individual clinical trials. 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.

Percentages of LANTUS-treated adult patients experiencing severe symptomatic hypoglycemia in the Lantus OptiSet clinical trials were comparable to percentages of NPH-treated patients for all treatment regimens. In the pediatric phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to the adult trials with type 1 diabetes.

Study A

Type 1 Diabetes

Adults

28 weeks

In combination with regular insulin

 Study B

Type 1 Diabetes

Adults

28 weeks

In combination with regular insulin

 Study C

Type 1 Diabetes

Adults

16 weeks

In combination with insulin lispro

 Study D

Type 1 Diabetes

Pediatrics

26 weeks

In combination with regular insulin
Lantus OptiSet

N=292

 NPH

N=293

 Lantus OptiSet

N=264

 NPH

N=270

 Lantus OptiSet

N=310

 NPH

N=309

 Lantus OptiSet

N=174

 NPH

N=175
Percent of patients 10.6 15.0 8.7 10.4 6.5 5.2 23.0 28.6
Study E

Type 2 Diabetes

Adults

52 weeks

In combination with oral agents

 Study F

Type 2 Diabetes

Adults

28 weeks

In combination with regular insulin

 Study G

Type 2 Diabetes

Adults

5 years

In combination with regular insulin
Lantus OptiSet

N=289

 NPH

N=281

 Lantus OptiSet

N=259

 NPH

N=259

 Lantus OptiSet

N=513

 NPH

N=504
Percent of patients 1.7 1.1 0.4 2.3 7.8 11.9

Table 7 displays the proportion of patients experiencing severe symptomatic hypoglycemia in the Lantus OptiSet and Standard Care groups in the ORIGIN Trial .

ORIGIN Trial

Median duration of follow-up: 6.2 years
Lantus OptiSet

N=6231

 Standard Care

N=6273
Percent of patients 5.6 1.8

Peripheral Edema

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

Lipodystrophy

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

Insulin initiation and intensification of glucose control

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

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

Allergic Reactions

Local Allergy

As with any insulin therapy, patients taking Lantus OptiSet may experience injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation. In clinical studies in adult patients, there was a higher incidence of treatment-emergent injection site pain in LANTUS-treated patients (2.7%) compared to NPH insulin-treated patients (0.7%). The reports of pain at the injection site did not result in discontinuation of therapy.

Systemic Allergy

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

6.2 Immunogenicity

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. In phase 3 clinical trials of Lantus OptiSet, increases in titers of antibodies to insulin were observed in NPH insulin and Lantus OptiSet treatment groups with similar incidences.

6.3 Postmarketing Experience

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

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

7. DRUG INTERACTIONS

Table 8 includes clinically significant drug interactions with Lantus OptiSet.

Drugs That May Increase the Risk of Hypoglycemia
Drugs: 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.
Intervention: Dose reductions and increased frequency of glucose monitoring may be required when Lantus OptiSet is co-administered with these drugs.
Drugs That May Decrease the Blood Glucose Lowering Effect of Lantus OptiSet
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
Intervention: Dose increases and increased frequency of glucose monitoring may be required when Lantus OptiSet is co-administered with these drugs.
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Lantus OptiSet
Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Lantus OptiSet is co-administered with these drugs.
Drugs That May Blunt Signs and Symptoms of Hypoglycemia
Drugs: beta-blockers, clonidine, guanethidine, and reserpine
Intervention: Increased frequency of glucose monitoring may be required when Lantus OptiSet is co-administered with these drugs.

8. USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

There are no well-controlled clinical studies of the use of Lantus OptiSet in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes, insulin requirements may decrease during the first trimester, generally increase during the second trimester, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking Lantus OptiSet.

Subcutaneous reproduction and teratology studies have been performed with Lantus OptiSet and regular human insulin in rats and Himalayan rabbits. Lantus OptiSet was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m2. In rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m2, were administered during organogenesis. The effects of Lantus OptiSet did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.

8.3 Nursing Mothers

Endogenous insulin is present in human milk; it is unknown whether Lantus OptiSet is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when Lantus OptiSet is administered to a nursing woman. Use of Lantus OptiSet is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

8.4 Pediatric Use

The safety and effectiveness of Lantus OptiSet have been established in pediatric patients with type 1 diabetes . The safety and effectiveness of Lantus OptiSet in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes have not been established.

The dosage recommendation when changing to Lantus OptiSet in pediatric patients (age 6 to 15 years) with type 1 diabetes is the same as that described for adults [see Dosage and Administration (2.2, 2.4) and Clinical Studies (14)]. As in adults, the dosage of Lantus OptiSet must be individualized in pediatric patients (age 6 to 15 years) with type 1 diabetes based on metabolic needs and frequent monitoring of blood glucose.

In the pediatric clinical trial, pediatric patients (age 6 to 15 years) with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in trials with type 1 diabetes .

8.5 Geriatric Use

Of the total number of subjects in controlled clinical studies of patients with type 1 and type 2 diabetes, who were treated with Lantus OptiSet, 15% were ≥65 years of age and 2% were ≥75 years of age. The only difference in safety or effectiveness in the subpopulation of patients ≥65 years of age compared to the entire study population was a higher incidence of cardiovascular events typically seen in an older population in the Lantus OptiSet and NPH treatment groups.

Nevertheless, caution should be exercised when Lantus OptiSet 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.

8.6 Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of Lantus OptiSet has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for Lantus OptiSet in patients with hepatic impairment .

8.7 Renal Impairment

The effect of renal impairment on the pharmacokinetics of Lantus OptiSet has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Frequent glucose monitoring and dose adjustment may be necessary for Lantus OptiSet in patients with renal impairment .

8.8 Obesity

In controlled clinical trials, subgroup analyses based on BMI did not show differences in safety and efficacy between Lantus OptiSet and NPH.

10. OVERDOSAGE

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.

11. DESCRIPTION

Lantus OptiSet (insulin glargine injection) is a sterile solution of Lantus OptiSet for subcutaneous use. Lantus OptiSet is a recombinant human insulin analog that is a long-acting, parenteral blood-glucose-lowering agent . Lantus OptiSet has low aqueous solubility at neutral pH. At pH 4 Lantus OptiSet is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of Lantus OptiSet are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows once-daily dosing as a basal insulin. Lantus OptiSet is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Lantus OptiSet differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, Lantus OptiSet is 21A-Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. Lantus OptiSet has the following structural formula:

Lantus OptiSet consists of Lantus OptiSet dissolved in a clear aqueous fluid. Each milliliter of Lantus OptiSet (insulin glargine injection) contains 100 Units (3.6378 mg) Lantus OptiSet.

The 10 mL vial presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection.

The 3 mL prefilled pen presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. Lantus OptiSet has a pH of approximately 4.

Chemical Structure

12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The primary activity of insulin, including Lantus OptiSet, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

12.2 Pharmacodynamics

In clinical studies, the glucose-lowering effect on a molar basis of intravenous Lantus OptiSet is approximately the same as that for human insulin. Figure 1 shows results from a study in patients with type 1 diabetes conducted for a maximum of 24 hours after the injection. The median time between injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH insulin, and 24 hours (range: 10.8 to >24.0 hours) (24 hours was the end of the observation period) for Lantus OptiSet.

* Determined as amount of glucose infused to maintain constant plasma glucose levels.
Figure 1. Activity Profile in Patients with Type 1 Diabetes


The duration of action after abdominal, deltoid, or thigh subcutaneous administration was similar. The time course of action of insulins, including Lantus OptiSet, may vary between individuals and within the same individual.

Figure

12.3 Pharmacokinetics

Absorption and Bioavailability

After subcutaneous injection of Lantus OptiSet in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH insulin.

Metabolism and Elimination

A metabolism study in humans indicates that Lantus OptiSet is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of human insulin, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin). Unchanged drug and these degradation products are also present in the circulation.

Special Populations

Age, Race, and Gender. Effect of age, race, and gender on the pharmacokinetics of Lantus OptiSet has not been evaluated. However, in controlled clinical trials in adults (n=3890) and a controlled clinical trial in pediatric patients (n=349), subgroup analyses based on age, race, and gender did not show differences in safety and efficacy between Lantus OptiSet and NPH insulin .

Obesity. Effect of Body Mass Index (BMI) on the pharmacokinetics of Lantus OptiSet has not been evaluated.

13. NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In mice and rats, standard two-year carcinogenicity studies with Lantus OptiSet were performed at doses up to 0.455 mg/kg, which was for the rat approximately 10 times and for the mouse approximately 5 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m2. The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown.

Lantus OptiSet was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames- and HGPRT-test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters).

In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 7 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m2, maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.

14. Clinical STUDIES

14.1 Overview of Clinical Studies

The safety and effectiveness of Lantus OptiSet given once-daily at bedtime was compared to that of once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of 2,327 adult patients and 349 pediatric patients with type 1 diabetes mellitus and 1,563 adult patients with type 2 diabetes mellitus. In general, the reduction in glycated hemoglobin (HbA1c) with Lantus OptiSet was similar to that with NPH insulin.

14.2 Clinical Studies in Adult and Pediatric Patients with Type 1 Diabetes

In two clinical studies (Studies A and B), patients with type 1 diabetes (Study A; n=585, Study B n=534) were randomized to 28 weeks of basal-bolus treatment with Lantus OptiSet or NPH insulin. Regular human insulin was administered before each meal. Lantus OptiSet was administered at bedtime. NPH insulin was administered either as once daily at bedtime or in the morning and at bedtime when used twice daily.

In Study A, the average age was 39.2 years. The majority of patients were White (99%) and 55.7% were male. The mean BMI was approximately 24.9 kg/m2. The mean duration of diabetes was 15.5 years.

In Study B, the average age was 38.5 years. The majority of patients were White (95.3%) and 50.6% were male. The mean BMI was approximately 25.8 kg/m2. The mean duration of diabetes was 17.4 years.

In another clinical study (Study C), patients with type 1 diabetes (n=619) were randomized to 16 weeks of basal-bolus treatment with Lantus OptiSet or NPH insulin. Insulin lispro was used before each meal. Lantus OptiSet was administered once daily at bedtime and NPH insulin was administered once or twice daily. The average age was 39.2 years. The majority of patients were White (96.9%) and 50.6% were male. The mean BMI was approximately 25.6 kg/m2. The mean duration of diabetes was 18.5 years.

In these 3 studies, Lantus OptiSet and NPH insulin had similar effects on HbA1c (Table 9) with a similar overall rate of severe symptomatic hypoglycemia .

Study A Study B Study C
Treatment duration 28 weeks 28 weeks 16 weeks
Treatment in combination with Regular insulin Regular insulin Insulin lispro
Lantus OptiSet NPH Lantus OptiSet NPH Lantus OptiSet NPH
Number of subjects treated 292 293 264 270 310 309
HbA1c
Baseline HbA1c 8.0 8.0 7.7 7.7 7.6 7.7
Adjusted mean change at trial end +0.2 +0.1 -0.2 -0.2 -0.1 -0.1
Treatment Difference (95% CI) +0.1 (0.0; +0.2) +0.1 (-0.1; +0.2) 0.0 (-0.1; +0.1)
Basal insulin dose
Baseline mean 21 23 29 29 28 28
Mean change from baseline -2 0 -4 +2 -5 +1
Total insulin dose
Baseline mean 48 52 50 51 50 50
Mean change from baseline -1 0 0 +4 -3 0
Fasting blood glucose (mg/dL)
Baseline mean 167 166 166 175 175 173
Adj. mean change from baseline -21 -16 -20 -17 -29 -12
Body weight (kg)
Baseline mean 73.2 74.8 75.5 75.0 74.8 75.6
Mean change from baseline 0.1 -0.0 0.7 1.0 0.1 0.5

Type 1 Diabetes – Pediatric.

In a randomized, controlled clinical study (Study D), pediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal. Lantus OptiSet was administered once daily at bedtime and NPH insulin was administered once or twice daily. The average age was 11.7 years. The majority of patients were White (96.8%) and 51.9% were male. The mean BMI was approximately 18.9 kg/m2. The mean duration of diabetes was 4.8 years. Similar effects on HbA1c (Table 10) were observed in both treatment groups .

Study D
Treatment duration 28 weeks
Treatment in combination with Regular insulin
Lantus OptiSet + Regular Insulin NPH+ Regular Insulin
Number of subjects treated 174 175
HbA1c
Baseline mean 8.5 8.8
Change from baseline (adjusted mean) +0.3 +0.3
Difference from NPH (adjusted mean) 0.0
(95% CI ) (-0.2; +0.3)
Basal insulin dose
Baseline mean 19 19
Mean change from baseline -1 +2
Total insulin dose
Baseline mean 43 43
Mean change from baseline +2 +3
Fasting blood glucose (mg/dL)
Baseline mean 194 191
Mean change from baseline -23 -12
Body weight (kg)
Baseline mean 45.5 44.6
Mean change from baseline 2.2 2.5

14.3 Clinical Studies in Adults with Type 2 Diabetes

In a randomized, controlled clinical study (Study E) (n=570), Lantus OptiSet was evaluated for 52 weeks in combination with oral anti-diabetic medications (a sulfonylurea, metformin, acarbose, or combinations of these drugs). The average age was 59.5 years. The majority of patients were White (92.8%) and 53.7% were male. The mean BMI was approximately 29.1 kg/m2. The mean duration of diabetes was 10.3 years. Lantus OptiSet administered once daily at bedtime was as effective as NPH insulin administered once daily at bedtime in reducing HbA1c and fasting glucose (Table 11). The rate of severe symptomatic hypoglycemia was similar in Lantus OptiSet and NPH insulin treated patients .

In a randomized, controlled clinical study (Study F), in patients with type 2 diabetes not using oral anti-diabetic medications (n=518), a basal-bolus regimen of Lantus OptiSet once daily at bedtime or NPH insulin administered once or twice daily was evaluated for 28 weeks. Regular human insulin was used before meals, as needed. The average age was 59.3 years. The majority of patients were White (80.7%) and 60% were male. The mean BMI was approximately 30.5 kg/m2. The mean duration of diabetes was 13.7 years. Lantus OptiSet had similar effectiveness as either once- or twice-daily NPH insulin in reducing HbA1c and fasting glucose (Table 11) with a similar incidence of hypoglycemia .

In a randomized, controlled clinical study (Study G), patients with type 2 diabetes were randomized to 5 years of treatment with once-daily Lantus OptiSet or twice-daily NPH insulin. For patients not previously treated with insulin, the starting dose of Lantus OptiSet or NPH insulin was 10 units daily. Patients who were already treated with NPH insulin either continued on the same total daily NPH insulin dose or started Lantus OptiSet at a dose that was 80% of the total previous NPH insulin dose. The primary endpoint for this study was a comparison of the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. HbA1c change from baseline was a secondary endpoint. Similar glycemic control in the 2 treatment groups was desired in order to not confound the interpretation of the retinal data. Patients or study personnel used an algorithm to adjust the Lantus OptiSet and NPH insulin doses to a target fasting plasma glucose ≤100 mg/dL. After the Lantus OptiSet or NPH insulin dose was adjusted, other anti-diabetic agents, including pre-meal insulin were to be adjusted or added. The average age was 55.1 years. The majority of patients were White (85.3%) and 53.9% were male. The mean BMI was approximately 34.3 kg/m2. The mean duration of diabetes was 10.8 years. The Lantus OptiSet group had a smaller mean reduction from baseline in HbA1c compared to the NPH insulin group, which may be explained by the lower daily basal insulin doses in the Lantus OptiSet group (Table 11). The incidences of severe symptomatic hypoglycemia were similar between groups .

Study E Study F Study G
Treatment duration 52 weeks 28 weeks 5 years
Treatment in combination with Oral agents Regular insulin Regular insulin
Lantus OptiSet NPH Lantus OptiSet NPH Lantus OptiSet NPH
Number of subjects treated 289 281 259 259 513 504
HbA1c
Baseline mean 9.0 8.9 8.6 8.5 8.4 8.3
Adjusted mean change from baseline -0.5 -0.4 -0.4 -0.6 -0.6 -0.8
LANTUS – NPH -0.1 +0.2 +0.2
95% CI for Treatment difference (-0.3; +0.1) (0.0; +0.4) (+0.1, +0.4)
Basal insulin doseIn Study G, the baseline dose of basal or total insulin was the first available on-treatment dose prescribed during the study (on visit month 1.5).
Baseline mean 14 15 44.1 45.5 39 44
Mean change from baseline +12 +9 -1 +7 +23 +30
Total insulin dose
Baseline mean 14 15 64 67 48 53
Mean change from baseline +12 +9 +10 +13 +41 +40
Fasting blood glucose (mg/dL)
Baseline mean 179 180 164 166 190 180
Adj. mean change from baseline -49 -46 -24 -22 -45 -44
Body weight (kg)
Baseline mean 83.5 82.1 89.6 90.7 100 99
Adj. mean change from baseline 2.0 1.9 0.4 1.4 3.7 4.8

Lantus OptiSet Timing of Daily Dosing.

The safety and efficacy of Lantus OptiSet administered pre-breakfast, pre-dinner, or at bedtime were evaluated in a randomized, controlled clinical study in patients with type 1 diabetes (study H, n=378). Patients were also treated with insulin lispro at mealtime. The average age was 40.9 years. All patients were White (100%) and 53.7% were male. The mean BMI was approximately 25.3 kg/m2. The mean duration of diabetes was 17.3 years. Lantus OptiSet administered at different times of the day resulted in similar reductions in HbA1c compared to that with bedtime administration. In these patients, data are available from 8-point home glucose monitoring. The maximum mean blood glucose was observed just prior to injection of Lantus OptiSet regardless of time of administration.

In this study, 5% of patients in the LANTUS-breakfast arm discontinued treatment because of lack of efficacy. No patients in the other two arms discontinued for this reason. The safety and efficacy of Lantus OptiSet administered pre-breakfast or at bedtime were also evaluated in a randomized, active-controlled clinical study (Study I, n=697) in patients with type 2 diabetes not adequately controlled on oral anti-diabetic therapy. All patients in this study also received glimepiride 3 mg daily. The average age was 60.8 years. The majority of patients were White (96.6%) and 53.7% were male. The mean BMI was approximately 28.7 kg/m2. The mean duration of diabetes was 10.1 years. Lantus OptiSet given before breakfast was at least as effective in lowering HbA1c as Lantus OptiSet given at bedtime or NPH insulin given at bedtime.

Study H Study I
Treatment duration 24 weeks 24 weeks
Treatment in combination with: Insulin lispro Glimepiride
Lantus OptiSet

Breakfast

 Lantus OptiSet

Dinner

 Lantus OptiSet

Bedtime

 Lantus OptiSet

Breakfast

 Lantus OptiSet

Bedtime

 NPH

Bedtime
**total number of patients evaluable for safety
Number of subjects treated Intent to treat 112 124 128 234 226 227
HbA1c
Baseline mean 7.6 7.5 7.6 9.1 9.1 9.1
Mean change from baseline -0.2 -0.1 0.0 -1.3 -1.0 -0.8
Basal insulin dose (U)
Baseline mean 22 23 21 19 20 19
Mean change from baseline 5 2 2 11 18 18
Total insulin dose (U) NA Not applicable NA NA
Baseline mean 52 52 49
Mean change from baseline 2 3 2
Body weight (kg)
Baseline mean 77.1 77.8 74.5 80.7 82 81
Mean change from baseline 0.7 0.1 0.4 3.9 3.7 2.9

Five-year Trial Evaluating the Progression of Retinopathy

Retinopathy was evaluated in the Lantus OptiSet clinical studies by analysis of reported retinal adverse events and fundus photography. The numbers of retinal adverse events reported for Lantus OptiSet and NPH insulin treatment groups were similar for patients with type 1 and type 2 diabetes.

Lantus OptiSet was compared to NPH insulin in a 5-year randomized clinical trial that evaluated the progression of retinopathy as assessed with fundus photography using a grading protocol derived from the Early Treatment Diabetic Retinopathy Scale (ETDRS). Patients had type 2 diabetes (mean age 55 yrs) with no (86%) or mild (14%) retinopathy at baseline. Mean baseline HbA1c was 8.4%. The primary outcome was progression by 3 or more steps on the ETDRS scale at study endpoint. Patients with pre-specified post-baseline eye procedures (pan-retinal photocoagulation for proliferative or severe nonproliferative diabetic retinopathy, local photocoagulation for new vessels, and vitrectomy for diabetic retinopathy) were also considered as 3-step progressors regardless of actual change in ETDRS score from baseline. Retinopathy graders were blinded to treatment group assignment. The results for the primary endpoint are shown in Table 13 for both the per-protocol and Intent-to-Treat populations, and indicate similarity of Lantus OptiSet to NPH in the progression of diabetic retinopathy as assessed by this outcome.

Lantus OptiSet (%) NPH (%) DifferenceDifference = Lantus OptiSet – NPH , using a generalized linear model (SAS GENMOD) with treatment and baseline HbA1c strata (cutoff 9.0%) as the classified independent variables, and with binomial distribution and identity link function (SE) 95% CI for difference
Per-protocol 53/374 (14.2%) 57/363 (15.7%) -2.0% (2.6%) -7.0% to +3.1%
Intent-to-Treat 63/502 (12.5%) 71/487 (14.6%) - 2.1% (2.1%) -6.3% to +2.1%

The Origin Study

The Outcome Reduction with Initial Glargine Intervention trial (i.e., ORIGIN) was an open-label, randomized, 2-by-2, factorial design study. One intervention in ORIGIN compared the effect of Lantus OptiSet to standard care on major adverse cardiovascular outcomes in 12,537 participants ≥ 50 years of age with abnormal glucose levels [i.e., impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)] or early type 2 diabetes mellitus and established cardiovascular (i.e., CV) disease or CV risk factors at baseline.

The objective of the trial was to demonstrate that Lantus OptiSet use could significantly lower the risk of major cardiovascular outcomes compared to standard care. Two co-primary composite cardiovascular endpoints were used in ORIGIN. The first co-primary endpoint was the time to first occurrence of a major adverse cardiovascular event defined as the composite of CV death, nonfatal myocardial infarction and nonfatal stroke. The second co-primary endpoint was the time to the first occurrence of CV death or nonfatal myocardial infarction or nonfatal stroke or revascularization procedure or hospitalization for heart failure.

Participants were randomized to either Lantus OptiSet (N=6264) titrated to a goal fasting plasma glucose of ≤ 95 mg/dL or to standard care (N=6273). Anthropometric and disease characteristics were balanced at baseline. The mean age was 64 years and 8% of participants were 75 years of age or older. The majority of participants were male (65%). Fifty nine percent were Caucasian, 25% were Latin, 10% were Asian and 3% were Black. The median baseline BMI was 29 kg/m2. Approximately 12% of participants had abnormal glucose levels (IGT and/or IFG) at baseline and 88% had type 2 diabetes. For patients with type 2 diabetes, 59% were treated with a single oral antidiabetic drug, 23% had known diabetes but were on no antidiabetic drug and 6% were newly diagnosed during the screening procedure. The mean HbA1c (SD) at baseline was 6.5% (1.0). Fifty nine percent of participants had had a prior cardiovascular event and 39% had documented coronary artery disease or other cardiovascular risk factors.

Vital status was available for 99.9% and 99.8% of participants randomized to Lantus OptiSet and standard care respectively at end of trial. The median duration of follow-up was 6.2 years [range: 8 days to 7.9 years]. The mean HbA1c (SD) at the end of the trial was 6.5% (1.1) and 6.8% (1.2) in the Lantus OptiSet and standard care group respectively. The median dose of Lantus OptiSet at end of trial was 0.45 U/kg. Eighty-one percent of patients randomized to Lantus OptiSet were using Lantus OptiSet at end of the study. The mean change in body weight from baseline to the last treatment visit was 2.2 kg greater in the Lantus OptiSet group than in the standard care group.

Overall, the incidence of major adverse cardiovascular outcomes was similar between groups. All-cause mortality was also similar between groups.

Lantus OptiSet

N=6264

 Standard Care

N=6273

 Lantus OptiSet vs Standard Care
n

(Events per 100 PY)

 n

(Events per 100 PY)

 Hazard Ratio (95% CI)
Co-primary endpoints
CV death, nonfatal myocardial infarction, or nonfatal stroke 1041

(2.9)

 1013

(2.9)

 1.02 (0.94, 1.11)
CV death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure or revascularization procedure 1792

(5.5)

 1727

(5.3)

 1.04 (0.97, 1.11)
Components of co-primary endpoints
CV death 580 576 1.00 (0.89, 1.13)
Myocardial Infarction (fatal or non-fatal) 336 326 1.03 (0.88, 1.19)
Stroke (fatal or non-fatal) 331 319 1.03 (0.89, 1.21)
Revascularizations 908 860 1.06 (0.96, 1.16)
Hospitalization for heart failure 310 343 0.90 (0.77, 1.05)

In the ORIGIN trial, the overall incidence of cancer (all types combined) or death from cancer (Table 15) was similar between treatment groups.

Lantus OptiSet

N=6264

 Standard Care

N=6273

 Lantus OptiSet vs Standard Care
n

(Events per 100 PY)

 n

(Events per 100 PY)

 Hazard Ratio (95% CI)
Cancer endpoints
Any cancer event (new or recurrent) 559

(1.56)

 561

(1.56)

 0.99 (0.88, 1.11)
New cancer events 524

(1.46)

 535

(1.49)

 0.96 (0.85, 1.09)
Death due to Cancer 189

(0.51)

 201

(0.54)

 0.94 (0.77, 1.15)

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Lantus OptiSet is supplied as a solution containing 100 units per mL (U-100) of Lantus OptiSet and is available in:

Dosage Unit/Strength Package size NDC #

0088
10 mL vials

100 Units/mL

 Pack of 1 2220-33
3 mL SoloStar prefilled pen

100 Units/mL

 package of 5 2219-05

Needles are not included in the packs.

BD Ultra-Fine needlesThe brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC to be used in conjunction with SoloStar are sold separately and are manufactured by BD.

16.2 Storage

Lantus OptiSet should not be stored in the freezer and should not be allowed to freeze. Discard Lantus OptiSet if it has been frozen. Protect Lantus OptiSet from direct heat and light.

Storage conditions are summarized in the following table:

Not in-use (unopened) Not in-use (unopened) In-use (opened)
Refrigerated Room Temperature
(36°F – 46°F [2°C – 8°C]) (below 86°F [30°C])
10 mL Vial Until expiration date 28 days 28 days

Refrigerated or room temperature
3 mL SoloStar prefilled pen Until expiration date 28 days 28 days

Room temperature only

(Do not refrigerate)

17. PATIENT COUNSELING INFORMATION

Advise the patient to read FDA-approved patient labeling (Patient Information and Instructions for Use).

Never Share a Lantus OptiSet SoloStar Prefilled Pen or Syringe between Patients

Advise patients that they must never share a Lantus OptiSet SoloStar prefilled pen with another person, even if the needle is changed. Advise patients using Lantus OptiSet vials not to reuse or share needles or syringes with another person. Sharing carries a risk for transmission of blood-borne pathogens .

Hyperglycemia or Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia. Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery

Advise patients that changes in insulin regimen can predispose to hyper- or hypoglycemia.

Advise patients that changes in insulin regimen should be made under close medical supervision.

Medications Errors

Instruct patients to always check the insulin label before each injection..

Administration

Advise patients that Lantus OptiSet must NOT be diluted or mixed with any other insulin or solution and that Lantus OptiSet must only be used if the solution is clear and colorless with no particles visible.

Management of Hypoglycemia and handling of Special Situations

Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia.

Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.

Pregnancy

Advise patients to inform their health care professional if they are pregnant or are contemplating pregnancy.

Refer patients to the Lantus OptiSet "Patient Information" for additional information about the potential side effects of insulin therapy, including lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia.

FDA Approved Patient Labeling

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

A SANOFI COMPANY

©2015 sanofi-aventis U.S. LLC

Lantus OptiSet, TOUJEO and SoloStar are registered trademarks of sanofi-aventis U.S. LLC.

Patient Information

Lantus OptiSet® (LAN-tus)

(insulin glargine injection) for subcutaneous use, 100 Units/mL (U-100)


Do not share your syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What is Lantus OptiSet?

Lantus OptiSet is a long-acting man-made-insulin used to control high blood sugar in adults with diabetes mellitus.

  • Lantus OptiSet is not for use to treat diabetic ketoacidosis.
  • It is not known if Lantus OptiSet is safe and effective in children less than 6 years of age with type 1 diabetes.
  • It is not known if Lantus OptiSet is safe and effective in children with type 2 diabetes.

Who should not use Lantus OptiSet?

Do not use Lantus OptiSet if you:

  • are having an episode of low blood sugar (hypoglycemia)
  • have an allergy to Lantus OptiSet or any of the ingredients in Lantus OptiSet. See the end of this Patient Information leaflet for a complete list of ingredients in Lantus OptiSet.

What should I tell my healthcare provider before using Lantus OptiSet?

Before using Lantus OptiSet, tell your healthcare provider about all your medical conditions including if you:

  • have liver or kidney problems
  • take other medicines, especially ones called TZDs (thiazolidinediones)
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Lantus OptiSet.
  • are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Lantus OptiSet may harm your unborn baby or breastfeeding baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before you start using Lantus OptiSet, talk to your healthcare provider about low blood sugar and how to manage it.


How should I use Lantus OptiSet?

  • Read the detailed Instructions for Use that come with your Lantus OptiSet insulin.
  • Use Lantus OptiSet exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Lantus OptiSet to use and when to use it.
  • Know the amount of Lantus OptiSet you use. Do not change the amount of Lantus OptiSet you use unless your healthcare provider tells you to.
  • Check your insulin label each time you give your injection to make sure you are using the correct insulin.
  • Do not re-use needles. Always use a new needle for each injection. Re-use of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of Lantus OptiSet. Using a new needle for each injection lowers your risk of getting an infection.
  • You may take Lantus OptiSet at any time during the day but you must take it at the same time every day.
  • Only use Lantus OptiSet that is clear and colorless. If your Lantus OptiSet is cloudy or slightly colored, return it to your pharmacy for a replacement.
  • Lantus OptiSet is injected under your skin (subcutaneously). Do not use Lantus OptiSet in an insulin pump or inject Lantus OptiSet into your vein (intravenously).
  • Change (rotate) injection sites within the area you chose with each dose. Do not use the exact spot for each injection.
  • Do not mix Lantus OptiSet with any other type of insulin or liquid medicine.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

Keep Lantus OptiSet and all medicines out of the reach of children.

Your dose of Lantus OptiSet may need to change because of:

  • a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of the medicines you take.

What should I avoid while using Lantus OptiSet?

While using Lantus OptiSet do not:

  • drive or operate heavy machinery, until you know how Lantus OptiSet affects you
  • drink alcohol or use over-the counter medicines that contain alcohol

What are the possible side effects of Lantus OptiSet and other insulins?

Lantus OptiSet may cause serious side effects that can lead to death, including:

  • low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
    • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger
  • severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
    • a rash over your whole body, trouble breathing, a fast heartbeat, or sweating
  • low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Lantus OptiSet may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Lantus OptiSet. Your healthcare provider should monitor you closely while you are taking TZDs with Lantus OptiSet. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
    • shortness of breath, swelling of your ankles or feet, sudden weight gain
    Treatment with TZDs and Lantus OptiSet may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

  • trouble breathing; shortness of breath; fast heartbeat; swelling of your face, tongue, or throat; sweating; extreme drowsiness; dizziness; confusion.

The most common side effects of Lantus OptiSet include:

  • low blood sugar (hypoglycemia); weight gain; allergic reactions, including reactions at your injection site; skin thickening or pits at the injection site (lipodystrophy).

These are not all the possible side effects of Lantus OptiSet. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Lantus OptiSet.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Lantus OptiSet for a condition for which it was not prescribed. It may harm them.

This Patient Information leaflet summarizes the most important information about Lantus OptiSet. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Lantus OptiSet that is written for healthcare professionals. For more information, go to www.lantus.com or call 1-800-633-1610.

What are the ingredients in Lantus OptiSet?

  • Active ingredient: Lantus OptiSet
  • 10 ml vial inactive ingredients: zinc, m-cresol, glycerol, polysorbate, and water for injection

Manufactured By: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807

This Patient Information has been approved by the U.S. Food and Drug Administration

Approved: July/2015

Instructions for Use

Lantus OptiSet® (LAN-tus)

(insulin glargine injection) for subcutaneous use

10 mL Vial (100 Units/mL, U-100)

Read the Instructions for Use before you start taking Lantus OptiSet and each time you get a new Lantus OptiSet vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your Lantus OptiSet syringes with other people even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Supplies needed to give your injection:


Preparing your Lantus OptiSet dose:


Step 1:

If you are using a new vial, remove the protective cap. Do not remove the stopper.

Step 2:

Wipe the top of the vial with an alcohol swab. You do not have to shake the vial of Lantus OptiSet before use.

Step 3:

Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.


Step 4:

Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw the correct dose into the syringe.

Step 5:

Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct dose.

Step 6:

Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.

Giving your Lantus OptiSet injection:


Step 7:

Choosing your injection site: Lantus OptiSet is injected under the skin (subcutaneously) of your upper arm, thigh, or stomach area (abdomen). Wipe the skin with an alcohol swab to clean the injection site. Let the injection site dry before you inject your dose.

Step 8:


Step 9:

Disposing of used needles and syringes:


How should I store Lantus OptiSet?


This Instructions for Use have been approved by the U.S. Food and Drug Administration. Revised: July/2015

Patient Information

Lantus OptiSet® (LAN-tus)

(insulin glargine injection) for subcutaneous use, 100 Units/mL (U-100)


Do not share your Lantus OptiSet SoloStar® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What is Lantus OptiSet?

Lantus OptiSet is a long-acting man-made insulin used to control high blood sugar in adults with diabetes mellitus.

  • Lantus OptiSet is not for use to treat diabetic ketoacidosis.
  • It is not known if Lantus OptiSet is safe and effective in children less than 6 years of age with type 1 diabetes.
  • It is not known if Lantus OptiSet is safe and effective in children with type 2 diabetes.

Who should not use Lantus OptiSet?

Do not use Lantus OptiSet if you:

  • are having an episode of low blood sugar (hypoglycemia)
  • have an allergy to Lantus OptiSet or any of the ingredients in Lantus OptiSet. See the end of this Patient Information leaflet for a complete list of ingredients in Lantus OptiSet.

What should I tell my healthcare provider before using Lantus OptiSet?

Before using Lantus OptiSet, tell your healthcare provider about all your medical conditions including if you:

  • have liver or kidney problems
  • take other medicines, especially ones called TZDs (thiazolidinediones)
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Lantus OptiSet.
  • are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Lantus OptiSet may harm your unborn baby or breastfeeding baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before you start using Lantus OptiSet, talk to your healthcare provider about low blood sugar and how to manage it.


How should I use Lantus OptiSet?

  • Read the detailed Instructions for Use that come with your Lantus OptiSet SoloStar disposable prefilled pen.
  • Use Lantus OptiSet exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Lantus OptiSet to use and when to use it.
  • Know the amount of Lantus OptiSet you use. Do not change the amount of Lantus OptiSet you use unless your healthcare provider tells you to.
  • Check your insulin label each time you give your injection to make sure you are using the correct insulin.
  • Lantus OptiSet comes in a SoloStar disposable prefilled pen that you must use to give your Lantus OptiSet. The dose counter on your pen shows your dose of Lantus OptiSet. Do not make any dose changes unless your healthcare provider tells you to.
  • Do not use a syringe to remove Lantus OptiSet from your SoloStar disposable prefilled pen.
  • Do not re-use needles. Always use a new needle for each injection. Re-use of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of Lantus OptiSet. Using a new needle for each injection lowers your risk of getting an infection. If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use.
  • You may take Lantus OptiSet at any time during the day but you must take it at the same time every day.
  • Lantus OptiSet is injected under your skin (subcutaneously). Do not use Lantus OptiSet in an insulin pump or inject Lantus OptiSet into your vein (intravenously).
  • Change (rotate) injection your sites within area you chose with each dose. Do not use the exact spot for each injection
  • Do not mix Lantus OptiSet with any other type of insulin or liquid medicine.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

Keep Lantus OptiSet and all medicines out of the reach of children.


Your dose of Lantus OptiSet may need to change because of:

  • a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of the medicines you take.

What should I avoid while using Lantus OptiSet?

While using Lantus OptiSet do not:

  • drive or operate heavy machinery, until you know how Lantus OptiSet affects you
  • drink alcohol or use over-the-counter medicines that contain alcohol

What are the possible side effects of Lantus OptiSet and other insulins?

Lantus OptiSet may cause serious side effects that can lead to death, including:

  • low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
    • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger
  • severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
    • a rash over your whole body, trouble breathing, a fast heartbeat, or sweating
  • low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Lantus OptiSet may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Lantus OptiSet. Your healthcare provider should monitor you closely while you are taking TZDs with Lantus OptiSet. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
    • shortness of breath, swelling of your ankles or feet, sudden weight gain
    Treatment with TZDs and Lantus OptiSet may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

  • trouble breathing; shortness of breath; fast heartbeat; swelling of your face, tongue, or throat; sweating; extreme drowsiness; dizziness; confusion.

The most common side effects of Lantus OptiSet include:

  • low blood sugar (hypoglycemia); weight gain; allergic reactions, including reactions at your injection site; skin thickening or pits at the injection site (lipodystrophy).

These are not all the possible side effects of Lantus OptiSet. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Lantus OptiSet.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Lantus OptiSet for a condition for which it was not prescribed. It may harm them.

This Patient Information leaflet summarizes the most important information about Lantus OptiSet. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Lantus OptiSet that is written for healthcare professionals. For more information about Lantus OptiSet call 1-800-633-1610 or go to the website www.lantus.com.

What are the ingredients in Lantus OptiSet?

  • Active ingredient: Lantus OptiSet
  • 3 ml SoloStar prefilled pen inactive ingredients: zinc, m-cresol, glycerol and water for injection

Hydrocholoric acid and sodium hydroxide may be added to adjust the pH.

Manufactured By: sanofi-aventis U.S. LLC Bridgewater, NJ 08807

This Patient Information has been approved by the U.S. Food and Drug Administration

Approved: July/2015

Lantus OptiSet® SOLOSTAR®

(insulin glargine injection)

Instruction Leaflet

Your healthcare professional has decided that SoloStar is right for you. Talk with your healthcare professional about proper injection technique before using SoloStar.

Read these instructions carefully before using your SoloStar. If you are not able to follow all the instructions completely on your own, use SoloStar only if you have help from a person who is able to follow the instructions.

Do not share your Lantus OptiSet SoloStar pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Follow these instructions completely each time you use SoloStar to ensure that you get an accurate dose. If you do not follow these instructions you may get too much or too little insulin, which may affect your blood glucose.

SoloStar is a disposable pen for the injection of insulin. Each SoloStar contains in total 300 units of insulin. You can set doses from 1 to 80 units in steps of 1 unit. The pen plunger moves with each dose. The plunger will only move to the end of the cartridge when 300 units of insulin have been given.

Keep this leaflet for future reference.

If you have any questions about SoloStar or about diabetes, ask your healthcare professional, go to www.lantus.com or call sanofi-aventis at 1-800-633-1610.

Important information for use of SoloStar:


Step 1. Check the insulin


Step 2. Attach the needle

Do not reuse needles. Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.


Step 3. Perform a Safety test

Always perform the safety test before each injection.

Performing the safety test ensures that you get an accurate dose by:


You may have to perform the safety test several times before insulin is seen.


Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.


Step 5. Inject the dose


Step 6. Remove and discard the needle

Always remove the needle after each injection and store SoloStar without a needle attached. This helps prevent:


Storage Instructions

Please check the leaflet for the insulin for complete instructions on how to store SoloStar.

If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.

Keep SoloStar out of the reach and sight of children.

Keep your SoloStar in cool storage (36°F – 46°F [2°C – 8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator, or next to a freezer pack.

Once you take your SoloStar out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time.

SoloStar in use must not be stored in a refrigerator.

Do not use SoloStar after the expiration date printed on the label of the pen or on the carton.

Protect SoloStar from light.

Discard your used SoloStar as required by your local authorities.

Maintenance

Protect your SoloStar from dust and dirt.

You can clean the outside of your SoloStar by wiping it with a damp cloth.

Do not soak, wash or lubricate the pen as this may damage it.

Your SoloStar is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloStar might be damaged. If you are concerned that your SoloStar may be damaged, use a new one.

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

A SANOFI COMPANY

Date of revision:

July 2015

©2015 sanofi-aventis U.S. LLC

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Lantus OptiSet pharmaceutical active ingredients containing related brand and generic drugs:


Lantus OptiSet available forms, composition, doses:


Lantus OptiSet destination | category:


Lantus OptiSet Anatomical Therapeutic Chemical codes:


Lantus OptiSet pharmaceutical companies:


References

  1. Dailymed."LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Insulin glargine". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  3. "Insulin Glargine - DrugBank". http://www.drugbank.ca/drugs/DB0004... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lantus OptiSet?

Depending on the reaction of the Lantus OptiSet after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Lantus OptiSet not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Lantus OptiSet addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Lantus OptiSet, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Lantus OptiSet consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

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One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Lantus OptiSet is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Expensive1
100.0%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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