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Lantus® is a once-daily, long-acting insulin that provides 24-hour basal
coverage with no pronounced peak.1

How Lantus® Works Lantus® Efficacy Lantus® Safety Lantus®
SoloSTAR® Pen
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  1. Lantus® Prescribing Information. October 2013.
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Dosing guidelines and titration for Lantus®

Dosing Titration
Interactive dosing calculator Titration options
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Education is an important part of prescribing insulin therapy to help manage
patients' concerns about insulin use.

Therapy Considerations Initiating Treatment Improving Self-Management
Stepwise Approach
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Provide educational support for your patients with type 2 diabetes.
Help them understand, know what to expect, and become active participants in their own care.

Day by Day Guide Explaining Diabetes to Patients Getting Patients Started Improving Patient
Self-Care Skills
Useful guides to reinforce your conversations with patients
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There are a variety of ways Sanofi can help your patients access their insulin therapy.

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Save on Lantus® SoloSTAR®

* Certain eligibility restrictions apply

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Tools, links, and educational materials to help you support patients move
toward their glycemic goals.

Professional Resources Patient Resources
Educational materials

Frequently Asked Questions About Lantus®

1.
How can the Lantus® SoloSTAR® pen help my patients?

Prefilled, disposable pens like the Lantus® SoloSTAR® are easy-to-use devices for administering insulin.

  • Lantus® SoloSTAR® is prefilled with Lantus®—the only 24-hour insulin approved exclusively for use once a day1
  • Lantus® SoloSTAR® is the only insulin pen in which the dose can be set from 1-80 units in 1-unit steps, dialed both up and down
  • Once opened, Lantus® SoloSTAR® can be used for up to 28 days and should not be refrigerated1
  • A vial of Lantus® contains 10 mL, while the same prescription for the Lantus® SoloSTAR® pen has 5 pens with 3 mL each. A patient can get 50% more Lantus® units for the same copay as the Lantus® vial on most insurance plansa

aBased on TRx data from IMS Health, NPA™ monthly database, time period from May 2003 to October 2013.

2.
When it comes to taking insulin, what are the features of the Lantus® SoloSTAR® pen?

The Lantus® SoloSTAR® pen is:

  • Prefilled with the #1 prescribed insulina
  • Easy to teach, with only 6 straightforward steps21,22
  • Easy to use—dial lets patients select the appropriate Lantus® dose from 1 to 80 units, 1 unit at a time21,22
  • Easy to inject—dose cannot be dialed past the number of units left in the pen22,23
    • It is important to keep the injection button pressed all the way in and to slowly count to 10 before withdrawing needle from skin. After a full injection, the number in the dose window will return to zero. These steps help ensure that a full dose has been delivered
    • Insulin dose dialed is the dose delivered24
    • Dose dial returns to zero once dose has been delivered
  • Portable25—once opened, the Lantus® SoloSTAR® pen can be used for up to 28 days and should not be refrigerated. Instruct patients to keep the opened Lantus® SoloSTAR® pen at room temperature (below 86°F). Lantus® SoloSTAR® pens must be discarded 28 days after being opened1
3.
How long can Lantus® be stored?

Each Lantus® SoloSTAR® pen contains 300 units of insulin and may be used up to 28 days after the first injection. Before being used, the Lantus® SoloSTAR® pen should be stored in the refrigerator. Do not store it in the freezer, nor should it be used if it has accidentally been frozen. Once opened, pen should not be refrigerated, but kept at room temperature, up to 86°F. Instruct your patients to keep the Lantus® SoloSTAR® pen away from direct sunlight.

Vials must also be discarded 28 days after being opened. Once the vial is opened, you can keep it in the refrigerator or at room temperature but away from direct heat and light.

4.
Does the Lantus® SoloSTAR® pen have good insurance coverage?

The Lantus® SoloSTAR® pen is available for the same copay as the Lantus® vial for most managed care plans. This may translate to patients receiving 50% more Lantus® units per prescription for the same copay as the vial. One prescription for the Lantus® SoloSTAR® pen provides a box with 5 pens, each pen containing 300 units of Lantus® insulin for a total of 1500 units. One prescription for a vial of Lantus® insulin is only 1000 units. For the same copay, many of your patients could save on the cost of Lantus® insulin with the Lantus® SoloSTAR® pen.

*Depending on your out of pocket costs the benefit may vary. Card carries a maximum benefit of $100 per prescription for the duration of the program. Get program details when you register at Lantus.com.

5.
How does Lantus® work?

Long-acting Lantus® is a recombinant human insulin analog that works as a parenteral blood glucose-lowering agent.

Lantus® differs from human insulin in that the physiochemical properties have been modified, shifting the isoelectric point and producing a solution that is completely soluble at a pH of approximately 4.1

When injected into the neutral pH environment of the subcutaneous tissue, the acidic solution microprecipitates, slowly releasing insulin. This accounts for the lack of a pronounced peak and longer duration of action, which allows Lantus® to be dosed once daily at the same time each day.1

Lantus® is metabolized at the injection site and in the systemic circulation to two main active metabolites, designated M1 and M2. M1 and M2 are very close in structure and function to human insulin, but have slightly weaker interactions with the insulin and IGF-1 receptors than human insulin. Both Lantus® and its active metabolites have been detected in systemic circulation.1

Do not dilute or mix Lantus® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Lantus® via an insulin pump or intravenously because severe hypoglycemia can occur.

6.
Can Lantus® be mixed with other insulin?

Lantus® cannot be diluted or mixed with any other solution, including insulin. Diluting or mixing Lantus® may produce a cloudy solution, and pharmacokinetic/pharmacodynamic profiles may be altered in an unpredictable manner.1

If your patients' A1C goals are not being reached by a basal insulin that has been properly titrated to appropriate FPG target, consider timely intensification of insulin therapy to a basal-prandial regimen.3 If your patients are on a basal-prandial regimen, know that Lantus® may be taken in conjunction with a rapid-acting insulin such as Apidra®.

Hypoglycemia is the most common adverse reaction of insulin, including Lantus®. The risk of hypoglycemia increases with intensive glycemic control. Patients must be educated to recognize and manage hypoglycemia.

7.
What data demonstrate the efficacy of Lantus® in combination with oral agents?

Adding Lantus® to an oral regimen has been shown to be effective at improving and sustaining glycemic control.4

Please click here to review efficacy profiles

8.
What is the appropriate dose when starting a patient on Lantus®?

When starting a type 2 diabetes patient on Lantus®, there are certain guidelines for effective once-daily dosing depending on the patient's treatment history:

Initiating Lantus

  • When initiating Lantus® in insulin-naïve patients, add 10 units or 0.2 units/kg to OADs
  • When switching patients from once-daily NPH to Lantus®, substitute 1 unit for 1 unit
  • Twice-daily NPH users who switch should initiate their Lantus® dose at 80% of their total daily NPH dose
  • When switching a premix insulin patient to Lantus®, begin their dose at 80% of the intermediate-acting portion of their premixed insulin

The recommended starting dose of Lantus® in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Prandial insulin should be used at mealtime to satisfy the remainder of the daily insulin requirements.1

The starting dose should be individualized based on the type of diabetes and whether the patient is insulin naïve. Administer Lantus® subcutaneously once daily at any time of day, but at the same time every day. Rotate injection sites within an injection area (abdomen, thigh, or upper arm) to reduce the risk of lipodystrophy. Converting from other insulin therapies may require adjustment of timing and dose of Lantus®. Closely monitor glucose levels, especially upon converting to Lantus® and during the initial weeks thereafter.

To learn more about Lantus® dosing, please visit the dosing page, or read the full Prescribing Information.

9.
What is an option for titrating Lantus®?

Structure titration to help patients reach target fasting blood glucose levels.

Titration

Adapted from Gerstein.4
FPG=fasting plasma glucose.

Two suggested titration options6-8,a

The dose of Lantus® should be adjusted according to blood glucose measurements. The dosage of Lantus® should be individualized under the supervision of a treating healthcare provider in accordance with the needs of the patient.

aOther titration options are available. Lantus® should be used with oral antidiabetic drugs or rapid-acting insulin.

10.
What insulin delivery systems are available for use with Lantus®?

Lantus® long-acting insulin is a solution for injection, and is available in the following delivery systems:1

  • 10 mL vial (1000 Units/10 mL)
  • 3 mL Lantus® SoloSTAR® prefilled disposable insulin pen (300 Units/3 mL)

Lantus® SoloSTAR® is an easy-to-use pen for administering Lantus®. It is a prefilled, disposable insulin pen delivery system. It is easy to teach, and easy to use. The Lantus® SoloSTAR® can be set from 1 to 80 units in 1-unit steps, dialed both up and down. Once opened, Lantus® SoloSTAR® may be used for up to 28 days without refrigeration.

Patients should be instructed on proper injection technique and to closely follow the instructions in the instruction leaflet that accompanies the Lantus® SoloSTAR® pen. If instructions are not followed, the patient may get too much or too little insulin, which can affect blood glucose levels.

11.
What is Lantus®?

Lantus®, or insulin glargine, is a once-daily, long-acting basal insulin for patients with diabetes mellitus. It is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. Lantus® should be administered once a day at the same time each day. Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

A recombinant human insulin analog, Lantus® provides 24-hour basal coverage with no pronounced peak, mimicking the steady basal secretion of insulin provided by a normal pancreas.1

Lantus® is engineered to begin microprecipitation upon subcutaneous injection, slowly releasing small amounts of basal insulin for the next 24 hours. This profile allows Lantus® to be dosed once a day as a patient's basal insulin.

The time course of action of insulin, including Lantus®, may vary between individuals and within the same individual.

Adapted from Lantus® Prescribing Information1 and McKeage.9

12.
What are the benefits of Lantus® long-acting basal insulin?

Long-acting basal insulins like Lantus® mimic normal physiologic basal insulin secretion.

As this chart demonstrates, to closely mimic normal physiologic insulin secretion, a constant supply of basal insulin (glargine) and a mealtime dosing of prandial insulin is essential.10

Lantus + rapid acting insulin

Long-acting Lantus® insulin:1

  • Is relatively continuous over 24 hours
  • Suppresses blood glucose production between meals and overnight
  • Should contribute approximately 50% of daily insulin needs
  • Has no pronounced peak1
13.
What are some of the possible risks or adverse reactions of insulin therapy, including Lantus®?

Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®, which may be serious. Some of the other common adverse reactions associated with Lantus® include1:

  • Allergic reactions
    • Severe, life-threatening, generalized allergy, including anaphylaxis, can occur
  • Rash, lipodystrophy, pruritus
  • Weight gain
  • In order to limit the risk of hypoglycemia, it's important for healthcare professionals to ensure that patients are taking their insulin as directed. Patients should be made aware of the activities that might alter blood glucose such as exercise, which stimulates glucose removal from the blood.14

These are some of the side effects for insulins such as Lantus®. See the full Prescribing Information for full details.

14.
How can I help my patients succeed in controlling their blood glucose?

Patient adherence is an important part of insulin therapy. Several psychological barriers to the initiation of insulin therapy have been identified: injection anxiety, fear of hypoglycemia, or personal failure.12,13,20

  • A Certified Diabetes Educator* or CDE*, can help support you and your patients when you transition them to insulin therapy. Patients can sign up for a FREE online education session with a CDE live on webcam to answer questions. Patients will learn the basics of diabetes self-management to support informed decision-making, as well as step-by-step injection instructions for starting on Lantus® SoloSTAR® or vial and syringe.
  • Another way to help patients initiate insulin is to address the method of insulin administration. Explain all options available for insulin delivery, including easy-to-use pens.19

Patients should be informed that changes to insulin regimens must be made cautiously and only under medical supervision. It is important to inform patients about the potential side effects of insulin therapy, including hypoglycemia, lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, and allergic reactions.

It is critical to instruct patients on self-management procedures, including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed 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.

15.
Can earlier initiation of insulin help my patients with type 2 diabetes?

Patients with type 2 diabetes suffer from insulin deficiency long before their diagnosis.11

Rate of mean ß-cell decline

Adapted from Holman.11

By the time most patients are diagnosed with type 2 diabetes, their pancreatic beta-cell function may have deteriorated up to 50%.11 In one study, it was shown that from the time of diagnosis to the start of insulin therapy, the average patient spent nearly 5 years with an A1C >8% and about 10 years with A1C >7%.a,11

aBased on retrospective observational data from 7208 episodes of treatment initiation and secondary failure.

16.
How do the pharmacodynamic profiles of basal insulins compare?

Lantus® is the only 24-hour insulin approved exclusively for use once a day.1

Profile of Lantus vs NPH in patients with type 1 diabetes

aGlucose utilization rate in mg/kg/min, determined as the amount of glucose infused to maintain constant plasma glucose levels (hourly mean values); indicative of insulin activity.
A double-blind, randomized, crossover, euglycemic clamp study involving 20 patients with type 1 diabetes.
From Lepore15 and Lantus® Prescribing Information.1

  • Lantus® should be taken once a day at the same time each day
  • The time course of action of insulins, including Lantus®, may vary between individuals and within the same individual

Click for more information.

Profile of Lantus vs detemir

Glucose infusion rate (mg/kg/min).
Adapted from Porcellati.16

Click for more information.

Profile of detemir vs NPH

Detemir dose, duration of action

Glucose infusion rate (mg/kg/min).
Adapted from Plank.17

Click for more information.

Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)

Lantus® is a long-acting 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. Lantus® should be administered once a day at the same time every day.

Important Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

Indications and Usage for Apidra® (insulin glulisine [rDNA origin] injection)

Apidra® is a rapid-acting insulin analog indicated to improve glycemic control in adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes.

When used as a mealtime insulin, the dose of Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal. Apidra® given by subcutaneous injection should normally be used in regimens that include a longer-acting insulin.

Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection) & Apidra® (insulin glulisine [rDNA origin] injection)

Contraindications

Lantus® is contraindicated in patients hypersensitive to insulin glargine or one of its excipients.

Apidra® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Apidra® or any of its excipients.

Warnings and Precautions

Closely monitor blood glucose in all patients treated with insulin. Modify insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. As with all insulin preparations, the time course of action may vary by individual or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus® and Apidra®, and may be serious and life-threatening.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus® and/or Apidra®, monitor and treat if indicated.

A reduction in the Lantus® and/or Apidra® dose may be required in patients with renal or hepatic impairment.

Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.

Drug Interactions

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).

Adverse Reactions

Adverse reactions commonly associated with Lantus® and Apidra® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.

In clinical studies in adult patients there was a higher incidence of treatment-emergent injection-site pain (2.7% Lantus® vs. 0.7% NPH) The reports of pain at the injection site were usually mild and did not result in discontinuation of therapy.

Important Safety Information for Lantus® SoloSTAR®

Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose.

Please click here for Full Prescribing Information for Lantus®.

Please click here for Full Prescribing Information for Apidra® .

aBased on TRx data from IMS Health, NPA™ monthly database, time period from May 2003 to November 2011.

References:

  1. Lantus® Prescribing Information. October 2013.
  2. Meece J. Am J Health-Syst Pharm. 2008;65:1076-1082.
  3. Raccah D, Bretzel RG, Owens D, Riddle M. Diabetes Metab Res Rev. 2007;23(4):257-264.
  4. Gerstein HC, Yale J-F, Harris SB, et al. Diabetic Med. 2006;23(7): 736-742.
  5. Riddle MC, Rosenstock J, Gerich J, on behalf of the Insulin Glargine 4002 Study Investigators. Diabetes Care. 2003;26:3080-3086.
  6. Davies M, Storms F, Shutler S, et al. ATLantus® Study Group. Diabetes Care. 2005;28(6):1282-1288.
  7. Yki-Järvinen H, Ziemen M, Dressler A; HOE 901/3002 Study Group. Diabetes Care. 2000;23(8):1130-1136.
  8. Nathan DM, Buse JB, Davidson MB, et al. Diabetes Care. 2009; 32(1):193-203.
  9. McKeage K, Goa KL. Drugs. 2001;61(11):1599-1624.
  10. Leahy JL. In: Leahy JL, Cefalu WT, eds. Insulin Therapy. New York, NY: Marcel Dekker Inc; 2002: 87-112.
  11. Holman RR. Diabetes Res Clin Pract. 1998;40(suppl):S21-S25.
  12. Polonsky WH, Fisher L, Guzman S, et al. Diabetes Care. 2005;28(10):2543-2545.
  13. Hirsch IB, Bergenstal RM, Perkin CG, et al. Clin Diabetes. 2005; 23(2):78-86.
  14. American Diabetes Association. Diabetes Care. 2009;32(suppl 1):S13-S61.
  15. Lepore M, Pampanelli S, Fanelli C, et al. Diabetes. 2000; 49(12):2142-2148.
  16. Porcellati F, Rossetti P, Busciantella NR, et al. Diabetes Care. 2007;30(10):2447-2452.
  17. Plank J, Bodenlenz M, Sinner F, et al. Diabetes Care. 2005;28(5):1107-1112.
  18. Levemir Prescribing Information. July 2009.
  19. Korytkowski M, Bell D, Jacobsen C, Suwannasari R, for the FlexPen® Study Team. Clin Ther. 2003;25(11):2836-2848.
  20. Funnell M. Clin Diab. 2007;25(1):36-38.
  21. Hancu N, Czupryniak L, Genestin E, Sourij H. J Diabetes Sci Techol, 2011; 5(5):1224-1234
  22. Data on file, Sanofi U.S. LLC.
  23. Clarke A, Spollett G. Expert Opin Drug Deliv. 2007;4(2):165-174.
  24. Krzywon M, Abdel-Tawab M, van der Burg T, Fuhr U, Schubert-Zsilavecz M. Curr Med Res Opin. 2010;26(4):901-905.
  25. Haak T, Edelman S. Walter C, et al. Clin Ther. 2007;29(4):650-660.

Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)

Lantus® is a long-acting 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. Lantus® should be administered once a day at the same time every day.

Important Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Contraindications

Lantus® is contraindicated in patients hypersensitive to insulin glargine or one of its excipients.

Warnings and Precautions

Monitor blood glucose in all patients treated with insulin. Modify insulin regimen cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment.

Important Safety Information for Lantus® SoloSTAR®

Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose.

Click here for additional Important Safety Information.

  • Indications and Usage for Lantus®

    (insulin glargine [rDNA origin] injection)

    Lantus® is a long-acting 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. Lantus® should be administered once a day at the same time every day.

    Important Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

    Important Safety Information for Lantus®

    (insulin glargine [rDNA origin] injection)

    Contraindications
    Lantus® is contraindicated in patients hypersensitive to insulin glargine or one of its excipients.

    Warnings and Precautions
    Monitor blood glucose in all patients treated with insulin. Modify insulin regimen cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment.

    Do not dilute or mix Lantus® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Lantus® via an insulin pump or intravenously because severe hypoglycemia can occur. Insulin devices and needles must not be shared between patients.

    Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®, and may be life-threatening.

    Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus®, monitor and treat if indicated.

    A reduction in the Lantus® dose may be required in patients with renal or hepatic impairment.

    Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.

    Drug Interactions
    Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).

    Adverse Reactions
    Adverse reactions commonly associated with Lantus® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.

    Important Safety Information for Lantus® SoloSTAR®

    Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose.

    Click here for Full Prescribing Information for Lantus®.

    Click here for information on drug anti-counterfeiting.

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