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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.

Click here for additional Important Safety Information.

Insulin, Glucose and You

Insulin and Glucose

When you hear the word insulin, you may think of a drug taken by people who have diabetes.
While this is true, what you may not know is that insulin is one of the many hormones created in the human body.
Insulin is important to the body. It allows blood sugar (or glucose) to get into cells to provide them with energy.
When you eat, your body breaks down food into glucose in your small intestine.
This is your body's source of energy for everything it does, from working and thinking to exercising and healing.
Glucose travels through your bloodstream, looking for individual cells that need energy.
For glucose to get into the cells, it requires insulin.
Insulin is the key that unlocks cells for glucose to enter and deliver energy.
When insulin arrives, it signals the cell to activate glucose transporters.
These transporters pull glucose through cell walls.
When glucose moves into the cell, it delivers energy!

Insulin Deficiency

Insulin is normally produced in the pancreas.
When glucose enters your bloodstream, the pancreas matches it with the right amount of insulin to move glucose into your cells.
In people with type 2 diabetes, the pancreas may not be doing its entire job. It may produce less and less insulin over time.
If this happens, there isn't enough insulin in the bloodstream to unlock cells. With the cells locked, glucose can't get where it is needed to provide energy.

Insulin Resistance

In some type 2 diabetes patients, cells build up a resistance to insulin. Even though there may be enough insulin in the bloodstream, it can't unlock cells to allow glucose to enter.
As a result, it takes more insulin to find the right key to unlock the cell for glucose. This makes it more difficult for cells to get the energy they need.

The Effects of Diabetes

When glucose can't get into cells - either because there isn't enough insulin or because the body is resisting it, glucose begins to build up in the bloodstream.
As a result, all that energy is wasted. It does not get to cells where it is needed. Without glucose in your cells, they lack the energy they require to keep your body working.

Proven HbA1c control

See how Lantus® provides effective, improved glycemic control in diabetes patients.

Lantus® Prescribing Information. February 2015.

Once-daily dosing

Lantus® is a once-daily, long-acting insulin.**

**Lantus® Prescribing Information. February 2015.

Demonstrated long-term CV safety

Lantus® is a basal insulin with demonstrated long-term CV safety data††

††Including CV death, nonfatal MI, nonfatal stroke, revascularization, or hospitalization for heart failure. No difference was observed between Lantus® and standard of care in overall incidence of CV death, nonfatal MI, or nonfatal stroke. No difference was observed between treatment groups for death of any cause.

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

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

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.

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.

Full Prescribing Information for Lantus®
Sanofi's Commitment to Fighting Counterfeit Drugs

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

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

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.

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.

Full Prescribing Information for Lantus®
Sanofi's Commitment to Fighting Counterfeit Drugs

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