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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.

Lantus® is a Basal Insulin That Provides Once-Daily Dosing2

A longer action profile than detemir demonstrates true once-daily dosing.1

Study Design

Twenty-four subjects with type 1 diabetes na├»ve to glargine and detemir were studied twice in a randomized, double-blind crossover study. Plasma glucose was clamped at 100 mg/dL for 24 hours after subcutaneous injection of 0.35 Units/kg of either Lantus® or detemir.

Profile of Lantus® vs detemir

From Porcellati.1
aGlucose infusion rate (mg/kg/min).

  • Detemir has effects similar to those of Lantus® during the initial 12 hours after administration, but effects are lower during 12-24 hours
  • Duration of action (time at which PG >118 mg/dL) for a single dose of detemir is shorter than for Lantus® (15.5 vs 24 hours)

Important Considerations

  • Detemir is approved to be administered once or twice daily
  • The time course of action of insulins, including Lantus®, may vary between individuals and within the same individual

Lantus® has no pronounced peak, so it mimics the steady rate of physiologic basal insulin secretion.2

Action Profiles of Detemir and NPH in Patients With Type 1 Diabetes

Study Design

In a single-center, double-blind, 6-period, randomized, dose-response trial, 12 isoglycemic (130 mg/dL), C-peptide-negative (<0.03 nmol/L) subjects with type 1 diabetes were randomized to a specific treatment sequence encompassing 5 dose levels of insulin detemir (0.1, 0.2, 0.4, 0.8, and 1.6 Units/kg) and 1 dose level of NPH insulin (0.3 Units/kg).

Profile of detemir vs NPH

Profile of detemir vs NPH

From Plank3 and Levemir Prescribing Information.4
aGlucose infusion rate (mg/kg/min).

  • Detemir is approved to be administered once or twice daily4
  • The mean duration of action of detemir ranged from 5.7 hours at the lowest dose to 23.2 hours at the highest dose (sampling period of 24 hours)4
  • The time course of action of insulins may vary between individuals and within the same individual

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, non-fatal MI, or non-fatal 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

References:

  1. Porcellati F, Rossetti P, Busciantella NR, et al. Diabetes Care. 2007;30(10):2447-2452.
  2. Lantus® Prescribing Information. February 2015.
  3. Plank J, Bodenlenz M, Sinner F, et al. Diabetes Care. 2005;28(5):1107-1112.
  4. Levemir Prescribing Information. Feburary 2015.

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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