Healthcare professionals have chosen Lantus® for over 18 years1
DEMONSTRATED LONG-TERM CV SAFETY DATA IN THE LANDMARK ORIGIN TRIAL1-3*
*Including CV death, nonfatal MI, nonfatal stroke, revascularization, or hospitalization for heart failure.
CV Evaluation from the ORIGIN Trial over 6.2 Years (N=12,537)
Limitations:
- Metformin was used by 47% of the insulin-glargine group and 60% of the standard-care group which may have been cardioprotective.
- The trial involved people who were not normally prescribed insulin and in whom insulin glargine was used to achieve fasting plasma glucose levels much lower than those typically achieved with insulin therapy. However, the effect in participants with and those without diabetes was similar.
- The trial was designed to test the effect of using titrated basal insulin to control glucose levels vs standard-care with guideline-suggested degrees of glycemic control; the trial was specifically not designed to test more intense vs less intense glucose lowering.
No statistically significant differences between Lantus® and standard care in the co-primary endpoints
- Similar results were observed between Lantus® and standard care for all cause mortality
Mean A1C over 6.2 years (median)
Safety results
Study Design
A randomized study of patients with IFG and/or IGT or early type 2 diabetes mellitus and established CV disease or CV risk at baseline. Patients received either Lantus® (n=6264) titrated to a target FPG of ≤95 mg/dL or standard care (n=6273). Standard care patients remained on their original treatment, if applicable, at randomization. Additional agents could be added as needed at the discretion of the investigator. The co-primary outcomes were nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes and these events plus revascularization or hospitalization for heart failure. Microvascular outcomes, incident diabetes, hypoglycemia, weight, and cancers were also compared between groups. Median follow-up: 6.2 years.
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Indication and Use
LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Limitations of Use
Lantus is not recommended for the treatment of diabetic ketoacidosis.
Important Safety Information for Lantus (insulin glargine injection) 100 Units/mL
Important Safety Information for Lantus (insulin glargine injection) 100 Units/mL
Contraindications
Lantus is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or any of the excipients in LANTUS.
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 only under medical supervision. Changes in insulin regimen including, strength, manufacturer, type, injection site or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant drugs.
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.
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.
Hypoglycemia due to medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus, treat and monitor until symptoms resolve.
A reduction in the Lantus dose may be required in patients with renal or hepatic impairment.
As with all insulins, Lantus use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
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 single-patient-use 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 Sharps Medical Waste Disposal.
Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.
*Eligibility Restrictions & Offer Terms:
Insulins Valyou Savings Program:
This savings program is not insurance. For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs, or commercial/private insurance. Only patients without prescription medication insurance can apply for this offer. Void where prohibited by law. For the duration of the program, eligible cash paying patients will pay $35 per 30 Day Supply. To pay $35 per 30 Day Supply, you must fill all your Sanofi Insulin prescriptions at the same time, together each month. The Insulins Valyou Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Insulins Valyou Savings Program at (833) 813-0190 (833) 813-0190 (8:00 am-8:00 pm EST, Monday-Friday).Sanofi Insulins Co-pay Savings Program: This savings program is not insurance.
For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs. If you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note: the Federal Employees Health Benefits (FEHB) Program is not a federal or state government health care program for purposes of the savings program. Void where prohibited by law. For the duration of the program, eligible commercially insured patients pay no more than $35 per 30-day supply, up to 10 packs per fill; Offer valid for one fill every 30 days. Savings may vary depending on patients’ out-of-pocket costs. The Sanofi Insulins Co-pay Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Sanofi Insulins Co-pay Savings Program at (866) 255-8661 (866) 255-8661 (8:00 am-8:00 pm EST, Monday-Friday).References:
1. Lantus® Prescribing Information.
2. ORIGIN Trial Investigators. Am Heart J. 2008;155(1):26-32.
3. ORIGIN Trial Investigators. N Engl J Med. 2012;367(4):319-328.
All registered trademarks cited are property of their respective owners.
Important Safety Information for Lantus (insulin glargine injection) 100 Units/mL
Contraindications
Lantus is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or any of the excipients in LANTUS.
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 only under medical supervision. Changes in insulin regimen including, strength, manufacturer, type, injection site or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant drugs.
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.
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.
Hypoglycemia due to medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus, treat and monitor until symptoms resolve.
A reduction in the Lantus dose may be required in patients with renal or hepatic impairment.
As with all insulins, Lantus use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
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 single-patient-use 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 Sharps Medical Waste Disposal.
Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.
*Eligibility Restrictions & Offer Terms:
Insulins Valyou Savings Program:
This savings program is not insurance. For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs, or commercial/private insurance. Only patients without prescription medication insurance can apply for this offer. Void where prohibited by law. For the duration of the program, eligible cash paying patients will pay $35 per 30 Day Supply. To pay $35 per 30 Day Supply, you must fill all your Sanofi Insulin prescriptions at the same time, together each month. The Insulins Valyou Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Insulins Valyou Savings Program at (833) 813-0190 (833) 813-0190 (8:00 am-8:00 pm EST, Monday-Friday).Sanofi Insulins Co-pay Savings Program: This savings program is not insurance.
For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs. If you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note: the Federal Employees Health Benefits (FEHB) Program is not a federal or state government health care program for purposes of the savings program. Void where prohibited by law. For the duration of the program, eligible commercially insured patients pay no more than $35 per 30-day supply, up to 10 packs per fill; Offer valid for one fill every 30 days. Savings may vary depending on patients’ out-of-pocket costs. The Sanofi Insulins Co-pay Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Sanofi Insulins Co-pay Savings Program at (866) 255-8661 (866) 255-8661 (8:00 am-8:00 pm EST, Monday-Friday).References:
1. Lantus® Prescribing Information.
2. ORIGIN Trial Investigators. Am Heart J. 2008;155(1):26-32.
3. ORIGIN Trial Investigators. N Engl J Med. 2012;367(4):319-328.
All registered trademarks cited are property of their respective owners.