Read Full Important Safety Information

For U.S. Healthcare Professionals Only
Search

About Apidra®

Rapid-Acting Apidra

PK/PD Studies: Results show a fast onset of action2,5, lower post-meal BG levels3,5 and fast absorption regardless of weight4,5

Faster Onset and Shorter Duration of Action

vs. RHI and lispro‡: Insulin activity in obese (BMI: 30-40 kg/m2), non-diabetic subjects in a PK study5,6,7,a

The action profile of Apidra was not affected by skin thickness or BMI2

a There is no evidence to suggest that these PK/PD differences impact overall glycemic control.
‡For the purposes of this trial, references to lispro refer to Humalog® (insulin lispro).

n=18


Expand All | Collapse All
Expand All | Collapse All

Becker study: The pharmacokinetics and pharmacodynamics of Apidra, RHI, and lispro‡ were examined in a single-dose, randomized, double-blind, 3-way crossover euglycemic clamp study of 18 obese, nondiabetic subjects. An SC injection of 0.3 U/kg of each insulin was administered in the abdominal area in predetermined sequences. The washout periods between the clamp procedures for each insulin were at least 7 days. After administration, infusion of a 20% glucose solution started when BG fell below 10% of mean baseline level. PD parameters were derived from the individual glucose infusion rate profiles.2,5 Point estimate vs Apidra (95% CI): RHI: -36 min (-96; -20 min).

Limitations of Study

  • Study findings represent chance findings in light of the exploratory nature of this study and small sample size; therefore, these results should not be generalized to the population.
  • The open-label design could have introduced bias.
  • This type of open-label design has been a necessity with any study comparing a rapid-acting insulin analog with RHI due to considerable differences in the timing of the administration of these two types of insulin.

Lower Post-Meal Blood Glucose

vs. aspart§: During the first hour following a meal3

Apidra was associated with lower BG levels during the first hour after a standard meal in insulin naive, obese patients with T2DM3

§For the purposes of this trial, references to aspart refer to Novolog® (insulin aspart injection).

n=30

Expand All | Collapse All

Bolli study: A multinational, randomized, double-blind, two-way crossover trial to compare the PK and PD properties of SC Apidra and insulin aspart§ in 30 insulin-naive, obese, T2DM subjects. Patients fasted overnight and received a 0.2 U/kg SC dose of either Apidra or aspart§ 2 minutes before starting a standardized meal. The procedure was repeated with the alternative insulin after a 7-day washout period. The primary objective was to assess the PD effect (as measured by AUC) of each insulin during the first hour after a standard meal.3

Limitations of Study

  • This exploratory study is a small sample size and represents chance findings. No conclusions of statistical or clinical significance can be drawn.
  • It must also be noted that a strictly defined meal size and content and a fixed insulin dose were used in this study; therefore, these results should not be generalized to the population.

Faster absorption vs. Lispro‡ regardless of weight4,a

Absorption in non-diabetic patients4,a

The onset of action overall was faster for Apidra in the first dosing hour (GIR-AUC0-1h with 0.2U/kg was 102.3+/-75.1 vs. 83.1+/-72.8 mg/kg, P<0.05)

a There is no evidence to suggest that these PK/PD differences impact overall glycemic control.
‡For the purposes of this trial, references to lispro refer to Humalog®.

n=20

Expand All | Collapse All

Heise study: A randomized, double-blind, single-center, 4-way crossover euglycemic clamp study examined the PD and PK of Apidra and lispro‡. Eighty nondiabetic subjects (ages 18-65) were randomized to treatment groups and stratified by BMI into 4 classes as indicated on the graph, with 20 subjects in each group. Subjects fasted overnight prior to the day of receiving study medication. Insulin (0.2 or 0.4 U/kg) was administered by SC injection into the abdominal area. The euglycemic clamp device measured BG continuously and automatically adjusted and recorded the infusion rate of a 20% glucose solution each minute to maintain BG levels at 10% below the individual fasting BG concentration. PD parameters were derived from the individual glucose infusion rate profiles.4

Limitations of Study

This exploratory study is a small sample size and represents chance findings; therefore, these results should not be generalized to the population.

For additional information about Apidra contact Sanofi US Medical Information
CONTACT MEDICAL INFORMATION

Clinical results

See how Apidra performed in a 24-week OPAL study.

SEE STUDY RESULTS

Dosing

Get information about how to initiate and dose Apidra using the AACE Algorithm.

LEARN ABOUT AACE ALGORITHM

See Savings Offers

Apidra offers options for patients with and without prescription insurance. Eligibility and restrictions apply*.

SEE OFFERS

Indications and Usage for Apidra® (insulin glulisine injection)

Apidra is a rapid-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

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 may be infused subcutaneously by external insulin infusion pumps.

Important Safety Information

Contraindications

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

Warnings and Precautions

Insulin pens and needles must never be shared between patients, even if the needle is changed. Do NOT reuse needles.

Monitor blood glucose in all patients treated with insulin. Modify insulin regimens 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 oral antidiabetic treatment. Dosing should be individualized based on patient characteristics and lifestyle.

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.

Hypoglycemia is the most common adverse reaction associated with insulins, including Apidra, and maybe life-threatening.

To avoid medication errors between APIDRA and other insulins, instruct patients to always check the insulin label before each injection.

All insulin products, including Apidra, can cause hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including APIDRA. If hypersensitivity reactions occur, discontinue APIDRA, treat per standard of care and monitor until symptoms and signs resolve.

Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. Observe for signs and symptoms of heart failure. Consider dosage reduction or discontinuation of TZD if heart failure occurs.

Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Adverse Reactions

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

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).

Important Safety Information for Apidra® (insulin glulisine injection) SoloSTAR®

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

Important Safety Information for Apidra Use in Pump

Inform patients to replace the infusion sets (reservoir, tubing, and catheter) and the Apidra in the reservoir at least every 48 hours and select a new infusion site. Pump failure or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause is necessary. Interim subcutaneous injections with APIDRA may be required. Patients using a pump must be trained to administer insulin by injection and have alternative insulin therapy available in case of pump system failure.

Click here for Full Prescribing Information for Apidra.
Click here for information on Sharps Medical Waste Disposal.

Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.

*Eligibility & 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 (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 (8:00 am-8:00 pm EST, Monday-Friday).

REFERENCES:

  1. Sheldon B, Russel-Jones D, Wright J. Diabetes Obes Metab. 2009;11:5-9.
  2. Becker RHA, Frick AD, Burger F, Potgieter JH, Scholtz H. Exp Clin Endocrinol Diabetes. 2005;13:435-443.
  3. Bolli GB, Luzio S, Marzotti S, et al. Diabetes Obes Metab. 2011;13:251-257.
  4. Heise T, Nosek L, Spitzer H, et al. Diabetes Obes Metab. 2007;9:746-753.
  5. Apidra® Prescribing Information.
  6. NovoLog® Prescribing Information.
  7. Humalog® Prescribing Information.

All registered trademarks cited are the property of their respective owners.

REFERENCES:

†Humalog® savings card information. Available at: https://www.humalog.com/hcp/humalog-u200/#savings-card-section.
NovoLog® savings card information. Available at: https://www.novologpro.com/savings-and-coverage.html.

‡Relay: Data Months: September 2016 – August 2017.

All registered trademarks cited are the property of their respective owners.

REFERENCES:

  1. AACE/ACE Consensus Statement. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2016 Executive Summary. T2D Algorithm, Executive Summary. Endocr Pract. 2016;22(No.1).
  2. Apidra® Prescribing Information.
  3. NovoLog® Prescribing Information.
  4. Humalog® Prescribing Information.

All registered trademarks cited are the 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 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 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 oral antidiabetic treatment.

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.

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:

Sanofi insulins included in this program are: ADMELOG® (insulin lispro injection) 100 Units/mL, TOUJEO® (insulin glargine injection) 300 Units/mL, LANTUS® (insulin glargine injection) 100 Units/mL and APIDRA® (insulin glulisine injection) 100 Units/mL. This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs, or commercial / private insurance. Only people without prescription medication insurance can apply for this offer. Void where prohibited by law. For the duration of the program, eligible patients will pay $99 for up to 10 vials or packs of pens per fill. Offer is valid for one fill per month. To pay $99 per month, you must fill all your Sanofi Insulin prescriptions at the same time, together each month. Not valid for SOLIQUA 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL or Toujeo Max SoloStar pen. When using the Insulins Valyou Savings Card, prices are guaranteed for 12 consecutive monthly fills. The Insulins Valyou Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment.

Sanofi Copay Program:

This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, TRICARE, or similar federal or state programs including any state pharmaceutical assistance program. 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 healthcare program for purposes of the savings program. Void where prohibited by law.

  • Apidra: $0 copay with maximum savings up to $100 per pack up to 1 pack per fill.

Savings may vary depending on patients’ out-of-pocket costs. Upon registration, patients receive all program details. Sanofi US reserves the right to change the maximum cap amount, rescind, revoke or amend these programs without notice.

REFERENCES:

  1. Lankisch MR, Ferlinz KC, Leahy JL, Scherbaum WA. Orals Plus Apidra® and Lantus® (OPAL) study group. Diabetes Obes Metab. 2008;10(12):1178-1185.
  2. Apidra® Prescribing Information.
  3. Philotheou A, Arslanian S, Blatniczky L, Peterkova V, Souhami E, Danne T. Diabetes Technol Ther. 2011;13(3):327-334.
  4. American Diabetes Association. Diabetes Care. 2015;38(Suppl. 1):S70–S76.
  5. Daily G, et al. Diabetes Care. 2004;27:2363-2368.

All registered trademarks cited are the property of their respective owners.

*

back to top ▲

© 2023 sanofi-aventis U.S. LLC. All rights reserved.

Legal Disclaimer | Privacy Policy | Cookie Policy | Contact SANOFI |

This site is intended for use by U.S. Healthcare Professionals only.

MAT-US-2007040-v4.0-11/2023

Important Safety Information

Contraindications

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

Warnings and Precautions

Insulin pens and needles must never be shared between patients, even if the needle is changed. Do NOT reuse needles.

Monitor blood glucose in all patients treated with insulin. Modify insulin regimens cautiously and only under medical supervision.