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Basal-Plus 1 Regimen

Proven A1C reduction with a Basal-Plus 1 regimen1 eases patients into mealtime therapy

ADA/EASD Consensus Statement

Prandial insulin can be added in a stepwise fashion, starting with 1 dose at the largest meal2

Adding Prandial insulin in stepwise function

Adapted from Raccah.3

In the OPAL study, the Apidra® Basal-Plus 1 regimen helped patients reach A1C goal1

OPAL study

OPAL = Orals Plus Apidra® and Lantus®

Results from a 24-week, multicenter, randomized, open-label, parallel-group study of 316 patients with type 2 diabetes who were suboptimally controlled with Lantus® (insulin glargine [rDNA origin] injection) + OADs. Patients were randomized to the breakfast group (n=162) or the main meal group (n=154). One dose of Apidra® was added to their existing therapy to assess the relative basal-bolus regimen of administering prandial insulin before breakfast or before the main meal.

From Lankisch.1

 
 
  • Treatment equivalence of both breakfast and main-meal Apidra® regimens was demonstrated
  • Adding 1 dose of Apidra® a day achieved significant A1C reductions from baseline to endpoint–breakfast group, from 7.35% to 7.03%; main meal group, from 7.29% to 6.94% (P<0.0001)1
Effect on weight

Rates of AEs in the OPAL study

Rates of AEs in the OPAL study

a Hypoglycemia was confirmed by a BG measurement of ≤60 mg/dL. Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia during which a patient required assistance of another person and associated with a BG ≤36 mg/dL and/or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.

b P=NS

From Lankisch.1

 
 
  • There were a total of 6 patients with AEs possibly related to treatment: 2 patients in the breakfast group and 4 patients in the main meal group. Among the most common AEs possibly related to treatment were allergic dermatitis and weight increase.

In another study, the Apidra® Basal-Plus 1 regimen led to a significant A1C improvement4

  • Electronic transfer group: baseline A1C, 7.9% to endpoint, 7.2%; standard monitoring group: baseline A1C, 7.8% to endpoint, 7.0% (P<0.0001)
  • A1C goal of ≤7.0% was achieved in 55% of patients who measured their BG levels using standard monitoring and 45% of patients who electronically transferred their BG readings (P=NS)
  • Serious AEs: electronic transfer group, n=4 (2.8%); standard monitoring group, n=7 (4.7%)
  • Severe symptomatic hypoglycemia: electronic transfer group=0.04 events/patient-year; standard monitoring group=0.02 events/patient-year

Read more...

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

CONTRAINDICATIONS

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. Change 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 Apidra® 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 Apidra®, which may be serious.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. All insulins, including Apidra®, can cause hypokalemia, which if untreated, may be serious.

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

Apidra® for subcutaneous injection should not be mixed with insulins other than NPH. Do not mix Apidra® with any insulin when used in the pump or for intravenous administration. Insulin devices and needles must not be shared between patients.

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

Other adverse reactions commonly associated with Apidra® include injection site reactions, lipodystrophy, pruritus, and rash.

Important Safety Information for Apidra® (insulin glulisine [rDNA origin] injection) SoloSTAR®

Apidra® SoloSTAR® is a disposable 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.

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.

Please click here for Full Prescribing Information for Apidra®.

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. Insulin regimens should be modified 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.

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

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

Other adverse reactions commonly associated with Lantus® are injection site reaction, lipodystrophy, pruritus, and rash.

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 children (6 years and older) 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.

Please click here for Full Prescribing Information for Lantus®

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*Offer is not valid for patients if their prescriptions are paid in part or full by any state or federally funded programs, including, but not limited to, Medicare or Medicaid, Medigap, VA, DOD, or TriCare. Offer is not valid for residents of MA (except for cash-paying patients) and where prohibited by law. Sanofi US reserves the right to rescind, revoke, or amend this offer without notice. Maximum benefit is $100 off per prescription depending on your out of pocket costs. Offer expires 12/31/2012.

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. Nathan DM, Buse JB, Davidson MB, et al. Diabetes Care. 2009;32(1):193-203.
  3. Raccah D, Bretzel RG, Owens D, Riddle M. Diabetes Metab Res Rev. 2007;23(4): 257-264.
  4. Data on file, sanofi-aventis U.S. LLC.
     Last Update: November 2011


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