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Apidra®
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Mealtime Masters Program

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For U.S. Healthcare Professionals

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*Must register to request samples. Certain restrictions may apply.

Important pen information: Update on the temporary shortage of Apidra® (insulin glulisine [rDNA origin] injection) SoloSTAR® pens in the United States

This update provides the latest estimated timing for the reintroduction of Apidra® SoloSTAR® pens in the United States.

The current shortage of Apidra® SoloSTAR® pens is due to a technical incident that occurred at the Sanofi manufacturing site in Frankfurt, Germany, which has led to a temporary interruption in production. In compliance with Good Manufacturing Practices, Sanofi is currently making every effort to resolve the issue. Following stringent quality tests, we expect to achieve normal supply levels by the second quarter of 2012.

All Apidra® SoloSTAR® product currently available is safe to use. No other Sanofi insulin products, eg, Lantus® (insulin glargine [rDNA origin] injection) are affected.

While the shortage is in effect, one option that you might consider for patients using Apidra® SoloSTAR® pens is to switch them to Apidra® vials and syringes.

In this case, there is no need for dose adjustment or changes in timing of injections. Please use your professional judgment on the need for patient training and guidance on syringe use to facilitate administration. Furthermore, self-monitoring of blood glucose (SMBG) is recommended.

Sanofi is providing support and education for patients and healthcare professionals to facilitate the appropriate handling of Apidra® vials and syringes during the temporary shortage situation. Support resources include:

  • - "How-to guide" to help patients learn appropriate handling of vials and syringes
  • - Video demonstrating use of vials and syringes
  • - Call center (1-800-633-1610) to provide guidance and support related to vial use
  • - Nurse support for patients who switch to Apidra® vials

Patient safety is the highest priority for Sanofi, and we are committed to providing high-quality insulins. We apologize for any inconvenience this shortage of Apidra® SoloSTAR® pens may cause. We are working diligently to minimize the impact of this situation on you and your patients, and we will provide relevant updates in a timely manner.

For further information, please do not hesitate to contact our call center at 1-800-633-1610.

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.

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