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Sanofi Diabetes
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Apidra® insulin glulisine [rDNA origin] injection
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Important pen information: Temporary shortage of the Apidra® SoloSTAR®
(insulin glulisine [rDNA origin] injection) pen

This is to inform you of a temporary shortage of Apidra® SoloSTAR® pens. The shortage 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 first 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.

Note: Apidra® vials are still available and are unaffected by this event. Click here to learn more about how you can save on Apidra® vials.

If you are currently using the Apidra® SoloSTAR® pen, talk to your
healthcare provider about temporarily switching to Apidra® vials

To reduce disruption to your regimen, you and your healthcare provider may want to consider using Apidra® vial-and-syringe administration while the shortage is in effect. There is no need for dose adjustment or changes in timing of injections if your healthcare provider decides to switch you to the Apidra® vial.

Our first priority is to assist you in transitioning as smoothly as possible to Apidra® vials. Sanofi has notified the U.S. Food and Drug Administration and healthcare professionals regarding the timing for the shortage to allow you sufficient time to transfer to Apidra® vials if you need to make the switch. Sanofi is providing support resources to guide healthcare professionals and patients during this shortage situation. 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

You can contact Sanofi U.S. Medical Information at 1-800-633-1610 with any questions.

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 your care, and we will provide relevant updates in a timely manner.

Changing insulins should be done cautiously and only under medical supervision.

Important Safety Information for Apidra®

Do not use Apidra® during a low blood sugar reaction (hypoglycemia) or if you are allergic to any of the ingredients in Apidra®.

You must test your blood sugar levels while using insulin, such as Apidra®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. Apidra® must only be used if the solution is clear and colorless with no particles visible. Do not share needles, insulin pens or syringes with others.

Apidra®, when given by injection under the skin, 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.

The most common side effect of insulin, including Apidra®, is low blood sugar (hypoglycemia), which may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. Severe hypoglycemia may be serious and life threatening. It may cause harm to your heart or brain. Other possible side effects may include low blood potassium, injection site reactions, such as changes in fat tissue at the injection site, and allergic reactions, such as itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy to insulin, including anaphylactic reactions.

Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works. Before starting Apidra®, tell your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to breast-feed.

If the pump or infusion set does not work right, you may not receive the right amount of insulin. Hypoglycemia, hyperglycemia, or ketosis can happen. Problems should be identified and corrected as quickly as possible. Change the Apidra® in the pump reservoir every 48 hours.

Apidra® SoloSTAR® is a disposable prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instruction Leaflet that accompanies the pen.

Indications and Usage for Apidra®

Prescription Apidra® is a rapid-acting insulin for adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes to improve blood sugar control. Apidra® given by subcutaneous injection is usually used with a longer-acting insulin. When used as a mealtime insulin, 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.

Click here for additional important information for Apidra®.


Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Do not take Lantus® if you are allergic to insulin or any of the inactive ingredients in Lantus®.

You must test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Lantus® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus® must only be used if the solution is clear and colorless with no particles visible. Do not share needles, insulin pens or syringes with others.

The most common side effect of insulin, including Lantus®, is low blood sugar (hypoglycemia), which may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. Severe hypoglycemia may be serious and life threatening. It may cause harm to your heart or brain. Other possible side effects may include injection site reactions, including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening.

Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works. Before starting Lantus®, tell your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to breast-feed.

Indications and Usage for Lantus®

Prescription Lantus® is a long-acting insulin used to treat adults with type 2 diabetes and adults and children (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.

Do not use Lantus® to treat diabetic ketoacidosis.

Click here for additional important information for Lantus®.

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The health information contained herein is provided for general educational purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.