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Apidra®
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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.

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

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

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.

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.

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.

Please click here for Full Prescribing Information for Apidra®.

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* Certain restrictions apply. The Apidra® No Co-Pay offer is not valid for patients whose prescriptions are paid in part or full by any state or federally funded programs including but not limited to Medicare, Medicaid, Medigap, VA, DOD or TriCare. Void where prohibited by law. Sanofi US reserves the right to rescind, revoke, or amend this program without notice. Depending on out-of-pocket costs the benefits may vary. Card carries a maximum offer benefit of $100 per prescription for the duration of the program. As of November 2014.

Data on file, Sanofi US. IMS Anonymized Patient Level Data (APLS) (data on file, Sanofi US).

References

  1. Becker RHA, Frick AD, Burger F, Potgieter JH, Scholtz H. Exp Clin Endocrinol Diabetes. 2005;13:435‑443.
  2. Bolli GB, Luzio S, Marzotti S, et al. Diabetes Obes Metab. 2011;13:251‑257.
  3. Heise T, Nosek L, Spitzer H, et al. Diabetes Obes Metab. 2007;9:746‑753.
  4. Data on file, Sanofi US.
  5. Apidra® Prescribing Information. May 2014.
  6. NovoLog® Prescribing Information. April 2014.
  7. Humalog® Prescribing Information. November 2013.
Novolog® is a registered trademark of Novo Nordisk A/S.
Humalog® is a registered trademark of Eli Lilly and Company.

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.

Important Safety Information for Apidra®

Contraindications

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

Warnings and Precautions

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

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.

Click here for additional Important Safety Information.

Click here for full prescribing information for Apidra®.

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