Apidra®
Brand Name: Apidra®
Active Ingredient:   Insulin Glulisine [recombinant DNA origin]
Strength(s): 100 units per mL 
Dosage Form(s):   Injection
Company Name:    Aventis Pharmaceuticals Inc.
Availability:         Prescription only
*Date Approved by FDA:   April 16, 2004
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Apidra used for?     

Apidra is a rapid-acting man made insulin that is like insulin made by your body.  Apidra is used to treat adults with diabetes for the control of high blood sugar.  Apidra starts working faster than regular insulin and does not work as long.  It is used with a longer-acting insulin or by itself as insulin pump therapy to maintain proper blood sugar control.  

Who should not take Apidra?:

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

Special Warnings with Apidra:

·       You should take Apidra within 15 minutes before a meal or within 20 minutes after starting the meal.

·       Follow the instructions given by your healthcare provider about the type or types of insulin you are using. Do not make any changes with your insulin unless you have talked to your healthcare provider.

·       Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your healthcare provider about how to adjust your insulin dose.

·       Follow your healthcare provider’s instructions for testing your blood sugar.

General Precautions with Apidra:

·       Only use Apidra that is clear and colorless. If your Apidra is cloudy or colored, return it to your pharmacy for a replacement.

·       Change (rotate) injection sites within the same body area.

·       Always use a syringe that is marked for U-100 insulin. If you use the wrong syringe, you may get the wrong dose. You could get a blood sugar level that is too low or too high.

·       If you are mixing Apidra with NPH human insulin, draw Apidra into the syringe first. Inject the mixture right away.  Do not mix Apidra with any other type of insulin than NPH.

·       Do not mix Apidra with any other insulin when used in a pump.

What should I tell my health care provider?

Tell your health care provider:

  • If you get any allergic reaction or injection site reaction

·       about all your medical problems

·       if you have liver or kidney problems

·       if you are pregnant or breast feeding

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Some medicines may affect how Apidra works or Apidra may affect how your other medicines work.

What are some possible side effects of Apidra? (This list is NOT a complete list of side effects reported with Apidra.  Your health care provider can discuss with you a more complete list of side effects.)

The most common side effects of Apidra include:

  • hypoglycemia (low blood sugar)

·       allergic reactions

·       injection site reactions

·       lipodystrophy (loss of body fat at injection sites)

·       itching

·       rash

Reports of patients’ experience after Apidra became available:

For more detailed information about Apidra, ask your health care provider or pharmacist.

Link to Apidra's label

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Posted 5/26/04