What is Apidra?
Apidra is a fast (rapid) acting man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
- It is not known if Apidra is safe or effective in children less than 4 years of age with type 1 diabetes.
- It is not known if Apidra is safe or effective in children with type 2 diabetes.
What is the most important information I should know about Apidra?
Do not share your Apidra SoloStar pen or syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Who should not use Apidra?
Do not use Apidra if you:
- are having an episode of low blood sugar (hypoglycemia).
- have an allergy to insulin glulisine or any of the ingredients in Apidra. See the end of this Patient Information leaflet for a complete list of ingredients in Apidra.
What should I tell my healthcare provider before using Apidra?
Before using Apidra, tell your healthcare provider about all your medical conditions including if you:
- have liver or kidney problems.
- take other medicines, especially ones called TZDs (thiazolidinediones).
- have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Apidra.
- are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Apidra may harm your unborn baby or breastfeeding baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before you start using Apidra, talk to your healthcare provider about low blood sugar and how to manage it.
How should I use Apidra?
- Apidra comes in a SoloStar single-patient-use prefilled pen or in a vial.
- Read the detailed Instructions for Use that come with your Apidra.
- Use Apidra exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Apidra to use and when to use it.
- Know the amount of Apidra you use. Do not change the amount of Apidra you use unless your healthcare provider tells you to.
- Know the best time for you to take your insulin. This may change if you take a different type of insulin or if the way you give your insulin changes, for example, using an insulin pump instead of giving injections under the skin (subcutaneous injections).
- Check your insulin label each time you give your injection to make sure you have the correct insulin. This is especially important if you also take long-acting insulin.
- Do not reuse needles. Always use a new needle for each injection. Reuse of needles increase your risk of having blocked needles, which may cause you to get the wrong dose of Apidra. Using a new needle for each injection lowers your risk of getting an infection.
- Apidra is a rapid-acting insulin. Take Apidra within 15 minutes before a meal or within 20 minutes after starting a meal.
- Apidra is injected under the skin (subcutaneously) of your upper arms, thighs, buttocks, or stomach area (abdomen), or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.
- Change (rotate) injection sites within the area you chose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites:
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly, or hard, or into scars or damaged skin.
- Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
Keep Apidra and all medicines out of the reach of children.
Your dose of Apidra may need to change because of:
- a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.
What should I avoid while using Apidra?
While using Apidra do not:
- drive or operate heavy machinery until you know how Apidra affects you.
- drink alcohol or use over-the-counter medicines that contain alcohol.
What are the possible side effects of Apidra?
Apidra may cause serious side effects that can lead to death, including:
- low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
dizziness or light-headedness, sweating, trouble concentrating or confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger
- severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
- a rash over your whole body, shortness of breath, trouble breathing, fast pulse, sweating, or feeling faint
- low potassium in your blood (hypokalemia).
- heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Apidra may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Apidra. Your healthcare provider should monitor you closely while you are taking TZDs with Apidra. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
- shortness of breath, swelling of your ankles or feet, sudden weight gain.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
The most common side effects of Apidra include:
- low blood sugar (hypoglycemia), weight gain, itching, rash, swelling, allergic reactions including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy).
These are not all the possible side effects of Apidra. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Apidra
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Apidra for a condition for which it was not prescribed. Do not give Apidra to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Apidra. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about APIDRA that is written for health professionals.
How should I store Apidra?
Apidra 10 mL vial
- Keep in the refrigerator or below 77°F (25°C).
- Keep vials away from direct heat and light.
- Dispose of any opened vial after 28 days after the first use, even if there is insulin left in the vial.
- Do not refrigerate Apidra SoloStar after first use.
- Keep at room temperature below 77°F (25°C).
- Throw away (dispose of) any opened Apidra SoloStar 28 days after first use.
What are the ingredients in Apidra?
- Active ingredient: insulin glulisine
- Inactive ingredients: metacresol, tromethamine, sodium chloride, polysorbate 20, and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.
For more information, go to www.APIDRA.com or call 1-800-633-1610.