Apidra (Insulin glulisine): Uses, Side Effects and Dosage

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.

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, 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

  Treatment with TZDs and APIDRA may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

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.

What are the ingredients in APIDRA?

• Active ingredient: insulin glulisine
• Inactive ingredients: metacresol, polysorbate 20, sodium chloride, tromethamine, and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

Manufactured by: sanofi-aventis U.S. LLC, Morristown, NJ 07960, A SANOFI COMPANY. U.S. License No. 1752

For more information, go to www.APIDRA.com or call 1-800-633-1610.

Instructions for Use

APIDRA^® 10 mL vial (100 Units/mL)

(insulin glulisine) injection

for subcutaneous use

These Instructions for Use contain information on how to inject APIDRA using the vial. Read these Instructions for Use before you start taking APIDRA and each time you get a new APIDRA vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your APIDRA 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.

Supplies needed to give your injection

• an APIDRA 10 mL vial
• a U-100 insulin syringe and needle
• 2 alcohol swabs
• 1 sharps container for throwing away used needles and syringes. See "Disposing of used needles and syringes" at the end of these instructions.

Preparing your APIDRA dose

• Wash your hands with soap and water or clean your hands with alcohol.
• Check the APIDRA label to make sure that you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
• Look at the APIDRA in the vial. It should look clear and colorless. Do not use this vial of APIDRA if the solution is colored, or cloudy, or if you see particles in it.
• Do not use APIDRA after the expiration date stamped on the label or 28 days after you first use it.
• Always use a syringe that is marked for U-100 insulin. If you use a syringe other than a U-100 insulin syringe, you may get the wrong dose of insulin.
• Always use a new syringe or needle for each injection to help prevent infections and prevent blocked needles. Do not reuse or share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.

Step 1:

If you are using a new vial, remove the protective cap. Do not remove the stopper.

Step 2:

Wipe the rubber stopper with an alcohol swab. You do not have to shake the vial of APIDRA before use.

Step 3:

Draw air into the syringe equal to the insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.

Step 4:

Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw the correct dose into the syringe.

Step 5:

Before you take the needle out of the vial, check the syringe for air bubbles. If you see bubbles in the syringe, hold the syringe straight up and tap the side of the syringe with your finger a few times to make any air bubbles float to the top. Gently push the air bubbles out with the plunger and draw insulin back into the syringe until you have the correct dose. If you are mixing APIDRA with NPH insulin, check with your healthcare provider on how to mix it the right way.

Step 6:

Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.

Giving your APIDRA injection with a syringe

• Inject your insulin exactly as your healthcare provider has shown you.
• APIDRA starts acting fast, so give your injection within 15 minutes before or right after you eat a meal.

Step 7:

• Choose your injection site: APIDRA is injected under the skin (subcutaneously) of your upper arms, thighs, or stomach area (abdomen).
• Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in the skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
• 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.

• Wipe the skin with an alcohol swab to clean the injection site. Let the injection site dry before you inject.

Step 8:

• Pinch the skin.
• Insert the needle in the way your healthcare provider showed you.
• Release the skin.
• Slowly push in the plunger of the syringe all the way, making sure you have injected all the insulin.
• Leave the needle in the skin for about 10 seconds.

Step 9:

• Pull the needle straight out of your skin.
• Gently press the injection site for several seconds. Do not rub the area.
• Do not recap the used needle. Recapping the needle can lead to a needle-stick injury.

Giving your APIDRA using an insulin pump

• If you have been prescribed an insulin pump, check the pump manufacturer's user manual to see if APIDRA can be used with the pump.
• APIDRA should be given into an area of your body recommended in the instructions that come with your insulin pump.
• Change (rotate) your injection sites within the area you choose for each insertion 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 inject into 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.
• Call your healthcare provider and choose a new infusion site if the skin at the infusion site becomes red, itchy, or thickened.
• Change the insulin in the reservoir at least every 2 days or according to the pump user manual, whichever is shorter, even if you have not used all of the insulin.
• Do not dilute or mix APIDRA with other insulins in your insulin pump.
• You should be trained on how to give insulin by injection and have an alternative insulin delivery system in case of pump failure.
• When you start using APIDRA by infusion pump, your insulin dose may need to be adjusted. Check with your healthcare provider before making any changes to your insulin dose.
• Your healthcare provider should provide recommendations for appropriate pump basal and meal-time infusion rates. Call your healthcare provider if you have any questions about using the insulin pump.

Disposing of used needles and syringes

• Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.

• If you do not have a FDA-cleared sharps container, you may use a household container that is:

  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store APIDRA 10 mL vial?

Unopened (not in-use) APIDRA vials

• Store unused APIDRA vials in the refrigerator from 36°F to 46°F (2°C to 8°C).
• Do not freeze APIDRA.
• Keep APIDRA away from direct heat and light.
• If a vial has been frozen or overheated, throw it away.
• Unopened vials can be used until the expiration date on the carton and label if they have been stored in the refrigerator.
• Unopened vials should be thrown away after 28 days if they are stored at room temperature.

After APIDRA vials have been opened (in-use)

• Store in-use (opened) APIDRA vials in a refrigerator from 36°F to 46°F (2°C to 8°C) or at room temperature below 77°F (25°C) for up to 28 days.
• Do not freeze APIDRA.
• Keep APIDRA out of direct heat and light.
• If a vial has been frozen, throw it away.
• The APIDRA vial you are using should be thrown away after 28 days, even if it still has insulin left in it.

APIDRA in an insulin pump

• Throw away APIDRA in the pump reservoir if it has been exposed to temperatures higher than 98.6°F (37°C). This may occur if the pump housing, cover, tubing, or sport case is exposed to sunlight or direct heat.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: May 2025

Manufactured by:

sanofi-aventis U.S. LLC

Morristown, NJ 07960

A SANOFI COMPANY

U.S. License No. 1752

©2025 sanofi-aventis U.S. LLC

INSTRUCTIONS FOR USE

APIDRA^® SoloStar^®

(insulin glulisine) injection

for subcutaneous use

3 mL single-patient-use PREFILLED PEN: (100 units/mL, U-100)

Read these Instructions for Use before you start taking the APIDRA Solostar pen and each time you get a new APIDRA SoloStar pen. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your APIDRA SoloStar pen 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.

People who are blind or have vision problems should not use APIDRA SoloStar prefilled pen without help from a person trained to use APIDRA SoloStar prefilled pen.

APIDRA SoloStar is a disposable prefilled pen used to inject APIDRA. Each APIDRA SoloStar has 300 units of insulin which can be used for many doses. You can select a dose from 1 to 80 units in steps of 1 unit. The pen plunger moves with each dose. The plunger will only move to the end of the cartridge when 300 units of insulin have been given.

Important information You Need to Know Before Injecting APIDRA

• Do not use your pen if it is damaged or if you are not sure that it is working properly.
• Do not use a syringe to remove insulin from your pen.
• Do not reuse needles. If you do, you might get the wrong dose of APIDRA and/or increase the chance of getting an infection.
• Always perform a safety test before each injection (see Step 3).
• Always carry a spare pen and spare needles in case they got lost or stop working.
• Change (rotate) your injection sites within the area you choose for each dose (see "Places to inject").

Learn to inject

• Talk with your healthcare provider about how to inject before using your pen.
• Ask for help if you have problems handling the pen, for example if you have problems with your sight.
• Read all of these instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little insulin.

Need help?

If you have any questions about APIDRA SoloStar or about diabetes, ask your healthcare provider, go to www.apidra.com, or call sanofi-aventis U.S. at 1-800-633-1610.

Extra items you will need:

• a new sterile needle (see Step 2 ).
• an alcohol swab.
• a puncture-resistant container for used needles and pens. (See "Throwing your pen away".)

Places to inject

• Inject your insulin exactly as your healthcare provider has shown you.
• Inject your insulin under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
• Change (rotate) your injection sites within the area you choose for 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 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.

Get to know your pen

Step 1. Check your pen

Take a new pen out of the refrigerator at least 1 hour before you inject. Cold insulin is more painful to inject.

1A Check the name and expiration date on the label of your pen.

• Make sure you have the correct insulin.

  • Do not use your pen after the expiration date.

  

1B Pull off the pen cap.

1C Check that the insulin is clear.

• Do not use the pen if the insulin looks cloudy, colored or contains particles.

1D Wipe the rubber seal with an alcohol swab.

If you have other injector pens:

• Making sure you have the correct medicine is especially important if you have other injector pens.

Step 2. Attach a new needle

• Do not reuse needles. Always use a new sterile needle for each injection. This helps stop blocked needles, contamination, and infection.
• APIDRA SoloStar may be used with pen needles from Becton Dickinson and Company, Ypsomed, and Owen Mumford. Contact your healthcare provider for further information.

2A Take a new needle and peel off the protective seal.

2B Keep the needle straight and screw it onto the pen until fixed. Do not over-tighten.

2C Pull off the outer needle cap. Keep this for later.

2D Pull off the inner needle cap and throw away.

Handling needles

• Take care when handling needles to prevent needle-stick injury and cross-infection.

Step 3. Do a Safety Test

Always do a safety test before each injection to:

• Check your pen and the needle to make sure they are working properly.
• Make sure that you get the correct insulin dose.

3A Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.

3B Press the injection button all the way in.

• When insulin comes out of the needle tip, your pen is working correctly

If no insulin appears:

• You may need to repeat this step up to 3 times before seeing insulin.

• If still no insulin comes out after the third time, the needle may be blocked. If this happens:

  • change the needle (see Step 6 and Step 2 ),
  • then repeat the safety test (Step 3).
• Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
• Do not use a syringe to remove insulin from your pen.

If you see air bubbles:

• You may see air bubbles in the insulin. This is normal, they will not harm you.

Step 4. Select the Dose

• Do not select a dose or press the injection button without a needle attached. This may damage your pen.

4A Make sure a needle is attached and the dose is set to "0."

4B Turn the dose selector until the dose pointer lines up with your dose.

• If you turn past your dose, you can turn back down.
• If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
• If you cannot select your full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete your dose.

How to read the dose window

Even numbers are shown in line with dose pointer.

20 units selected

Odd numbers are shown as a line between even numbers.

21 units selected

Units of insulin in your pen:

• Your pen contains a total of 300 units of insulin. You can select doses from 1 to 80 units in steps of 1 unit. Each pen contains more than 1 dose.
• You can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.

Step 5. Inject your dose

If you find it hard to press the injection button in, do not force it as this may break your pen. See the section below for help.

5A Choose a place to inject as shown in the picture above (Places to inject).

5B Push the needle into your skin as shown by your healthcare provider.

Do not touch the injection button yet.

5C Place your thumb on the injection button. Then press all the way in and hold.

• Do not press at an angle. Your thumb could block the dose selector from turning.

5D Keep the injection button held in and when you see "0" in the dose window, slowly count to 10.

• This will make sure you get your full dose.

5E After holding and slowly counting to 10, release the injection button. Then remove the needle from your skin.

If you find it hard to press the button in:

• Change the needle (see Step 6 and Step 2 ) then do a safety test (see Step 3 ).
• If you still find it hard to press in, get a new pen.
• Do not use a syringe to remove insulin from your pen.

Step 6. Remove the Needle

• Take care when handling needles to prevent needle-stick injury and cross-infection.
• Do not put the inner needle cap back on.

6A Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap. Then push firmly on.

• The needle can puncture the cap if it is recapped at an angle.

6B Grip and squeeze the widest part of the outer needle cap. Turn your pen several times with your other hand to remove the needle.

• Try again if the needle does not come off the first time.

6C Throw away the used needle in a puncture-resistant container (see "Throwing your pen away" at the end of this Instructions for Use).

6D Put your pen cap back on.

• Do not put the pen back in the refrigerator.

How to store your pen

Before first use

• Keep new pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze. Do not use APIDRA if it has been frozen.

After first use

• Keep your pen at room temperature up to 77ºF (25ºC).
• Keep your pen away from heat or light.
• Store your pen with the pen cap on.
• Do not put your pen back in the refrigerator.
• Do not store your pen with the needle attached.
• Keep out of the reach of children.
• Only use your pen for up to 28 days after its first use. Throw away the APIDRA SoloStar pen you are using after 28 days, even if it still has insulin left in it.

How to care for your pen

Handle your pen with care

• Do not drop your pen or knock it against hard surfaces.
• If you think that your pen may be damaged, do not try to fix it. Use a new one.

Protect your pen from dust and dirt

• You can clean the outside of your pen by wiping it with a damp cloth (water only). Do not soak, wash or lubricate your pen. This may damage it.

Throwing your pen away

• The used APIDRA SoloStar pen may be thrown away in your household trash after you have removed the needle.
• Put the used needle in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.

• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: https://fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: May 2025

Manufactured by:

sanofi-aventis U.S. LLC

Morristown, NJ 07960

A SANOFI COMPANY

U.S. License No. 1752

©2025 sanofi-aventis U.S. LLC