APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Injection: 100 units per mL (U-100), a clear and colorless solution available as:

• 10 mL multiple-dose vial
• 3 mL single-patient-use APIDRA SoloStar prefilled pen

APIDRA is contraindicated:

• during episodes of hypoglycemia
• in patients with known hypersensitivity to insulin glulisine or to any of the excipients in APIDRA; systemic allergic reactions have occurred with APIDRA [see Adverse Reactions (6.1)].

The following adverse reactions are discussed elsewhere:

• Hypoglycemia [see Warnings and Precautions (5.3)]
• Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4)]
• Hypokalemia [see Warnings and Precautions (5.5)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.6)]

Excess insulin may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa.

APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.

The safety and efficacy of APIDRA were studied in adult patients with type 1 and type 2 diabetes (n=1833) and in pediatric patients (4 to 17 years) with type 1 diabetes (n=572). The primary efficacy parameter in these trials was glycemic control, assessed using glycated hemoglobin (GHb reported as HbA1c equivalent).

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Manufactured by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
U.S. License No. 1752

©2022 sanofi-aventis U.S. LLC

Other brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC

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: November 2022

Manufactured by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

U.S. License No. 1752

©2022 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: November 2022

Manufactured by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
U.S. License No. 1752

©2022 sanofi-aventis U.S. LLC

NDC 0088-2500-33
Rx only

Apidra®
(insulin glulisine)
injection

100 units/mL
(U-100)

For subcutaneous use

For intravenous infusion
after further dilution
ONLY under direct
medical supervision

Use only if solution is
clear and colorless
with no particles visible

One 10 mL
multiple-dose vial

sanofi

NDC 0088-2502-05
Rx only

Apidra® SoloStar®
(insulin glulisine) injection

For Single Patient Use Only

100 units/mL (U-100)
For subcutaneous use

Five 3 mL Prefilled Pens – Dispense in this sealed carton
Solution for injection in a disposable insulin delivery device
Use only if solution is clear and colorless with no particles visible
Use within 28 days after initial use
*Needles not included (see back panel)

sanofi