Apidra insulin glulisine

Get an overview of APIDRA (insulin glulisine injection, solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Apidra can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Apidra.

Drug Basics

Brand Name: Apidra

Generic Name: INSULIN GLULISINE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: SUBCUTANEOUS

Dosage Form: INJECTION, SOLUTION

Data Current As Of: 2019-01-14

indications & usage

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

patient counseling information

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

Never Share an APIDRA SoloStar Pen or Syringe or Needle between Patients

Advise patients that they must never share an APIDRA SoloStar pen with another person, even if the needle is changed. Advise patients using APIDRA vials not to reuse or share needles or syringes with another person. Sharing carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1)].

Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of APIDRA therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia [see Warnings and Precautions (5.3)].

Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

Hypoglycemia due to Medication Errors

Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions (5.4)].

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with APIDRA. Inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur [see Warnings and Precautions (5.6)].

Instructions For Patients Using Continuous Subcutaneous Insulin Pumps

Train patients using external pump infusion therapy appropriately.

Inform patients to replace the infusion sets (reservoir, tubing, and catheter) and the APIDRA in the reservoir at least every 48 hours and select a new infusion site. The temperature of the insulin may exceed ambient temperature when the pump housing, cover, tubing or sport case is exposed to sunlight or radiant heat. Discard insulin exposed to temperatures higher than 98.6°F (37°C). Instruct patients to report infusion sites that are erythematous, pruritic, or thickened to their healthcare professional and select a new site.

Inform patients that pump or infusion set malfunctions or handling errors or insulin degradation can lead to rapid hyperglycemia, and ketosis and diabetic ketoacidosis. Instruct patients to resume therapy with subcutaneous insulin injection and contact their healthcare professional if pump problems cannot be promptly corrected [see Dosage and Administration (2.2), Warnings and Precautions (5.8), How Supplied/Storage and Handling (16.2)].

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

© 2018 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

PATIENT INFORMATION
APIDRA® (uh PEE druh)
(insulin glulisine injection) for subcutaneous use
100 units/mL (U-100)
This Patient Information has been approved by the U.S. Food and Drug Administration. Approved: December 2018
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.
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.
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 disposable 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 your skin (subcutaneously) and by continuous infusion under your skin through an insulin pump.
  • Change (rotate) injection sites within the area you chose with each dose. Do not use the exact spot for each injection.
  • 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:

    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, tromethamine, sodium chloride, polysorbate 20, and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.
sanofi-aventis U.S. LLC Bridgewater, NJ 08807, A SANOFI COMPANY
For more information, go to www.APIDRA.com or call 1-800-633-1610.

INSTRUCTIONS FOR USE
APIDRA® 10 mL vial (100 Units/mL)

Do not share your 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.

This Instructions for Use has two parts:
  Part 1 Use with a syringe
  Part 2 Use with an external insulin infusion pump

Be sure to read, understand and follow these instructions before taking APIDRA.

Part 1 Use with a syringe

If you will give yourself subcutaneous injections of APIDRA:

  • You should take APIDRA within 15 minutes before a meal or within 20 minutes after starting a meal.
  • Do not inject APIDRA if you are not going to eat within 15 minutes.
  • Inject APIDRA into the skin of your upper arm, thigh, or stomach area. Do not inject APIDRA into a vein or into a muscle.
  • Choose an injection area (upper arm, thigh, or stomach area). Change injection sites within the area you choose with each dose. Do not inject into the exact same spot for each injection.
  • Do not mix APIDRA with insulins other than NPH, for subcutaneous injections. If mixing APIDRA with NPH insulin, draw up APIDRA into the syringe first. Inject the mixture right away.
  • Use the needles and syringes prescribed by your healthcare provider.
  • Do not reuse or share your syringes with other people. You may give other people a serious infection, or get a serious infection from them.
  • Do not reuse needles.

Before every injection make sure you have the following items:

Drawing the insulin into a syringe

  • 1.Use a new syringe each time you give an injection of APIDRA. Do not reuse or share your syringes with other people. You may give other people a serious infection, or get a serious infection from them.

Preparing for an injection

  • 2. Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin.
  • 3. Look at the APIDRA in the vial. It should look clear. Do not use this vial of APIDRA if the solution is colored, or cloudy, or if you see particles in it.
  • 4. If you are using a new vial, remove the protective cap. Do not remove the stopper.

    apidra 09.jpg

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

    apidra 10.jpg

  • 6. Use the needles and syringes prescribed by your healthcare provider. APIDRA 10 mL vials come with 100 units of insulin in 1 mL of APIDRA.
  • 7. Use a new needle and syringe for each injection. Use disposable syringes and needles only one time. Do not reuse or share your syringes with other people. You may give other people a serious infection, or get a serious infection from them. Do not reuse needles.
  • 8. Draw air into the syringe equal to the insulin dose prescribed by your healthcare provider.

    apidra 11.jpg

  • 9. Put the needle through the rubber stopper of the vial and push the plunger to inject the air into the vial.

    apidra 12.jpg

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

    apidra 13.jpg

  • 12Before 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.

    apidra 14.jpg

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

Giving the injection

Do the injection exactly as shown to you by your healthcare provider. Inject APIDRA under your skin.

  • 14. Choose an injection area (for example upper arm, thigh or stomach area). Change injection sites within the area you choose. Do not inject in the same spot.
  • 15. Clean the area with an alcohol swab. Let the injection site dry before you inject.

    apidra 15.jpg

  • 16. Pinch the skin. Insert the needle into the skin. Release the skin.
  • 17. Inject the dose by slowly pushing in the plunger of the syringe all the way, making sure you have injected all the insulin. Keep the needle in the skin for at least 10 seconds.

    apidra 16.jpg

    Pull the needle out of your skin, gently press the injection site with a finger for several seconds. Do not rub the area.

  • 18.Do not recap the needle. Recapping can lead to a needle stick injury and passing of infection. See "How do I dispose of used needles and syringes?".
    If your injection is given by another person, this person must also be careful to prevent accidental needle stick injury and passing infections.

How do I dispose of used needles and syringes?

  • 19. Check with your healthcare provider's office for instructions about the right way to dispose of used needles and syringes. There may be local or state laws about how to dispose of used needles and syringes. Do not dispose of used needles or syringes in household trash and do not recycle them.
  • 20.Put used needles and syringes in a container specially made for throwing away syringes and needles (called a "sharps" container) or a hard plastic container with a screw-on cap or a metal container with a plastic lid labeled "Used Syringes". These containers should be sealed and dispose of the right way.

See "How should I store APIDRA?" in the Patient Information leaflet that comes With APIDRA for complete instructions on how to store APIDRA vials.

Part 2 Use with an external insulin pump:

Be sure to read, understand, and follow these instructions before using APIDRA with an external insulin infusion pump. Always read the instruction manual for your pump. These instructions may differ from the instructions that accompany your insulin infusion pump. When you use Apidra in the pump system, it is important that you always follow these Apidra specific instructions. Failure to follow the Apidra specific instructions may lead to serious adverse events.

If you will be using an insulin pump:

  • APIDRA should be given into the stomach area.
  • Change injection sites in the stomach area.
  • Do not mix APIDRA with other insulins and do not dilute APIDRA.
  • Use only insulin pumps that have been specially tested with APIDRA.
    Follow your healthcare provider or pharmacist instructions for which insulin pumps may be used.
  • Change the infusion set (reservoir, tubing, and catheter), and the APIDRA in the reservoir at least every 2 days (48 hours). Change all of these parts sooner if they have been exposed to temperatures higher than 98.6°F (37°C).

Important information about using APIDRA with an external insulin infusion pump

  • Do not mix APIDRA with any other insulin or liquid when used in a pump.
  • If your APIDRA infusion pump set is not working the right way or in case of handling errors, you may not get the right amount of insulin that can cause:
    • low blood sugar (hypoglycemia)
    • high blood sugar (hyperglycemia)
    • high amounts of sugar and ketones in your blood or urine
    • build-up of acid in your blood because your body is breaking down fat instead of sugar (diabetic ketoacidosis)
  • You must 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.

How to use APIDRA with an external insulin infusion pump?

  • Check with your healthcare provider or pharmacist to see if your pump and infusion set can be used with APIDRA. See the instruction manual of your specific pump on proper use of insulin in a pump. Call your healthcare provider if you have questions about using the pump.
  • Change the infusion set, reservoir with insulin, and injection site:
    • at least every 48 hours, change more often than every 48 hours if you have high blood sugar (hyperglycemia), or the pump alarm sounds.
    • if the insulin has been in temperatures over 98.6°F (37°C). Dark colored pump cases or sport covers can increase this type of heat. The location where the pump is worn may affect the temperature.

If you get reactions at the injections infusion site you may need to change infusion sites more often.

If your APIDRA infusion pump is not working the right way, follow these steps:

  • Use insulin from a new vial of APIDRA if infusion pump alarms do not respond to all of the following:
    • a repeat injection or bolus of APIDRA
    • a change in the infusion set and the reservoir
    • a change in the infusion injection site
  • If the same problems happen again, do not use your infusion pump with APIDRA. You may need to restart insulin injections with syringes and needles.
    • Contact your healthcare provider right away.
    • See section I of the Instructions for Use ("Use with a syringe") for the steps for giving injections of APIDRA using syringes and needles.
    • Continue to check your blood sugar often.

How should I store 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.

Rev. February 2015

sanofi-aventis U.S. LLC
Bridgewater NJ 08807
A SANOFI COMPANY

©2015 sanofi-aventis U.S. LLC

APIDRA® SoloStar®
(insulin glulisine injection) for subcutaneous use
3 mL SoloStar prefilled pen

Instructions for Use

Be sure that you read, understand, and follow these instructions before you use your APIDRA SoloStar. Talk with your healthcare provider about the right way to use your APIDRA SoloStar before you use it for the first time. Keep this leaflet in case you need to look at it again later.

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.

apidra 17.jpg

If you will give yourself subcutaneous injections of APIDRA:

  • You should take APIDRA within 15 minutes before a meal or within 20 minutes after starting a meal.
  • Do not inject APIDRA if you are not going to eat within 15 minutes.
  • Inject APIDRA into the skin of your upper arm, thigh, or stomach area. Do not inject APIDRA into a vein or into a muscle.
  • Choose an injection area (upper arm, thigh, or stomach area). Change injection sites within the area you choose with each dose. Do not inject into the exact same spot for each injection.

Important information for use of APIDRA SoloStar:

  • 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.
  • Do not reuse needles. Use a new needle for each injection.
  • APIDRA SoloStar may be used with pen needles from Becton Dickinson and Company, Ypsomed, and Owen Mumford. Contact your healthcare provider for further information.
  • Do a safety test before each injection (see step 3).
  • Do not select a dose or press the injection button without a needle attached.
  • If your injection is given by another person, this person must be careful to avoid accidental needle stick injury and prevent passing (transmission of) infection.
  • Do not use APIDRA SoloStar if it is damaged or if you are not sure that it is working correctly.
  • Always carry an extra APIDRA SoloStar prefilled pen in case your APIDRA SoloStar is lost or damaged.

Step 1. Preparing for an Injection

Make sure you have the following items:

  • A.Check the label on your APIDRA SoloStar to make sure you have the right insulin. The APIDRA SoloStar is blue. It has a dark blue injection button with a raised ring on the top.
  • B.Check the expiration date, located on the carton or the label of your APIDRA SoloStar, to make sure the date has not passed. Do not use an APIDRA SoloStar if the date has passed.
  • C.Take off the pen cap.
  • D.Look at the insulin in your APIDRA SoloStar. Check to make sure that the insulin looks clear. Do not use this APIDRA SoloStar if the insulin is cloudy, colored, or has particles in it.

Step 2. Attaching the Needle

Do not reuse needles. Always use a new sterile needle for each injection to help prevent you from getting a serious infection (contamination) and potential needle blocks.

Read the pen needle "Instructions for Use" before you use them.

Please note: Pen needles may look different. The pen needles shown are for illustrative purposes only.

  • A.Wipe the Rubber Seal with alcohol.
  • B.Remove the protective seal from the new pen needle.
  • C.Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).

    apidra 18.jpg

    • If you do not keep the needle straight while you attach it this can damage the rubber seal and cause leakage of insulin or break the needle.

      apidra 19.jpg

Step 3. Doing a Safety Test

Do a safety test before each injection to make sure that you get the correct dose of APIDRA. The safety test:

  • makes sure that the pen and needle work properly
  • removes air bubbles
  • A.Select a dose of 2 units by turning the dosage selector.

    apidra 20.jpg

  • B.Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and dispose of it.

    apidra 21.jpg

  • C.Hold the pen with the needle pointing upwards.
  • D.Tap the insulin reservoir so that any air bubbles rise up towards the needle.
  • E.Press the injection button all the way in. Check if insulin comes out of the needle tip.

    apidra 22.jpg

You may have to do the safety test more than one time before you see the insulin.

  • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
  • If still no insulin comes out, the needle may be blocked. Change the needle and try again.
  • If no insulin comes out after changing the needle, your APIDRA SoloStar may be damaged. Do not use this APIDRA SoloStar.

Step 4. Selecting your Dose

Select the APIDRA dose prescribed by your healthcare provider. You can select the insulin dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose larger than 80 units, you should give it as two or more injections.

  • A.Check that the dose window shows "0" after the safety test.
  • B.Select your needed dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.

    apidra 23.jpg

    • Do not push the injection button while turning, insulin will come out.
    • You cannot turn the dosage selector passed the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject the amount of insulin that is still in the pen and finish your dose with a new APIDRA SoloStar or you can use a new APIDRA SoloStar for your full dose.

Step 5. Giving the Injection

  • A.Give the injection exactly as shown to you by your healthcare provider.
  • B.Insert the needle into your skin.

    apidra 24.jpg

  • C.Inject the dose by pressing the injection button in all the way. Only push the injection button when you are ready to inject. The number in the dose window will return to "0" as you inject.

    apidra 25.jpg

  • D.Keep the injection button pressed all the way in. Slowly count to 10 before you take the needle out of your skin. This will make sure that the full dose has been given.

Step 6. Removing and Disposing of the Pen Needle

Always remove the pen needle after each injection and store your APIDRA SoloStar without a needle attached. This helps prevent:

  • Contamination and infection
  • Air from getting into the insulin reservoir and leakage of insulin. This will help to make sure you inject the right dose of insulin.
  • A.Follow the instructions from your healthcare provider when removing and disposing of the needle. For example "scoop" the outer needle cap back on the needle and use it to unscrew the used needle from the pen. To lessen the risk of accidental needle stick injury and passing infection:
    • do not recap needles with your fingers.
    • never replace the inner needle cap.

    If your injection is given by another person, this person must also be careful when removing and disposing of the needles to prevent accidental needle stick injury and passing infection.

  • B.Dispose of the needle the right way into your special puncture-resistant container (See "How Do I Dispose of used needles and APIDRA SoloStar?").
  • C.Always put the pen cap back on the pen, then store the APIDRA SoloStar until your next injection.

How do I dispose of used needles and APIDRA SoloStar?

  • Check with your healthcare provider for instructions about the right way to dispose of used needles and APIDRA SoloStar.
  • Put used needles and used empty APIDRA SoloStar 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.

How should I store APIDRA SoloStar?

  • 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.

Maintenance

  • Protect your APIDRA SoloStar from dust and dirt.
  • You can clean the outside of your APIDRA SoloStar by wiping it with a damp cloth.
  • Do not soak, wash, or lubricate the pen as this may damage it.
  • Handle your APIDRA SoloStar with care. Avoid situations where your APIDRA SoloStar might be damaged. If you are concerned that your APIDRA SoloStar may be damaged, use a new one.

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.

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

Revised: December 2018

©2018 sanofi-aventis U.S. LLC

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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