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ADLYXIN- lixisenatide kitADLYXIN- lixisenatide injection, solution


  1. Patient Information
  2. What Is Adlyxin?
  3. Do Not Use Adlyxin If You:
  4. Your Dose Of Adlyxin And Other Diabetes Medicines May Need To Change Because Of:
  5. Adlyxin May Cause Serious Side Effects Including:
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. What Do I Do If There Are Air Bubbles In The Container?
  9. What Do I Do If No Liquid Comes Out During Activation?
  10. What Do I Do If It Is Hard To Press The Injection Button All The Way In?

Patient Information 

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

Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions, including anaphylaxis, have been reported in clinical trials of ADLYXIN and during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, inform patients that they must stop taking ADLYXIN and Do not share your ADLYXIN 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.ADLYXIN can cause serious side effects including inflammation of the pancreas (pancreatitis), which may be severe and lead to death.
Before using ADLYXIN, tell your healthcare provider if you have had:

  • pancreatitis
  • stones in your gallbladder (cholelithiasis)
  • a history of alcoholism
These medical problems may make you more likely to get pancreatitis.
Stop taking ADLYXIN and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

What Is Adlyxin? 

ADLYXIN is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise.
  • ADLYXIN is not insulin.
  • ADLYXIN is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
  • ADLYXIN has not been studied in people with a history of pancreatitis.
  • ADLYXIN has not been studied in people who use short-acting insulin.
  • ADLYXIN has not been studied in people who have a stomach problem that causes slow emptying of the stomach (gastroparesis). ADLYXIN is not for people with slow emptying of the stomach.
  • It is not known if ADLYXIN is safe and effective in children.
Who should not use ADLYXIN?

Do Not Use Adlyxin If You: 

  • are allergic to lixisenatide or any of the other ingredients in ADLYXIN.
    • Read the detailedInstructions for Usethat comes with your ADLYXIN for instruction on using the ADLYXIN pen and injecting ADLYXIN.
    • ADLYXIN comes as a disposable prefilled pen.
    • Use ADLYXIN exactly as your healthcare provider tells you to. Do not change your dose unless your healthcare provider has told you to change your dose.
    • Your healthcare provider should teach you how to inject ADLYXIN before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider.
    • Use ADLYXIN 1 time each day within 60 minutes (1 hour) before the first meal of the day and at the same time each day.
    • If you miss a dose of ADLYXIN, take it within 1 hour before your next meal.
    • Check the label on the pen each time you give your ADLYXIN injection to make sure you are using the correct medication.
    • You must activate each ADLYXIN pen before you use it for the first time.
    • Do not re-use or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
    • Inject your dose of ADLYXIN under the skin (subcutaneously) of your abdomen, thigh or upper arm.Do not inject into a vein.
    • Change (rotate) your injection sites within the area you chose with each dose. Do not use the same 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.

Your Dose Of Adlyxin And Other Diabetes Medicines May Need To Change Because Of: 

  • 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.

Adlyxin May Cause Serious Side Effects Including: 

    • Store your new, unused ADLYXIN pen in the refrigerator at 36 F to 46 F (2 C to 8 C).
    • After activation, store your ADLYXIN pen at room temperature no higher than 86 F (30 C).
    • Do not freeze ADLYXIN pens and do not use ADLYXIN if it has been frozen.
    • Protect the pen from light.
    • Replace the pen cap after each use to protect the container window from light.
    • After activation, use the ADLYXIN pen for up to 14 days. Throw away the used ADLYXIN pen after 14 days, even if there is some medicine left in the pen.
    • Do not use ADLYXIN past the expiration date printed on the label of the carton and pen.
    • Do not store the ADLYXIN pen with the needle attached. If the needle is left on, this might lead to contamination and cause air bubbles which might affect your dose of medicine.

Active Ingredient: 

lixisenatide

Inactive Ingredients: 

glycerol 85%, sodium acetate trihydrate, methionine, metacresol, hydrochloric acid, sodium hydroxide solution and water for injection.Manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807. A SANOFI COMPANY.For more information, go to www. ADLYXIN.com or call sanofi-aventis at 1-800-633-1610.This Medication Guide has been approved by the U.S. Food and Drug AdministrationApproved: Jul 2016

INSTRUCTIONS FOR USE
ADLYXIN (ad-LIX-in)
(lixisenatide)
Injection, for subcutaneous use

Starter pack - Contains two pre-filled pens each with14doses.

One10 microgram (mcg)pen, each dose contains10 micrograms in 0.2 ml.

One20 microgram (mcg)pen, each dose contains20 micrograms in 0.2 ml.

Section 1 - Important Information

Read these instructions carefully before using your ADLYXIN pens.

Keep this leaflet for future reference.

Do not share your ADLYXIN 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.

ADLYXIN pen Information

  • ADLYXIN comes as a pre-filled pen for injection.
  • Inject 1 dose per day.
  • There is no need to measure each dose.
  • Talk with your healthcare provider about how to use the ADLYXIN pen and to inject correctly before using it.
  • If you cannot follow all the instructions completely on your own, or are not able to handle the pen (for example, if you have vision problems), only use it if you have help.

About Your Starter Pack

The ADLYXIN Starter pack includes two different colored pens that contain different strengths of ADLYXIN. Both pens are used in the same way.

  • The green pen contains 14 pre-set doses; each dose contains 10 micrograms of ADLYXIN.
  • The burgundy pen contains 14 pre-set doses; each dose contains 20 micrograms of ADLYXIN.

You must start your treatment with the green 10 microgram ADLYXIN pen. You must first use all 14 doses from this pen. Then use the burgundy 20 microgram ADLYXIN pen.

About Your ADLYXIN Pens

Green 10 microgram (mcg) ADLYXIN pen

Figure

Figure

The plunger will advance along the dose scale after each injection. In the example above, the dose number shows there are 13 injections left in the ADLYXIN pen.

Burgundy 20 microgram (mcg) ADLYXIN pen

Figure

  • Always check the label to make sure you have the correct ADLYXIN pen. Also check that it has not passed the expiration date printed on the ADLYXIN pen. Do not use ADLYXIN past the expiration date. Using the wrong medicine could be harmful to your health.
  • Inject ADLYXIN only by using this pen injector. Never use a syringe to withdraw ADLYXIN from the pen.

About pen needles(supplied separately)

Figure

  • Pen needles are not included with your pen.
  • Always use a new needle for each injection to prevent contamination of ADLYXIN or possible needle blockage.
  • Only use needles that have been approved for use with ADLYXIN. The ADLYXIN pen may be used with certain pen needles from Becton Dickinson, Ypsomed and Owen Mumford that are 8 mm long or shorter. Ask your healthcare provider which needle gauge and length is best for you.
  • Do not reuse or share needles with another person. .

Section 2 Getting Started

Begin with the green 10 mcg ADLYXIN pen.

  • Do not activate the burgundy 20 microgram ADLYXIN pen until you have finished the green pen.

First activate your new pen

  • Before injecting the first dose of ADLYXINyou must activate the new pen. This is a one-time process called 'activation'.Steps 1 to 5below show you how to do this.
  • Activation is done to make sure that the pen is working correctly and that the dose for your first injection is correct.
  • Do not repeatthe activation process or you will not receive 14 doses from your ADLYXIN pen.

The pictures below show how the activation window on the injection button of your pen changes after activation.

Before activation
(orange window)
After activation
(white window)

Figure

Figure

The pen is not activated when the activation window is orange. The pen must be activated before injecting your first dose of ADLYXIN.The pen is activated and ready for injections when the activation window is white.

How to activate your new ADLYXIN pen

Step 1. Pull off cap and check pen

Figure

Step 2. Screw needle on and remove needle caps

Figure

  • Always use anew needlefor activation.
  • Remove the protective seal from the outer needle cap.
  • Line up the needle with the pen. Push the outer needle cap containing the needle straight onto the pen, then screw the needle on until secure.

Figure

Pull off(do not unscrew) the outer needle cap.

  • Pull off the inner needle cap and throw it away.
  • Keep the outer needle cap to remove the needle later.

Take care not to injure yourself when the needle is exposed.

Step 3. Pull the injection button out

Figure

Pull the injection button out firmly until it stops.

Figure

The arrow will now be pointing towards the needle.

Step 4. Firmly press and hold the injection button to remove the liquid

Figure

  • Do notinject into the body.
  • Point the needle into a container (like a paper cup or tissue).
  • Firmly press the injection button all the way into discard the liquid.You may feel or hear a "click".
  • Keep the injection button pressed in andslowly count to 2, which is equal to 2 seconds.
  • If no liquid comes out of your pen,

    If you have injected yourself before activating the pen, do not correct this by giving yourself a second injection. Contact your healthcare provider for advice on checking your blood sugar.

What Do I Do If There Are Air Bubbles In The Container? 

Small air bubbles in the container are normal and they will not harm you. Your dose will be correct and you can keep following the instructions. Contact your healthcare provider if you need help.

What Do I Do If No Liquid Comes Out During Activation? 

The needle may be blocked or not properly attached. Remove the needle from the pen, attach a new one and repeat Steps 4 and 5 of Section 2 only. If still no liquid comes out, your ADLYXIN pen may be damaged. Do not use this ADLYXIN Starter pack. Contact your healthcare provider for help.

What Do I Do If It Is Hard To Press The Injection Button All The Way In? 

The needle may be blocked or not properly attached. Pull the needle out of your skin and remove the needle from the pen. Attach a new needle and repeat Steps 5 and 6 of Section 3 only. If it is still hard to press in the injection button, your ADLYXIN pen may be damaged. Do not use this ADLYXIN starter pack. Contact your healthcare provider for help.

If you have any questions about ADLYXIN or about diabetes, ask your healthcare provider or call sanofi-aventis U.S. LLC at 1-800-633-1610.

Date of Revision: Jul/2016a

INSTRUCTIONS FOR USE
ADLYXIN (ad-LIX-in)
(lixisenatide)
Injection, for subcutaneous use

One pre-filled pen contains 14 doses, each dose contains20 micrograms (mcg) in 0.2 ml.

Section 1 Important Information

Read these instructions carefully before using your ADLYXIN pen.

Keep this leaflet for future reference

Do not share your ADLYXIN 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.

ADLYXIN pen Information

  • ADLYXIN comes as a pre-filled pen for injection.
  • Inject 1 dose per day.
  • There is no need to measure each dose.
  • Talk with your healthcare provider about how to use the ADLYXIN pen and to inject correctly before using it.
  • If you cannot follow all the instructions completely on your own, or are not able to handle the pen (for example, if you have vision problems), only use it if you have help.

About Your ADLYXIN Pen

Figure

Figure

The plunger will move along the dose scale after each injection. In the example above the dose number shows there are 13 injections left in the ADLYXIN pen.

  • Always check the label to ensure you have the correct ADLYXIN pen. Also, check that it has not passed the expiration date printed on the ADLYXIN pen. Do not use ADLYXIN past the expiration date. Using the wrong medicine could be harmful to your health.
  • Inject ADLYXIN only by using this pen injector. Never use a syringe to withdraw ADLYXIN from the pen.

About your pen needles(supplied separately)

Figure

  • Pen needles are not included with your pen.
  • Always use a new needle for each injection. This helps prevent contamination of ADLYXIN or possible needle blockage.
  • Only use needles that have been approved for use with ADLYXIN. The ADLYXIN pen may be used with certain pen needles from Becton Dickinson, Ypsomed and Owen Mumford that are 8 mm long or shorter. Ask your healthcare provider which needle gauge and length is best for you.
  • Do not reuse or share needles with another person.

Section 2 Getting Started

  • Activate the pen on the same day as your first injection with your new pen.

First activate your new pen

  • Before injecting the first dose of ADLYXIN,you must activate the new pen. This is a one-time process called 'activation'.Steps 1 to 5below show you how to do this.
  • Activation is done to make sure that the pen is working correctly and that the dose for your first injection is correct.
  • Do not repeatthe activation process or you will not receive 14 doses from your ADLYXIN pen.

The pictures below show how the injection button of your pen changes after activation.

Before activation
(orange window)
After activation
(white window)

Figure

Figure

The pen is not activated when the activation window is orange. The pen must be activated before injecting your first dose of ADLYXIN.The pen is activated and ready for injections when the activation window is white.

How to activate your new ADLYXIN pen

Step 1. Pull off the pen cap and check the pen

Figure

Step 2. Screw needle on and remove needle caps

Figure

  • Always use anew needlefor activation.
  • Remove the protective seal from the outer needle cap.
  • Line up the needle with the pen. Push the outer needle cap containing the needle straight onto the pen, then screw the needle on until secure.

Figure

  • Pull off(do not unscrew) the outer needle cap.
    • Pull off the inner needle cap and throw it away.
    • Keep the outer needle cap to remove the needle later.
  • Take care not to injure yourself when the needle is exposed.

Step 3. Pull injection button out

Figure

The arrow in the window will be pointing towards the injection button.

Pull the injection button out firmly until it stops.

Figure

The arrow will now be pointing towards the needle.

Step 4. Firmly press and hold injection button to remove the liquid

Figure

  • Do notinject into the body
  • Point the needle into a container (like a paper cup or tissue).
  • Firmly press the injection button all the way into discard the liquid.You may feel or hear a "click".
  • Keep the injection button pressed inand slowly count to 2, which is equal to 2 seconds.
  • If no liquid comes out of your pen,

    If you have injected yourself before activating the pen, do not correct this by giving yourself a second injection. Contact your healthcare provider for advice on checking your blood sugar.



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