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Adlyxin

Generic name: lixisenatide

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 for use in people with type 1 diabetes.
  • Adlyxin has not been studied in people with a history of pancreatitis.
  • 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.

What is the most important information I should know about Adlyxin?

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.

Who should not use Adlyxin?

Do not use Adlyxin if you:

Symptoms of a severe allergic reaction with Adlyxin may include:

  • swelling of your face, lips, tongue, or throat
  • problems breathing or swallowing
  • severe rash or itching
  • fainting or feeling dizzy
  • very rapid heartbeat

What should I tell my healthcare provider before using Adlyxin?

Before using Adlyxin, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had pancreatitis, stones in your gallbladder, or a history of alcoholism.
  • have or have had kidney problems.
  • have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
  • are pregnant or plan to become pregnant. It is not known if Adlyxin will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using Adlyxin.
  • are breastfeeding or plan to breastfeed. It is not known if Adlyxin passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you use Adlyxin.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially tell your healthcare provider if you take:

  • antibiotics or the pain reliever acetaminophen. Take these medicines at least 1 hour before using Adlyxin. If you must take these medicines, take them with a meal or a snack. You should not take these medicines at the same time that you take Adlyxin.
  • birth control pills that are taken by mouth (oral contraceptives). Adlyxin may lower the amount of the medicine in your blood from your birth control pills and they may not work as well to prevent pregnancy. Take your birth control pill at least 1 hour before your injection of Adlyxin or at least 11 hours after your Adlyxin injection.
  • other anti-diabetes medicines, especially sulfonylurea medicines or insulin.

Ask your healthcare provider if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use Adlyxin?

  • Read the detailed Instructions for Use that 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.

What are the possible side effects of Adlyxin?

Adlyxin may cause serious side effects including:

  • See "What is the most important information I should know about Adlyxin?"
  • Severe allergic reactions. Severe allergic reactions can happen with Adlyxin. Stop taking Adlyxin and get medical help right away if you have any symptoms of a severe allergic reaction. See "Who should not use Adlyxin?"
  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you use Adlyxin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine may need to be lowered while you use Adlyxin. Signs and symptoms of low blood sugar include:
    • headache
    • drowsiness
    • weakness
    • hunger
    • fast heartbeat
    • dizziness
    • confusion
    • irritability
    • sweating
    • feeling jittery

      Talk with your healthcare provider about how to treat low blood sugar.
  • Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
  • Gallbladder problems. Gallbladder problems have happened in some people who take Adlyxin. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:
  • pain in your upper stomach (abdomen)
  • fever
  • yellowing of skin or eyes (jaundice)
  • clay-colored stools

The most common side effects of Adlyxin include:

  • nausea
  • vomiting
  • headache
  • diarrhea
  • feeling dizzy

These are not all the possible side effects of Adlyxin. 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 Adlyxin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adlyxin for a condition for which it was not prescribed. Do not give Adlyxin to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Adlyxin that is written for health professionals.

How should I store Adlyxin?

  • 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.
  • See the Instructions for Use that come with Adlyxin about the right way to throw away the Adlyxin pen.

Keep your Adlyxin pen, pen needles, and all medicines out of the reach of children.

What are the ingredients in Adlyxin?

Active ingredient: lixisenatide

Inactive ingredients: glycerol 85%, metacresol, methionine, sodium acetate trihydrate, and Water for Injection, USP. Hydrochloric acid and sodium hydroxide solution are added as needed to adjust the pH.

For more information, go to www. ADLYXIN.com or call sanofi-aventis at 1-800-633-1610.

Instructions for use for Adlyxin

Adlyxin Starter Pack Instructions

Adlyxin (ad-LIX-in)
(lixisenatide)
Injection, for subcutaneous use

Starter pack - Contains 2 prefilled pens each with 14 doses.

One 10 microgram (mcg) pen, each dose contains 10 mcg in 0.2 mL.

One 20 microgram (mcg) pen, each dose contains 20 mcg in 0.2 mL.

Section 1 – Important Information

Read these instructions carefully before using your Adlyxin pens.

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 single-patient-use prefilled 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 Starter Pack

The Adlyxin Starter pack includes 2 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 mcg of Adlyxin.
  • The burgundy pen contains 14 pre-set doses. Each dose contains 20 mcg of Adlyxin.

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

About Your Adlyxin Pens

  • Green 10 mcg Adlyxin pen

Image of the Adlyxin 10 mcg green pen in starter pack.

Black plunger in green 10 mcg Adlyxin Pen moves along the dose scale as shown.

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.

  • Burgundy 20 mcg Adlyxin pen

Image of a Burgundy 20 mcg Adlyxin Pen.

  • 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 your pen needles (supplied separately)

Adlyxin pen needle parts.

  • 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

  • Begin with the green 10 mcg Adlyxin pen.
  • Do not activate the burgundy 20 mcg Adlyxin pen until you have finished the green 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."Step 1 to Step 5 below 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 repeat the 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)
Orange showing in activation window meaning that pen is not activated.
The pen is not activated when the activation window is orange. The pen must be activated before injecting your first dose of Adlyxin.
After activation (white window)
White showing in activation window of Adlyxin pen meaning that it is activated and ready for use.
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

Pull the cap off your Adlyxin pen and check the pen.

Step 2. Screw needle on and remove needle caps

Screw the needle on to your Adlyxin pen and pull off the needle cap.

  • Always use a new needle for 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.

Pull off outer needle cap and keep for later, then pull off inner needle cap and throw away.

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

Step 3. Pull the injection button out

Pull out injection button. The arrow in the window on your Adlyxin pen will be pointing towards the button.

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

Pull the injection button out firmly until it stops.

Once the injection button is fully pulled out the arrow in the window will point towards the needle.

The arrow will now be pointing towards the needle.

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

Press down firmly on the injection button and hold.

A click sound will be heard.

Keep holding the button down for a further 2 seconds to remove the liquid.

  • Do not inject into the body.
  • Point the needle into a container (like a paper cup or tissue).
  • Firmly press the injection button all the way in to discard the liquid. You may feel or hear a "click."
  • Keep the injection button pressed in and slowly count to 2, which is equal to 2 seconds.
  • If no liquid comes out of your pen, see the QUESTIONS AND ANSWERS section at the end of this Instructions for Use.
  • Check that the activation window is now white.

Step 5. The pen is now ready for use.

  • Do not activate this pen again.

For your first injection, go directly to Section 3 – Step 3.

  • You do not need to replace the needle between activation and first injection if you inject yourself immediately after activation.

Section 3 – Daily use of pen

Inject only 1 dose each day.

Check to make sure the activation window is white before continuing in this section.

White activation window on Adlyxin pen means its activated.

Step 1. Pull off pen cap and check pen

Pull the cap off your Adlyxin pen and check the pen.

Step 2. Attach a new needle and remove the needle caps

Screw the needle on to your Adlyxin pen and pull off the needle cap.

  • Always use a new needle for each injection.
  • Remove the protective seal from the outer needle cap.
  • Line up the needle with the pen. Put the outer needle cap containing the needle straight on the pen, then screw the needle on until secure.

Pull off outer needle cap and keep for later, then pull off inner needle cap and throw away.

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

Step 3. Pull the injection button out

Pull out injection button. The arrow in the window on your Adlyxin pen will be pointing towards the button.

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

Pull the injection button out firmly until it stops.

Once the injection button is fully pulled out the arrow in the window will point towards the needle.

The arrow will now be pointing towards the needle.

Step 4. Choosing Injection Sites

Injection sites

Adlyxin injection sites on body image.

Adlyxin must be injected under the skin and can be injected in any of the areas shown above in blue. These areas include the thigh, abdomen, or upper arm. Ask your healthcare provider about how to inject correctly.

Step 5. Press and hold the injection button to inject the dose

Grasp a fold of skin and insert the needle while pressing and holding the injection button of your Adlyxin pen.

Press and hold the injection button until you here your Adlyxin pen click.

Press and hold the injection button for a further 2 seconds.

  • Grasp a fold of skin and insert the needle (see the INJECTION SITES section about where to inject).
  • Press the injection button all the way in. You may feel or hear a "click."
  • Keep the injection button pressed in, hold the pen in place and slowly count to 2, which is equal to 2 seconds, before you pull the needle out of the skin.

If you do not hold the injection button in or if you remove the injector too early you may not get the full dose.

Your dose has now been given. Pull the needle out of your skin.

Step 6. Remove and throw away needle after each injection

  • 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.

Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap.

  • 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.

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

  • Replace the pen cap.

Replace the pen on your Adlyxin pen.

  • Put the needle in a puncture-resistant container (or as instructed by your healthcare provider).

Step 7. Repeat all steps in Section 3 for each injection.

Throw away a pen 14 days after activation, even if there is some medicine left.

After the green pen is thrown away continue to Section 4 to begin using the burgundy pen.

Section 4 – Moving to the burgundy pen

Completed use of the green 10 mcg pen

The green 10 mcg ADLYXIN pen is empty when the black plunger has reached "0" on the dose scale and the injection button cannot be pulled out fully.

The green 10 mcg Adlyxin pen is empty when the black plunger has reached "0" on the dose scale and the injection button cannot be pulled out fully.

After the green 10 mcg Adlyxin pen is empty you must continue your treatment the next day using the burgundy 20 mcg Adlyxin pen. This is used in exactly the same way.

Use of burgundy 20 mcg pen

Image of the burgundy 20 mcg Adlyxin pen.

Burgundy 20 mcg pen activation

The burgundy 20 mcg Adlyxin pen must also be activated before use. Follow all steps in Section 2.

Burgundy 20 mcg pen use

To inject a dose with the burgundy 20 mcg Adlyxin pen, follow all steps in Section 3. Repeat Section 3 for your daily injections until your pen is empty.

Table of activation and disposal

In the table write the date when you activated your pen and the date to throw it away 14 days later.

Pen Date of activation Date to throw away
10 mcg ___ / ___ / ___ ___ / ___ / ___
20 mcg ___ / ___ / ___ ___ / ___ / ___

Storage

General information

  • Keep your Adlyxin pens in a safe place out of the reach and sight of children.
  • Protect your Adlyxin pens from dust and dirt.
  • Replace the pen cap after each use in order to protect the container window from light.
  • Protect the Adlyxin pen from light.
  • Do not use Adlyxin after the expiration date, which is stated on the label and on the carton. The expiration date refers to the last day of that month.

Before activation of the pen:

  • Store your unused Adlyxin pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze Adlyxin pens and do not use Adlyxin if it has been frozen.
  • Allow your pen to warm at room temperature before using.

After activation of the pen:

  • After activation, store your Adlyxin pen at room temperature no higher than 86°F (30°C).
  • Do not store your Adlyxin pen with the needle attached. An attached needle might lead to contamination and may cause air bubbles which might affect your dose of medicine.
  • After your Adlyxin pen is activated it can be used for up to 14 days. Throw away a used Adlyxin pen after 14 days. Do this even if there is some medicine left in the pen.

Throwing your pen away

  • Replace the pen cap before throwing away (disposing of) your Adlyxin pen.
  • Put the used Adlyxin pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the Adlyxin pen and loose needles in your household trash.
  • If you do not have an 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: 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.

Maintenance

  • Handle your Adlyxin pen with care.
  • You can clean the outside of your Adlyxin pen by wiping it with a damp cloth.
  • Do not soak, wash, or put liquid on (lubricate) your Adlyxin pen. This may damage it.
  • If you think your Adlyxin pen may be damaged, do not use it. Get a new one. Do not try to repair the pen.

Questions and Answers

What do I do if I forget to activate the Adlyxin pen or inject myself before activation?

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 needle, and repeat Step 4 and Step 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 Step 5 and Step 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.

Instructions for use revised 07/2021.

Adlyxin Pen 20 mcg

Adlyxin(ad-LIX-in)
(lixisenatide)
Injection, for subcutaneous use

One pre-filled pen contains 14 doses, each dose contains 20 micrograms (mcg) in 0.2 mL.

Section 1 – Important Information

Read these instructions carefully before using your Adlyxin pens.

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 single-patient-use prefilled 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 Pens

  • Burgundy 20 mcg Adlyxin pen

Image of the Adlyxin 20 mcg burgundy pen

Black plunger in burgundy 20 mcg Adlyxin Pen moves along the dose scale as shown.

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 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 your pen needles (supplied separately)

Adlyxin pen needle parts.

  • 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."Step 1 to Step 5 below 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 repeat the 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)
Orange showing in activation window meaning that pen is not activated.
The pen is not activated when the activation window is orange. The pen must be activated before injecting your first dose of Adlyxin.
After activation (white window)
White showing in activation window of Adlyxin pen meaning that it is activated and ready for use.
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

Pull the cap off your Adlyxin pen and check the pen.

Step 2. Screw needle on and remove needle caps

Screw the needle on to your Adlyxin pen and pull off the needle cap.

  • Always use a new needle for 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.

Pull off outer needle cap and keep for later, then pull off inner needle cap and throw away.

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

Step 3. Pull the injection button out

Pull out injection button. The arrow in the window on your Adlyxin pen will be pointing towards the button.

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

Pull the injection button out firmly until it stops.

Once the injection button is fully pulled out the arrow in the window will point towards the needle.

The arrow will now be pointing towards the needle.

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

Press down firmly on the injection button and hold.

A click sound will be heard.

Keep holding the button down for a further 2 seconds to remove the liquid.

  • Do not inject into the body.
  • Point the needle into a container (like a paper cup or tissue).
  • Firmly press the injection button all the way in to discard the liquid. You may feel or hear a "click."
  • Keep the injection button pressed in and slowly count to 2, which is equal to 2 seconds.
  • If no liquid comes out of your pen, see the QUESTIONS AND ANSWERS section at the end of this Instructions for Use.
  • Check that the activation window is now white.

Step 5. The pen is now ready for use.

  • Do not activate this pen again.

For your first injection, go directly to Section 3 – Step 3.

  • You do not need to replace the needle between activation and first injection if you inject yourself immediately after activation.

Section 3 – Daily use of pen

Inject only 1 dose each day.

Check to make sure the activation window is white before continuing in this section.

White activation window on Adlyxin pen means its activated.

Step 1. Pull off pen cap and check pen

Pull the cap off your Adlyxin pen and check the pen.

Step 2. Attach a new needle and remove the needle caps

Screw the needle on to your Adlyxin pen and pull off the needle cap.

  • Always use a new needle for each injection.
  • Remove the protective seal from the outer needle cap.
  • Line up the needle with the pen. Put the outer needle cap containing the needle straight on the pen, then screw the needle on until secure.

Pull off outer needle cap and keep for later, then pull off inner needle cap and throw away.

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

Step 3. Pull the injection button out

Pull out injection button. The arrow in the window on your Adlyxin pen will be pointing towards the button.

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

Pull the injection button out firmly until it stops.

Once the injection button is fully pulled out the arrow in the window will point towards the needle.

The arrow will now be pointing towards the needle.

Step 4. Choosing Injection Sites

Injection sites

Adlyxin injection sites on body image.

Adlyxin must be injected under the skin and can be injected in any of the areas shown above in blue. These areas include the thigh, abdomen, or upper arm. Ask your healthcare provider about how to inject correctly.

Step 5. Press and hold the injection button to inject the dose

Grasp a fold of skin and insert the needle while pressing and holding the injection button of your Adlyxin pen.

Press and hold the injection button until you here your Adlyxin pen click.

Press and hold the injection button for a further 2 seconds.

  • Grasp a fold of skin and insert the needle (see the INJECTION SITES section about where to inject).
  • Press the injection button all the way in. You may feel or hear a "click."
  • Keep the injection button pressed in, hold the pen in place and slowly count to 2, which is equal to 2 seconds, before you pull the needle out of the skin.

If you do not hold the injection button in or if you remove the injector too early you may not get the full dose.

Your dose has now been given. Pull the needle out of your skin.

Step 6. Remove and throw away needle after each injection

  • 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.

Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap.

  • 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.

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

  • Replace the pen cap.

Replace the pen on your Adlyxin pen.

  • Put the needle in a puncture-resistant container (or as instructed by your healthcare provider).

Step 7. Repeat all steps in Section 3 for each injection.

Throw away a pen 14 days after activation, even if there is some medicine left.

Table of activation and disposal

In the table write the date when you activated your pen and the date to throw it away 14 days later.

Pen Date of activation Date to throw away
1
2
3
4
5
6

Storage

General information

  • Keep your Adlyxin pens in a safe place out of the reach and sight of children.
  • Protect your Adlyxin pens from dust and dirt.
  • Replace the pen cap after each use in order to protect the container window from light.
  • Protect the Adlyxin pen from light.
  • Do not use Adlyxin after the expiration date, which is stated on the label and on the carton. The expiration date refers to the last day of that month.

Before activation of the pen:

  • Store your unused Adlyxin pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze Adlyxin pens and do not use Adlyxin if it has been frozen.
  • Allow your pen to warm at room temperature before using.

After activation of the pen:

  • After activation, store your Adlyxin pen at room temperature no higher than 86°F (30°C).
  • Do not store your Adlyxin pen with the needle attached. An attached needle might lead to contamination and may cause air bubbles which might affect your dose of medicine.
  • After your Adlyxin pen is activated it can be used for up to 14 days. Throw away a used Adlyxin pen after 14 days. Do this even if there is some medicine left in the pen.

Throwing your pen away

  • Replace the pen cap before throwing away (disposing of) your Adlyxin pen.
  • Put the used Adlyxin pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the Adlyxin pen and loose needles in your household trash.
  • If you do not have an 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: 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.

Maintenance

  • Handle your Adlyxin pen with care.
  • You can clean the outside of your Adlyxin pen by wiping it with a damp cloth.
  • Do not soak, wash, or put liquid on (lubricate) your Adlyxin pen. This may damage it.
  • If you think your Adlyxin pen may be damaged, do not use it. Get a new one. Do not try to repair the pen.

Questions and Answers

What do I do if I forget to activate the Adlyxin pen or inject myself before activation?

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 needle, and repeat Step 4 and Step 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 Step 5 and Step 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.

Instructions for use revised 07/2021.

Source: Food and Drug Administration (FDA). Last updated June 10, 2022.