EHS
EHS

DailyMed – ADLYXIN- lixisenatide kit ADLYXIN- lixisenatide injection, solution


INSTRUCTIONS FOR USE
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.

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 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

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.

Burgundy 20 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 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

  • 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.

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 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.

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

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 the injection button to remove the liquid

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.

Figure

Step 1. Pull off pen cap and check pen

Figure

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

Figure

  • 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.

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

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. Choosing Injection Sites

Injection sites

Figure

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

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.

Figure

  • 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.

Figure

Figure

  • 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

Figure

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

Figure

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.

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.

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

©2021 sanofi-aventis U.S. LLC

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.

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

Revised: July 2021



Source link

EHS
Back to top button