SOLIQUA™ 100/33 Prescribing Information
(insulin glargine and lixisenatide injection), for subcutaneous use Rx only

Instructions for Use
SOLIQUA™ 100/33 (So - lee - kwa)
(insulin glargine and lixisenatide injection) for subcutaneous use

Read these instructions carefully before using your SOLIQUA™ 100/33 pen.

Do not share your SOLIQUA 100/33 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.

SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide in a SoloStar® pen. The drug combination in this pen is only for the daily injection of 15 to 60 units of SOLIQUA 100/33. Each unit dialed contains 1 unit insulin glargine and 0.33 mcg lixisenatide.

Important information

Learn to inject

Need help?

If you have any questions about your pen or about diabetes, ask your healthcare provider, go to www.soliqua100-33.com or call sanofi-aventis at 1-800-633-1610.

Supplies you will need:

Places to inject

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Get to know your pen

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Step 1: Check your pen

Take a new pen out of the refrigerator at least 1 hour before you inject. Cold medicine is more painful to inject.

1A
 Check the name and expiration date on the label of your pen.
  • Make sure you have the correct medicine. This pen is colored light green with an orange injection button (see the "Get to know your pen" diagram).
  • Do not use your pen after the expiration date on the pen label.

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1B
 Pull off the pen cap.

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1C
 Check that the medicine is clear and to almost colorless.
  • If you see small particles, return it to your pharmacy for a replacement

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1D
 Wipe the rubber seal with an alcohol swab.

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If you have other injector pens

Step 2: Attach a new needle

2A
 Take a new needle and peel off the protective seal.

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2B
 Keep the needle straight and screw it onto the pen until fixed. Do not over-tighten.

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2C
 Pull off the outer needle cap. Keep this for later.

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2D
 Pull off the inner needle cap and throw it away.

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Handling needles

Step 3: Do a safety test

Perform a safety test before each injection to:

3A
 Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.

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3B
 Press the injection button all the way in.
  • When the medicine comes out of the needle tip, your pen is working correctly.

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If no liquid appears:

If you see air bubbles

Step 4: Select the dose

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4A
 Make sure a needle is attached and the dose is set to '0'.

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4B
 Turn the dose selector until the dose pointer lines up with your dose.
  • Do not dial your dose by counting the clicks, because you might dial the wrong dose. Always check the number in the dose window to make sure you dialed the correct dose.
  • If you turn past your dose, you can turn back down.
  • If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
  • If you cannot select your full prescribed dose, use a new pen.

How to read the dose window

image30 units selected

image29 units selected

Units of medicine in your pen

STEP 5: Inject your dose

If you find it hard to press the injection button in, do not force it as this may break your pen. See the section after Step 5E below for help.

5A
 Choose a place to inject as shown in the picture labeled "Places to inject."
5B
 Push the needle into your skin as shown by your healthcare provider.
  • Do not touch the injection button yet.

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5C
 Place your thumb on the injection button. Then press all the way in and hold.
  • Do not press injection button at an angle. Your thumb could block the dose selector from turning.

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5D
 Keep the injection button held in and when you see "0" in the dose window, slowly count to 10.
  • This will make sure you get your full dose.

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5E
 After holding and slowly counting to 10, release the injection button. Then remove the needle from your skin.

If you find it hard to press the injection button in:

STEP 6: Remove the needle

6A
 Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap back. Then push firmly on.
  • The needle can puncture the cap if it is recapped at an angle.

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6B
 Grip and squeeze the widest part of the outer needle cap. Turn your pen several times with your other hand to remove the needle.
  • Try again if the needle does not come off the first time.

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6C
 Throw away the used needle in a puncture-resistant container (see "Throwing your pen away" at the end of these Instructions for Use).

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6D
 Put your pen cap back on.
  • Do not put the pen back in the refrigerator.

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Use by

How to store your pen

Before first use

After first use

Keep this pen out of the sight and reach of children.

How to care for your pen

Handle your pen with care

Protect your pen from dust and dirt

Throwing your pen away

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

©2016 sanofi-aventis U.S. LLC

SOLIQUA and SoloStar are trademarks of sanofi-aventis U.S. LLC.

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

Approved: November 2016

GLX-WIFU-WPLR-NOV16