Soliqua Patient Counseling Information

Soliqua Solostar 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen (30-60).
Instructions for Use: Soliqua Solostar (30-60) pen contains insulin glargine and lixisenatide. The combination of medicinal products in this pen is for the daily injection of 30 to 60 dose steps of Soliqua.
Never re-use needles. If you do, you might not get your full dose (under dosing) or get too much (overdosing) as the needle could block.
Never use a syringe to remove medicine from your pen. If you do, you may not get the correct amount of medicine.
Important information: Never share your pen - it is only for you.
Never use your pen if it is damaged or if you are not sure that it is working properly.
Always perform a safety test. See STEP 3.
Always carry a spare pen and spare needles in case they get lost or stop working.
Always check the label of the pen before use to make sure you have the correct pen.
Learn to inject: Talk with your healthcare provider about how to inject, before using your pen.
Ask for help if you have problems handling the pen, for example if you have problems with your sight.
Read all of these instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little medicine.
Need help? If you have any questions about Soliqua, the pen or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number.
Extra items you will need: a new sterile needle (see STEP 2).
a sharps container for used needles and pens. (see Throwing your pen away).
Places to inject: Upper arms; Stomach; Thighs.
STEP 1: Check your pen: Take a new pen out of the refrigerator at least 1 hour before you inject. Injecting cold medication is more painful.
A. Check the name and expiry date on the label of your pen.
Make sure you have the correct medicine. This pen is olive coloured with an brown injection button.
Do not use this pen if you need a daily dose less than 30 dose steps or if you need more than 60 dose steps. Discuss with your doctor which pen is suitable for your needs.
Do not use your pen after the expiry date.
B. Pull off the pen cap.
C. Check that the medicine is clear.
Do not use the pen if the medicine looks cloudy, coloured or contains particles.
STEP 2: Attach a new needle: Do not reuse needles. Always use a new sterile needle for each injection. This helps stop blocked needles, contamination, and infection.
Always use needles that are compatible for use with Soliqua pen.
A. Take a new needle and peel off the protective seal.
B. Keep the needle straight and screw it onto the pen until fixed. Do not over-tighten.
C. Pull off the outer needle cap. Keep this for later.
D. Pull off the inner needle cap and throw away.
Handling needles: Take care when handling needles to prevent needle injury and cross-infection.
STEP 3: Do a safety test: Always do a safety test before each injection to: Check your pen and the needle to make sure they are working properly.
Make sure that you get the correct dose.
A. Select 2 dose steps by turning the dose selector until the dose pointer is at the 2 mark.
B. Press the injection button all the way in.
When medicine comes out of the needle tip, your pen is working correctly, the dose selector will be reset to "0".
If no liquid appears: You may need to repeat this step up to 3 times before seeing medicine.
If no medicine comes out after the third time, the needle may be blocked. If this happens: change the needle (see STEP 6 and STEP 2), then repeat the safety test (STEP 3).
Do not use your pen if there is still no medicine coming out of the needle tip. Use a new pen.
Do not use a syringe to remove medicine from your pen.
If you see air bubbles: You may see air bubbles in the medicine. This is normal, they will not harm you.
STEP 4: Select the dose: Only use this pen to inject single daily doses from 30 to 60 dose steps.
Do not select a dose or press the injection button without a needle attached. This may damage your pen.
A. Make sure a needle is attached and the dose is set to '0'.
B. Turn the dose selector until the dose pointer lines up with your dose.
If you turn past your dose, you can turn back down.
If there are not enough dose steps left in your pen for your dose, the dose selector will stop at the number of dose steps left.
If you cannot select your full prescribed dose, use a new pen or inject the remaining dose steps and use a new pen to complete your dose. Only in this case, it is okay to inject a partial dose of less than 30 dose steps. Always use another Soliqua (30-60) pen to complete your dose and no other pen.
How to read the dose window: Do not use the pen if your single daily dose is less than 30 dose steps, shown as white numbers on a black background.
Units of medicine in your pen: Your pen contains a total of 300 dose steps. You can select your dose in steps of 1 dose step.
Do not use this pen if you need a single daily dose that is less than 30 dose steps, or more than 60 dose steps.
Each pen contains more than 1 dose.
STEP 5: Inject the dose: If you find it hard to press the injection button in, do not force it as this may break your pen.
Change the needle (see STEP 6 Remove the needle and STEP 2 Attach a new needle) then do a safety test (see STEP 3).
If you still find it hard to press in, get a new pen.
Do not use a syringe to remove medicine from your pen.
A. Choose a place to inject.
B. Push the needle into your skin as shown by your healthcare provider.
Do not touch the injection button yet.
C. Place your thumb on the injection button. Then press all the way in and hold.
Do not press at an angle. Your thumb could block the dose selector from turning.
D. 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.
E. After holding and slowly counting to 10, release the injection button. Then remove the needle from your skin.
STEP 6: Remove the needle: Take care when handling needles to prevent needle injury and cross-infection.
Do not put the inner needle cap back on.
A. 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.
B. 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.
C. Throw away the used needle in a puncture resistant container (see "Throwing your pen away" as follows).
D. Put your pen cap back on.
Do not put the pen back in the refrigerator.
How to store your pen: Before first use: Keep new pens in the refrigerator between 2°C to 8°C.
Do not freeze.
After first use: Keep your pen at room temperature, below 25°C.
Do not put your pen back in the refrigerator.
Do not store your pen with the needle attached.
Store the pen with your pen cap on.
Only use your pen for up to 28 days after its first use.
How to care for your pen: Handle your pen with care: If you think that your pen may be damaged, do not try to fix it. Use a new one.
Protect your pen from dust and dirt: You can clean the outside of your pen by wiping it with a damp cloth (water only).
Do not soak, wash or lubricate the pen. This may damage it.
Throwing your pen away: Remove the needle before throwing your pen away.
Throw away your used pen as instructed by your pharmacist or local authority.