Soliqua Patient Counseling Information

Hyperglycaemia and Hypoglycaemia: If you use insulin, you should always carry the following things with you: Foods containing sugar, such as dextrose tablets or a sugary drink (at least 20 grams).
Information so that others know you have diabetes.
Hyperglycaemia (high blood sugar levels): If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Reasons why hyperglycaemia may happen: Examples include: You have not injected your Soliqua or not injected enough.
Your medicine has become less effective - for example because it was not stored properly.
Your pen does not work properly.
You are doing less exercise than usual.
You are under stress - such as emotional distress or excitement.
You have an injury, infection or fever or have had an operation.
You are taking or have taken certain other medicines (see "Other medicines and Soliqua" under the Package leaflet).
Warning signs of hyperglycaemia: Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and urine test showing glucose and ketone bodies. Stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
What to do if you experience hyperglycaemia: Test your blood sugar level and, if it is high, as agreed with your doctor or nurse, test your urine for ketones as soon as you notice any of the above signs.
Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis. This must always be treated by a doctor, normally in a hospital.
Hypoglycaemia (low blood sugar levels): If your blood sugar level falls too much you may pass out (become unconscious). Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You should learn to recognise the signs when your blood sugar is falling - so you can take action to stop it getting worse.
Reasons why hypoglycaemia may happen: Examples include: You inject too much Soliqua.
You miss meals or delay them.
You do not eat enough, or eat food containing less carbohydrates than normal - artificial sweeteners are not carbohydrates.
You drink alcohol - especially when you have not eaten much.
You lose carbohydrates from being sick (vomiting) or diarrhoea.
You are doing more exercise than usual or a different type of physical activity.
You are recovering from an injury, operation or other stress.
You are recovering from an illness or from fever.
You are taking or have stopped taking certain other medicines (see "Other medicines and Soliqua" under the Package leaflet).
Hypoglycaemia is also more likely to happen if: You have just started Soliqua treatment - if low blood sugar occurs, it may be more likely to happen in the morning.
Your blood sugar levels are almost normal or are unstable.
You change the area where you inject Soliqua. For example from the thigh to the upper arm.
You have severe kidney or liver disease, or some other disease such as hypothyroidism.
Warning signs of hypoglycaemia: The first signs may be in your body generally. Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heartbeat, high blood pressure and palpitations. These signs often develop before the signs of a low sugar level in the brain.
Other signs include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.
When the signs of hypoglycaemia may be less clear: The first warning signs of hypoglycaemia may change, be weaker or missing altogether if: You are elderly.
You have had diabetes for a long time.
You have a certain type of nerve damage (called "diabetic autonomic neuropathy").
You have recently had too low blood sugar (for example the day before).
Your low blood sugar comes on slowly.
Your low blood sugar is always around "normal" or your diabetes control has greatly improved recently.
You have recently changed from animal insulin to a manufactured insulin, like there is in Soliqua.
You are taking or have taken certain other medicines (see "Other medicines and Soliqua" under the Package leaflet).
In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening. Be familiar with your warning signs. If necessary, you might need to test your blood sugar more often. This can help to spot mild hypoglycaemic episodes. If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
What to do if you experience hypoglycaemia: 1. Do not inject Soliqua. Take about 15 to 20 grams sugar straight away - such as glucose, sugar cubes or a sugary drink. Drink or eat foods that contain artificial sweeteners (such as diet drinks) do not help treat low blood sugar.
2. You might then need to eat something (such as bread or pasta) that will raise your blood sugar over a longer time, especially if your next meal is not due. Ask your doctor or nurse if you are not sure which foods you should eat.
With Soliqua, it may take longer to recover from low blood sugar because it contains along-acting insulin (insulin glargine).
3. Test your blood glucose levels after 10-15 minutes after taking sugar. If blood glucose levels are still too low (<4 mmol/L) or hypoglycaemia comes back take another 15 to 20 grams of sugar.
4. Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes back again.
What other people should do if you have hypoglycaemia: Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to swallow or if you pass out (become unconscious).
You will require glucose or glucagon (a medicine which increases blood sugar) and it should be given even if it is not certain that you have hypoglycaemia.
You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia.
Instructions for Use: Read the Package Leaflet and these Instructions for Use before first use of Soliqua.
Soliqua 100 units/mL + 33 micrograms/mL solution for injection in a pre-filled pen (30-60): Soliqua (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 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.
Keep these Instructions For Use for future reference.
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 as follows).
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 doctor or pharmacist or nurse 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.
Additional items you will need: A new sterile needle (see STEP 2 as follows).
A sharps container for used needles. (see Throwing your pen away as follows).
STEP 1: Check your pen: For first use of a new pen take it out of the refrigerator at least 1 hour before you inject. Injecting cold medicine is more painful. After first use the pen will be stored at temperatures below 25°C.
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 a 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.
Look at the transparent cartridge holder. 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.
If you try to put it back on, you may accidentally stick yourself with the needle.
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: Use this pen only 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) Solostar pen to complete your dose and no other pen.
How to read the dose window: Even numbers are presented in line with the dose pointer and odd numbers are presented as a line between even numbers.
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. Discuss with your doctor which pen is suitable for your needs.
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 doctor or pharmacist or nurse.
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" at the end of this Instructions for Use).
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.
Soliqua 100 units/mL + 50 micrograms/mL solution for injection in a pre-filled pen (10-40): Soliqua (10-40) pen contains insulin glargine and lixisenatide. The combination of medicinal products in this pen is for the daily injection of 10 to 40 dose steps of Soliqua.
Never re-use needles. If you do, you might not get your full dose (underdosing) 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.
Keep these Instructions For Use for future reference.
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 as follows).
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 doctor or pharmacist or nurse 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.
Additional items you will need: A new sterile needle (see STEP 2 as follows).
A sharps container for used needles. (see Throwing your pen away as follows).
STEP 1: Check your pen: For first use of a new pen, take it out of the refrigerator at least 1 hour before you inject. Injecting cold medicine is more painful. After first use the pen will be stored at temperatures below 25°C.
A. Check the name and expiry date on the label of your pen.
Make sure you have the correct medicine. This pen is peach coloured with an orange injection button.
Do not use this pen if you need a daily dose less than 10 dose steps or if you need more than 40 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.
Look at the transparent cartridge holder. 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.
If you try to put it back on, you may accidentally stick yourself with the needle.
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: Use this pen only to inject single daily doses from 10 to 40 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 10 dose steps. Always use another Soliqua (10-40) Solostar pen to complete your dose and no other pen.
How to read the dose window: Even numbers are presented in line with the dose pointer and odd numbers are presented as a line between even numbers.
29 units selected: Do not use the pen if your single daily dose is less than 10 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 10 dose steps, or more than 40 dose steps. Discuss with your doctor which pen is suitable for your needs.
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 doctor or pharmacist or nurse.
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" at the end of this Instructions for Use).
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.