LYXUMIA 10 micrograms + 20 micrograms Injectable Solution

Introduction

Package Leaflet: Information for the User

Lyxumia 10micrograms solution for injection

Lyxumia 20micrograms solution for injection

Lixisenatide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Lyxumia and what is it used for
2. What you need to know before you use Lyxumia
3. How to use Lyxumia
4. Possible side effects
5. Storage of Lyxumia
6. Contents of the pack and further information

1. What is Lyxumia and what is it used for

Lyxumia contains the active substance lixisenatide.

It is an injectable medicine used to help your body control your blood sugar levels when they are too high. It is prescribed for adult patients with type 2 diabetes.

Lyxumia is used together with other diabetes medicines when your blood sugar levels are not adequately controlled with:

• oral anti-diabetics (such as metformin, pioglitazone, sulfonylureas) and/or,
• a basal insulin, a type of insulin that acts throughout the day.

2. What you need to know before you use Lyxumia

Do not use Lyxumia if

• you are allergic to lixisenatide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Lyxumia if:

• you have type 1 diabetes or "diabetic ketoacidosis" (a complication of diabetes that occurs when your body cannot break down glucose because there is not enough insulin), as this medicine is not suitable for you.

• you have or have ever had pancreatitis (inflammation of the pancreas),

• you have a severe intestinal or stomach problem, such as a disease of the stomach muscles called "gastroparesis" that leads to delayed gastric emptying,

• you have severe kidney disease or are on dialysis, as the use of this medicine is not recommended,

• you are also taking a sulfonylurea or a basal insulin. This is because you may have low blood sugar (hypoglycemia). Your doctor may want to check your blood sugar levels and then decide to reduce your dose of basal insulin or sulfonylurea. Lyxumia must not be used with the combination of both, a basal insulin and a sulfonylurea.

• you are taking other medicines, as there are other medicines such as antibiotics or gastro-resistant tablets or capsules that should not stay in the stomach for too long (see section "Using Lyxumia with other medicines").

• you experience fluid loss/dehydration; for example, in case of vomiting, nausea, and diarrhea. It is important that you drink a lot of fluids to avoid dehydration, especially when starting treatment with Lyxumia.

• you have heart problems that can cause you to have difficulty breathing or swelling in your ankles, as there is limited experience in this population.

Children and adolescents

There is no experience with Lyxumia in children and adolescents under 18 years of age, and therefore, the use of Lyxumia is not recommended in this age group.

Using Lyxumia with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

The effect of some medicines you take may be affected by Lyxumia. It may be necessary for some medicines, such as antibiotics or gastro-resistant tablets or capsules that should not stay in your stomach for too long, to be taken at least one hour before or 4 hours after the injection of Lyxumia.

Pregnancy and breastfeeding

Lyxumia must not be used during pregnancy. It is not known if Lyxumia could harm the fetus.

Lyxumia must not be used during breastfeeding. It is not known if Lyxumia passes into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

If you use Lyxumia with a sulfonylurea or a basal insulin, you may have low blood sugar (hypoglycemia). This could make it difficult to concentrate and you may feel dizzy or drowsy. If this happens, do not drive or use tools or machines.

Important information about some of the ingredients of Lyxumia

This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it is essentially "sodium-free".

This medicine contains metacresol, which may cause allergic reactions.

3. How to use Lyxumia

Follow exactly the administration instructions for this medicine given by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse again.

How much to inject

• The starting dose is 10 micrograms once a day for the first 14 days (injected using the greenpen).
• After that, the dose will be 20 micrograms once a day (using the purplepen).

When to inject

Inject Lyxumia within the hour before any meal of the day. It is preferable to inject Lyxumia before the same meal every day, once you have chosen the most suitable meal for your injection.

Where to inject

Inject Lyxumia into the skin (subcutaneously) of your stomach (abdomen), the top of your leg (thigh), or the top of your arm.

Learning to use the pre-filled pens

Before using the pen for the first time, your doctor or nurse will show you how to inject Lyxumia.

• Always read the "Instructions for Use" that come with the pack.
• Always use the pen as described in the "Instructions for Use".

Other important information about using the pre-filled pens

You can find more information about using the pens in the "Instructions for Use". The key points are:

• Always use a new needle for each injection. The needle should be discarded after each use in a suitable container for sharp objects, following local recommendations. Talk to your doctor, nurse, or pharmacist about how to dispose of the needles.
• Only use needles compatible with the Lyxumia pen (see "Instructions for Use").
• You must activate the Lyxumia pen before using it for the first time.This is to ensure that it works correctly and that the dose of the first injection is correct.
• If you think the Lyxumia pen may be damaged, do not use it. Get a new one. Do not try to repair the pen.

If you use more Lyxumia than you should

If you use more Lyxumia than you should, call your doctor immediately. Too much Lyxumia may make you feel sick or vomit.

If you forget to use Lyxumia

If you forget a dose of Lyxumia, you can inject it within the hour before your next meal. Do not inject two doses at the same time to make up for a forgotten dose.

If you stop using Lyxumia

Do not stop using Lyxumia without talking to your doctor first. If you stop using Lyxumia, your blood sugar levels may increase.

If you have any other questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Lyxumia can cause side effects, although not everybody gets them.

Rarely, some serious allergic reactions (such as anaphylaxis) have been reported in patients taking Lyxumia. You should seek immediate medical attention if you experience symptoms such as swelling of the face, tongue, or throat that make it difficult to breathe.

Stop using Lyxumia and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area) that may radiate to your back, as well as nausea and vomiting, as these may be signs of pancreatitis (inflammation of the pancreas).

The most frequently reported side effects with Lyxumia that may affect more than 1 in 10 users (frequency: very common) were nausea (feeling sick) and vomiting. These side effects were mostly mild and usually went away over time.

Other side effects

Very common: may affect more than 1 in 10 people

• Diarrhea
• Headache

• Low blood sugar (hypoglycemia) especially when Lyxumia is used with insulin or a sulfonylurea.

The warning signs of low blood sugar may include: cold sweats, cool pale skin, headache, drowsiness, weakness, dizziness, confusion or irritability, feeling hungry, fast heartbeat, and nervousness. Your doctor will tell you what to do if you experience low blood sugar.

This is more likely to happen if you are taking a sulfonylurea or a basal insulin at the same time. Your doctor may reduce the dose of these medicines before you start using Lyxumia.

Common: may affect up to 1 in 10 people

• Flu (influenza)
• Cold (upper respiratory tract infection)
• Dizziness
• Indigestion (dyspepsia)
• Back pain
• Cystitis
• Viral infection
• Low blood sugar (when Lyxumia is taken with metformin)
• Drowsiness. Reactions at the injection site (such as itching).

Uncommon: may affect up to 1 in 100 people

• • Hives
• Gallstones
• • Inflammation of the gallbladder.

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lyxumia

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Before first use

Store in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezer compartment.

During use of the pen

The pen can be used for 14 days when stored below 30°C. Do not freeze. Do not store with a needle attached. When not in use, keep the pen cap on to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Lyxumia

• The active substance is lixisenatide.
• Lyxumia 10 micrograms solution for injection: Each dose contains 10 micrograms of lixisenatide (50 micrograms per ml).
• Lyxumia 20 micrograms solution for injection: Each dose contains 20 micrograms of lixisenatide (100 micrograms per ml)
• The other ingredients are glycerol 85%, sodium acetate trihydrate, methionine, metacresol, hydrochloric acid (for pH adjustment) and sodium hydroxide solution (for pH adjustment) and water for injections.

Appearance of Lyxumia and Container Contents

Lyxumia is a clear and colorless injectable solution, contained in a glass cartridge inserted into a pre-filled pen.

Each green pen of Lyxumia 10 micrograms solution for injection contains 3 ml of solution containing 14 doses of 10 micrograms. Pack with 1 pre-filled pen.

Each purple pen of Lyxumia 20 micrograms solution for injection contains 3 ml of solution containing 14 doses of 20 micrograms. Packs with 1, 2 or 6 pre-filled pens. Only some pack sizes may be available in your country.

A starter pack for treatment initiation is also available, to be used during the first 28 days of treatment, containing a green pen of Lyxumia 10 micrograms solution for injection and a purple pen of Lyxumia 20 micrograms solution for injection.

Marketing Authorisation Holder

sanofi-aventis groupe

54, rue La Boétie

F – 75008 Paris

France

Manufacturer

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst - 65926 Frankfurt am Main

Germany

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Lyxumia

lixisenatide

INSTRUCTIONS FOR USE

Starter Pack for Treatment Initiation – Contains two pre-filled pens, each with 14 doses.

One green pen of 10 micrograms(Lyxumia 10 micrograms solution for injection), each dose contains 10 micrograms in 0.2 ml.

One purple pen of 20 micrograms(Lyxumia 20 micrograms solution for injection), each dose contains 20 micrograms in 0.2 ml

Section 1 – IMPORTANT INFORMATION

Read these instructions carefully before using your Lyxumia pens.

Keep this leaflet for future reference.

Information about the Lyxumia Pen

• Inject only one dose each day.

• Each Lyxumia pen contains 14 pre-selected doses. You do not need to measure each dose.

• Talk to your healthcare professional about the correct way to perform the injection before using Lyxumia.
• If you cannot strictly follow the instructions by yourself or are not able to handle the pen (for example, if you have severe vision problems), use it only if you have help from another person.

About Your Starter Pack

The Starter Pack includes two pens of different colors. Each pen contains a different dose of Lyxumia. Both pens are used in the same way.

• The green pen contains 14 pre-selected doses; each dose contains 10 micrograms of Lyxumia.

• The purple pen contains 14 pre-selected doses; each dose contains 20 micrograms of Lyxumia.

You must start your treatment with the Lyxumia green pen of 10 micrograms. First, you must use the 14 doses of this pen. Then use the Lyxumia purple pen of 20 micrograms.

About Your Lyxumia Pens

Green Lyxumia Pen of 10 micrograms

Purple Lyxumia Pen of 20 micrograms

• These pens are for single use only. Do not share them with anyone else.

• Always check the label to ensure you are using the correct Lyxumia pen. Also, check that the expiry date has not passed. Using the wrong medicine can harm your health.

• Do not attempt to withdraw liquid from the cartridge with a syringe.

About Your Needle(supplied separately)

About Your Needle(supplied separately)

• Use only needles approved for use with Lyxumia. Use disposable pen needles of 29 to 32 gauge with the Lyxumia pen. Ask your doctor, pharmacist or nurse what gauge and length of needle are most suitable for you.

• If someone else is giving you the injection, they must be careful to avoid needle accidents, as they could transmit an infection.
• Always use a new needlefor each injection. This helps to avoid contamination of Lyxumia or possible blockage of the needle.

Section 2 – FIRST STEPS

Start with the Green Lyxumia Pen of 10 micrograms.

• Do not activate the Purple Lyxumia Pen of 20 micrograms until you have finished the green pen.
• Activate the pen on the same day as your first injection

First, activate your new pen

• Before injecting a dose:before injection, you must remove excess liquid from the new pen. This is done only once and is called the "activation" process. The following steps, from 1 to 5, show how to do it.

• Activation is performed to ensure that the pen works correctly and that the dose of the first injection is correct.
• Do not repeatthe activation process, as you will then not get the 14 doses of the Lyxumia pen.

The following images show how the activation window of the injection button of the pen changes after activation.

New PenPen Ready for Injections

(orange window) (white window)

The pen is activated and ready for injections. The window remains white after activation.

How to Activate Your New Lyxumia Pen

Step 1 Remove the cap and check the pen

Step 2 Place a needle and remove the caps

Always use a new needlefor activation.

Remove the protective seal from the outer needle cap.

Align the needle with the pen. Keep it straight while screwing.

Be careful not to prick yourself when the needle is exposed.

Remove the inner and outer caps of the needle. Keep the outer cap, as you will need it to discard the needle later.

Step 3 Pull the injection button out

Pull the injection button firmly until it stops.

Now the arrow will be pointing towards the needle

Step 4 Press and hold the injection button to remove excess liquid

Direct the needle towards a suitable container (such as a glass or paper towel) to collect the liquid and dispose of it.

Press the injection button all the way.You may hear or feel a “click”.

Hold the injection button down and count slowly to 5to extract the last drops.

Click

seconds

If no liquid comes out, consult the "Questions and Answers" section.

Check that the activation window is now white.

Step 5 The pen is now activated.

Do not activate it again.

Noneed to replace the needle between pen activation and the first injection.

To inject the first dose, go directly to Section 3, step C.

Turn over

Section 3 - DAILY USE OF THE PEN

Go to this section only when the activation window iswhite.

Injectonedose each day.

Step A. Remove the cap and check the pen

Check the liquid. It should be transparent, colorless, and without visible particles. If it is not, do not use this Starter Pack.

If you observe air bubbles, consult the "Questions and Answers" section.

Check the number of doses of the pen. It is shown by the position of the black plunger in the dose scale.

Check that the activation window is white. If it is orange, go to Section 2.

Check the pen label to ensure you are using the correct medicine.

Step B. Place a new needle and remove the caps

Always use a new needlefor each injection.

Remove the protective seal from the outer needle cap.

Align the needle with the pen. Keep it straight while screwing.

Be careful not to prick yourself when the needle is exposed.

Remove the inner and outer caps of the needle. Keep the outer cap, as you will need it to discard the needle later.

Step C. Pull the injection button out

Pull the injection button firmly until it stops.

Now the arrow will be pointing towards the needle.

Step D Press and hold the injection button to inject the dose

seconds

Hold a skin fold and insert the needle into it (see the "Injection Sites" section to know where to inject).

Press the injection button all the way.You may hear or feel a “click”.

Hold the injection button down and count slowly to 5to get the full dose.

Then the dose will have been administered. Remove the needle from the skin.

Step E. Remove and discard the needle after each injection

Place the outer needle cap on a flat surface. Guide the needle into the outer cap.

Replace the outer needle cap.

Press the outer cap to grasp the needle and use it to unscrew it from the pen.

Ask your pharmacist how to dispose of the needle you will not use again.

Put the cap back on the pen

Step F. Repeat all the steps of Section 3 for each injection.

Discard the pen 14 days after activation. Do this even if there is still some medicine left in the pen.

Section 4 – SWITCHING TO THE PURPLE PEN Complete use of the green pen of 10 micrograms

The green Lyxumia pen of 10 micrograms will be empty when the black plunger has reached the '0' on the dose scale and the injection button can no longer be pulled out completely.

When the green Lyxumia pen of 10 micrograms is empty, you must continue treatment, injecting when due and using the purple Lyxumia pen of 20 micrograms. This is used in exactly the same way.

Using the Purple Pen of 20 micrograms

Activation of the purple pen of 20 micrograms

The purple Lyxumia pen of 20 micrograms must also be activated before use. Follow all the steps of Section 2.

Using the Purple Pen of 20 micrograms

To inject a dose with the purple Lyxumia pen of 20 micrograms, follow all the steps of Section 3. Repeat the procedure of Section 3 for each daily injection until the pen is empty.

Activation and Disposal Table

Write in this table the date you activated your pen and the date you must discard it, 14 days later.

Storage

General Information

• Keep Lyxumia pens in a safe place, out of sight and reach of children. Protect the Lyxumia pen from dust and dirt.

• Replace the pen cap after each use to protect it from light.

• Do not use Lyxumia after the expiration date shown on the label and carton. The expiration date is the last day of the month indicated.

Before activating the pen:

• Store unused Lyxumia pens in the refrigerator (2°C to 8°C).

Do not freeze Lyxumia pens and do not use Lyxumia if it has been frozen. Allow the pen to reach room temperature before using it.

After activating the pen:

• Once activated, keep the Lyxumia pen below 30°C. Do not freeze Lyxumia once it has been activated.
• Do not store the Lyxumia pen with the needle attached, as this may cause contamination and possible air entry, which could affect the accuracy of the doses.
• Once the Lyxumia pen is activated, it can be used for 14 days. Discard the used Lyxumia pen after 14 days. Do this even if there is still some medicine left in the pen.

Disposal

• Put the Lyxumia pen cap back on before disposing of it.

• Dispose of the Lyxumia pen as your pharmacist has told you to dispose of medicines that are no longer needed.

Maintenance

• Handle the Lyxumia pen with care.

• The outside of the Lyxumia pen can be cleaned with a damp cloth.

• Do not get the Lyxumia pen wet, wash it, or put liquid in (lubricate) it, as this may damage it.

• If you think the Lyxumia pen may be damaged, do not use it. Do not try to repair the pen.

Injection sites

Front part Back part

The Lyxumia pen is for injection under the skin, and injections can be given in any of the areas shown in blue in the image above. These are the thigh, abdominal area, or arm. Consult your doctor, pharmacist, or nurse for the correct injection technique.

Questions and answers

What if I forget to activate the Lyxumia pen or inject before activation?

If you accidentally inject before activating the pen, do not correct this by administering a second injection.

Contact your healthcare professional if a blood sugar check is necessary.

What if there are air bubbles in the reservoir?

It is normal to have small air bubbles in the reservoir; they are not harmful to you. Your dose will be correct, and you can continue following the instructions. Contact your doctor, pharmacist, or nurse if you need help.

Why doesn't liquid come out during activation?

The needle may be blocked, or it may not have been screwed on properly. Remove the needle from the pen, attach a new one, and repeat steps 4 and 5. If the liquid still does not come out, the Lyxumia pen may be damaged. Do not use this Lyxumia pen. Ask your doctor, pharmacist, or nurse for advice.

What if it's hard to push the injection button all the way?

The needle may be blocked, or it may not have been screwed on properly. Remove the needle from the skin and from the pen. Insert a new needle and repeat steps D and E. If it's still hard to press the injection button, the Lyxumia pen may be damaged. Do not use this Treatment Starter pen. Ask your doctor, pharmacist, or nurse for advice.

If you have any questions about Lyxumia or diabetes, consult your doctor, pharmacist, or nurse, or contact the local representative of the Marketing Authorization Holder listed in this "package leaflet: information for the user" (which is included separately in the box).