Toujeo 300 units/ml DoubleStar solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Toujeo 300 units/ml DoubleStar solution for injection in a pre-filled pen

Insulin glargine

Each DoubleStar pen delivers 2–160 units in 2-unit steps

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Toujeo is and what it is used for

Toujeo is a type of long-acting insulin called "insulin glargine".

• It is very similar to human insulin.
• It contains three times as much insulin in 1 ml as standard insulin which contains 100 units/ml. If necessary, you may adjust the timing of your injection (for more information, see section 3).
• It lowers your blood sugar level steadily over a long period of time.
• It is injected once daily.

Toujeo is used in the treatment of diabetes mellitus (diabetes) in adults, adolescents, and children from the age of 6 years. This is a condition in which your body does not produce enough insulin to control your blood sugar level.

2. What you need to know before using Toujeo

Do not use Toujeo

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Toujeo. Follow your doctor's instructions exactly regarding how much Toujeo to use, how to monitor your blood and urine, your diet, physical activity levels, and your injection technique.

Important:

• If your blood sugar level is too low (hypoglycemia) – see “What to do if your blood sugar level is low” at the end of this leaflet.
• Changing insulin – If you switch to a different type, brand, or manufacturer of insulin, you may need to adjust your dose.
• Pioglitazone used together with insulin may cause serious problems – see “Pioglitazone” below.
• Always use the correct type of insulin – always check the label on your insulin before each injection to avoid confusion with other insulins, particularly between long-acting and short-acting insulins.
• Never use a syringe to withdraw Toujeo from your pen. This is to prevent dosing errors and potential overdoses that could lead to low blood sugar.
• To avoid underdosing of insulin, perform the safety checks before first use of a new pen and also before each pen use (see Step 3 of the Instructions for Use). See section 3.
• If you are blind or have reduced vision, do not use the pre-filled pen without assistance, as you cannot read the dose window on the pen. Ask for help from someone with good eyesight who has been trained in pen use.

Skin changes at the injection site

Change the site where you inject regularly. This helps prevent skin changes such as thickening, shrinking, or lumps. Insulin may not work well if injected into a lumpy area.

• Contact your doctor, pharmacist, or nurse if you are currently injecting into a lumpy area, before switching to a different injection site.

Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or other antidiabetic medications.

Illness and injury

You may need to monitor your blood and urine more carefully to manage your diabetes if:

• you are ill or have a serious injury. Your blood sugar level may rise – hyperglycemia.
• you are not eating enough. Your blood sugar level may drop too low – hypoglycemia.

Contact your doctor as soon as you feel unwell or suffer an injury.

If you have Type 1 diabetes and are ill or injured:

• do not stop taking your insulin.
• continue to consume adequate carbohydrates.

Always inform anyone caring for you or treating you that you have diabetes.

Antibodies to insulin

Treatment with insulin may cause your body to produce antibodies to insulin (substances that act against insulin). However, this very rarely requires a change in your insulin dose.

Travel and Toujeo

If you travel abroad, changes in time zones may affect your insulin needs and injection schedule. Consult your doctor before traveling. You may need to discuss:

• Whether your type of insulin is available in the country you are visiting.
• How to obtain insulin, needles, and other supplies.
• How to store your insulin properly during travel.
• Meal and insulin administration schedules.
• Possible effects of moving across time zones.
• Health risks in the countries you are visiting.
• What to do in emergency situations if you become unwell.

Children and adolescents

Do not administer this medicine to children under 6 years of age, as there is no experience with Toujeo in children of this age.

Other medicines and Toujeo

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. Some medicines can affect your blood sugar level. Your doctor will tell you if you need to adjust your insulin dose. You should also be cautious when stopping a medicine.

The following are common medicines that may affect your insulin treatment:

Your blood sugar level may decrease (hypoglycemia) if you take:

• other medicines for diabetes
• disopyramide – for certain heart problems
• fluoxetine – for depression
• pentamidine – for certain parasitic infections. This may cause very low blood sugar levels, which may sometimes be followed by very high blood sugar levels.
• sulfonamide antibiotics – for infections
• fibrates – to reduce high blood fat levels
• monoamine oxidase inhibitors (MAOIs) – for depression
• pentoxifylline, propoxyphene, and salicylates (such as aspirin) – for pain and mild fever
• angiotensin-converting enzyme (ACE) inhibitors – for heart problems or high blood pressure

Your blood sugar level may increase (hyperglycemia) if you take:

• danazol – for endometriosis
• diazoxide – for high blood pressure
• glucagon – for very low blood sugar
• isoniazid – for tuberculosis
• somatropin – a growth hormone
• thyroid hormones – for thyroid gland problems
• estrogens and progestogens – such as oral contraceptives for birth control
• corticosteroids such as cortisone – for inflammation
• protease inhibitors – for HIV
• diuretics – for high blood pressure or fluid retention
• clozapine, olanzapine, and phenothiazine derivatives – for mental health conditions
• sympathomimetics such as epinephrine (adrenaline), salbutamol, and terbutaline – for asthma

Your blood sugar level may increase or decrease if you take:

• beta-blockers or clonidine – for high blood pressure
• lithium salts – for mental health conditions

Beta-blockers

Beta-blockers and other “sympatholytic” medicines (such as clonidine, guanethidine, and reserpine – for high blood pressure) may mask or delay the symptoms of low blood sugar (hypoglycemia) or make it harder to recognize warning signs.

Pioglitazone

Some patients with long-standing type 2 diabetes mellitus and existing heart disease or prior stroke who were treated with pioglitazone and insulin developed heart failure.

• Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling.

If any of the above affect you, or if you are unsure, inform your doctor, pharmacist, or nurse before using Toujeo.

Use of Toujeo with alcohol

Your blood sugar level may rise or fall if you drink alcohol; you will need to check your blood sugar level more often than usual.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

• You may need to adjust your insulin dose during pregnancy and after childbirth, or your insulin dose and diet during breastfeeding.
• It is important to control your diabetes and prevent low blood sugar to protect your baby.

Driving and using machines

Low or high blood sugar levels or vision problems may affect your ability to drive or operate tools or machinery. Your concentration may be impaired. This could be dangerous for you and others. Consult your doctor, pharmacist, or nurse if you can drive or use tools or machines if:

• your blood sugar drops frequently.
• you have difficulty recognizing when your blood sugar is low.

Toujeo contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially “sodium-free”.

3. How to use Toujeo

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

Toujeo and insulin glargine 100 units/ml are not interchangeable, even if they contain the same active substance. Switching from one insulin treatment to another requires medical prescription, medical supervision, and blood glucose monitoring. For more information, consult your doctor.

How much to use

The Toujeo DoubleStar pre-filled pen can deliver doses from 2 to 160 units in a single injection, in 2-unit increments. The pen is recommended for patients who require at least 20 units of insulin per day (see section 2).

The dose window of the DoubleStar pen displays the number of units of Toujeo to be injected and does not require dose readjustment.

Your doctor will decide:

• how much Toujeo you need each day and at what time,
• when to check your blood sugar level and whether you need urine tests,
• when you may need higher or lower doses.

This decision is based on your lifestyle, your blood glucose monitoring results, and your previous insulin use.

Contact your doctor, as you may need a lower dose if:

• you are 65 years of age or older,
• you have kidney or liver problems.

Toujeo is a long-acting insulin. Your doctor may instruct you to use it in combination with a short-acting insulin or with other medications for high blood sugar.

Make sure you are using the correct type of insulin

• Always check the label on your insulin before each injection to avoid confusion with other insulins, particularly between long-acting and short-acting insulins.

The number “300” is highlighted in gold on the label of your Toujeo DoubleStar pre-filled pen. Consult your doctor or pharmacist if you have any doubts.

Many factors can affect your blood sugar level; you should know what they are and what to do if your sugar level changes. This will help prevent it from becoming too high or too low. For more information, see “hyperglycaemia and hypoglycaemia” at the end of this leaflet.

When to use Toujeo

• Use Toujeo once daily, preferably at the same time each day.
• You may inject it up to 3 hours earlier or later than your usual time.

Before injecting Toujeo

• Read the instructions for use provided in this leaflet.
• If you do not follow the instructions completely, you may receive too much or too little insulin.
• Perform the safety test described in Step 3 of the Instructions for Use. If you do not, the full dose may not be delivered. If this happens, you should increase the frequency of blood glucose checks and may need additional insulin (see section 2).

How to inject

• Inject Toujeo under the skin. This is called the “subcutaneous” or “SC” route.
• Inject it into the front of your thighs, the upper part of your arms, or the front of your waist (abdomen).
• Change the injection site daily within an injection area to reduce the risk of skin shrinking or thickening (see section 4).
• Always use a new sterile needle for each injection to reduce the risk of infection and the risk of needle blockages, which could lead to too much or too little insulin being delivered.
• Dispose of used needles in a sharps-resistant container or as instructed by your pharmacist or local authority.
• Do not share your insulin pen with anyone else, even if you change the needle – to prevent transmission of diseases.
• Do not use a syringe to withdraw Toujeo from your pen – to avoid potential overdoses.

Do not use Toujeo

• Into a vein – this will alter how it works and may cause your blood sugar level to drop too much.
• In an insulin pump.
• If particles appear in the insulin – the liquid should be clear, colourless, and watery-looking.

Discard the pen and use a new one if:

• you notice that your blood sugar control worsens inexplicably,
• the pen is damaged or has not been stored properly.

Contact your doctor, pharmacist, or nurse if you are unsure whether your pen is working correctly.

If you use more Toujeo than you should

If you have injected too much medicine, your blood sugar level may drop too low – see “low blood sugar level” at the end of this leaflet for more information.

If you forget to use Toujeo

• If you miss a dose, inject the missed dose within 3 hours of your usual injection time.
• If you remember more than 3 hours after your usual time, do not inject the missed dose – check your blood sugar and inject your next dose at the usual time the following day.
• Do not inject a double dose to make up for a missed dose.
• If you miss a dose of Toujeo or do not inject enough insulin, your blood sugar level may become too high – see “high blood sugar level, hyperglycaemia” at the end of this leaflet for more information.

If you stop using Toujeo

Do not stop your treatment without consulting your doctor. If you stop using this medicine, you may develop very high blood sugar levels and an increase in blood acid, called “ketoacidosis”. See “high blood sugar level” at the end of this leaflet for more information.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Serious adverse effects

Contact your doctor, pharmacist, or nurse immediately if you notice any of the following serious adverse effects – you may require urgent medical treatment:

Low blood sugar (hypoglycaemia) – very common: may affect more than 1 in 10 people

• If your blood sugar level drops too low, you may faint.
• Severe hypoglycaemia can cause brain damage and may be potentially fatal.

If you have signs of low blood sugar, try to raise your blood sugar level immediately. See “low blood sugar” at the end of this leaflet for more information.

Signs of serious allergic reactions (rare, may affect up to 1 in 1,000 people) may include:

• feeling short of breath
• swelling of the skin or mouth
• rash and itching all over the body
• feeling dizzy with rapid heartbeat and sweating.

Contact your doctor, pharmacist, or nurse immediately, as allergic reactions can become potentially life-threatening.

Other adverse effects

Tell your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Changes in the skin at the injection site:

If you inject insulin too frequently in the same place, your skin may change, including:

• skin shrinking (lipoatrophy) (may affect up to 1 in 100 people)
• skin thickening (lipohipertrophy) (may affect up to 1 in 10 people)
• lumps under the skin. These may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work as well if injected into a lumpy area.

Rotate your injection sites regularly to prevent these skin changes.

Common: may affect up to 1 in 10 people

• skin reactions and allergic reactions at the injection site. Signs may include redness, unusually severe pain at injection, itching, hives, swelling, or inflammation. These reactions may spread around the injection site. Most minor reactions to insulin usually disappear within a few days or weeks.

Uncommon: may affect up to 1 in 1,000 people

• eye problems – a significant change in blood sugar control, either improvement or worsening, may affect your vision. If you have a diabetes-related eye disorder called "proliferative retinopathy", episodes of very low blood sugar levels may cause temporary loss of vision.
• swelling of the calves and ankles due to your body retaining more fluid than normal.

Rare: may affect up to 1 in 10,000 people

• changes in taste (dysgeusia)
• muscle pain (myalgia)

Inform your doctor, pharmacist, or nurse if you notice any of the adverse effects listed above.

Reporting of adverse effects

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

5. Storage of Toujeo

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

Do not use this medicine after the expiry date stated on the carton and on the label of the pen after EXP. The expiry date refers to the last day of the month indicated.

Before first use

• Store in a refrigerator, between 2°C - 8°C.
• Do not freeze, and do not place near the freezer compartment or a cold pack.
• Keep the pen in its outer packaging to protect it from light.

After first use or when carried as a spare

• Do not store the pen in the refrigerator.
• The pen may be stored for up to 6 weeks at room temperature below 30°C, protected from direct heat or direct light. Dispose of the pen after this period.
• Do not leave your insulin in a car on very hot or cold days.
• When not in use, always replace the pen cap to protect it from light.

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

6. Contents of the pack and other information

Composition of Toujeo

• The active substance is insulin glargine. Each ml of solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each DoubleStar pen contains 3 ml of injectable solution, equivalent to 900 units.
• The other components are: zinc chloride, metacresol, glycerol, water for injectable preparations, sodium hydroxide (see section 2 “Toujeo contains sodium”), and hydrochloric acid (to adjust pH).

Appearance of Toujeo and contents of the pack

• Toujeo is a clear, colourless solution.
• Each DoubleStar pen contains 3 ml of injectable solution (equivalent to 900 units).
• Pack sizes: 1, 3, 6 (2 packs of 3), 9 (3 packs of 3), and 10 pre-filled pens.
• Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00	Lithuania UAB sanofi-aventis Lietuva Tel: +370 5 2755224
	Luxembourg/Luxembourg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgium/Belgium)
Czech Republic sanofi-aventis, s.r.o. Tel: +420 233 086 111	Hungary sanofi-aventis zrt., Hungary Tel.: +36 1 505 0050
Denmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.p.A. Tel: 30 02 39394275
Germany Sanofi-Aventis Deutschland GmbH Tel: 0800 52 52 010 Tel. from abroad: +49 69 305 21 131	Netherlands sanofi-aventis Netherlands B.V. Tel: +31 20 245 4000
Estonia sanofi-aventis Estonia OÜ Tel: +372 627 34 88	Norway sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Greece sanofi-aventis AEBE Tel: +30 210 900 16 00	Austria sanofi-aventis GmbH Tel: +43 1 80 185 – 0
Spain sanofi-aventis, S.A. Tel: +34 93 485 94 00	Poland sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
France sanofi-aventis France Tél: 0 800 222 555 Call from abroad: +33 1 57 63 23 23	Portugal Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400
Croatia sanofi-aventis Croatia d.o.o. Tel: +385 1 600 34 00	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00	Slovenia sanofi-aventis d.o.o. Tel: +386 1 560 48 00
Iceland Vistor ehf. Sími: +354 535 7000	Slovak Republic sanofi-aventis Pharma Slovakia s.r.o. Tel: +421 2 33 100 100
Italy Sanofi S.p.A. Tel: 800 131212 (technical inquiries) 800 536389 (other inquiries)	Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Cyprus sanofi-aventis Cyprus Ltd. Tel: +357 22 871600	Sweden Sanofi AB Tel: +46 (0)8 634 50 00
Latvia sanofi-aventis Latvia SIA Tel: +371 67 33 24 51

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.euopa.eu.

Hyperglycemia and hypoglycemia If you take insulin, you should always carry the following: Sugar (at least 20 grams). Information so that others know you have diabetes. High blood sugar level (hyperglycemia) Warning signs of high blood sugar: thirst, need to urinate more frequently feeling tired or dry skin, flushed face, loss of appetite low blood pressure, rapid heartbeat glucose and ketones in urine stomach pain, deep and rapid breathing, drowsiness or fainting (loss of consciousness) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin. What to do if your blood sugar level is high Check your blood sugar level and test your urine for ketones as soon as you notice any of the above signs. Contact your doctor immediately if you have severe hyperglycemia or ketoacidosis. This must always be treated by a doctor, usually in a hospital. High blood sugar levels may occur if: you have not injected your insulin or have not injected enough insulin. your insulin is not working properly; this could be due to improper storage. your insulin pen is not working correctly. you are doing less exercise than usual. you are under stress, such as emotional distress or anxiety. you have an injury, infection, or fever, or have undergone surgery. you are taking or have taken other medications; see section 2: “Other medicines and Toujeo”. Low blood sugar level (hypoglycemia) A very low blood sugar level may cause you to faint (lose consciousness), lead to a heart attack or brain damage, and can be potentially fatal. Learn to recognize the signs of low blood sugar and what to do to prevent it from worsening. Warning signs of low blood sugar The early signs that usually appear in your body: feeling sweaty skin feeling moist and sticky feeling anxious rapid or irregular heartbeat, high blood pressure, palpitations Other signs affecting the brain may appear slightly later: headache, trembling, dizziness changes in vision feeling very hungry, nausea or vomiting changes in behavior, aggression, depression feeling tired or drowsy, sleep problems, restlessness difficulty concentrating, confusion, slow reactions, or difficulty speaking (sometimes complete loss of speech) inability to move (paralysis), tingling in hands or arms, frequent numbness and tingling around the mouth loss of self-control, inability to care for yourself, seizures, loss of consciousness. What to do if your blood sugar level is low Do not inject insulin. Immediately take 10 to 20 grams of sugar, such as glucose tablets, sugar cubes, or a sugary drink. Do not drink or eat foods containing artificial sweeteners (such as diet drinks). These do not help treat low blood sugar. <3> Then eat something, such as bread or pasta, that raises your blood sugar for a longer period. Ask your doctor or nurse if you are unsure what foods to eat. With Toujeo, recovery from low blood sugar may take longer because it is long-acting.<4> If low blood sugar recurs, take another 10 to 20 grams of sugar.<5> Consult a doctor immediately if you are unable to control the low blood sugar or if it recurs. What others should do if you have low blood sugar Instruct your family, friends, and close contacts to seek immediate medical help if you are unable to swallow or if you faint (lose consciousness). You will need an injection of glucose or glucagon (a medicine that raises blood sugar). These injections should be given even if you are not certain of hypoglycemia. You should check your blood sugar level immediately after receiving glucose to confirm that you actually had hypoglycemia. Low blood sugar may occur if: you inject too much insulin. you skip meals or eat late. you do not eat enough, or eat foods containing less sugar than usual; artificial sweeteners are not sugars. you drink alcohol, especially if you have not eaten much. you have nausea (vomiting) or diarrhea. you do more exercise than usual or a different type of physical activity. you are recovering from an injury, surgery, or other type of stress. you are recovering from an illness or fever. you are taking or have taken other medications; see section 2: “Other medicines and Toujeo”. Low blood sugar is more likely to occur if: you have recently started insulin treatment or switched to another insulin: if low blood sugar occurs, it is more likely to happen in the morning. your blood sugar levels are nearly normal or unstable. you change the body area where you inject insulin, for example, from the thigh to the upper arm. you have severe kidney or liver disease, or another condition such as hypothyroidism. Warning signs of low blood sugar may be different, less clear, or absent if: you are elderly. you have had diabetes for a long time. you have a nerve disease called “autonomic diabetic neuropathy”. you recently had a very low blood sugar level, for example, the previous day. your blood sugar drops slowly. your low blood sugar is always “normal” or your blood sugar has improved significantly. you recently switched from animal insulin to human insulin, such as Toujeo. you are taking or have taken other medications; see section 2: “Other medicines and Toujeo”. In these cases, you may experience very low blood sugar and even faint before realizing what is happening. Know your warning signs. You may need to check your blood sugar level more frequently to help detect low blood sugar. If you find it difficult to detect your warning signs, you should avoid situations (such as driving a car) in which you or others may be at risk due to low blood sugar.

Toujeo 300 units/ml solution for injection in a pre-filled pen (DoubleStar)

USER INSTRUCTIONS

Read this first

Toujeo DoubleStar contains 300 units/ml of insulin glargine in a disposable pre-filled pen of 3 ml.

• Never reuse needles. Doing so may result in not receiving the required dose (underdosing) or receiving too much (overdosing), as the needle could become blocked.

• Never use a syringe to withdraw insulin from your pen. This could result in withdrawing too much insulin. The scale on most syringes is designed only for non-concentrated insulin.

• The dose selector on the Toujeo DoubleStar pen displays doses in increments of 2 units.

Important information

Never share your pen – it is for your use only.

Never use your pen if it is damaged or if you are unsure whether it is working properly.

Always perform a safety test the first time you use a new pen, until you see insulin coming out from the tip of the needle (see STEP 3). If you see insulin coming out from the needle tip, the pen is ready to use. If you do not see insulin coming out from the needle tip before administering your dose, you may receive a lower dose of insulin or no insulin at all. This could cause high blood sugar levels.

To ensure the pen and needle are working properly, always perform a safety test until you see insulin coming out from the needle tip before each injection (see STEP 3). If you do not perform the safety test before each injection, you may receive too little insulin.

Always carry a spare pen and needles in case your pen is lost or stops working.

Learning how to inject

• Ask your doctor, pharmacist, or nurse how to inject before using your pen.
• This pen is not recommended for use by blind or visually impaired individuals without assistance from someone trained in the proper use of the product.
• Read all these instructions before using your pen. If you do not follow these instructions, you may receive too much or too little insulin.

Need help?

If you have questions about your pen or your diabetes, consult your doctor, pharmacist, or nurse, or call the Sanofi number listed at the beginning of this leaflet.

Additional items you will need:

• A new sterile needle (see STEP 2).
• A puncture-resistant container for used needles and pens.

Injection sites

Get to know your pen

STEP 1: Check your pen

Remove a new pen from the refrigerator at least 1 hour before your injection. Injecting cold insulin is more painful.

A Check the name and expiration date on the label of your pen.

• Make sure you have the correct insulin. This is especially important if you use other pens.
• Do not use the pen after the expiration date.

B Remove the pen cap.

C Check that the insulin is clear.

• Do not use the pen if the insulin is cloudy, discolored, or contains particles.

STEP 2: Attach a new needle

Always use a new, sterile needle for each injection. This helps prevent needle blockage, contamination, and infection.

Use only needles compatible for use with Toujeo DoubleStar (e.g., BD, Ypsomed, Artsana, or Owen Mumford needles) that are 8 mm in length or shorter.

A Take a new needle and remove the protective seal.

B Hold the needle straight and screw it onto the pen until it is secure. Do not overtighten.

C Remove the outer needle cap. Keep it for later use.

D Remove the inner needle cap and discard it.

Handling needles

• Be careful when handling needles to avoid puncture injuries and cross-contamination.

STEP 3: Perform a safety test

Always perform a safety test before each injection to:

• Verify that your pen and needle are working correctly.
• Ensure you receive the correct insulin dose.

If the pen is new, you must perform the safety test before first use until you see insulin coming out from the needle tip. If you see insulin coming out from the needle tip, the pen is ready to use. If you do not see insulin coming out from the needle tip before administering your dose, you may receive a lower dose of insulin or no insulin at all. This could cause high blood sugar levels.

A Select 4 units by turning the dose selector until the dose marker aligns with the 4 mark.

B Press the injection button fully down.

• If insulin comes out from the needle tip, your pen is working correctly.

C Repeat this step if no insulin appears:

• If using the pen for the first time, you may need to repeat this step up to 6 times before insulin appears.

• Do not use your pen if insulin still does not come out from the needle tip. Use a new pen.

• For all injections, if no insulin appears, the needle may be blocked. If this occurs:

• Change the needle (see STEP 6 and STEP 2),

• Then repeat the safety test (STEP 3A and STEP 3B).

• Do not use your pen if insulin still does not come out from the needle tip. Use a new pen.

• Never use a syringe to withdraw insulin from your pen.

If you see air bubbles

• You may see air bubbles. This is normal and will not harm you.

STEP 4: Select the dose

Never select the dose or press the injection button before the needle is attached, as this could damage your pen.

Toujeo DoubleStar allows administration of the number of insulin units prescribed by your doctor. Do not make any dose adjustments.

A Ensure the needle is attached and the dose display reads “0”.

B Turn the dose selector until the dose marker aligns with your prescribed dose.

• Set the dose by turning the dose selector to a line in the dose window. Each line equals 2 units.

• The marker clicks as you turn it.

• Do not select your dose by counting clicks. This may result in an incorrect dose, leading to too much or too little insulin.

• Always check the number in the dose window to confirm you have selected the correct dose.

• If you go past your dose, you may turn the selector backward.

• If there are not enough units left in your pen to administer your full dose, the dose selector will stop at the number of units remaining.

• If you cannot select your full prescribed dose, divide the dose into two injections or use a new pen. If using a new pen, perform a safety test (see STEP 3).

How to read the dose window

The dose selector adjusts in 2-unit increments.

Even numbers are shown on the same line as the dose marker:

60 units selected

58 units selected

Insulin units in your pen

• Your pen contains a total of 900 units of insulin. You can select doses from 2 to 160 units in 2-unit increments. Each pen contains more than one dose.
• You can estimate how many units remain by observing the position of the plunger in the insulin scale.

STEP 5: Inject the dose

If you have difficulty pressing the injection button, do not force it, as this could damage your pen. See below for assistance.

A Choose an injection site as shown in the “Injection sites” diagram.

B Insert the needle into your skin as instructed by your doctor, pharmacist, or nurse.

• Do not press the injection button yet.

C Place your thumb on the injection button. Press it fully down and hold it down.

• Do not press the button at an angle: your thumb could block the dose selector and prevent it from turning.

D Keep holding the injection button down and, when you see “0” in the dose window, count slowly to 5.

• This ensures you receive your full dose.

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

If you have difficulty pressing the button:

• Change the needle (see STEP 6 and STEP 2), then perform a safety test (see STEP 3).
• If you still have difficulty pressing the button, use a new pen.
• Do not use a syringe to withdraw insulin from your pen.

STEP 6: Remove the needle

Be careful when handling needles to avoid puncture injuries and cross-infection.

Do not reattach the inner needle cap.

A Replace the outer needle cap and use it to unscrew the needle from the pen.

• To reduce the risk of accidental needle sticks, never reattach the inner cap.
• Extra caution is required when removing or disposing of the needle if someone else administers the injection or if you are injecting another person.
• Follow safety procedures for removing and disposing of needles (consult your doctor, pharmacist, or nurse) to reduce the risk of accidental needle sticks and transmission of infectious diseases.

B Dispose of the used needle in a puncture-resistant container, or as directed by your pharmacist or local authority.

C Replace the pen cap.

• Do not return the pen to the refrigerator.

Usage

• Use your pen for a maximum of 6 weeks after first use.

How to store your pen

Before first use

• Store new pens in the refrigerator at a temperature between 2°C and 8°C.
• Do not freeze.

After first use

• Store your pen at room temperature, below 30°C.
• Do not return your pen to the refrigerator.
• Do not store your pen with the needle attached.
• Store your pen with the cap on.
• Keep your pen and needles out of the sight and reach of children.

How to care for your pen

Handle your pen with care

• Do not drop your pen or hit it against hard surfaces.
• If you suspect your pen is damaged, do not attempt to repair it; use a new one.

Protect your pen from dust and dirt

• You may clean the exterior of your pen with a damp cloth. Do not soak, wash, or lubricate your pen, as this could damage it.

Disposing of your pen

• Remove the needle before disposing of your pen.

Dispose of your used pen as directed by your healthcare professional or local authority.