HIGHLIGHT
Toujeo

Toujeo

insulin glargine

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Full Prescribing Info
Contents
Insulin glargine.
Description
Toujeo contains insulin called "insulin glargine". This is a modified insulin, very similar to human insulin.
Toujeo contains 3 times more insulin in 1 mL than standard insulin, which contains 100 unit/mL.
The active substance is insulin glargine. Each mL of the solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each pen contains 1.5 mL of solution for injection, equivalent to 450 units.
Excipients/Inactive Ingredients: The other ingredients are: Zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see Important Information About Some of the Ingredients of Toujeo under Precautions) and hydrochloric acid (for pH adjustment).
Indications/Uses
It is used to treat diabetes mellitus in adults. Diabetes mellitus is an illness where the body does not make enough insulin to control the blood sugar.
Toujeo lowers the blood sugar steadily over a long period of time. It is used for once daily dosing. The patients can change the time of the injection if they need to. This is because this medicine lowers the blood sugar over a long period of time (for more information, see Dosage & Administration).
Dosage/Direction for Use
Always use this medicine exactly as the doctor has told the patient. Check with the doctor, pharmacist or nurse if the patient is not sure.
Although Toujeo contains the same active substance as insulin glargine 100 units/mL, these medicines are not interchangeable. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Please, consult the doctor for further information.
How Much to Use: The Toujeo SoloStar pre-filled pen can provide a dose of 1 to 80 units in one injection, in steps of 1 unit. The dose window of the SoloStar pen shows the number of units of Toujeo to be injected. Do not make any dose re-calculation.
Based on the lifestyle, the blood sugar tests and the previous insulin use, the doctor will tell the patient: How much Toujeo the patient needs each day and at what time. When to check the blood sugar level and if the patient needs to carry out urine tests. When the patient may need a higher or lower dose.
Toujeo is a long-acting insulin. The doctor may tell the patient to use it with a short-acting insulin, or with other medicines for high blood sugar.
If the patient uses more than one insulin always ensure to use the right insulin by checking the insulin label before each injection. Ask the doctor or pharmacist if the patient is not sure.
Many factors may affect the blood sugar level. The patient should know these factors so that the patient can take the right action if the blood sugar level changes and help step it becoming too high or too low.
Flexibility in Time of Administration: Use Toujeo once a day, preferably at the same time every day. When needed, the patient can inject it up to 3 hours before or after the usual time that the patient uses it.
Use in Elderly Patients (65 Years and Over): If the patient is 65 years or older, talk to a doctor as the patient may need a lower dose.
If the Patient has Kidney or Liver Problems: If the patient has kidney or liver problems, talk to a doctor as the patient may need a lower dose.
Before Injecting Toujeo: See Instructions for Use under Cautions for Usage. If the patient does not follow all of these instructions, the patient may get too much or too little insulin.
How to Inject: Toujeo is injected under the skin (subcutaneous use or "SC"). Inject it into the front of the thighs, upper arms or the front of the waist (abdomen).
Change the place within the area the patient injects each day. This will reduce the risk of skin shrinking or thickening (for more information, see Other Side Effects under Side Effects).
To prevent the possible transmission of disease, insulin pens should never be used for more than one person, even when the needle is changed.
Always attach a new sterile needle before each injection. Never re-use needles. If the patient re-uses a needle this increases the risk of it becoming blocked and of the patient getting too much or too little insulin.
Throw away the used needle in a puncture resistant container, or as told by the pharmacist or local authority.
Do Not Use Toujeo: In a vein. This will change the way it works and may cause the blood sugar to become too low. In an insulin infusion pump. If there are particles in the insulin. The solution should be clear, colourless and water-like.
Never use a syringe to remove Toujeo from the SoloStar pen or severe overdose can result.
If the SoloStar pen is damaged, has not been stored correctly, if the patient is not sure that it is working properly or the patient notices that the blood sugar control is unexpectedly getting worse: Throw the pen away and use a new one. Talk to a doctor, pharmacist or nurse if the patient thinks there is a problem with the pen.
If the Patient Use More Toujeo Than It Should Be: If the patient had injected too much of this medicine, the blood sugar level may become too low. Check the blood sugar and eat more food to prevent the blood sugar getting too low.
If the Patient Forgets to Use Toujeo: When needed, Toujeo can be injected up to 3 hours before or after the time the patient usually injects it.
If the patient had missed a dose of Toujeo or if the patient had not injected enough insulin, the blood sugar level may become too high (hyperglycaemia): Do not inject a double dose to make up for a forgotten dose. Check the blood sugar and then inject the next dose at the usual time.
If the Patient Stops Using Toujeo: Do not stop using this medicine without talking to a doctor. If the patient does, it could lead to very high blood sugar and a build-up of acid in the blood (ketoacidosis).
Contraindications
Do not use Toujeo: If the patient is allergic to insulin glargine or to any of the other ingredients of this medicine (listed in Description).
Special Precautions
Talk to a doctor, pharmacist or nurse before using Toujeo.
Follow closely the instructions for dose monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique, as discussed with the doctor.
Be especially aware of the following: Too low blood sugar (hypoglycaemia). If the blood sugar is too low, follow the guidance for hypoglycaemia.
If the patient switched from another type, brand or manufacturer of insulin the insulin dose may need to be changed.
Pioglitazone. See Pioglitazone Used Together With Insulin under Interactions.
Ensure to use the right insulin. Always check the insulin label before each injection to avoid mix-ups between Toujeo and other insulins.
If the patient is blind or has poor eye sight, do not use the pre-filled pen without help. This is because the patient will not be able to read the dose window on the pen. Get help from a person with good eye sight who is trained in using the pen.
Illnesses and Injuries: In the following situations, the management of the diabetes may require extra care (for example, blood and urine tests): If the patient is ill or had a major injury. The blood sugar level may increase (hyperglycaemia). If the patient is not eating enough. The blood sugar level may become too low (hypoglycaemia).
In most cases talk to a doctor. Contact a doctor as soon as the patient feels ill or got an injury.
If the has "Type 1" diabetes and had an illness or injury: Do not stop the insulin. Keep eating enough carbohydrates.
Always tell people who are caring or treating the patient, that the patient has diabetes.
Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to the insulin dose.
Travel: Talk to a doctor before travelling. The patient may need to talk about: If the type of insulin is available in the country the patient is visiting. How to arrange the supply of insulin, needles and other items. How to correctly store the insulin while travelling. The time the patient eats meals and use the insulin. The possible effects of changing to different time zones. Any health risks in the countries the patient will visit. What the patient should do in an emergency situation if the patient feels unwell or become ill.
Driving and Using Machines: Having too low or too high blood sugar or sight problems can affect the ability to drive and use tools or machines. The concentration may be affected. This could be dangerous to the patient and others. Ask the doctor whether the patient can drive if: The blood sugar is often too low. The patient finds it hard to recognise when the blood sugar is too low.
Important Information About Some of the Ingredients of Toujeo: This medicine contains less than 1 mmol (23 mg) sodium per dose. This means it is essentially 'sodium-free'.
Use in Children and Adolescents: This medicine should not be used in children or adolescents under 18 years of age. This is because there is no experience with Toujeo in this age group.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks might be pregnant or is planning to have a baby, ask the doctor for advice before using this medicine. The insulin dose may need to be changed during pregnancy and after giving birth. For the health of the baby, it is particularly important to carefully control the diabetes and to prevent hypoglycaemia.
If the patient is breast-feeding, talk to a doctor, as the insulin doses and the diet might need to be changed.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient notices signs of the blood sugar being too low (hypoglycaemia), take action to increase the blood sugar level straight away.
Hypoglycaemia can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people).
Low blood sugar means that there is not enough sugar in the blood.
If the blood sugar falls too low, the patient may pass out (become unconscious).
Serious low blood sugar may cause brain damage and may be life-threatening.
Severe allergic reactions (rare, may affect up to 1 in 1,000 people). The signs may include rash and itching all over the body, swelling of skin or mouth, shortness of breath, feeling faint (a fall in blood pressure) with fast heart beat and sweating. Severe allergic reactions may become life-threatening. Tell a doctor straight away if the patient notices signs of a severe allergic reaction.
Other Side Effects: Tell the doctor, pharmacist or nurse if the patient notices any of the following side effects: Common: May affect up to 1 in 10 people.
Skin changes where the injection is given: If the patient injects insulin too often at the same place, the skin may either shrink (lipoatrophy) or thicken (lipohypertrophy). The insulin may not work very well. Change the injection site with each injection to help prevent these skin changes.
Skin and allergic reactions at the injection site: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks.
Rare: May affect up to 1 in 1,000 people.
Eye Reactions: A big change in the blood sugar control (getting better or worse) can disturb the vision. If the patient has an eye disorder related to diabetes called "proliferative retinopathy", very low blood sugar attack may cause temporary loss of vision.
Swelling in the calves and ankles, caused by temporary build-up of water in the body.
Very Rare: May affect up to 1 in 10,000 people.
Changes in taste (dysgeusia).
Muscular pain (myalgia).
Tell a doctor, pharmacist or nurse if the patient notices any of the side effects previously mentioned.
Reporting of Side Effects: If the patient gets any side effects, talk to a doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects the patient can help provide more information on the safety of this medicine.
Drug Interactions
Tell the doctor, pharmacist or nurse if the patient is taking, had recently taken or might take any other medicines.
Some medicines can change the blood sugar level. This may mean the insulin dose has to change. So, before taking a medicine ask the doctor if it will affect the blood sugar and what action, if any, the patient needs to take. The patient also needs to be careful when stopping taking a medicine.
The blood sugar level may fall (hypoglycaemia) if the patient takes: Any other medicine to treat diabetes. Disopyramide - for some heart problems. Fluoxetine - for depression. Sulfonamide antibiotics. Fibrates - for lowering high levels of blood fats. Monoamine oxidase inhibitors (MAOIs) - for depression. Angiotensin converting enzyme (ACE) inhibitors - for heart problems or high blood pressure. Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates (such as acetylsalicylic acid).
Pentamidine - for some infections caused by parasites. This may cause too low blood sugar which is sometimes followed by too high blood sugar.
The blood sugar level may rise (hyperglycaemia) if the patient takes: Corticosteroids such as cortisone - for inflammation. Danazol - for endometriosis. Diazoxide - for high blood pressure. Protease inhibitors - for HIV. Diuretics - for high blood pressure or fluid retention. Glucagon - for very low blood sugar. Isoniazid - for tuberculosis. Somatropin - a growth hormone. Thyroid hormones - for thyroid gland problems. Oestrogens and progestogens - such as in the contraceptive pill for birth control. Clozapine, olanzapine and phenothiazine derivatives - for mental health problems. Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline - for asthma.
The blood sugar level may either rise or fall if the patient takes: Beta-blockers or clonidine - for high blood pressure. Lithium salts - for mental health problems.
Beta-Blockers: Beta-blockers like other "Sympatholytic medicines" (such as clonidine, guanethidine, reserpine - for high blood pressure) may make it harder to recognise warning signs of the blood sugar being too low (hypoglycaemia). It can even hide or stop the first signs that the blood sugar is too low.
Pioglitazone Used Together with Insulin: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. If the patient experiences signs of heart failure such as unusual shortness of breath, a rapid increase in weight or localised swelling (oedema). Inform the doctor as soon as possible.
If any of the previously mentioned apply to the patient (or the patient is not sure), talk to the doctor, pharmacist or nurse before using Toujeo.
Toujeo with Alcohol: The blood sugar level may either rise or fall if the patient drinks alcohol. Check the patient's blood sugar level more than usual.
Caution For Usage
Instruction for Use: Toujeo SoloStar contains 300 units/mL insulin glargine in a 1.5 mL disposable prefilled pen.
Never re-use needles. If the patient does the patient might not get the dose (underdosing) or get too much (overdosing) as the needle could block.
Never use a syringe to remove insulin from the pen. If the patient does the patient will get too much insulin. The scale on most syringes is made for non-concentrated insulin only.
Important Information: Never share the pen - it is only for the patient. Never use the pen if it is damaged or if the patient is not sure that it is working properly. Always perform a safety test. Always carry a spare pen and spare needles in case they got lost or stop working.
Learn to Inject: Talk with a doctor, pharmacist or nurse about how to inject, before using the pen.
Ask for help if the patient had problems handling the pen, for example if the patient has problems with sight. Read all of these instructions before using the pen. If the patient does not follow all of these instructions, the patient may get too much or too little insulin.
Extra Items the Patient Will Need: A new sterile needle (see Step 2 as follows). A puncture resistant container for used needles and pens.
Use By: Only use the pen for up to 4 weeks after its first use.
How to Store the Pen: Before First Use: Keep new pens in a fridge, at 2°C to 8°C. Do not freeze.
After First Use: Keep the pen at room temperature, below 30°C. Never put the pen back in the fridge. Never store the pen with the needle attached. Store the pen with the pen cap on.
How to Care for the Pen: Handle the Pen with Care: Do not drop the pen or knock it against hard surfaces. If the patient thinks that the pen may be damaged, do not try to repair it, use a new one.
Protect the Pen from Dust and Dirt: Clean the outside of the pen by wiping it with a damp cloth. Do not soak, wash or lubricate the pen - this may damage it.
Throwing the Pen Away: Remove the needle before throwing the pen away. Throw away the used pen as told by the pharmacist or local authority.
Step 1: Check the Pen: Take a new pen out of the fridge at least 1 hour before injecting. Cold insulin is more painful to inject.
A. Check the name and expiration date on the label of the pen.
Make sure the patient has the correct insulin. This is especially important if the patient has other injector pens.
Never use the pen after the expiration date.
B. Pull off the pen cap.
C. Check that the insulin is clear.
Do not use the pen if the insulin looks cloudy, coloured or contains particles.
Step 2: Attach a New Needle: Always use a new sterile needle for each injection. This helps stop blocked needles, contamination and infection.
Only use needles that are compatible for use with Toujeo (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford).
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 overtighten.
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 - this is to prevent needle injury and cross-infection.
Step 3: Do a Safety Test: Always do a safety test before each injection - this is to: Check the pen and the needle are working properly. Make sure that the patient gets the correct insulin dose.
A. Select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and 4.
B. Press the injection button all the way in.
When insulin comes out of the needle tip, the pen is working correctly.
If No Insulin Appears: The patient may need to repeat this step up to 3 times before seeing insulin.
If no insulin 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 the pen if there is still no insulin coming out of the needle tip. Use a new pen.
Never use a syringe to remove insulin from the pen.
If the Patient Sees Air Bubbles: The patient may see air bubbles in the insulin. This is normal, they will not harm the patient.
Step 4: Select the Dose: Never select a dose or press the injection button without a needle attached. This may damage the 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 the dose.
If the patient turns past the dose, the patient can turn it back down.
If there are not enough units left in the pen for the dose, the dose selector will stop at the number of units left.
If the patient cannot select the full prescribed dose, split the dose into two injections or use a new pen.
How to Read the Dose Window: Even numbers are shown in line with the dose pointer. Odd numbers are shown as a line between even numbers.
Units of Insulin in the Pen: The pen contains a total of 450 units of insulin. The patient can select doses from 1 to 80 units in steps of 1 unit. Each pen contains more than one dose.
The patient can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.
Step 5: Inject the Dose: If the patient finds it hard to press the injection button in, do not force it as this may break the pen.
A. Choose a place to inject (upper arms, stomach, thighs).
B. Push the needle into the skin as shown by the doctor, pharmacist or nurse.
Do not touch the injection button yet.
C. Place thumb on the injection button. Then press all the way in and hold.
Do not press at an angle - the thumb could block the dose selector from turning.
D. Keep the injection button held in and when the patient sees "0" in the dose window, slowly count to 5.
This will make sure the patient gets the full dose.
E. After holding and slowly counting to 5, release the injection button. Then remove the needle from the skin.
If the Patient Finds It Hard to Press the Button In: Change the needle (see Step 6 and Step 2) then do a safety test (see Step 3). If the patient still finds it hard to press in, get a new pen. Never use a syringe to remove insulin from the pen.
Step 6: Remove the Needle: Take care when handling needles - this is to prevent needle injury and cross-infection.
Never put the inner needle cap back on.
A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.
To reduce the risk of accidental needle injury, never replace the inner needle cap.
If the injection is given by another person, or if giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Follow recommended safety measures for removal and disposal of needles (contact the doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
B. Throw away the used needle in a puncture resistant container, or as told by the pharmacist or local authority.
C. Put the pen cap back on.
Do not put the pen back in the fridge.
Storage
Before First Use: Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Keep the pen in the outer carton in order to protect from light.
After First Use or If Carried as a Spare: Do not store the pen in a refrigerator. The pen may be stored for a maximum of 4 weeks below 30°C and away from direct heat or direct light. Discard the pen after this time period. Do not leave the insulin in a car on an exceptionally warm or cold day. Always keep the cap on the pen when not using it in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that are no longer used. These measures will help protect the environment.
ATC Classification
A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Soln for inj (pre-filled pen with cartridge) 300 u/mL (clear and colourless solution) x 1.5 mL x 5's.
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