Toujeo contains insulin called “insulin glargine”. This is a modified insulin, very similar to human insulin.
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).
Toujeo lowers the blood sugar steadily over a long period of time. It is used for once daily dosing. The patient 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).
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.
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.
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).
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.
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.
Never use a syringe to remove Toujeo from the SoloStar pen or severe overdose can result.
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.
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.
Pioglitazone. See Pioglitazone Used Together With Insulin under Interactions.
Ensure to use the right insulin. Medication errors due to mix-up between insulins, particularly between long-acting insulins and rapid-acting insulins have been reported. The patient must always check the insulin label before each injection to avoid mix-ups between Toujeo and other insulins.
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 patient 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.
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’.
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.
If the patient is breast-feeding, talk to a doctor, as the insulin doses and the diet might need to be changed.
If the patient notices signs of the blood sugar being too low (hypoglycaemia), take action to increase the blood sugar level straight away.
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.
Tell the doctor, pharmacist or nurse if the patient notices any of the side effects as previously mentioned.
Some medicines can change the blood sugar level. This may mean the insulin dose has to change. So, before taking a medicine ask a 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 the patient stops taking a medicine.
Disopyramide: for some heart problems.
Fibrates: for lowering high levels of blood fats.
Monoamine oxidase inhibitors (MAOIs): for depression.
Pentamidine: for some infections caused by parasites. This may cause too low blood sugar which is sometimes followed by too high blood sugar.
Danazol: for endometriosis.
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.
Lithium salts: for mental health problems.
Caution For Usage
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.
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.
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.
A. Check the name and expiration date on the label of the pen.
Never use the pen after the expiration date.
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.
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.
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.
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.
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.
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.
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 6 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.