300 units/ml solution for injection SoloStar in a pre-filled pen
Insulin glargine. Each SoloStar pen provides 1-80 units in dose increments of 1 unit
What Toujeo is and what it is used for
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 regular insulin, which contains 100 units/ml.
Toujeo is used to treat diabetes mellitus in adults, adolescents and children from 6 years of age. Diabetes mellitus is a disease in which the body does not produce enough insulin to keep your blood sugar level under control.
Toujeo lowers your blood sugar steadily over a longer period. It is given once daily. You can change the time of your injection if you need it. This is because this medicine lowers your blood sugar over a longer period (for more information, see section 3).
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 using Toujeo.
Be sure to follow the dosage instructions and instructions for monitoring (of blood and urine), diet, physical activities (physical work and exercise) and injection technique as discussed with your doctor.
Pay particular attention to the following:
- Too low blood sugar ( hypoglycaemia ). If your blood sugar is too low, follow the advice on treating hypoglycaemia (see information in the box at the end of this leaflet).
- If you switch from another type of insulin, another brand or another manufacturer, your insulin dose may need to be changed.
- Pioglitazone. See “Use of pioglitazone with insulin”.
- Make sure you use the right insulin. Medication errors due to confusion between insulins, especially between long-acting insulins and rapid-acting insulins, have been reported. You must always check the insulin label before each injection, to avoid mixing Toujeo with other insulins.
- Never use a syringe to remove Toujeo from your pre-filled SoloStar pen. This is to avoid dosing errors and possible overdose, which can lead to low blood sugar. See also section 3.
- If you are blind or have poor vision, do not use the pre-filled syringe without assistance, as you will not be able to read the dosing window on the pen. Be sure to get the help of a person with good vision who is trained in using this pen. If you have poor vision, see section 3.
Skin changes at the injection site
To prevent skin changes, e.g. knots under the skin, you should constantly change the injection site. Insulin it may not work as well if you inject it into an area with nodules (see How to use Toujeo). Contact the doctor before changing the injection site if you are currently injecting into an area with nodules. The doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.
Diseases and injuries
In the following situations, the management of your diabetes may require extra care (for example, blood and urine samples):
- If you are ill or have had a serious accident. Your blood sugar level may increase ( hyperglycaemia ).
- If you don’t eat enough. Your blood sugar level may become too low ( hypoglycaemia ).
In most cases, you will speak to a doctor. Contact a doctor as soon as you feel sick or injured.
If you have type 1 diabetes and have an illness or injury
- Do not stop insulin et.
- Continue to eat enough carbohydrates.
Always tell those who look after you or treat you that you have diabetes.
Insulin treatment can cause the body to form antibodies against insulin (substances that react against insulin ). Only in very rare cases is a change in the insulin dose required.
Travels
Talk to your doctor before you travel. You may need to address issues such as:
- If your insulin is available in the country you are visiting.
- How the supply of insulin, syringes and other items should be arranged?
- How your insulin can be stored correctly during the trip.
- Times for meals and insulin use.
- Possible consequences of travelling to other time zones.
- Any health risks in the countries you are going to visit?
- What to do in an emergency, if you feel unwell or become ill.
Children and young people
This medicine should not be used in children younger than 6 years. There is no experience with the use of Toujeo in this age group.
Other medicines and Toujeo
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Some medicines can change blood sugar levels. This may mean that your insulin dose needs to be changed. Before taking a medicine, ask your doctor if it can affect your blood sugar level and what to do if so. You also need to be careful when you stop taking medicine.
Your blood sugar level may drop ( hypoglycaemia ) if you take:
- All other medicines for the treatment of diabetes.
- Disopyramide – in certain heart conditions.
- Fluoxetine – for depression.
- Sulfonamide antibiotics.
- Fibrates – to lower high levels of blood fats.
- MAO inhibitors – in depression.
- ACE inhibitors – in case of heart disease or high blood pressure.
- Pain-relieving and antipyretic medicines such as pentoxifylline, propoxyphene and salicylates (eg aspirin ).
- Pentamidine – in certain infections caused by parasites. This can cause low blood sugar, which is sometimes followed by high blood sugar.
Your blood sugar level may increase ( hyperglycaemia ) if you take:
- Corticosteroid, e.g. cortisone – in case of inflammation.
- Danazol – for endometriosis .
- Diazoxide – in case of high blood pressure.
- Protease inhibitors – in HIV.
- Diuretics – in case of high blood pressure or if you have accumulated fluid.
- Glucagon – in case of very low blood sugar.
- Isoniazid – in tuberculosis .
- Somatropin – a growth hormone.
- Thyroid hormones – in thyroid diseases.
- Estrogens and progestogens – e.g. birth control pills used for birth control.
- Clozapine, olanzapine and phenothiazine derivatives – in mental illnesses.
- Sympathomimetics e.g. adrenaline ( epinephrine ), salbutamol and terbutaline – in asthma.
Blood sugar levels may sometimes increase and sometimes decrease if you take:
- Beta-blockers or clonidine – in case of high blood pressure.
- Lithium salts – in mental illnesses.
Beta-blockers
Beta-blockers as well as other sympatholytic drugs (such as clonidine, guanethidine and reserpine – in high blood pressure ) can make it harder to recognize warning signs if your blood sugar is too low ( hypoglycaemia ). It can also hide or stop the first signs that your blood sugar is too low.
Use of pioglitazone 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, developed heart failure. If you develop signs of heart failure such as increased shortness of breath, rapid weight gain or local swelling ( oedema ), inform your doctor as soon as possible.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Toujeo.
Toujeo with alcohol
Your blood sugar can either rise or fall if you drink alcohol. Check your blood sugar more often than usual.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor before using this medicine. The insulin dose may need to be adjusted during pregnancy and after delivery. For the sake of the baby, it is especially important that your diabetes is kept under control and that hypoglycaemia is prevented.
Talk to your doctor if you are breastfeeding as your insulin dose and diet may need to be adjusted.
Driving ability and use of machinery
Too low or too high blood sugar or vision problems can affect the ability to drive or use tools or machines. Your ability to concentrate may be affected. It can be dangerous to yourself and others.
Ask your doctor if you can drive over:
- Your blood sugar is often too low.
- You have difficulty recognizing when your blood sugar is too low.
Important information about any excipient in Toujeo
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that it is almost “sodium-free”.
How to use Toujeo
Always use this medicine as directed by your doctor. Consult a doctor, pharmacist or nurse if you are unsure.
Although Toujeo contains the same active substance as insulin glargine at 100 units/ml, these medicines are not interchangeable. The transition from one insulin treatment to another requires a prescription, medical monitoring and blood sugar control. Consult a doctor for further information.
How much to take
The Toujeo SoloStar pre-filled pen can deliver a dose of 1 to 80 units for each injection, in 1 unit dose increments.
The dosing window on the SoloStar pen shows the number of units of Toujeo to be injected. Do not recalculate dose one.
Depending on your lifestyle, the results of your blood sugar test and previous insulin treatment, the doctor will tell you:
- How much Toujeo you will need each day and at what time of day?
- When to check your blood sugar level and if you need to do a urine test.
- When you may have to increase or decrease the dose a.
Toujeo is a long-acting insulin. The doctor may prescribe it in combination with fast-acting insulin or other medicines for high blood sugar.
If you use more than one insulin, make sure you are taking the correct insulin by checking the insulin label before each injection. Medication errors due to confusion between insulins, especially between long-acting insulins and rapid-acting insulins, have been reported. The “300” strength is marked in honey yellow on the label of your pre-filled Toujeo SoloStar pen. Ask your doctor or pharmacy staff if you are unsure.
Many factors can affect blood sugar levels. You need to know these factors to react correctly when the blood sugar level changes and to prevent the level from becoming too high or too low. See the box at the end of this leaflet for more information.
Flexible timing of administration
- Use Toujeo once daily, preferably at the same time each day.
- If necessary, you can inject Toujeo up to 3 hours before or after the usual dosing time.
Use in elderly patients (65 years and older)
Talk to your doctor if you are 65 or older, as you may need a lower dose.
If you have kidney or liver problems
Talk to your doctor if you have kidney or liver problems, as you may need a lower dose.
Before injecting Toujeo
- Read the instructions for use that come with the package insert.
- If you do not follow all instructions, you may receive too much or too little insulin.
How to inject
- Toujeo is injected under the skin ( subcutaneous use, sc).
- Give an injection in the front of the thighs, in the upper arms or the front of the waist (abdomen).
- Vary the injection site within the area of skin you use for injection each day. It reduces the risk of the skin shrinking or thickening (for more information, see “Other side effects” in section 4).
To prevent the possible transmission of disease, injection pens should never be used for more than one person, even if the injection needle is changed.
Always attach a new sterile needle before each injection. Never reuse needles. Reusing a needle increases the risk of it becoming clogged and giving you too much or too little insulin.
Dispose of the used needle in a puncture-proof container or according to current procedures.
Do not use Toujeo
- In a vein. That would change the way it works and cause low blood sugar.
- In an insulin infusion pump.
- If there are particles in insulin et. The solution should be clear, colourless and water-like.
Never use a syringe to remove Toujeo from a SoloStar pen. It can lead to serious overdoses. See also section 2.
If the SoloStar pen is damaged or has not been stored properly, if you are not sure if it is working properly, or if you notice that your blood sugar control has unexpectedly worsened:
- Discard the pen and use a new one.
- Talk to your doctor, pharmacist or nurse if you think you have a problem with the pen.
If you have used too much Toujeo
If you have injected too much of this medicine, your blood sugar level may become too low. Check your blood sugar and eat more food to prevent blood sugar from getting too low. If your blood sugar gets too low, read the advice in the box at the end of this leaflet.
If you forget to use Toujeo
If needed, Toujeo can be injected up to 3 hours before or after the time you usually inject it.
If you have forgotten a dose of Toujeo or if you have not injected enough insulin, your blood sugar level may become too high ( hyperglycaemia ).
- Do not inject a double dose to make up for a missed dose.
- Check the blood sugar and then inject the next dose at the usual time.
- For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.
If you stop using Toujeo
Do not stop taking this medicine without talking to your doctor. If you stop taking the medicine, it can lead to very high blood sugar and acid build-up in the blood ( ketoacidosis ).
If you have further questions about this medicine, contact your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice that your blood sugar is getting too low ( hypoglycaemia ), take immediate action to raise your blood sugar level (see the box at the end of this leaflet).
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 your blood.
If your blood sugar level gets too low, you may pass out (pass out).
Very low blood sugar can cause brain damage and can be life-threatening.
For more information, see the box at the end of this leaflet.
Serious allergic reaction (rare, may affect up to 1 in 1,000 people). Symptoms may include rash and itching all over the body, swelling of the skin and mouth, shortness of breath, feeling faint (drop in blood pressure) with rapid heartbeat and sweating. Severe allergic reactions to insulin can be life-threatening. Contact a doctor immediately if you notice signs of a severe allergic reaction.
Other side effects are
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
- Skin changes at the injection site: If you inject insulin too often in the same place, the skin may either shrink (lipoatrophy) ( may affect up to 1 in 100 people ) or thicken (lipohypertrophy) ( may affect up to 1 in 10 people ). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis. How often this occurs is not known). Insulin it may not work as well if you inject it into an area with nodules. Change the injection site for each injection to prevent these skin changes.
Common: may affect up to 1 in 10 people
- Skin side effects and allergic reactions at the injection site: The reactions may include redness, unusually intense pain at the injection site, itching, hives, swelling and inflammation. These reactions may spread around the injection site. Most less serious insulin reactions usually go away within a few days to a few weeks.
Rare: may affect up to 1 in 1,000 people
- Visual impact: A marked change (improvement or deterioration) in blood sugar control can impair your vision. If you have an eye disease associated with diabetes called proliferative retinopathy, attacks of very low blood sugar can cause temporary loss of vision.
- Swelling in the calves and ankles is caused by the temporary accumulation of water in the body.
Very rare: may affect up to 1 in 10,000 people
- Taste changes ( dysgeusia ).
- Muscle pain ( myalgia ).
Inform the doctor, pharmacist or nurse if you notice any of the above side effects.
How Toujeo should be stored
Use before the expiry date which is stated on the carton and the pen label after “EXP”. The expiration date is the last day of the specified month.
Before first use
Store in a refrigerator (2°C-8°C).
May not be frozen or stored in direct contact with freezer compartments or cooling clamps.
Store the pre-filled pen in the outer carton. Light sensitive.
After first use or if it is taken as a spare
Do not store the injection pen in the refrigerator. The pen can be stored for a maximum of 6 weeks below 30°C and protected from direct heat and direct light. Discard the pen after this period. Do not leave insulin in a car on an unusually hot or cold day. Always keep the protective cap on the pen when not in use to protect it from light.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is insulin glargine. Each ml of solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each injection pen contains a 1.5 ml injection solution, corresponding to 450 units.
- Other ingredients are zinc chloride, metacresol, glycerol, water for injections and sodium hydroxide (see section 2 “Important information about any ingredient in Toujeo”) and hydrochloric acid (for pH adjustment).
Appearance and package sizes of the medicine
Toujeo is a clear and colourless solution.
Each injection pen contains 1.5 ml of solution for injection (equivalent to 450 units).
Packs of 1, 3, 5 and 10 pre-filled pens are available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH, D–65926 Frankfurt am Main, Germany.