100 units/ml + 50 micrograms/ml solution for injection , solution in pre-filled pen
Insulin glargine + lixisenatide
What Suliqua is and what it is used for
Suliqua is an injection medicine for diabetes that contains two active substances:
- insulin glargine – a type of long-acting insulin that helps regulate blood sugar throughout the day
- lixisenatide – a so-called GLP-1 analog that helps the body produce its insulin in response to blood sugar increases, and prolongs the absorption of sugar from food.
Suliqua is used in the treatment of type 2 diabetes in adults, to regulate blood sugar levels when they are too high and is a supplement to diet and exercise. It is given with metformin, with or without sodium-glucose co-transporter 2 (SGLT-2) inhibitors (gliflozin products), when other medicines are not sufficient to control your blood sugar levels.
What you need to know before using Suliqua
Do not use Suliqua:
- if you are allergic to insulin glargine or 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 Suliqua
- if you have type 1 diabetes, as Suliqua is used for type 2 diabetes and this medicine will therefore not be right for you.
- you have diabetic ketoacidosis (a diabetes complication that occurs when the body is unable to use glucose because there is not enough insulin ) because this medicine will not be right for you.
- you have severe problems with your stomach or intestines, such as a disease of the stomach muscle called gastroparesis, which leads to delayed gastric emptying. Because Suliqua can cause stomach side effects (see section 4), the medicine has not been studied in patients with severe stomach or intestinal problems. See information regarding medicines that should not be left in the stomach for too long under the section “Other medicines and Suliqua”.
- you have severe kidney disease or if you are receiving dialysis treatment, as the use of this medicine is not recommended then.
Carefully follow the instructions for dosage, sampling (blood and urine tests), diet and physical activity (physical work and exercise), and injection technique as discussed with your doctor.
Pay particular attention to the following:
- too low blood sugar (hypoglycemia). If your blood sugar is too low, follow the advice on treating hypoglycemia (see information in the box at the end of this leaflet).
- too high blood sugar (hyperglycemia) If your blood sugar is too high, follow the advice on treating hyperglycemia (see information in the box at the end of this leaflet).
- make sure you are using the right medicine. Always check the label before each injection, to avoid Suliqua being confused with other insulins.
- if you have poor vision, see section 3.
Pay particular attention to the following when using this medicine and talk to your doctor, pharmacist, or nurse before using Suliqua:
- severe stomach pain that does not go away. This may be a sign of an inflamed pancreas ( acute pancreatitis ).
- loss of fluid from your body ( dehydration ), for example in the case of vomiting and diarrhea. It is important to avoid dehydration by drinking a lot, especially during the first weeks of treatment with Suliqua.
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 Suliqua). 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.
Trip
Consult your doctor before you travel. You may need to raise questions about:
- the availability of your medicine in the country you are visiting,
- the availability of medicines, syringes, and other items,
- correct storage of the medicine during the trip,
- times for meals and medication use during the trip,
- possible consequences of traveling to other time zones,
- any new health risks in the countries you visit,
- what to do in an emergency if you feel unwell or become ill.
Children and young people
Experience from treatment with Suliqua in children and adolescents under 18 is lacking, Suliqua is therefore not recommended for this age group.
Other medicines and Suliqua
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. If you are using any other diabetes medicine, talk to your doctor about whether you should stop taking the medicine when you start using Suliqua.
Some medicines can change your blood sugar level. This may mean that your doctor needs to change your Suliqua dose. Therefore, consult a doctor before starting to take any medicine. Ask if it will affect your blood sugar and what possible measures you need to take if so. You also need to pay attention when you stop taking a medicine.
The effect of some medicines that you swallow can be affected by Suliqua. Certain drugs such as antibiotics, birth control pills, statins (cholesterol-lowering drugs such as atorvastatin) or enteric-resistant tablets, capsules, granules, oral powder, or suspension that should not remain in the stomach for too long may need to be taken at least one hour before or four hours after injection with Suliqua.
Medicines that can cause your blood sugar level to drop (hypoglycemia) include:
- All other medicines for the treatment of diabetes.
- Disopyramide – in certain heart conditions.
- Fluoxetine – for depression.
- Sulfonamide antibiotics – to treat the infection.
- Fibrates – to lower high blood fat levels.
- MAO inhibitors – in depression or Parkinson’s disease.
- ACE inhibitors – in certain heart conditions or high blood pressure.
- Pain relievers and antipyretics such as pentoxifylline, propoxyphene, and salicylates (such as aspirin ).
- Pentamidine – in certain parasitic infections. This can cause low blood sugar which is sometimes accompanied by high blood sugar.
Medicines that can cause your blood sugar level to rise (hyperglycemia) include:
- Corticosteroids such as cortisone and prednisolone – for inflammation.
- Danazol – for endometriosis (misplaced endometrium).
- Diazoxide – in case of high blood pressure.
- Protease inhibitors – in HIV.
- Diuretics – fluid-reducing drugs for high blood pressure or fluid retention.
- Glucagon – in case of very low blood sugar.
- Isoniazid – for tuberculosis.
- Somatropin, is a growth hormone.
- Thyroid hormones – in thyroid diseases.
- Estrogens and progestogens, e.g. birth control pills used for birth control or use of estrogen for osteoporosis.
- Clozapine, olanzapine, and phenothiazine derivatives – in mental illness.
- Sympathomimetic drugs e.g. adrenaline ( epinephrine ), salbutamol, and terbutaline – in asthma.
Blood sugar levels may either increase or decrease if you use:
- Beta-blockers or clonidine – in case of high blood pressure.
- Lithium salts – in case of mental illness.
Medicines that can affect the warning signals of low blood sugar
Beta-blockers and some other drugs (eg clonidine, guanethidine, reserpine – in high blood pressure ) can make it harder to recognize the first warning signs of low blood sugar levels (hypoglycemia). It can even hide or prevent the first warning signs that your blood sugar is too low.
If you are unsure whether the above applies to you, consult a doctor, pharmacist, or nurse before using this medicine.
Warfarin or other blood-thinning drugs
Tell your doctor if you are using warfarin or other blood thinners (medicines that prevent the blood from forming clots). You may need to take blood samples more often to measure the clotting ability of the blood (called the INR test – which stands for International Normalized Ratio).
Suliqua with alcohol
Your blood sugar can either rise or fall if you drink alcohol. You should check your blood sugar more often.
Pregnancy and breastfeeding
Suliqua should not be used during pregnancy. It is not known whether Suliqua can harm your unborn baby.
Suliqua should not be used if you are breastfeeding. It is not known whether Suliqua 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 ability and use of machinery
Having too low or too high blood sugar (see information box at the end of this leaflet) can affect your ability to drive and operate tools or machines. Your ability to concentrate may be affected. This can pose a danger to yourself and others.
Ask your doctor for advice on whether you should overtake:
- Your blood sugar is often too low
- You have a hard time feeling when your blood sugar is too low
Suliqua contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is almost “sodium-free”.
Suliqua contains metacresol
This medicine contains metacresol which can cause allergic reactions.
How to use Suliqua
Always use this medicine as directed by your doctor. Your doctor may tell you to use a different dose compared to your previous dose of insulin or glucose-lowering medicine. Consult a doctor, pharmacist, or nurse if you are unsure.
Depending on your lifestyle, the results of your blood sugar test, and previous insulin treatment, the doctor will tell you:
- How much Suliqua 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.
Your doctor may recommend that you use Suliqua together with other medicines for high blood sugar.
How much to use
Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen:
- This pen gives you doses from 10 to 40 dose steps in one injection, in steps of 1 dose step.
- Each dose step you turn forward contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide
Your Suliqua dose is given as “dose steps”. The dosing window of the injection pen shows the number of dose steps.
Do not inject a lower dose than 10 dose increments. Do not inject a larger dose than 40 dose increments. If a larger dose than 40 dose increments is required, your doctor will prescribe a different strength. For dose steps between 30-60 units, Suliqua 100 units/ml + 33 micrograms/ml solution for injection in the pre-filled pen is available.
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.
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.
When to inject Suliqua
Use Suliqua once daily, within an hour before a meal. Ideally, inject Suliqua before the same meal every day, when you have selected the most suitable meal.
Before injecting Suliqua
- Always follow the instructions for use that come with this leaflet and use the pen as described
- If you do not follow all directions, you may receive too much or too little Suliqua.
To avoid mistakes: always check the medicine package and the pen label before each injection to make sure you have the right pen, especially if you use more than one injection. Ask your doctor or pharmacist if you are unsure.
How to inject
- Suliqua 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 developing bumps or nodules in the skin at the injection site (for more information, see “Other side effects” in section 4).
Do not use Suliqua
- If there are particles in Suliqua. The solution should be clear, colorless, and water-like.
Other important information about using pre-filled pens
- Always attach a new needle before each injection. Reusing needles increases the risk of clogged needles, which can cause under- or overdosing. Dispose of used needles safely after each injection.
- To prevent the transmission of disease from one person to another, the injection pens should never be used for more than one person, even if the injection needle is changed.
- Use only needles designed for the Suliqua pen (see instructions for use).
- A safety test must be performed before each injection.
- Dispose of the used needle in a needle container or according to current procedures.
Never use a syringe to draw up medicine from the injection pen, to avoid dosing errors and potential overdose.
If the 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 Suliqua
If you have injected too much of this medicine, your blood sugar level may become too low (hypoglycemia). 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 Suliqua
If you have forgotten a dose of Suliqua or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycemia).
If necessary, Suliqua can be injected before the next meal.
- Do not inject a double dose to make up for a missed dose.
- Do not take two injections per day.
- Check the blood sugar and then inject the next dose at the usual time.
- For information on the treatment of hyperglycemia, see the box at the end of this leaflet.
If you stop using Suliqua
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 (hyperglycemia) 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 (hypoglycemia), take immediate action to raise your blood sugar level (see the box at the end of this leaflet). Hypoglycemia 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 faint (pass out). If your blood sugar is very low for a long time, it can cause brain damage and can be life-threatening. For more information, see the box at the end of this leaflet.
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 at the same site, the skin may either shrink (lipoatrophy) or thicken (lipohypertrophy). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis). It is not known how often these skin changes occur. 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)
- Dizziness
- Nausea
- Vomiting
- Diarrhea
- Skin side effects and allergic reactions at the injection site: The reactions may include redness, unusually intense pain during injection, 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.
Uncommon (may affect up to 1 in 100 people)
- Cold symptoms, runny nose, sore throat
- Hives ( urticaria )
- Headache
- Poor digestion ( dyspepsia )
- Stomach ache
- Fatigue
How to store Suliqua
Keep this medicine out of the sight and reach of children.
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 injection pen in the outer carton. Light sensitive.
After first use
Store the injection pen you are using at a maximum of 25°C for a maximum of 28 days. Discard the pen after this time.
Must not be put back in the refrigerator and must not be frozen. Store the injection pen away from direct heat or direct light. The protective cap must be put back on the injection pen after each injection. Light sensitive.
Do not leave the pen in a car on an unusually hot or cold day.
Do not store the pen with the needle attached.
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
What Suliqua contains
- The active substances are insulin glargine and lixisenatide. Each injection pen contains 300 units of insulin glargine and 150 micrograms of lixisenatide in a 3 ml solution for injection. Each ml contains 100 units of insulin glargine and 50 micrograms of lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
- Other excipients are glycerol (85%), methionine, metacresol, zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections. See also section 2 “What you need to know before you use Suliqua” for information on sodium and meta cresol.
Appearance and pack sizes of Suliqua
Suliqua is a clear, colorless solution for injection (for injection ) filled in a glass cartridge and inserted into a pre-filled injection pen (SoloStar).
Pack sizes of 3, 5, and 10 pre-filled pens.
Not all pack sizes may be marketed.
Injection needles are not included in the package.
Marketing Authorisation Holder
sanofi-aventis groupe
54, rue La Boétie
75008 Paris
France
Manufacturer
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst – 65926 Frankfurt am Main
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
Sanofi AB
Phone: +46 (0)8 634 50 00