LYXUMIA 10 micrograms solution for injection LYXUMIA 20 micrograms solution for injection
lixisenatide
What Lyxumia is and what it is used for
Lyxumia contains the active substance lixisenatide.
Lyxumia is medicine for injection that is used to help the body control your blood sugar level in cases where it is too high. It is used in adults with type 2 diabetes.
Lyxumia is used with other diabetes medicines when these are not enough to control your blood sugar levels. These may include:
- oral diabetes medicines (such as metformin , pioglitazone, sulphonylurea medicines) and / or
- a basal insulin, a type of insulin that works throughout the day
What you need to know before using Lyxumia
Do not use Lyxumia
- if you are allergic to lixisenatide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Lyxumia about:
- you have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body can not break down glucose because there is not enough insulin ) because this medicine will not be right for you
- you have or have had inflammation of the pancreas ( pancreatitis )
- you have severe problems with the stomach or intestines, such as a disease of the abdominal muscle called gastroparesis which leads to delay in gastric emptying
- you have severe kidney disease or if you are receiving dialysis treatment, as the use of this medicine is not recommended
- you also use a sulphonylurea or a basal insulin, as it can cause low blood sugar ( hypoglycaemia ). Your doctor may want to check your blood sugar level and then decide whether to reduce the dose of a basal insulin or sulphonylurea. Lyxumia should not be used with a combination of both basal insulin and sulphonylurea.
- you are taking other medicines, as there are other medicines such as antibiotics or gastric juice-resistant tablets or capsules that should not be left in the stomach for too long (see section Other medicines and Lyxumia)
- you experience fluid loss / dehydration, such as vomiting, nausea and diarrhea. It is important to avoid dehydration by drinking a lot, especially when starting treatment with Lyxumia.
- you suffer from heart problems that can cause shortness of breath or swollen ankles, as there is limited experience from this population.
Children and young people
Experience from the treatment of children and adolescents under the age of 18 is lacking and therefore Lyxumia is not recommended for this age group.
Other medicines and Lyxumia
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
The effect of certain medicines that you swallow may be affected by Lyxumia. Some medicines such as antibiotics or gastric juice-resistant tablets or capsules that should not be left in the stomach for too long may need to be taken at least one hour before or four hours after injection with Lyxumia.
Pregnancy and breastfeeding
Lyxumia should not be used during pregnancy. It is not known if Lyxumia can harm your fetus.
Lyxumia should not be used if you are breastfeeding. It is not known if Lyxumia 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 taking this medicine.
Driving and using machines
If you use Lyxumia with a sulphonylurea or basal insulin you may have low blood sugar (hypoglycemia). This can impair your ability to concentrate and you may feel dizzy or sleepy. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Lyxumia
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. This medicine contains metacresol, which may cause allergic reactions.
How to use Lyxumia
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
How much to inject
- The starting dose is 10 micrograms once daily for the first 14 days – injected with the green pen.
- The next dose will be 20 micrograms once daily – injected with the purple pen.
When to inject
Inject Lyxumia within one hour before any meal during the day. Decide on which meal suits you best, then inject Lyxumia preferably before the same meal every day.
Where to inject
Inject Lyxumia under the skin ( subcutaneously ) into the abdomen, upper leg (thigh), or upper arm.
Learning how to use pre-filled pens
Before using Lyxumia for the first time, your doctor or nurse will show you how to inject Lyxumia.
- Always read the instructions in the package.
- Always use the pen as described in the instructions for use.
Other important information regarding the use of pre-filled pens
There is more information on how to use the pens in the instruction manual. The most important points are:
- Always use a new needle for each injection . You must dispose of the needle after each use in a suitable needle can, according to local guidelines. Talk to your doctor, nurse or pharmacist about how to dispose of needles.
- Use only needles that are intended for use with the Luxury Pen (see instructions for use).
- You must activate the Luxury pen before using it for the first time. This is to ensure that it works correctly and that the dose for the first injection is correct.
- Do not use the Luxury Pen if you think it is damaged, take a new one instead. Do not try to fix the pen.
If you use more Lyxumia than you should
If you use more Lyxumia than you should, talk to a doctor or nurse immediately. Too much Lyxumia can make you feel sick or vomit.
If you forget to use Lyxumia
If you forget to take a dose of Lyxumia, you can inject Lyxumia within one hour before the next meal. Do not take a double dose to make up for a forgotten dose.
If you stop using Lyxumia
Do not stop using Lyxumia without talking to your doctor. If you stop using Lyxumia, your blood sugar levels may increase.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some severe allergic reactions (such as anaphylactic reactions) have been reported very rarely in patients receiving Lyxumia. You should contact a doctor immediately if you experience symptoms such as swelling of the face, tongue, or throat which causes difficulty breathing.
Stop using Lyxumia and contact your doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdominal area that can also be felt in the back, as well as nausea and vomiting, as it can be a sign of inflamed pancreas ( pancreatitis )
The most frequent adverse reactions reported with Lyxumia may affect more than 1 in 10 patients (frequency very common) were nausea and vomiting. These side effects were mostly mild and usually subsided over time in most patients.
Other side effects include:
Very common side effects: may affect more than 1 in 10 people
- Diarrhea
- Headache
- Low blood sugar ( hypoglycaemia ) especially when Lyxumia is used with insulin or a sulphonylurea
The warning signs of low blood sugar may include cold sweats, pallor, headache, drowsiness, weakness, dizziness, confusion or irritation, hunger, palpitations, and tremors. Your doctor will tell you what to do if you get low blood sugar. Hypoglycemia
is more likely to occur if you take sulphonylurea or basal insulin. Your doctor may reduce the dose of one of these medicines before you start using Lyxumia.
Common side effects: may affect up to 1 in 10 people
- Influenza
- Cold ( upper respiratory tract infection )
- Dizziness
- Indigestion ( dyspepsia )
- Back pain
- Cystitis ( cystitis )
- Viral infections
- Low blood sugar (when Lyxumia is used with metformin )
- Drowsiness (sleepiness)
- Injection site reactions (such as pruritus )
Rare side effects: may affect up to 1 in 100 people
- Hives ( urticaria )
How to store Lyxumia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pen label and the carton after EXP. The expiration date is the last day of the specified month.
Before first use
Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Store protected from freezer compartments.
Using the pen The
a pen can be used for 14 days when stored at room temperature at a maximum of 30 ° C. Do not freeze.
Do not store with a needle attached. When you are not using the pen, keep the protective cap on the pen to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is lixisenatide.
- Lyxumia 10 micrograms solution for injection : Each dose contains 10 micrograms lixisenatide (50 micrograms per ml).
- Lyxumia 20 micrograms solution for injection : Each dose contains 20 micrograms lixisenatide (100 micrograms per ml).
- The other ingredients are glycerol 85%, sodium acetate trihydrate, methionine, metacresol, hydrochloric acid (for pH adjustment), sodium hydroxide solution (for pH adjustment) and water for injection .
What the medicine looks like and contents of the pack
Lyxumia is a clear and colorless solution ( solution for injection ) filled in a glass ampoule into a pre-filled pen.
Each green pencil Lyxumia 10 micrograms solution for injection contains 3 ml of solution and delivers 14 doses of 10 micrograms. Pack size is 1 pre-filled pen.
Each purple pencil Lyxumia 20 micrograms solution for injection contains a 3 ml solution and delivers 14 doses of 20 micrograms. Pack sizes are 1, 2, or 6 pre-filled pens. Not all pack sizes may be marketed in your country.
A starter pack is also available for use during the first 28 days of treatment. Starter pack one contains a green pen of Lyxumia 10 micrograms solution for injection and a purple pen of Lyxumia 20 micrograms solution for injection.
Marketing Authorisation Holder
sanofi-aventis groupe
54, rue La Boétie
F – 75008 Paris
France
Manufacturer
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst – 65926 Frankfurt am Main
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sanofi AB
Tel: +46 (0) 8 634 50 0