Insulin glargine + lixisenatide 100 units/mL + 33 mcg/mL solution for injection in prefilled pen

What Insulin glargine + lixisenatide is used for:

• Insulin glargine + lixisenatide is used to improve blood sugar levels in adult patients with type 2 diabetes mellitus. 
• It contains two active substances that help your body control your blood sugar: 
• insulin glargine – a long-acting basal insulin which lowers your blood sugar levels. 
• lixisenatide – a ‘GLP-1 analogue’ that helps your body make more insulin during meals and lowers the amount of sugar made by your body. 
• Insulin glargine + lixisenatide is used with oral medicines for diabetes (such as metformin, pioglitazone and sulfonylurea medicines). It is prescribed when these medicines (used alone or with GLP-1 treatment or with basal insulin) are not enough to control your blood sugar levels.

Do not use Insulin glargine + lixisenatide:

if you are allergic to insulin glargine or lixisenatide or any of the other ingredients of this medicine.

Warnings and Precautions:

Talk to your doctor, before using Insulin glargine + lixisenatide:

• If you are also taking other medicines to treat diabetes
• Do not use Insulin glargine + lixisenatide if you have type 1 diabetes mellitus or if you have ‘ketoacidosis’ (a condition with a build-up of acid in the blood).
• Do not use insulin glargine + lixisenatide before the age of 18 years.
• The use of Insulin glargine + lixisenatide is not recommended in patients with inflammatory bowel disease or delayed gastric emptying.
• If you have eye problems. 
• If you have or have had a thyroid disease.
• If you have a severe stomach ache which does not go away, this could be a sign of inflamed pancreas.
• If you have dehydration (loss of fluids from the body) which can happen if you are feeling or being sick (nausea or vomiting) or have diarrhea – it is important to drink plenty of fluids to stop dehydration.

Possible side effects of Insulin glargine + lixisenatide:

• Insulin glargine + lixisenatide is given as an injection under the skin (subcutaneously). Do not inject it into a vein or muscle.
• The best places to inject are the front of your thighs, upper arms or the front of your waist (abdomen).
• Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting.
• Always use a new needle for each injection. Re-use of needles may increase the risk of blocked
• needles leading to inaccurate dosing. Dispose of the needle safely after each use.

Other medicines and Insulin glargine + lixisenatide:

Please tell your doctor, if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially if you take medicines for: birth control, pain, hormonal replacement, diabetes, hypertension, asthma, depression, auto-immune diseases and infection.

How to take Insulin glargine + lixisenatide:

• Your dose of Insulin glargine + lixisenatide is administered as ‘dose steps’. The dose counter on the pen shows the number of dose steps.
• Use Insulin glargine + lixisenatide once each day, preferably at the same time every day. Choose a time of the day that works best for you.
• Insulin glargine + lixisenatide is given as an injection under the skin (subcutaneously). Do not inject it into a vein or muscle.
• The best places to inject are the front of your thighs, upper arms or the front of your waist (abdomen).
• Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting.
• Always use a new needle for each injection. Re-use of needles may increase the risk of blocked
• needles leading to inaccurate dosing. Dispose of the needle safely after each use.

How to store Insulin glargine + lixisenatide:

• 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 carton after ‘EXP’.
• Before opening: Store in a refrigerator (2°C to 8°C). Keep away from the freezing element. Do not freeze.
• During use: You can carry Insulin glargine + lixisenatide with you and keep it at room temperature (no more than 30°C) or in a refrigerator (2°C to 8°C) for up to 21 days. The product should be thrown away 21 days after first opening.
• Always keep the cap on the pre-filled pen when you are not using it in order to protect it from light.
• Do not throw away any medicines via wastewater or household waste.