Sanofi Receives FDA Approval of AdlyxinTM for Treatment of Adults with Type 2 Diabetes - Seite 2

Indication and Usage

What is Adlyxin (lixisenatide) injection?
Adlyxin is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise.

• Adlyxin is not insulin and should not be used instead of a long-acting insulin.
• Adlyxin is not for people with type 1 diabetes or people with diabetic ketoacidosis.
• Adlyxin has not been studied in people with a history of pancreatitis.
• Adlyxin has not been studied in people who use short-acting insulin.
• It is not known if Adlyxin is safe and effective in children.

Important Safety Information for Adlyxin (lixisenatide) injection

What is the most important information I should know about Adlyxin?
Do not share your Adlyxin pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Adlyxin can cause serious side effects, including:

• inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Stop using Adlyxin and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel pain from your abdomen to your back.

Do not use Adlyxin if you:

• are allergic to lixisenatide or any of the other ingredients in Adlyxin.

Symptoms of severe allergic reaction with Adlyxin may include swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Before using Adlyxin, tell your healthcare provider if you:

• have or have had pancreatitis, stones in your gallbladder, or a history of alcoholism.
• have or have had kidney problems.
• have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
• are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Adlyxin will harm your unborn baby.

Tell your healthcare provider about all the medicines you take, including prescription medicines (especially antibiotics and birth control pills) and over-the-counter medicines (especially acetaminophen), vitamins, herbal supplements or other medicines to treat diabetes, including sulfonylureas or insulin.