Generic Name: lixisenatide
Date of Approval: July 27, 2016
Treatment for: Type 2 Diabetes
FDA Approves Adlyxin
The U.S. Food and Drug Administration (FDA) has approved Adlyxin (lixisenatide), a once-daily mealtime glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
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.
- is not insulin and should not be used instead of a long-acting insulin.
- is not for people with type 1 diabetes or people with diabetic ketoacidosis.
- has not been studied in people with a history of pancreatitis.
- has not been studied in people who use short-acting insulin.
It is not known if this medicine is safe and effective in children.
Important Safety Information
Do not share your injection 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 treatment 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. Symptoms of severe allergic reaction 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 you start treatment, 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.
How should I use this injection?
Check the label on the pen each time you give your injection to make sure you are using the correct medication.
You must activate each injection pen before you use it for the first time.
Do not re-use or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
Inject your dose under the skin (subcutaneously) of your abdomen, thigh, or upper arm. Do not inject into a vein.
Change (rotate) your injection sites within the area you chose with each dose. Do not use the same spot for each injection.
Adlyxin side effects
Adlyxin may cause serious side effects including:
- severe allergic reactions. Severe allergic reactions can happen with Adlyxin. Stop treatment and get medical help right away if you have any symptoms of a severe allergic reaction.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you use Adlyxin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine may need to be lowered while you use Adlyxin. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, hunger, fast heartbeat, dizziness, confusion, irritability, sweating and feeling jittery.
Talk with your healthcare provider about how to treat low blood sugar.
Common side effects include:
- nausea, vomiting, headache, diarrhea and feeling dizzy.
What are the ingredients?
Active ingredient: lixisenatide
Inactive ingredients: glycerol, sodium acetate trihydrate, methionine, metacresol, water for injection, hydrochloric acid and/or sodium hydroxide.