Lixisenatide

Pronunciation: lix-i-sen-a-tide
Generic name: lixisenatide
Brand name: Adlyxin
Dosage form: single-patient-use prefilled pen for subcutaneous use
Drug class: GLP-1 Agonists (Incretin Mimetics)

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 5, 2025.

What is lixisenatide?

Lixisenatide (brand name Adlyxin) is used to improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.

• Lixisenatide injection is not for use in people with type 1 diabetes.

Lixisenatide’s mechanism of action involves copying a natural hormone in your body called GLP-1 to help control blood sugar in multiple ways. It tells your pancreas to make more insulin when needed, slows down food digestion to prevent blood sugar spikes after meals, reduces production of a hormone that raises blood sugar (glucagon), and helps you feel full sooner. Given as a daily injection before breakfast, it's particularly good at managing blood sugar levels after meals and may help with weight loss as an added benefit. Lixisenatide belongs to the drug class called GLP-1 receptor agonists.

Lixisenatide first gained FDA approval on July 27, 2016, under the brand name Adlyxin. There is no lixisenatide generic.

Lixisenatide side effects

The most common side effects of lixisenatide are:

• nausea
• vomiting
• headache
• diarrhea
• feeling dizzy.

Serious side effects and warnings

Lixisenatide may cause serious side effects including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. 

Severe allergic reactions. Severe allergic reactions can happen with lixisenatide. Stop taking lixisenatide and get medical help right away if you have any symptoms of a severe allergic reaction.

Low blood sugar (hypoglycemia). Your risk of getting low blood sugar is higher if you use lixisenatide with another medicine that can cause low blood sugar, such as sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine may need to be lowered while you use lixisenatide. Signs and symptoms of low blood sugar include:

• headache
• drowsiness
• weakness
• hunger
• fast heartbeat
• dizziness
• confusion
• irritability
• sweating
• feeling jittery.

Talk with your healthcare provider about how to treat low blood sugar.

Kidney problems (kidney failure). In people with kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.

Gallbladder problems. Gallbladder problems have happened in some people who take lixisenatide. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:

• pain in your upper stomach (abdomen)
• fever
• yellowing of skin or eyes (jaundice)
• clay-colored stools.

Food or liquid getting into the lungs during surgery or other procedures that use general anesthesia or deep sleepiness (deep sedation). Lixisenatide may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking lixisenatide before you are scheduled to have surgery or other procedures.

Lixisenatide has not been studied in people with a history of pancreatitis or in those who have a stomach problem that causes slow emptying of the stomach (gastroparesis). Lixisenatide is not for people with slow emptying of the stomach.

It is not known if lixisenatide is safe and effective in children.

These are not all the possible side effects of lixisenatide. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before use

Do not use lixisenatide if you:

• are allergic to lixisenatide, Adlyxin, or any of the ingredients in lixisenatide. See the end of this guide for a complete list of ingredients. Symptoms of a severe allergic reaction with lixisenatide may include swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching
• have a stomach problem that causes slow emptying of the stomach (gastroparesis).

Before using lixisenatide, tell your healthcare provider if you have had:

• pancreatitis
• stones in your gallbladder (cholelithiasis)
• a history of alcoholism.

These medical problems may make you more likely to get pancreatitis.

Also tell your healthcare provider about all of your other medical conditions, including if you:

• 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 scheduled to have surgery or other procedures that use general anesthesia or deep sleepiness (deep sedation)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if lixisenatide will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using lixisenatide.

Breastfeeding

It is not known if lixisenatide passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you use lixisenatide.

How do I use lixisenatide?

Read the detailed Instructions for Use on the Adlyxin (lixisenatide) Package Insert about using the lixisenatide pen and injecting lixisenatide. Use lixisenatide exactly as your healthcare provider tells you to. Do not change your dose unless your healthcare provider has told you to change your dose.

Lixisenatide comes as a single-patient-use prefilled pen.

• Your healthcare provider should teach you how to inject lixisenatide before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider.
• Check the label on the pen each time you give your lixisenatide injection to make sure you are using the correct medicine.
• You must activate each lixisenatide pen before you use it for the first time.

Use lixisenatide 1 time each day 60 minutes (1 hour) before the first meal of the day and at the same time each day.

• Inject your dose of lixisenatide 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.
• Do not share your lixisenatide 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.

Stop taking lixisenatide and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away.

• The pain may be felt going from your abdomen through to your back.
• The pain may happen with or without vomiting.
• These may be symptoms of pancreatitis.

What happens if I miss a dose?

If you miss a dose of lixisenatide, take it within 1 hour before your next meal.

What other drugs will affect lixisenatide?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take:

• antibiotics or the pain reliever acetaminophen. Take these medicines at least 1 hour before using lixisenatide. If you must take these medicines, take them with a meal or a snack. You should not take these medicines at the same time that you take lixisenatide
• birth control pills that are taken by mouth (oral contraceptives). lixisenatide may lower the amount of the medicine in your blood from your birth control pills and they may not work as well to prevent pregnancy. Take your birth control pill at least 1 hour before your injection of lixisenatide or at least 11 hours after your lixisenatide injection
• other anti-diabetes medicines, especially sulfonylurea medicines or insulin.

Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I store lixisenatide?

Store your new, unused lixisenatide pen in the refrigerator at 36°F to 46°F (2°C to 8°C).

• After activation, store your lixisenatide pen at room temperature no higher than 86°F (30°C).
• After activation, use the lixisenatide pen for up to 14 days.
• Throw away the used lixisenatide pen after 14 days, even if there is some medicine left in the pen.

Do not freeze lixisenatide pens and do not use lixisenatide if it has been frozen.

Protect the pen from light.

Replace the pen cap after each use to protect the container window from light.

Do not use lixisenatide past the expiration date printed on the label of the carton and pen.

Do not store the lixisenatide pen with the needle attached. If the needle is left on, this might lead to contamination and cause air bubbles which might affect your dose of medicine.

See the Instructions for Use in the Adlyxin (lixisenatide) Package Insert about the right way to throw away the lixisenatide pen.

Keep your lixisenatide pen, pen needles, and all medicines out of the reach of children.

Lixisenatide ingredients

Lixisenatide is only available under the brand name Adlyxin.

Active ingredient: lixisenatide

Inactive ingredients: glycerol 85%, metacresol, methionine, sodium acetate trihydrate, and Water for Injection, USP.
Hydrochloric acid and sodium hydroxide solution are added as needed to adjust the pH.

Who makes lixisenatide?

sanofi-aventis U.S. LLC, makes lixisenatide under the brand name Adlyxin.

Lixisenatide Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for lixisenatide.

Popular FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer