Adlyxin

Pronunciation: ad-LIX-in
Generic name: lixisenatide
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 3, 2025.

What is Adlyxin?

Adlyxin is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently.

• Adlyxin is used to improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise. Adlyxin injection is not for use in people with type 1 diabetes.
• The generic name for Adlyxin is lixisenatide.

Adlyxin’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. Adlyxin belongs to the drug class called GLP-1 receptor agonists.

Adlyxin first gained FDA approval on July 27, 2016. There is no Adlyxin generic.

Adlyxin side effects

The most common side effects of Adlyxin are:

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

Serious side effects and warnings

Adlyxin 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 Adlyxin. Stop taking Adlyxin 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 Adlyxin 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 Adlyxin. 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 Adlyxin. 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). Adlyxin may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Adlyxin before you are scheduled to have surgery or other procedures.

Adlyxin 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). Adlyxin is not for people with slow emptying of the stomach.

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

These are not all the possible side effects of Adlyxin. 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 Adlyxin if you:

• are allergic to lixisenatide, Adlyxin, or any of the ingredients in Adlyxin. See the end of this guide for a complete list of ingredients. Symptoms of a severe allergic reaction with Adlyxin 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 Adlyxin, 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 Adlyxin will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using Adlyxin.

Breastfeeding

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

How do I use Adlyxin?

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

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

• Your healthcare provider should teach you how to inject Adlyxin 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 Adlyxin injection to make sure you are using the correct medicine.
• You must activate each Adlyxin pen before you use it for the first time.

Use Adlyxin 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 Adlyxin 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 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.

Stop taking Adlyxin 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 Adlyxin, take it within 1 hour before your next meal.

What other drugs will affect Adlyxin?

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 Adlyxin. 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 Adlyxin
• birth control pills that are taken by mouth (oral contraceptives). Adlyxin 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 Adlyxin or at least 11 hours after your Adlyxin 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 Adlyxin?

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

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

Do not freeze Adlyxin pens and do not use Adlyxin 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 Adlyxin past the expiration date printed on the label of the carton and pen.

Do not store the Adlyxin 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 Package Insert about the right way to throw away the Adlyxin pen.

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

Adlyxin ingredients

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 Adlyxin?

sanofi-aventis U.S. LLC, makes Adlyxin.

Adlyxin 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 Adlyxin.

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Further information

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

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