For U.S. Residents Only

What is Adlyxin?

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 is not a substitute for insulin.
  • Adlyxin is not for use in 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.
  • Adlyxin has not been studied in, and is not for, people who have a stomach problem that causes slow emptying of the stomach (gastroparesis).
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Adlyxin is pronounced phonetically as “Ad‐lix‐in”

GLP-1 is a naturally-occurring hormone secreted from your small intestine when you eat. It helps control your blood sugar in several ways:

  • Helps the body produce more insulin
  • Helps slow down the process by which the liver releases sugar into the bloodstream
  • Slows the rate at which food leaves your stomach and passes into the intestine

Adlyxin comes in a disposable pre-filled pen. The starting dose of Adlyxin is 10 mcg (green pen) injected under the skin (subcutaneously) once daily for 14 days. Increase the dose to the maintenance dose of 20 mcg (Burgundy pen) injected under the skin (subcutaneously) once daily starting on day 15.

Adlyxin should be injected 1 time each day within 60 minutes (1 hour) before the first meal of the day and at the same time each day. It is important to take Adlyxin exactly how your doctor has prescribed and read the detailed Instructions for Use that comes with your Adlyxin.

Do not use Adlyxin if you:
are allergic to lixisenatide or any of the other ingredients in Adlyxin. See the Medication Guide for a complete list of ingredients in Adlyxin. 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
  • fainting or feeling dizzy
  • 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 plan to become pregnant. 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.
  • are breastfeeding or plan to breastfeed. 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.

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.

  • Read the detailed Instructions for Use that comes with your Adlyxin for instruction on using the Adlyxin pen and injecting Adlyxin.
  • Adlyxin comes as a disposable prefilled pen.
  • 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.
  • 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.
  • Use Adlyxin 1 time each day within 60 minutes (1 hour) before the first meal of the day and at the same time each day.
  • If you miss a dose of Adlyxin, take it within 1 hour before your next meal.
  • Do not change your dose unless your healthcare provider has told you to change your dose.
  • Check the label on the pen each time you give your Adlyxin injection to make sure you are using the correct medication.
  • You must activate each Adlyxin 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 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.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

Your dose of Adlyxin and other diabetes medicines may need to change because of:

  • change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

Adlyxin may cause serious side effects including:

  • inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before using Adlyxin, tell your healthcare provider if you have had: pancreatitis, stones in your gallbladder (cholelithiasis), or a history of alcoholism. These medical problems may make you more likely to get pancreatitis. 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.
  • 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 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 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 who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.

The most common side effects of Adlyxin include:

  • Nausea
  • vomiting
  • headache
  • diarrhea
  • feeling dizzy

These are not all the possible side effects of Adlyxin. Call your doctor for medical advice about side effects. If you are having a problem while taking Adlyxin please contact us at .

Pay as little as $0*

if enrolled in the Sanofi Rx Savings program and taking select Sanofi diabetes products. Pay as little as $15 if new to the program. See Program Restrictions below *

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 is not a substitute for 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.
  • Adlyxin has not been studied in, and is not for, people who have a stomach problem that causes slow emptying of the stomach (gastroparesis).

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 or if Adlyxin passes into your breastmilk.

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 Adlyxin?

  • Do not change your dose unless your healthcare provider has told you to change your dose.
  • Check the label on the pen each time you give your Adlyxin injection to make sure you are using the correct medication.
  • You must activate each Adlyxin 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 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.

What are the possible side effects of Adlyxin?

Adlyxin may cause serious side effects including:

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

The most common side effects of Adlyxin (lixisenatide) injection include:

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

If you are a patient experiencing problems with a Sanofi US product, please contact Sanofi US at .

The health information contained herein is provided for general educational purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.

*

*Co-Pay Program
Eligibility Restrictions:
This offer is for US residents over the age of 18 with commercial/private insurance and is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, or TRICARE, or similar federal or state programs including any state pharmaceutical assistance programs.
Should you begin receiving prescription benefits from any federal, state or government funded program at any time, you will no longer be able to participate in this program. Important to note that if you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Also, if you have a Federal Employee Health Benefits (FEHB) plan with Commercial or private insurance, you may be qualified to receive and use this savings card. Void where prohibited by law.

Program Terms:
Patients enrolled in the Sanofi Rx Savings Program and currently using Toujeo® (insulin glargine injection) 300 Units/mL or Lantus® (insulin glargine injection) 100 Units/mL have a $0 copay per prescription for Adlyxin for 12 months. All other eligible patients have a $15 copay per prescription for 12 consecutive months. This offer will cover a copay balance up to a maximum of $700 off each Adlyxin prescription for the duration of the program. Savings may vary depending on individual out-of-pocket costs. This offer only applies to prescriptions requiring a copay and cannot be applied to prescriptions being paid in cash. Sanofi reserves the right to rescind, revoke, or amend the program at any time without notice.

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SAUS.ADL.19.01.0295a Last Updated: January 2019

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 (lixisenatide) injection 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