Pronunciation: LIX i SEN a tide

Brand: Adlyxin

What is the most important information I should know about lixisenatide?

Stop using this medicine and call your doctor at once if you have nausea and vomiting with severe pain in your upper stomach spreading to your back.

What is lixisenatide?

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

Lixisenatide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Lixisenatide is not for treating type 1 diabetes.

Lixisenatide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using lixisenatide?

You should not use lixisenatide if you are allergic to it.

To make sure lixisenatide is safe for you, tell your doctor if you have:

  • a history of pancreatitis or gall stones;
  • problems with digestion;
  • kidney disease;
  • a history of alcoholism; or
  • diabetic ketoacidosis (call your doctor for treatment with insulin).

Follow your doctor's instructions about using lixisenatide if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

Lixisenatide can make birth control pills less effective. Ask your doctor about using a nonhormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Lixisenatide is not approved for use by anyone younger than 18 years old.

How should I use lixisenatide?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Lixisenatide is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Lixisenatide comes in a prefilled injection pen that contains 14 pre-set doses. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Lixisenatide is usually injected once per day. Use lixisenatide within 60 minutes (1 hour) before your first meal of the day. Try to use the medicine at the same time each day.

Your care provider will show you the best places on your body to inject lixisenatide. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Lixisenatide is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Storing unopened (not in use) lixisenatide: Refrigerate and protect from light. Take the injection pen out of the refrigerator and allow it to reach room temperature before using.

Do not freeze lixisenatide, and throw away the medicine if it has been frozen.

Storing opened (in use) lixisenatide: Store at room temperature with the pen cap attached, and use within 14 days. Do not store the injection pen with a needle attached.

What happens if I miss a dose?

Wait until your next meal and use the medicine within 1 hour before you eat. Then go back to your regular injection schedule the next day. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using lixisenatide?

Lixisenatide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

  • If you also take acetaminophen (Tylenol), take it at least 1 hour before you use lixisenatide.
  • If you also take any type of antibiotic, take it at least 1 hour before you use lixisenatide.
  • If you also take a birth control pill, take it at least 1 hour before or 11 hours after you use lixisenatide.

What are the possible side effects of lixisenatide?

Get emergency medical help if you have signs of an allergic reaction: hives, itching, severe rash; rapid heartbeats; trouble swallowing; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • low blood sugar --headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky; or
  • kidney problems --little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • headache;
  • dizziness; or
  • low blood sugar.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect lixisenatide?

Other drugs may interact with lixisenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about lixisenatide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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