When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to lixisenatide.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose. This medicine is usually given once a day, within 1 hour before the first meal of the day preferably on the same meal each day. It is given as a shot under the skin of your stomach, thighs, or upper arms.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• If the medicine in the prefilled pen has changed color, looks cloudy, or has particles in it, do not use it.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Use a missed dose within 1 hour before your next meal.
• Store your prefilled pens in the refrigerator and keep them in the original carton. Protect the pens from light. You may also store the pens at room temperature for up to 14 days. Do not freeze the medicine, and do not use the medicine if it has been frozen.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines may affect how lixisenatide works. Tell your doctor if you are using other diabetes medicine, including insulin or sulfonylurea.
• Take acetaminophen or antibiotics at least 1 hour before you inject this medicine.
• Take birth control pills at least 1 hour before or 11 hours after you inject lixisenatide.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease or a history of pancreas problems. Tell your doctor if you have severe digestion problems (such as gastroparesis).
• This medicine may cause the following problems:
  
  • Pancreatitis
  • Low blood sugar (more likely if you also take insulin or other diabetes medicine)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone. Do not share needles or pens because you can spread an infection.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Shaking, trembling, sweating, fast or pounding heartbeat, hunger, confusion
• Sudden and severe stomach pain, nausea, vomiting, fever, and lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Dizziness or headache
• Redness, itching, swelling, or any changes in your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088