Lixisenatide (lix-i-SEN-a-tide)

Treats type 2 diabetes.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is given into your stomach, thigh, or upper arm.
• 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.
• 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.
• Check the liquid in the pen. It should be clear and colorless. Do not use it if it is discolored, or has particles in 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.
• Never share medicine pens with others under any circumstances. Sharing needles or pens can result in transmission of infection.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, use it 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.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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, digestion problems (including gastroparesis), gallbladder disease (including cholelithiasis), or a history of pancreas problems or alcohol abuse.
• This medicine may cause the following problems:
  • Pancreatitis
  • Low blood sugar (more likely if you also take insulin or other diabetes medicine)
  • Kidney problems
  • Gallbladder problems, including cholelithiasis, cholecystitis
• 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.

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, lower back or side pain, blood in your urine
• Diarrhea, dry mouth, sunken eyes, thirst, wrinkled skin
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion
• Sudden and severe stomach pain, nausea, vomiting, fever, passing gas, stomach upset or bloating, yellow eyes or skin

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

• 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