Insulin Glargine, Recombinant (IN-su-lin GLAR-jeen, ree-KOM-bi-nant), Lixisenatide (lix-i-SEN-a-tide)

Treats diabetes.

Brand Name(s):

Soliqua 100/33

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 within the hour before the first meal of the day.
• If you use other type of insulin in addition to this medicine, do not mix them into the same syringe.
• 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.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.
• 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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store your new, unused medicine pen in the refrigerator, in the original carton, and protect it from light. Do not freeze this medicine, and do not use the medicine if it has been frozen. You may store the opened medicine pen at room temperature (below 77 degrees Fahrenheit) for 28 days. Replace the pen cap after each use to protect from light. Throw away your used pen after 28 days, even if it still has medicine in it. Remove the needle from the pen before you store it.
• 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 medicines can change the amount of insulin you need to use and make it harder for you to control your diabetes. Tell your doctor about all other medicines that you are using.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, digestion problems (including gastroparesis), gallbladder disease, vision problems, or a history of pancreas problems or angioedema (swelling of the arms, face, hands, mouth, or throat).
• This medicine may cause the following problems:
  • Pancreatitis
  • Low blood sugar (more likely if you also take other medicines, including beta-blockers)
  • Kidney problems
  • Fluid retention or heart failure (when used together with a thiazolidinedione [TZD] medicine)
  • Gallbladder problems, including cholelithiasis, cholecystitis
• This medicine can cause low blood sugar. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• 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, sunken eyes, wrinkled skin
• Dry mouth, increased thirst, muscle cramps
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Shaking, trembling, sweating, hunger, confusion, fast, pounding, or uneven 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:

• Redness, itching, swelling, or any changes in your skin where the shot was given
• Stuffy or runny nose, sore throat

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