insulin glargine and lixisenatide

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

What is insulin glargine and lixisenatide?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. Lixisenatide is a diabetes medicine that helps your pancreas produce insulin more efficiently.

Insulin glargine and lixisenatide is a combination medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes. This medicine is not for treating type 1 diabetes.

Insulin glargine and lixisenatide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using this medicine?

• you are having an episode of low blood sugar;
• you also use a short-acting mealtime insulin; or
• you also use lixisenatide (Adlyxin) or a medicine like lixisenatide (albiglutide, dulaglutide, exenatide, liraglutide, Byetta, Bydureon, Saxenda, Tanzeum, Trulicity, Victoza).

Tell your doctor if you have ever had:

• pancreatitis or gallstones;
• alcoholism;
• problems digesting food;
• heart failure;
• liver or kidney disease;
• low levels of potassium in your blood (hypokalemia); or
• diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use insulin glargine and lixisenatide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Do not use more than 60 units of this medicine each day.

Insulin glargine and lixisenatide is injected under the skin, usually within 1 hour before your first meal of the day. A healthcare provider will teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or 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.

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

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms include severe nausea and vomiting.

What should I avoid while using insulin glargine and lixisenatide?

Avoid medication errors by always checking the medicine label before injecting a dose.

What are the possible side effects of insulin glargine and lixisenatide?

• pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting;
• low blood sugar --headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky;
• heart problems --swelling, rapid weight gain, feeling short of breath; or
• low potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• low blood sugar;
• nausea, diarrhea;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 insulin glargine and lixisenatide?

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Lixisenatide can make it harder for your body to absorb other medicines you take by mouth. If you take any of the following medicines, take them at least 1 hour before your insulin glargine and lixisenatide injection:

• an antibiotic;
• acetaminophen (Tylenol); or
• birth control pills (take 1 hour before or 11 hours after your insulin glargine and lixisenatide injection).

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin glargine and lixisenatide. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

Your pharmacist can provide more information about insulin glargine and lixisenatide.