Pregnancy & Lactation: Risk data not available
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.
Warnings
You should not use this medicine if you are allergic to insulin or lixisenatide, or if:
- 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
Use Insulin Glargine and Lixisenatide (Soliqua 100 33) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
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.
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.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. Becoming dehydrated while using this medicine can lead to kidney failure. Drink plenty of water each day.
Storing the unopened (not in use) injection pen: Refrigerate and protect from light.
Do not freeze insulin glargine and lixisenatide, and throw away the medicine if it has been frozen.
Storing the opened (in use) injection pen: Store at room temperature with the pen cap attached (but not with a needle attached), and use within 28 days.
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.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Insulin Glargine and Lixisenatide side effects
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;
- 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?
Avoid medication errors by always checking the medicine label before injecting a dose.
Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.