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insulin glargine and lixisenatide

Pronunciation: IN soo lin GLAR jeen and LIX i SEN a tide

Brand: Soliqua 100/33

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

Stop using this medicine and call your doctor at once if you have nausea and vomiting with severe pain in your upper stomach spreading to your back.

Never share an injection pen or syringe with another person, even if the needle has been changed.

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 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).

Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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 may 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.

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.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can cause life-threatening hypoglycemia or hypokalemia (low levels of potassium in your blood).

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.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

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

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?

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2019 Cerner Multum, Inc. Version: 2.01. Revision date: 3/11/2019.

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