insulin glargine and lixisenatide

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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).

To make sure insulin glargine and lixisenatide is safe for you, tell your doctor if you have:

  • a history of pancreatitis or gall stones;
  • problems with digestion;
  • heart disease;
  • liver or kidney disease;
  • low levels of potassium in your blood (hypokalemia);
  • a history of alcoholism; or
  • diabetic ketoacidosis (call your doctor for treatment).

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.

Follow your doctor's instructions about using this medicine if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

Lixisenatide can make birth control pills less effective. Ask your doctor about using a nonhormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

How should I use insulin glargine and lixisenatide?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin glargine and lixisenatide is injected under the skin, usually injected once per day. Use the injection within 60 minutes (1 hour) before your first meal of the day. Try to use the medicine at the same time each day.

This medicine comes in a prefilled injection pen that contains 14 pre-set doses. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Your care provider will show you the best places on your body to inject this medicine. Use a different place each time. Do not inject into the same place two times in a row.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.

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.

Lixisenatide is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Storing unopened (not in use) insulin glargine and lixisenatide: Refrigerate and protect from light.

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

Storing opened (in use) insulin glargine and lixisenatide: Store at room temperature with the pen cap attached, and use within 14 days.

Do not store an injection pen with the needle attached.

Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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.

Lixisenatide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

  • If you also take acetaminophen (Tylenol), take it at least 1 hour before you use insulin glargine and lixisenatide.
  • If you also take any type of antibiotic, take it at least 1 hour before you use insulin glargine and lixisenatide.
  • If you also take a birth control pill, take it at least 1 hour before or 11 hours after you use insulin glargine and lixisenatide.

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:

  • heart problems --shortness of breath (even with mild exertion), swelling in your feet or ankles, rapid weight gain;
  • pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • low blood sugar --headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; 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;
  • allergic reactions; 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?

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.

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