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Insulin Glargine and Lixisenatide

Generic Name: Insulin Glargine and Lixisenatide (IN soo lin GLAR jeen & lix i SEN a tide)
Brand Name: Soliqua

Uses of Insulin Glargine and Lixisenatide:

  • It is used to lower blood sugar in patients with high blood sugar (diabetes).

What do I need to tell my doctor BEFORE I take Insulin Glargine and Lixisenatide?

  • If you have an allergy to insulin glargine and lixisenatide or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Acidic blood problem or type 1 diabetes.
  • If you have low blood sugar.
  • If your stomach empties slowly or you have trouble digesting food.
  • If you have kidney disease.
  • If you are using insulin.
  • If you are using another drug that has the same drug in it.
  • If you are using any of these drugs: Albiglutide, dulaglutide, exenatide, or liraglutide.

This is not a list of all drugs or health problems that interact with insulin glargine and lixisenatide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Insulin Glargine and Lixisenatide?

  • Tell all of your health care providers that you take insulin glargine and lixisenatide. This includes your doctors, nurses, pharmacists, and dentists.
  • Allergic reactions have happened with this medicine. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Low blood sugar may happen with insulin glargine and lixisenatide. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • Low blood potassium may happen with this medicine. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how insulin glargine and lixisenatide affects you.
  • Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • Wear disease medical alert ID (identification).
  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Talk with your doctor before you drink alcohol.
  • A very bad and sometimes deadly pancreas problem (pancreatitis) has happened with other drugs like this one. Talk with your doctor.
  • Kidney problems have happened with this medicine. Sometimes, kidney problems may need to be treated in the hospital. Dialysis may also be needed. Talk with your doctor.
  • If you cannot drink liquids by mouth or if you have upset stomach, throwing up, or diarrhea that does not go away, you need to avoid getting dehydrated. Contact your doctor to find out what to do. Dehydration may lead to new or worse kidney problems.
  • Birth control taken by mouth may not work as well to prevent pregnancy if taken at the same time as insulin glargine and lixisenatide. If you are taking birth control by mouth, take it at least 1 hour before or 11 hours after this medicine.
  • If you are 65 or older, use insulin glargine and lixisenatide with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Insulin Glargine and Lixisenatide) best taken?

Use insulin glargine and lixisenatide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Check the pen label closely each time you use this medicine. Be sure that you know how to measure and get your dose ready. If you have any questions, call your doctor or pharmacist.
  • Take insulin glargine and lixisenatide within the hour before the first meal every day.
  • Wash your hands before and after use.
  • Move site where you give the shot each time.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Put the cap back on after you are done using your dose.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • Attach new needle before each dose.
  • Remove all pen needle covers before injecting a dose (there may be 2). If you are not sure what type of pen needle you have or how to use it, talk with the doctor.
  • Do not mix with other liquids.
  • Do not move this medicine from the pen to a syringe or mix with other types of insulin.
  • Follow the diet and workout plan that your doctor told you about.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • This medicine may prevent other drugs taken by mouth from getting into the body. If you take other drugs by mouth, you may need to take them at some other time than insulin glargine and lixisenatide. Talk with your doctor.
  • Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Trouble swallowing.
  • Change in eyesight.
  • Dizziness or passing out.
  • Seizures.
  • Change in skin to thick or thin where the shot was given.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.

What are some other side effects of Insulin Glargine and Lixisenatide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Hard stools (constipation).
  • Belly pain.
  • Gas.
  • Not hungry.
  • Nose or throat irritation.
  • Signs of a common cold.
  • Headache.
  • Weight gain.
  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Insulin Glargine and Lixisenatide?

  • Store unopened pens in a refrigerator. Do not freeze.
  • Store in original container.
  • Protect from light.
  • Do not use if it has been frozen.
  • After opening, store at room temperature.
  • Throw away any part not used 2 weeks after first use.
  • Take off the needle after each shot. Do not store this device with the needle on it.
  • Keep the cap on the pen when not in use.
  • Do not use if insulin glargine and lixisenatide is out of date.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about insulin glargine and lixisenatide, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about insulin glargine and lixisenatide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using insulin glargine and lixisenatide.

Review Date: December 6, 2017

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