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Soliqua 100/33

Generic Name: insulin glargine and lixisenatide (IN soo lin GLAR jeen and LIX i SEN a tide)
Brand Names: Soliqua 100/33

What is Soliqua 100/33?

Soliqua 100/33 contains a combination of 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.

Soliqua 100/33 is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Soliqua 100/33 is not for treating type 1 diabetes.

Important information

Stop using Soliqua 100/33 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 with another person, even if the needle has been changed.

Before taking this medicine

You should not Soliqua 100/33 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 Soliqua 100/33 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 Soliqua 100/33 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 Soliqua 100/33?

Use Soliqua 100/33 exactly as it was prescribed for you. 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.

Soliqua 100/33 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.

Soliqua 100/33 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.

Your care provider will show you the best places on your body to inject Soliqua 100/33. 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 a Soliqua 100/33 injection pen with another person, even if the needle has been changed. Sharing the pen 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.

Using Soliqua 100/33 is 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) Soliqua 100/33: Refrigerate and protect from light.

Do not freeze Soliqua 100/33, and throw away the medicine if it has been frozen.

Storing opened (in use) Soliqua 100/33: Store at room temperature with the pen cap attached, and use within 14 days.

Do not store a Soliqua 100/33 injection pen with the needle attached.

Do not use Soliqua 100/33 if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

Soliqua 100/33 dosing information

Usual Adult Dose of Soliqua 100/33for Diabetes Type 2:

Insulin glargine 100 units/lixisenatide 33 mcg per mL (100/33); dosage is expressed in units

For Patients Inadequately Controlled on Less than 30 units of Basal Insulin or on Lixisenatide:
-Initial dose: 15 units subcutaneously once a day (insulin glargine 15 units/lixisenatide 5 mcg)

For Patients Inadequately Controlled on 30 to 60 units of Basal Insulin or on Lixisenatide:
-Initial dose: 30 units subcutaneously once a day (insulin glargine 30 units/lixisenatide 10 mcg)

Titrate dose in increments of 2 to 4 units weekly based on metabolic needs, blood glucose monitoring results, and glycemic goal until desired fasting plasma glucose is achieved.
-Maintenance dose: 15 to 60 units per day
-Maximum dose: Insulin glargine 60 units/lixisenatide 20 mcg once a day

Comments:
-Discontinue lixisenatide or basal insulin prior to initiation of this drug.
-Administer subcutaneously once a day within the hour prior to the first meal of the day.
-Alternative antidiabetic products should be used in patients requiring a dose below 15 units or over 60 units per day.
-Product labeling includes a chart that displays units of insulin glargine and micrograms of lixisenatide in each dosage of 100/33.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units per day) or lixisenatide.

See also: Dosage Information (in more detail)

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 Soliqua 100/33 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 Soliqua 100/33?

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 Soliqua 100/33.

  • If you also take any type of antibiotic, take it at least 1 hour before you use Soliqua 100/33.

  • If you also take a birth control pill, take it at least 1 hour before or 11 hours after you use Soliqua 100/33.

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

Soliqua 100/33 side effects

Get emergency medical help if you have signs of an allergic reaction to Soliqua 100/33: 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 Soliqua 100/33 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.

See also: Side effects (in more detail)

What other drugs will affect Soliqua 100/33?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of Soliqua 100/33. 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 Soliqua 100/33.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Soliqua 100/33 only for the indication prescribed.
  • Disclaimer: 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 1996-2017 Cerner Multum, Inc. Version: 1.01.

Date modified: February 03, 2017
Last reviewed: January 16, 2017

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