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.

Stop using Soliqua 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.

Use Soliqua 100/33 exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Do not use more than 60 units of Soliqua 100/33 each day.

Soliqua 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 Soliqua 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 Soliqua can lead to kidney failure. Drink plenty of water each day.

Storing the unopened (not in use) Soliqua 100/33 injection pen: Refrigerate and protect from light.

Do not freeze Soliqua, 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 a Soliqua 100/33 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.

Usual Adult Dose for Diabetes Type 2:

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

Discontinue basal insulin or glucagon-like peptide-1 (GLP-1) receptor agonist prior to initiation:

-For Patients Naive to Basal Insulin or GLP-1 Receptor Agonist; Currently on a GLP-1 Receptor Agonist; or Currently Receiving Less Than 30 units per day of Basal Insulin:
-Initial dose: 15 units subcutaneously once a day
For Patients Receiving 30 to 60 units of Basal Insulin With or Without a GLP-1 Receptor Agonist: -Initial dose: 30 units subcutaneously once a day

TITRATE dose in increments of 2 to 4 units/week 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:
-Administer subcutaneously once a day within the hour prior to the first meal of the day.
-This drug should be titrated until desired fasting plasma glucose is achieved.
-Additional titration may be needed to minimize the risk of hypoglycemia or hyperglycemia (e.g., with changes in physical activity, diet or timing of food intake, during acute illness; or when used with other medications.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

You should not use Soliqua is safe for you, tell your doctor if you have every had: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 is safe for you, tell your doctor if you have every 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 Soliqua 100/33 if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high sugar may cause complications in both the mother and the baby.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

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.

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.

Get emergency medical help if you have signs of an allergic reaction to Soliqua: hives, itching, severe rash; rapid heartbeats; trouble swallowing; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using Soliqua 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 Soliqua 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.

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 Soliqua 100/33 injection:

• an antibiotic;

• acetaminophen (Tylenol); or

• birth control pills (take 1 hour before or 11 hours after your Soliqua 100/33 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.