Brief Summary of Information for SOLIQUA® 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL and 33 mcg/mL

This is a brief summary of important information about SOLIQUA 100/33. This information does not take the place of talking with your healthcare professional about your medical condition or treatment. Only your healthcare professional can determine if SOLIQUA 100/33 is right for you.

What is SOLIQUA 100/33? SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise in people who are not controlled with long-acting (basal) insulin (less than 60 units daily) or lixisenatide. • It has not been studied in people with a history of pancreatitis. • It is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists.

• It is not for use in people with type 1 diabetes, diabetic ketoacidosis, or who have a stomach problem that causes slow emptying (gastroparesis). • It has not been studied together with short-acting insulin. • It is not known if SOLIQUA 100/33 is safe and efective in children under 18 years of age.

What is the most important information I should know about SOLIQUA 100/33? • Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

SOLIQUA 100/33 can cause serious side efects, including inflammation of the pancreas, which may be life-threatening.

Before using SOLIQUA 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder, or a history of alcoholism. These medical problems may make you more likely to get pancreatitis. Stop taking SOLIQUA 100/33 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.

Who should not use SOLIQUA 100/33? Do not use SOLIQUA 100/33 if you are having an episode of low blood sugar or if you are allergic to insulin glargine, lixisenatide, or any of the ingredients in SOLIQUA 100/33.

Tell your healthcare provider about all your medical conditions, including if you: • have or have had problems with your pancreas, kidneys, or liver, stones in your gallbladder, or a history of alcoholism.

• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs (thiazolidinediones).

• have severe problems with your stomach, such as slowed emptying of your stomach or problems digesting food.

• Do not take more than 60 units of SOLIQUA 100/33 each day. SOLIQUA 100/33 contains two medicines: insulin glargine and lixisenatide. If you take too much SOLIQUA 100/33, it can cause severe nausea and vomiting. Do not take SOLIQUA 100/33 with other GLP-1 receptor agonists. If you take too much SOLIQUA 100/33, call your healthcare provider or go to the nearest hospital emergency room right away. • Only use SOLIQUA 100/33 that is clear, colorless to almost colorless. If you see small particles, return it to your pharmacy for replacement. • Change (rotate) your injection sites within the area you chose with each dose. Do not use the same spot for each injection, to avoid skin thickening or pits at the injection site (lipodystrophy). • Inject your dose of SOLIQUA 100/33 under the skin (subcutaneously) of your abdomen, thigh or upper arm. Do not use SOLIQUA 100/33 in an insulin pump or inject SOLIQUA 100/33 into your vein (intravenously) or muscle (intramuscularly).

• Do not mix SOLIQUA 100/33 in any other type of insulin or liquid medicine prior to injection.

• Do not remove SOLIQUA 100/33 from the throwaway (disposable) prefilled pen with a syringe.

• Do not re-use or share your needles with other people. Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

Your dose of SOLIQUA 100/33 may need to change because of a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What are the possible side efects of SOLIQUA 100/33? SOLIQUA 100/33 may cause serious side efects, including: • Serious allergic reactions. Stop taking SOLIQUA 100/33 and get help right away if you have any symptoms of a serious allergic reaction including swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar may include: headache, dizziness, drowsiness, confusion, weakness, irritability, hunger, sweating, fast heartbeat and feeling jittery. Talk to your healthcare provider about how to treat low blood sugar.

• Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may worsen kidney problems.

• are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if SOLIQUA 100/33 will harm your unborn baby or passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIQUA 100/33 may afect the way some medicines work.

How should I use SOLIQUA 100/33? • Read the detailed Instructions for Use that come with your SOLIQUA 100/33 for instructions on using the SOLIQUA 100/33 pen and injecting SOLIQUA 100/33.

• Use SOLIQUA 100/33 exactly as your healthcare provider tells you to. • Do not change your dose unless your healthcare provider has told you to change your dose.

• Your healthcare provider should teach you how to inject SOLIQUA 100/33 before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider.

• Low potassium in your blood (hypokalemia). • Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with SOLIQUA 100/33 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with SOLIQUA 100/33. Tell your healthcare provider if you have any new or worse symptoms of heart failure, including shortness of breath, swelling of your ankles or feet, sudden weight gain. Your healthcare provider may need to change or stop your treatments if you have worsening heart failure.

The most common side efects of SOLIQUA 100/33 may include low blood sugar (hypoglycemia), stufy or runny nose, sore throat, upper respiratory tract infection, headache, allergic reactions, nausea, and diarrhea. Nausea and diarrhea usually happen more oſten when you start using SOLIQUA 100/33.

What are the ingredients in SOLIQUA 100/33? Active ingredients: insulin glargine and lixisenatide. Inactive ingredients: 3 mg of methionine, 2.7 mg of metacresol, 20 mg of glycerol, 30 mcg of zinc, hydrochloric acid, sodium hydroxide and water for injection.

• Take SOLIQUA 100/33 only 1 time each day within 1 hour before the first meal of the day.

Other Important Information The risk information presented here does not include everything that is in the FDA approved product label. To get more information:

• If you miss a dose of SOLIQUA 100/33, take your next scheduled dose at your regular time. Do not take an extra dose or increase your dose to make up for the missed dose. • Check the label on the SOLIQUA 100/33 pen each time you give your injection to make sure you are using the correct medicine.

sanofi-aventis U.S. LLC, Bridgewater, NJ 08807 A SANOFI COMPANY

• talk about SOLIQUA 100/33 with your healthcare provider or pharmacist.

• for FDA approved product labeling go to or call sanofi-aventis at 1-800-663-1610.

• call 1-800-FDA-1088 to report side efects to FDA. © 2017 sanofi-aventis U.S. LLC. All rights reserved. SAUS.SQA.17.06.3917

Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68