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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 effects, including inflammation of the pancreas, which may be severe and lead to death.

Before using SOLIQUA 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder (cholelithiasis), 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 (hypoglycemia)
• are allergic to insulin glargine, lixisenatide, or any of the ingredients in SOLIQUA 100/33. Symptoms of a severe allergic reaction with SOLIQUA 100/33 may include swelling of the face, lips, tongue, or throat, fainting or feeling dizzy, problems breathing or swallowing, very rapid heartbeat, severe rash or itching, or low blood pressure.

Before using SOLIQUA 100/33, tell your healthcare provider about all your medical conditions, including if you:

• have or have had problems with your pancreas, your kidneys, or your 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 thiazolidinediones (TZDs).
• have severe problems with your stomach, such as slowed emptying of your stomach or problems digesting food.
• are taking certain medicines called glucagon-like peptide 1 receptor agonists (GLP-1 receptor agonists).
• have had an allergic reaction to a GLP-1 receptor agonist.
• are pregnant or breastfeeding or plan to become pregnant or to breastfeed. It is not known if SOLIQUA 100/33 will harm your unborn baby or pass 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 affect the way some medicines work. Before using SOLIQUA 100/33, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use SOLIQUA 100/33?

• Do not change your dose without first talking to your healthcare provider.
• Check the pen label each time you inject to make sure you are using the correct medicine.
• Do not take more than 60 units of SOLIQUA 100/33 each day. Do not take SOLIQUA 100/33 with other GLP-1 receptor agonists.
• Only use SOLIQUA 100/33 that is clear and 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 to reduce your risk of getting pitted or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred or damaged.
• Do not remove SOLIQUA 100/33 from the pen with a syringe.
• Do not re-use or share needles with other people. You may give other people a serious infection, or get a serious infection from them.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check.

What are the possible side effects of SOLIQUA 100/33?

SOLIQUA 100/33 can cause serious side effects including:

• See "What is the most important information I should know about SOLIQUA 100/33?"
• Severe allergic reactions. Severe allergic reactions can happen with SOLIQUA 100/33. Stop taking SOLIQUA 100/33 and get medical help right away if you have any symptoms of a severe allergic reaction. See "Who should not use SOLIQUA 100/33?"
• 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 include: 

  headache	dizzines	drowsiness	sweating
  weakness	irritability	hunger	blurred vision
  fast heartbeat	feeling jittery	confusion	anxiety

  headache	drowsiness
  weakness	hunger
  fast heartbeat	confusion
  dizziness	sweating
  irritability	blurred vision
  feeling jittery	anxiety

• Kidney problems (kidney failure). In people who have kidney problems, the occurrence of diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
• Low potassium in your blood (hypokalemia).
• Heart failure. Taking certain diabetes pills called TZDs 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. Your healthcare provider should monitor you closely while you are taking 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, or sudden weight gain. Treatment with TZDs and SOLIQUA 100/33 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
• Gallbladder problems. Gallbladder problems have happened in some people who take SOLIQUA 100/33. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:

  pain in your upper stomach (abdomen)	yellowing of skin or eyes (jaundice)
  fever	clay-colored stools

  pain in your upper stomach (abdomen)

  fever

  yellowing of skin or eyes (jaundice)

  clay-colored stools

The most common side effects of SOLIQUA 100/33 include:

Nausea and diarrhea usually happen more often when you first start using SOLIQUA 100/33.

These are not all the possible side effects of SOLIQUA 100/33. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088.