SIDE EFFECTS AND SAFETY

What is the most important information I should know about SOLIQUA 100/33?

SOLIQUA 100/33 can cause serious side effects, including inflammation of the pancreas(pancreatitis)

Stop using SOLIQUA 100/33 and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Who should not use SOLIQUA 100/33?

Do not use SOLIQUA 100/33 if you:

• are having an episode of low blood sugar (hypoglycemia)
• have had a serious allergic reaction to insulin glargine, lixisenatide, or any of the ingredients in SOLIQUA 100/33. See "What are the possible side effects of SOLIQUA 100/33?" for symptoms of a serious allergic reaction.

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.
• 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).
• are scheduled to have surgery or other procedures that use general anesthesia or deep sleepiness (deep sedation)
• 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.
Especially tell your healthcare provider if you take:

• antibiotics or the pain reliever, acetaminophen. Take these medicines at least 1 hour before using SOLIQUA 100/33. If you must take these medicines, take them with a meal or a snack. You should not take these medicines at the same time that you take SOLIQUA 100/33.
• birth control pills that are taken by mouth (oral contraceptives). SOLIQUA 100/33 may lower the amount of the medicine in your blood from your birth control pills and they may not work as well to prevent pregnancy. Take your birth control pill at least 1 hour before your injection of SOLIQUA 100/33 or at least 11 hours after your SOLIQUA 100/33 injection.

How should I use SOLIQUA 100/33?

• Do not change your dose without first talking to your healthcare provider.
• Your healthcare provider should show you how to use SOLIQUA 100/33 before you use it for the first time.
• 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.
• If you take too much SOLIQUA 100/33, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check.

What should I avoid while taking SOLIQUA 100/33?

While taking SOLIQUA 100/33 do not:

• Drive or operate heavy machinery, until you know how SOLIQUA 100/33 affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

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. Stop taking SOLIQUA 100/33 and get medical help right away if you have any symptoms of a severe allergic reaction including

  swelling of your face, lips, tongue or throat	fainting or feeling dizzy
  problems breathing or swallowing	very rapid heartbeat
  severe rash or itching

  swelling of your face, lips, tongue or throat

  fainting or feeling dizzy

  problems breathing or swallowingg

  very rapid heartbeat

  severe rash or itching

• 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: 

  Dizziness or light-headedness	blurred vision	anxiety, irritability or mood changes
  sweating	slurred speech	hunger
  confusion or drowsiness	shakiness	weakness
  headache	fast heartbeat	feeling jittery

  Dizziness or light-headedness	blurred vision
  anxiety, irritability or mood changes	sweating
  slurred speech	hunger
  confusion or drowsiness	shakiness
  weakness	headache
  fast heartbeat	feeling jittery

• Dehydration leading to Kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
• Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use SOLIQUA 100/33. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• 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

• Food or liquid getting into the lungs during surgery or other procedures that use general anesthesia or deep sleepiness (deep sedation). SOLIQUA 100/33 may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking SOLIQUA 100/33 before you are scheduled to have a surgery or other procedures.

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

Talk to your healthcare provider about any side effect that bothers you or does not go away.
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.