1. Possible thyroid tumors, including cancer. During the drug testing process, the medicine in BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people.

   Before you start taking BYDUREON, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not take BYDUREON if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take BYDUREON.

   While taking BYDUREON, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

2. Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.
   Before taking BYDUREON, tell your healthcare provider if you have had:
   • pancreatitis
   • stones in your gallbladder (gallstones)
   • a history of alcoholism
   • high blood triglyceride levels

Stop taking BYDUREON 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 happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.

BYDUREON is a long-acting form of the medication in BYETTA^® (exenatide) injection so both drugs should not be used together. BYDUREON is not a substitute for insulin and has not been studied in combination with insulin. BYDUREON is not for people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYDUREON is not recommended for use in children. It is not known if BYDUREON is safe and effective in people with a history of pancreatitis or severe kidney problems.

Do not use BYDUREON if:

• you or any of your family members have a history of medullary thyroid cancer.
• you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body.
• you are allergic to exenatide or any of the ingredients in BYDUREON. Symptoms of a severe allergic reaction may include swelling of your face lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

Before using BYDUREON, tell your healthcare provider if you:

• have any of the conditions listed in the section “What is the most important information I should know about BYDUREON?”
• have severe problems with your stomach such as slow emptying of your stomach (gastroparesis) or problems digesting food.
• have or have had kidney problems, or have had a kidney transplant.
• have any other medical conditions.
• are pregnant or are planning to become pregnant. It is not known if BYDUREON may harm your unborn baby. Tell your healthcare provider if you become pregnant while taking BYDUREON.
• Pregnancy Registry: Amylin Pharmaceuticals has a registry for women who take BYDUREON during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you take BYDUREON at any time during pregnancy, you may enroll in this registry by calling 1-800-633-9081.
• are breastfeeding or plan to breastfeed. It is not known if BYDUREON passes into your breast milk. You and your healthcare provider should decide if you will take BYDUREON or breastfeed. You should not do both without talking with your healthcare provider first.

Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. BYDUREON may affect the way some medicines work and some other medicines may affect the way BYDUREON works.

Especially tell your healthcare provider if you take other diabetes medicines, especially insulin or sulfonylurea, any medicine taken by mouth, or warfarin sodium (Coumadin^®, Jantoven^®.)

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

For detailed instructions, see the Instructions for Use that comes with your BYDUREON.

Use BYDUREON exactly as your healthcare provider tells you to.

BYDUREON is a subcutaneous injection. Inject BYDUREON into your skin exactly the way your healthcare provider told you to. You can take the injection in your stomach area (abdomen), your thigh, or the back of your upper arm. Each week you can use the same area of your body. But be sure to choose a different injection site in that area.

Your healthcare provider must teach you how to inject BYDUREON before you use it for the first time. If you have any questions or do not understand the instructions, talk with your healthcare provider or pharmacist.

If you are taking BYETTA and your healthcare provider prescribed BYDUREON, you should follow your healthcare provider’ds instructions about when to stop taking BYETTA and when to start taking BYDUREON.

BYETTA is a different form of the same medicine that is in BYDUREON, so do not take BYETTA when you are taking BYDUREON. When you first change from BYETTA to BYDUREON, your blood sugar levels may be higher than usual and should get better in about 2 weeks.

You only need to take BYDUREON once every 7 days. If you want to change your dosing day, you can. Your new dosing day must be at least 3 days after your last dose. Do not take 2 doses of BYDUREON less than 3 days apart.

For example, let’s say you want to change your dosing day from Friday to Sunday. Take your BYDUREON on Friday, as scheduled. Because Sunday is less than 3 days from your original dosing day, you should take your next dose of BYDUREON on the following Sunday. (See calendar below.)

Once you’ve selected a dosing day that works for you, try to stay with it. It’s not a good idea to change your dosing day often.

If you miss taking BYDUREON on your dosing day, take an injection as soon as you can, unless your next dosing day is 1 or 2 days away. In that case, wait until your next regular dosing day. Then take your next dose on your regular dosing day. Don’t take 2 doses less than 3 days apart.

You must take BYDUREON immediately after mixing it. If you do not inject BYDUREON right away, the medicine is more likely to clump and clog the needle.

Push the plunger down with your thumb and shake hard to mix the medicine. When the medicine is mixed well, it should look cloudy. There should not be any dry powder on the sides or bottom of the vial.

If you do see any dry powder, shake hard while continuing to push down on the plunger with your thumb.

No, small air bubbles will not harm you or affect your dose. BYDUREON is injected into your skin (subcutaneously). Air bubbles are not a problem with this type of injection.

First, be sure you have removed the blue cap. Then, twist the needle onto the syringe until snug. To prevent losing medicine, do not push in the plunger while attaching the needle.

With one hand, hold the syringe near the black dashed Dose Line. With your other hand, hold the needle cover. Pull the needle cover straight off.
Do not twist it.

The black dashed Dose Line shows the correct dose. If the top of the plunger has been pushed past the line, you should continue and take the injection. But next time, make sure the plunger matches the black dashed Dose Line so you can be sure to get the proper amount of medicine.

You may have a needle clog if the medicine wasn’t mixed well or you did not inject BYDUREON right away. That’s OK. That’s why there is an extra needle in your tray. Twist off the clogged needle, and twist on the extra needle included in your tray. Then pull off the new needle cover to inject.

One needle is an extra in case you need it. Do not share your BYDUREON tray with another person even if the needle is changed. Sharing your tray with another person can cause you or someone else to get an infection.

After 2 weeks, you may have better blood sugar levels before eating. Blood sugar levels may continue to improve over the next 6 to 7 weeks.

BYDUREON can also help lower your A1C number. A1C is a lab test ordered by your doctor or healthcare provider to show your average blood sugar level over the past 2 to 3 months. Your A1C results can help tell you how well your blood sugar is being controlled over time.

It's important to follow your healthcare provider's instructions for diet, exercise, how often you test your blood sugar, and when to get your HbA1c checked. If you see your blood sugar increasing during treatment with BYDUREON, talk to your healthcare provider because you may need to adjust your current treatment plan for your diabetes.

For serious side effects that may happen in people who take BYDUREON, see "What is the most important information I should know about BYDUREON?"

The most common side effects with BYDUREON include nausea, diarrhea, headache, vomiting, constipation, itching at injection site, a small bump (nodule) at the injection site, and indigestion. Nausea most commonly happens when first starting BYDUREON, but may become less over time.

These are not all the side effects of BYDUREON. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The most common side effect is nausea (feeling queasy). Nausea is more likely during the first weeks after starting BYDUREON but decreases over time.

Try these tips to help manage nausea:

• Avoid foods that are spicy, fatty, or fried.
• Try ginger. Although it hasn't been proven, ginger ale, fresh ginger, and ginger tea have been known to help relieve symptoms for some people.
• Decrease bad smells and tastes by sucking on hard candy, like lemon drops or sugar-free mints.
• Get up slowly and don't lie down right after eating.

*Each of these tips may not work for everyone. If nausea persists, consult your healthcare provider.

Low blood sugar—called hypoglycemia—may occur when BYDUREON is used with certain other medications. If you take BYDUREON in combination with a medication such as a sulfonylurea (a type of diabetes pill), your risk for developing low blood sugar is higher. The dose of your sulfonylurea medicine may need to be lowered while you use BYDUREON.

Signs and symptoms of low blood sugar may include:

• Shakiness
• Sweating
• Headache
• Drowsiness
• Weakness
• Dizziness
• Confusion
• Irritability
• Hunger
• Fast heartbeat
• Feeling jittery

Your healthcare provider may suggest that you carry something with you in case hypoglycemia occurs. Here are some options to take with you on the go:

• Glucose tablets
• Glucose gel
• Pieces of hard candy
• Regular soda (not diet)
• Fruit juice

Also, talk with your doctor or your healthcare provider about how to treat low blood sugar.

You may see or feel a small, raised bump within 2 to 4 weeks of injecting BYDUREON. The illustration below shows an average bump size. Your bump may be smaller or larger, but should go away on its own within 3 to 6 weeks. You may also have more than one bump at once, but this can be expected.

Call our toll-free support line during our extended business hours, 7 days a week, at 1-877-700-7365 to speak with a live BYDUREON specialist who can walk you through your injection and answer your questions.