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  Benefits of BYDUREON Possible Side Effects How BYDUREON Works Is BYDUREON Right for Me?
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What You Should Know

Because BYDUREON (exenatide extended-release for injectable suspension) is gradually released over the course of a week, you’ll notice some benefits fairly soon. Other benefits may take longer before they fully take effect.

BYDUREON May Help Improve Your Blood Sugar

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 and your healthcare provider how well your blood sugar is being controlled over time.

Important Safety Information: POSSIBLE THYROID TUMORS, INCLUDING CANCER

In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancer. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. Do not take BYDUREON if you or any of your family members have MTC or if you have Multiple Endocrine Neoplasia syndrome type 2. 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.

BYDUREON May Reduce the Amount of Food You Eat

While taking BYDUREON, you may eat less and lose weight. Although BYDUREON is not a weight-loss product, in a clinical trial, some patients experienced gradual weight loss. Overall, patients lost an average of 5 pounds over 24 weeks.

Serious Side Effects of BYDUREON

POSSIBLE THYROID TUMORS, INCLUDING CANCER: In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancer. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. Do not take BYDUREON if you or any of your family members have MTC or if you have Multiple Endocrine Neoplasia syndrome type 2. 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.

Do not take BYDUREON if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON. Severe allergic reactions can happen with BYDUREON. Symptoms of a severe allergic reaction to BYDUREON are severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop taking BYDUREON and call your healthcare provider right away.

Inflammation of the pancreas (pancreatitis) may happen, 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, or 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, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.

Important Information About Low Blood Sugar (Hypoglycemia)

Your risk for getting low blood sugar is higher if you take BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea. 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, and feeling jittery.

Talk with your healthcare provider about how to recognize and treat low blood sugar. Your healthcare provider may suggest that you carry something with you in case hypoglycemia occurs. Here are some good options to take with you on the go: glucose tablets, glucose gel, pieces of hard candy, regular soda (not diet), or fruit juice.

Your healthcare provider may have advised you to follow these steps if you do develop hypoglycemia:

• Step 1: Act quickly. Check your blood sugar and treat your hypoglycemia according to your doctor’s instructions.
• Step 2: Wait 15 to 20 minutes and check your blood sugar again.
• Step 3: If your blood sugar is still low, and your symptoms of hypoglycemia don’t go away, repeat this treatment.
• Step 4: After you feel better, be sure to eat your regular meals and snacks as planned to keep your blood sugar from going too low.

Talk to your healthcare provider about any side effect that bothers you or does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Most Common Side Effects of BYDUREON

The side effects of BYDUREON that occur most often are:

• Nausea (feeling queasy). Nausea is more likely during the first weeks after starting BYDUREON but decreases
  over time.
• Diarrhea
• Headache
• Vomiting
• Constipation
• Itching at the injection site
• You may see or feel a small, raised bump within 2 to 4 weeks of injecting BYDUREON, but should go away on its own within 3 to 6 weeks.
• Indigestion

These are not all the side effects of BYDUREON. Serious side effects can occur, including possible thyroid tumors, including cancer, and inflammation of the pancreas (pancreatitis).

Important Safety Information

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.

Pregnancy Registry: Amylin Pharmaceuticals, LLC 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.

Tips for Managing Nausea

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

Here are some tips you can try if you experience nausea* while taking BYDUREON:

• Eat smaller portions at mealtimes.
• 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.
• 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.

WHAT IS BYDUREON^® (exenatide extended-release for injectable suspension)?

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.

IMPORTANT SAFETY INFORMATION for BYDUREON

• POSSIBLE THYROID TUMORS, INCLUDING CANCER: In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancer. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. Do not take BYDUREON if you or any of your family members have MTC or if you have Multiple Endocrine Neoplasia syndrome type 2. 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.
• Do not take BYDUREON if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON. Severe allergic reactions can happen with BYDUREON. Symptoms of a severe allergic reaction to BYDUREON are severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop taking BYDUREON and call your healthcare provider right away.
• Inflammation of the pancreas (pancreatitis) may happen, 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, or 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, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.
• Your risk for getting low blood sugar (hypoglycemia) is higher if you take BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea may need to be lowered while you use BYDUREON. Signs and symptoms of low blood sugar may include shakiness, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
• Tell your healthcare provider if you have or had kidney problems or a kidney transplant. BYDUREON may cause nausea, vomiting, or diarrhea, leading to loss of fluids (dehydration). Dehydration may cause kidney failure; this can happen in people who have never had kidney problems before. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away or if you cannot drink liquids.
• Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
• 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.
• Before using BYDUREON, tell your doctor about all the medicines you take, as taking them with BYDUREON may affect how each medicine works. Tell your healthcare provider if you take other diabetes medicines, especially insulin or a sulfonylurea, or warfarin sodium (Coumadin^® or Jantoven^®).
• Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for Medication Guide, and click here for US Full Prescribing Information for BYDUREON, including Boxed WARNING about possible thyroid tumors including thyroid cancer.