MEDICATION GUIDE
`
`BYETTA® (bye-A-tuh)
`(exenatide)
`Injection
`
`Read this Medication Guide and the Pen User Manual that come with BYETTA before
`you start using it and each time you get a refill. There may be new information.
`This Medication Guide does not take the place of talking with your healthcare
`provider about your medical condition or your treatment. If you have questions
`about BYETTA after reading this information, ask your healthcare provider or
`pharmacist.
`
`What is the most important information I should know about
`BYETTA?
`
`Do not share your BYETTA 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.
`
`Serious side effects can happen in people who take BYETTA, including inflammation
`of the pancreas (pancreatitis) which may be severe and lead to death.
`
`Before taking BYETTA, tell your healthcare provider if you have had:
`
` pancreatitis
` stones in your gallbladder (gallstones)
` a history of alcoholism
` high blood triglyceride levels
`These medical conditions can make you more likely to get pancreatitis in general. It
`is not known if having these conditions will lead to a higher chance of getting
`pancreatitis while taking BYETTA.
`
`While taking BYETTA:
`
`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. These may be symptoms of pancreatitis.
`
`Reference ID: 3706632
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`What is BYETTA?
`
` BYETTA is an injectable prescription medicine that may improve blood sugar
`(glucose) control in adults with type 2 diabetes mellitus, when used with a
`diet and exercise program.
` BYETTA is not insulin.
`
` You should not take BYETTA instead of insulin.
`
` The use of BYETTA with short acting insulin is not recommended.
`
` The use of BYETTA with rapid acting insulin is not recommended.
`
` BYETTA is not for people with type 1 diabetes or people with diabetic
`
`ketoacidosis.
`It is not known if BYETTA is safe and effective in children.
`
` BYETTA has not been studied in people who have pancreatitis.
` BYETTA should not be used in people who have severe kidney problems.
`Who should not use BYETTA?
`
`Do not use BYETTA if:
`
` you have had an allergic reaction to exenatide or any of the other ingredients
`in BYETTA. See the end of this Medication Guide for a complete list of
`ingredients in BYETTA.
`
`Symptoms of a severe allergic reaction with BYETTA may include:
`
` swelling of your face, lips, tongue, or throat
` problems breathing or swallowing
` severe rash or itching
`
`fainting or feeling dizzy
`
` very rapid heartbeat
`
`What should I tell my healthcare provider before using BYETTA?
`
`Before taking BYETTA, tell your healthcare provider if you:
`
` have or have had pancreatitis, stones in your gallbladder (gallstones), a
`history of alcoholism, or high blood triglyceride levels.
` have severe problems with your stomach, such as delayed emptying of your
`stomach (gastroparesis) or problems with digesting food.
` have or have had kidney problems, or have had a kidney transplant.
` have any other medical conditions.
` are pregnant or plan to become pregnant. It is not known if BYETTA will
`harm your unborn baby
`
`Pregnancy Registry: A registry has been implemented for women who take
`BYETTA during pregnancy. The purpose of this registry is to collect
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`information about the health of you and your baby. If you take BYETTA at
`any time during pregnancy you may enroll in this registry by calling 1-800-
`633-9081.
` are breastfeeding or plan to breast-feed. It is not known if BYETTA passes
`into your breast milk. You and your healthcare provider should decide if you
`will take BYETTA or breast-feed. You should not do both without talking with
`your healthcare provider first.
`
`Tell your healthcare provider about all the medicines you take including prescription
`and nonprescription medicines, vitamins, and herbal supplements. BYETTA slows
`stomach emptying and can affect medicines that need to pass through the stomach
`quickly. BYETTA may affect the way some medicines work and some other
`medicines may affect the way BYETTA works.
`
`Especially tell your healthcare provider if you take:
`
` other anti-diabetes medicines, especially sulfonylurea medicines or insulin.
` birth control pills that are taken by mouth (oral contraceptives). BYETTA 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
`pills at least one hour before your injection of BYETTA. If you must take your
`birth control pills with food, take it with a meal or snack where you do not
`also take BYETTA.
` an antibiotic. Take antibiotic medicines at least one hour before taking
`
`BYETTA. If you must take your antibiotic with food, take it with a meal or
`snack where you do not also take BYETTA.
` warfarin sodium (Coumadin®, Jantoven®).
`
` a blood pressure medicine.
`
` a water pill (diuretic).
`
` a pain medicine.
`
`lovastatin (Altoprev®, Mevacor®, Advicor®).
`
`
`Ask your healthcare provider if you are not sure if your medicine is listed above.
`
`Know the medicines you take. Keep a list of them with you to show your healthcare
`provider and pharmacist each time you get a new medicine.
`
`How should I use BYETTA?
`
`See the Pen User Manual that comes with BYETTA for instructions for using the
`BYETTA Pen and injecting BYETTA.
`
` Your healthcare provider may prescribe BYETTA alone or with certain other
`medicines to help control your blood sugar.
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`Reference ID: 3706632
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`
`
` BYETTA comes in a prefilled pen.
` Use BYETTA exactly as prescribed by your healthcare provider. Do not
`change your dose unless your healthcare provider has told you to change
`your dose.
` Your healthcare provider must teach you how to inject BYETTA before you
`use it for the first time. If you have questions or do not understand the
`instructions, talk to your healthcare provider or pharmacist.
` Pen needles are not included. You may need a prescription to purchase pen
`needles from your pharmacist. Ask your healthcare provider which needle
`length and gauge is best for you. Do not reuse or share your needles
`with other people. You may give other people a serious infection, or
`get a serious infection from them.
`Inject your dose of BYETTA under the skin (subcutaneous injection) of your
`upper leg (thigh), stomach area (abdomen), or upper arm as instructed by
`your healthcare provider. Do not inject into a vein or muscle.
` Do not mix BYETTA and insulin in the same syringe or vial even if you take
`them at the same time.
` BYETTA is injected two times each day, at any time within the 60 minutes (1
`hour) before your morning and evening meals (or before the two main
`meals of the day, approximately 6 hours or more apart). Do not take
`BYETTA after your meal.
`If you miss a dose of BYETTA, skip that dose and take your next dose at the
`next prescribed time. Do not take an extra dose or increase the amount of
`your next dose to make up for a missed dose.
`If you use too much BYETTA, call your healthcare provider or poison control
`center at 1-800-222-1222 right away. Too much BYETTA can cause your
`blood sugar to drop quickly and you may have symptoms of low blood sugar.
`You may need medical treatment right away. Too much BYETTA can also
`cause severe nausea and vomiting.
` Follow your healthcare provider's instructions for diet, exercise, and how
`often to test your blood sugar. If you see your blood sugar increasing during
`treatment with BYETTA, talk to your healthcare provider because you may
`need to adjust your current treatment plan for your diabetes.
` Talk to your healthcare provider about how to manage high blood sugar
`(hyperglycemia) and low blood sugar (hypoglycemia), and how to recognize
`problems that can happen with your diabetes.
` Do not share your BYETTA 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.
`
`
`
`
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`Reference ID: 3706632
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`SANOFI-AVENTIS Exhibit 1027 - Page 36
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`IPR for Patent No. 8,951,962
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`What are the possible side effects of BYETTA?
`
`BYETTA can cause serious side effects.
`
`See "What is the most important information I should know about
`BYETTA?"
`
`It is not known whether BYETTA, or other anti-diabetes medications, increase your
`risk of a heart attack or stroke.
`
` Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is
`
`higher if you take BYETTA with another medicine that can cause low blood
`sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin
`medicine may need to be lowered while you use BYETTA. Signs and symptoms
`of low blood sugar may include:
` dizziness
` headache
` confusion
` drowsiness
`irritability
` weakness
`
` sweating
` hunger
`feeling jittery
`fast heart beat
`
`
`Talk with your healthcare provider about how to treat low blood sugar.
`
` Kidney problems. BYETTA may cause new or worse problems with kidney
`function, including kidney failure. Dialysis or kidney transplant may be
`needed.
` While taking BYETTA: Call your healthcare provider right away if you
`have nausea, vomiting, or diarrhea that will not go away, or if you
`cannot take liquids by mouth. You may be at increased risk for kidney
`problems.
` Severe allergic reactions. Severe allergic reactions can happen with
`BYETTA. Stop taking BYETTA and get medical help right away if you have any
`symptom of a severe allergic reaction. See "Who should not use
`BYETTA?"
`
`The most common side effects with BYETTA include:
`
` nausea. Nausea most commonly happens when first starting BYETTA, but
`may become less over time
`
` vomiting
`
` diarrhea
`
`feeling jittery
`
`
` dizziness
`
` headache
`
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` acid stomach
`
` constipation
`
` weakness
`
`Talk to your healthcare provider about any side effect that bothers you or that does
`not go away.
`
`These are not all the side effects with BYETTA.
`
`Call your doctor for medical advice about side effects. You may report side effects
`to FDA at 1-800-FDA-1088.
`
`How should I store BYETTA?
`
` Store your new, unused BYETTA Pen in the original carton in a refrigerator at
`36°F to 46°F (2°C to 8°C).
` After first use, keep your BYETTA Pen at a temperature cooler than 77°F
`(25°C).
` Do not freeze your BYETTA Pen. Do not use BYETTA if it has been frozen.
` Protect BYETTA from light.
` Use a BYETTA Pen for only 30 days. Throw away a used BYETTA Pen after 30
`days, even if there is some medicine left in the pen.
` Do not use BYETTA after the expiration date printed on the label.
` Do not store the BYETTA Pen with the needle attached. If the needle is left
`on, medicine may leak from the BYETTA Pen or air bubbles may form in the
`cartridge.
` See the BYETTA Pen User Manual for instructions about the right way to
`throw away your BYETTA Pen.
` Do not reuse or share your needles with other people. You may give
`other people a serious infection, or get a serious infection from them.
` Keep your BYETTA Pen, pen needles, and all medicines out of the
`reach of children.
`
`General information about BYETTA
`
`Medicines are sometimes prescribed for purposes other than those listed in a
`Medication Guide. Do not use BYETTA for a condition for which it was not
`prescribed. Do not give BYETTA to other people, even if they have the same
`symptoms you have. It may harm them.
`
`This Medication Guide includes the most important information you should know
`about using BYETTA. If you would like more information, talk with your healthcare
`provider. You can ask your healthcare provider or pharmacist for information about
`BYETTA that is written for health professionals.
`
`Reference ID: 3706632
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`For more information about BYETTA, go to www.BYETTA.com or call BYETTA
`Customer Service at 1-800-236-9933.
`
`What are the ingredients in BYETTA?
`
`Active Ingredient: exenatide
`
`Inactive Ingredients: metacresol, mannitol, glacial acetic acid, and sodium
`acetate trihydrate in water for injection.
`
`This Medication Guide has been approved by the U.S. Food and Drug
`Administration.
`
`BYETTA is a registered trademark of the AstraZeneca group of companies. All other
`trademarks are the trademarks of their respective owners.
`
`Distributed by:
`AstraZeneca Pharmaceuticals LP
`Wilmington, DE 19850
`
`Revised: February 2015
`
`Reference ID: 3706632
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`IPR for Patent No. 8,951,962