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Patient Information
��If you use too much BYETTA, call your healthcare provider or poison control center
right away. You may need medical treatment right away. Too much BYETTA can
cause nausea, vomiting, dizziness, or symptoms of low blood sugar.
BYETTA�(bye-A-tuh)
What are the possible side effects of BYETTA?
exenatide injection
When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia
(low blood sugar) can occur. The dose of your sulfonylurea medicine may need
Read this Patient Information and the Pen User Manual that come with BYETTA to be reduced while you use BYETTA. The signs and symptoms of low blood sugar
before you start using it and each time you get a refill. There may be new may include headache, drowsiness, weakness, dizziness, confusion, irritability,
information. This Patient Information does not take the place of talking with your hunger, fast heartbeat, sweating, and feeling jittery. Your healthcare provider should
healthcare provider about your medical condition or your treatment. If you have
tell you how to treat low blood sugar.
questions about BYETTA after reading this information, ask your healthcare
provider or pharmacist.
The most common side effects with BYETTA include nausea, vomiting, diarrhea,
dizziness, headache, feeling jittery, and acid stomach. Nausea is most common
What is BYETTA?
when first starting BYETTA, but decreases over time in most patients. Talk to your
healthcare provider if you experience the following severe and persistent
BYETTA is an injectable medicine used to improve glucose (blood sugar) control in symptoms, alone or in combination, because they could be signs of serious
adults with type 2 diabetes. BYETTA can be used with metformin, a sulfonylurea, or a medical conditions: abdominal pain, nausea, vomiting, or diarrhea.
thiazolidinedione. There are many antidiabetic medicines that contain a sulfonylurea.
Ask your healthcare provider or pharmacist if you are not sure if your antidiabetic
BYETTA may reduce your appetite, the amount of food you eat, and your weight.
medicine contains a sulfonylurea.
No changes in your dose are needed for these side effects.
Talk to your healthcare provider about any side effect that bothers you or that does
BYETTA is not a substitute for insulin in patients whose diabetes requires insulin
not go away.
treatment. BYETTA has not been studied in children.
These are not all the side effects with BYETTA. Ask your healthcare provider or
Who should not use BYETTA?
pharmacist for more information.
Do not use BYETTA if:
��You are allergic to exenatide or any of the other ingredients in BYETTA. See the
How should I store BYETTA?
end of this Patient Information for a complete list of ingredients. ��Store your new, unused BYETTA Pen in the original carton in a refrigerator at 36°F
to 46°F (2°C to 8ºC) protected from light. Do not freeze. Throw away any BYETTA
What should I tell my healthcare provider before using BYETTA?
Pen that has been frozen.
��After first use, your BYETTA Pen can be kept at a temperature not to exceed 77°F
Tell your healthcare provider about all of your medical conditions including if you:
(25°C). Do not freeze. Do not use BYETTA if it has been frozen. BYETTA should
��Have severe problems with your stomach (gastroparesis) or food digestion. BYETTA be protected from light.
slows stomach emptying so food passes more slowly through your stomach.
��Use a BYETTA Pen for only 30 days. Throw away a used BYETTA Pen after
��Have severe kidney disease or you are on dialysis. 30 days, even if some medicine remains in the pen.
��Are pregnant or planning to become pregnant. It is not known if BYETTA may
��BYETTA should not be used after the expiration date printed on the label.
harm your unborn child.
��Do not store the BYETTA Pen with the needle attached. If the needle is left
��Are breastfeeding. It is not known if BYETTA passes into your milk and can harm
on, medicine may leak from the BYETTA Pen or air bubbles may form in the
your child.
cartridge.
Tell your healthcare provider about all the medicines you take including ������������������������������������������������������������������������
prescription and nonprescription medicines, vitamins, and herbal supplements. of children.
BYETTA slows stomach emptying and can affect medicines that need to pass
through the stomach quickly. Ask your healthcare provider if the time at which you
take any of your oral medicines (for example, birth control pills, antibiotics) should
General information about BYETTA
be changed.
Medicines are sometimes prescribed for conditions that are not listed in the Patient
Know the medicines you take. Keep a list of them with you to show your healthcare
Information. Do not use BYETTA for a condition for which it was not prescribed.
provider and pharmacist each time you get a new medicine.
Do not give BYETTA to other people, even if they have the same symptoms you
have. It may harm them.
How should I use BYETTA? Your food and exercise plan, along with your periodic blood sugar testing and
scheduled A1C (also known as HbA1C) checks, will continue to be important in
See the accompanying Pen User Manual for instructions for using the BYETTA
managing your diabetes while you are taking BYETTA.
Pen and injecting BYETTA. BYETTA comes in a prefilled pen. Two prefilled pens
(5 mcg or 10 mcg) are available, depending on your prescribed dose (5 mcg or This Patient Information includes the most important information you should know
10 mcg, twice a day). Each pen has 60 doses to provide 30 days of twice-a-day
about using BYETTA. If you would like more information, talk with your healthcare
injections. You must do a “New Pen Set-Up” (see User Manual) one time only,
provider. You can ask your healthcare provider or pharmacist for information about
when starting a new prefilled BYETTA Pen. If you do this “New Pen Set-Up” before
BYETTA that is written for health professionals.
each injection, you will run out of medicine before 30 days.
��More information on BYETTA can be found at http://www.BYETTA.com.
��Use BYETTA exactly as prescribed by your healthcare provider. Your dose may be
increased after using BYETTA for 30 days. Do not change your dose unless your
��BYETTA Customer Service is available 24 hours a day at 1-800-868-1190.
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 What are the ingredients in BYETTA?
have questions or do not understand the instructions, talk to your healthcare
provider or pharmacist.
Active Ingredient: exenatide
��Pen needles are not included. You may need a prescription to purchase pen
Inactive Ingredients: metacresol, mannitol, glacial acetic acid, and sodium acetate
needles from your pharmacist. Ask your healthcare provider which needle length
trihydrate in water for injection.
and gauge is best for you.
��Inject your dose of BYETTA under the skin (subcutaneous injection) of your upper
Manufactured for Amylin Pharmaceuticals, Inc., San Diego, CA 92121
leg (thigh), stomach area (abdomen), or upper arm.
Marketed by Amylin Pharmaceuticals, Inc. and Eli Lilly and Company
��BYETTA is injected, twice a day, at any time within the 60 minutes (1 hour) before Literature Revised October 2007
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.
BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc.
��If you miss a dose of BYETTA, skip that dose and take your next dose at the next
� 2007 Amylin Pharmaceuticals, Inc. All rights reserved. 823005-AA
prescribed time. Do not take an extra dose or increase the amount of your
next dose to make up for the one you missed. 02-07-5748-A
BYETTA� exenatide injection 823005-AA BYETTA� exenatide injection 823005-AA
Amylin Pharmaceuticals PI.indd 1 7/7/09 16:08:34
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