(exenatide extended-release) injectable suspension, for
What is the most important information I should know
about BYDUREON BCISE?
BYDUREON BCISE may cause serious side effects, including:
- Possible thyroid tumors, including cancer. 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. In studies with rats, BYDUREON and medicines that work like
BYDUREON caused thyroid tumors, including thyroid cancer. It is not known if
BYDUREON BCISE will cause thyroid tumors or a type of thyroid cancer called
medullary thyroid carcinoma (MTC) in people.
- Do not use BYDUREON BCISE if you or any of your family
have ever had a type of thyroid cancer called medullary thyroid carcinoma
(MTC), or if you have an endocrine system condition called Multiple Endocrine
Neoplasia syndrome type 2 (MEN 2).
What is BYDUREON BCISE?
- BYDUREON BCISE 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 BCISE is not recommended as the first choice of
medicine for treating diabetes.
- BYDUREON BCISE is not a substitute for insulin and is not
for use in people with type 1 diabetes or people with diabetic ketoacidosis.
- It is not known if BYDUREON BCISE can be used with
- BYDUREON BCISE and BYDUREON are long-acting forms of the
medicine in BYETTA (exenatide). BYDUREON BCISE should not be used at the same
time as BYETTA or BYDUREON.
- It is not known if BYDUREON BCISE can be used in people
who have had pancreatitis.
- It is not known if BYDUREON BCISE is safe and effective for
use in children.
Do not use BYDUREON BCISE if:
- you or any of your family have ever had a type of thyroid
cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine
system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- you are allergic to exenatide or any of the ingredients
in BYDUREON BCISE. See the end of this Medication Guide for a complete list of
ingredients in BYDUREON BCISE.
Before using BYDUREON BCISE, tell your healthcare
provider about all of your medical conditions, including if you:
- have or have had problems with your pancreas or kidneys.
- have severe problems with your stomach, such as slowed
emptying of your stomach (gastroparesis) or problems with digesting food.
- are pregnant or plan to become pregnant. BYDUREON BCISE
may harm your unborn baby. Tell your healthcare provider if you become pregnant
while using BYDUREON BCISE. Talk to your healthcare provider about the best way
to control your blood sugar if you plan to become pregnant or while you are
- are breastfeeding or plan to breastfeed. It is not known
if BYDUREON BCISE passes into your breast milk. You should talk with your
healthcare provider about the best way to feed your baby while using BYDUREON
Tell your healthcare provider about all the medicines
you take, including prescription and over-the-counter medicines, vitamins,
and herbal supplements. BYDUREON BCISE may affect the way some medicines work
and some medicines may affect the way BYDUREON BCISE works.
Before using BYDUREON BCISE, talk to your healthcare
provider about low blood sugar and how to manage it. Tell your healthcare
provider if you are taking other medicines to treat diabetes including insulin
or sulfonylureas. Know the medicines you take. Keep a list of them to show your
healthcare provider and pharmacist when you get a new medicine.
How should I use BYDUREON BCISE?
- Read the Instructions for Use that comes with
- Use BYDUREON BCISE exactly as your healthcare provider
tells you to.
- BYDUREON BCISE should be injected right away after you
prepare your dose.
- Your healthcare provider should show you how to use
BYDUREON BCISE before you use it for the first time.
- BYDUREON BCISE is injected under the skin
(subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not
inject BYDUREON BCISE into a muscle (intramuscularly) or vein (intravenously).
- Use BYDUREON BCISE 1 time each week on the same day
each week at any time of the day.
- BYDUREON BCISE may be taken with or without food.
- If you miss a dose of BYDUREON BCISE, take the missed
dose as soon as possible if there are at least 3 days (72 hours) until your
next scheduled dose. If there are less than 3 days remaining, skip the missed
dose and take your next dose on the regularly scheduled day. Do not take
2 doses of BYDUREON BCISE within 3 days of each other.
- You may change the day of the week as long as your last
dose was given 3 or more days before.
- Do not mix insulin and BYDUREON BCISE together in
the same injection.
- You may give an injection of BYDUREON BCISE and insulin
in the same body area (such as, your stomach area), but not right next to each
- Change (rotate) your injection site with each weekly
injection. Do not use the same site for each injection.
- Your dose of other diabetes medicines may need to
change because of: change in level of physical activity or exercise, weight
gain or loss, increased stress, illness, change in diet, or because of other
medicines you take.
- Do not share your BYDUREON BCISE pen, syringe, or
needles with another person.You may give another person an infection or get an
infection from them.
What are the possible side effects of BYDUREON BCISE?
BYDUREON BCISE may cause serious side effects,
- See “What is the most important information I
should know about BYDUREON BCISE?&lquo;
- inflammation of your pancreas (pancreatitis). Stop
using BYDUREON BCISE 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.
- low blood sugar (hypoglycemia). Your risk for
getting low blood sugar may be higher if you use BYDUREON BCISE with another
medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs
and symptoms of low blood sugar may include:
- dizziness or lightheadedness
- blurred vision
- anxiety, irritability, or mood changes
- slurred speech
- confusion or drowsiness
- fast heartbeat
- feeling jittery
- kidney problems. In people who have kidney
problems, diarrhea, nausea, and vomiting may cause a loss of fluids
(dehydration) which may cause kidney problems to get worse or kidney failure.
- stomach problems. Other medicines like BYDUREON
BCISE may cause severe stomach problems. It is not known if BYDUREON BCISE
causes or worsens stomach problems.
- serious allergic reactions. Stop using BYDUREON
BCISE and get medical help right away if you have any symptoms of a serious
allergic reaction, including itching, rash, or difficulty breathing.
- injection-site reactions. Serious injection-site
reactions, with or without bumps (nodules), have happened in some people who
use BYDUREON. Some of these injection-site reactions have required surgery.
Call your healthcare provider if you have any symptoms of an injection-site
reaction, including severe pain, swelling, blisters, an open wound, a dark
- gallbladder problems. Gallbladder problems have happened
in some people who take BYDUREON or other medicines like BYDUREON. Tell your
healthcare provider right away if you get symptoms of gallbladder problems
which may include: pain in the right or middle upper stomach area, nausea and
vomiting, fever, or your skin or the white part of your eyes turns yellow.
The most common side effects of BYDUREON BCISE may
include a bump (nodule) at the injection site and nausea.
Nausea is most common when you first start using BYDUREON
BCISE but decreases over time in most people as their body gets used to the
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 BYDUREON
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
Keep BYDUREON BCISE and all medicines out of the reach
General information about the safe and effective use
of BYDUREON BCISE.
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use BYDUREON BCISE for a
condition for which it was not prescribed. Do not give your BYDUREON BCISE to
other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for
information about BYDUREON BCISE that is written for health professionals.
What are the ingredients in BYDUREON BCISE?
Contents of the powder:
Active Ingredient: exenatide
Inactive Ingredients: polylactide-co-glycolide and
Contents of liquid (diluent):
Inactive Ingredients: medium chain triglycerides
Instructions for Use
(exenatide extended-release), injectable suspension
For subcutaneous use only
Single-dose Autoinjector once weekly 2 mg
Read the Instructions for
Use before you start using BYDUREON BCISE.
Before using BYDUREON BCISE,
talk to your healthcare provider about how to use it the right way.
Before You Begin
Is a single use, fixed dose
autoinjector that automatically injects your medicine.
Is injected 1 time per week
under the skin.
Comes in the locked position
before you use it. Do not unlock the autoinjector until you are ready to inject
Needle is hidden. You do not
see it before, during, or after using the autoinjector.
Do not use the autoinjector if
any parts look to be broken or damaged.
Store flat in the refrigerator
between 36°F to 46°F (2°C to 8°C).
Never share your BYDUREON BCISE
autoinjector with anyone else. You may give an infection to them or get an
infection from them.
BYDUREON BCISE should not be
used by people who are blind or cannot see well, unless another person who is
trained to use this device can help.
Keep the autoinjector, and all
medicines, out of the reach of children.
Supplies needed to give your
BYDUREON BCISE autoinjector, Alcohol swab, A clean, flat
surface, Sharps container (see “disposal” instructions at the end of these
Step 1: Prepare for Injection
A. Let your autoinjector
come to room temperature.
Remove 1 autoinjector from the refrigerator and rest it
flat for 15 minutes.
Autoinjector can be kept at room temperature for up to 4
B. Check the expiration date
(labeled EXP) printed on the autoinjector label.
Do not use the autoinjector past the expiration date. If
the expiration date has passed, throw it away and get a new autoinjector.
C. Wash your hands.
D. Choose your injection
You can inject into your stomach, thigh, or back of the
upper arm, see Figure D.
Each week you can use the same area of your body, but
choose a different injection site in that area of your body. Clean the area
with an alcohol swab.
Step 2: Mix the medicine
A. Look in the window.
You may see white medicine along the sides, bottom or
top. This means the medicine is not mixed evenly.
B. Shake the autoinjector
hard, in an up-and-down motion, until the medicine is mixed
evenly and you do not see any white medicine along the sides, bottom or top.
Shake for at least 15 seconds. The autoinjector may need to be shaken longer
than 15 seconds if the autoinjector has not been correctly stored flat.
C. Check the mix.
Hold the autoinjector up to the light and look through
both sides and the bottom of the window. If not mixed well, repeat Step 2 and
Do not go to the next step
unless your medicine is mixed well. To get a full dose, the medicine must be
mixed well and look cloudy. If not mixed well, continue to shake hard.
Step 3: Prepare the
Important: After the medicine is
fully mixed, you must complete the preparation steps right away, and inject to
get the full dose. Do not save it to use later.
Only unlock the autoinjector
when you are ready to inject
A. Unlock the autoinjector.
Hold the autoinjector up
straight with the orange cap toward the ceiling. Turn the knob from the Lock to
the Unlock position until you hear a click.
B. While still holding the
autoinjector straight up, firmly unscrew the orange cap.
- You may need to turn the cap a
few times before it loosens (if you hear clicking you are turning in the wrong
- Continue holding the
autoinjector upright to prevent the medicine from accidently leaking.
- A green shield will pop up
after the cap is removed. The green shield hides the needle.
It is normal to see a few drops
of liquid inside the cap. Do not recap the autoinjector. Throw away the cap.
Hold upright and firmly unscrew
in a counterclockwise direction.
Figure K and Figure L
Figure M and Figure N
Step 4: Inject the Dose
A. Inject and hold:
- Push the autoinjector against
your skin. You will hear a “click” when the injection begins.
- Keep holding the autoinjector
against the skin for 15 seconds. This is to make sure you get the full dose.
B. Make sure you received
your full dose.
After you receive your
injection, you will see an orange rod in the window. After you lift the
autoinjector from your skin, the green shield will move back up to lock over
the needle. See the Common Questions and Answers for what to do if you do not
see the orange rod in the window after injection.
Step 4: Inject the Dose (continued)
Put your used autoinjector in a
FDA-cleared sharps disposal container right away after use.
Do not throw away (dispose of)
loose needles and syringes into your household trash. If you do not have an
FDA-cleared sharps disposal container, you may use a household container that
- Made of heavy-duty plastic
- Can be closed with a
tight-fitting, puncture-resistant lid that will not let sharps come out.
- Upright and stable during use
- Leak-resistant, and
- Properly labeled to warn of
hazardous waste inside the container
When your sharps disposal
container is almost full, you will need to follow your community guidelines for
the right way to dispose of your sharps disposal container. There may be state
or local laws about how you should throw away used needles and syringes. For
more information about safe sharps disposal, and for specific information about
sharps disposal in the state that you live in, go to FDA’s website at:
Do not dispose of your used
sharps disposal container in your household trash unless your community
guidelines permit this. Do not recycle your used sharps disposal container. See
“Common Questions and Answers” for additional disposal information.
Please keep these instructions
to use for your next dose.
Common Questions and Answers
1. Where is the needle?
The needle is attached to the
autoinjector and covered by the orange cap. When you unscrew the orange cap,
the green shield keeps the needle covered until you inject. For more
information, please see Figure N in Step 3B in the Instructions for Use.
2. How do I know if the
medicine is fully mixed?
After shaking the autoinjector,
look through both sides of the window. You should not see any white medicine
along the bottom, top, or sides. If you see white medicine, it is unmixed. To
mix, shake the autoinjector hard until the white medicine is no longer on the
bottom, top, or sides. The medicine should look even throughout.
3. Why do I need to hold the
autoinjector upright while removing the orange cap?
Holding the autoinjector with
the orange cap straight up helps prevent the medicine from leaking. It is
normal to see a few drops of medicine inside the orange cap after you unscrew
4. Why should I inject my
medicine right away after mixing it?
If you do not inject your
medicine right away after mixing, the medicine may separate, and you will not
get your full dose. You can re-mix your medicine if your autoinjector is in the
locked position. However, after you unlock it, you must complete the
preparation steps right away and inject to get the full dose. You cannot save
it for later use.
5. How do I know I gave
myself the full dose of medicine?
To be sure you get your full
dose, press and hold the autoinjector against your skin. You will feel the
needle go into your skin. Hold the needle against your skin for 15 seconds.
This will allow enough time for all the medicine to go from the autoinjector to
under your skin. After removing the needle, look for the orange rod in
the window as a way to tell that the dose has been given. If the orange rod
does not appear contact Customer Service at 1-877-700-7365.
6. Why should I store my autoinjectors flat in the
Autoinjectors stored vertically (with the needle up or
down) are more difficult to mix. The medicine can still be fully mixed, but it
will take more shaking and more time.
7. What if I do not have an FDA-cleared sharps
Do not throw away (dispose of) the autoinjector in
your household trash. If you do not have an FDA-cleared sharps disposal
container, you may use a household container that is:
- Made of heavy-duty plastic
- Can be closed with a tight-fitting, puncture-resistant
lid, that won't let sharps come out
- Upright and stable during use
- Properly labeled to warn of hazardous waste inside the
When your sharps disposal container is almost full, you
will need to follow your community guidelines for the right way to dispose of
your sharps disposal container. There may be state or local laws about how you
should throw away used needles and autoinjectors.
For more information about safe sharps disposal, and for
specific information about sharps disposal in the state you live in, go to the
FDA's website at: http://www.fda.gov/safesharpsdisposal.
8. What if I cannot unlock the autoinjector?
Review the Instructions for Use Step 3 to make sure you
are following the right instructions, then contact Customer Service,
1-877-700-7365 for help as needed. Do not try to unlock with excessive force or
9. What if I cannot remove the orange cap from the
Review the Instructions for Use Step 3 to make sure you
are following the right instructions. You should also check that the knob is
fully in the unlocked position, then contact Customer Service, 1-877-700-7365
for help as needed. Do not use tools or try to force the cap off.
10. For other questions about BYDUREON BCISE:
Visit www.BydureonBCise.com. Call Customer Service at
How to Store BYDUREON BCISE Autoinjector
- Store the autoinjector flat in the refrigerator between
36°F to 46°F (2°C to 8°C).
- Each autoinjector can be kept at room temperature not to
exceed 86°F (30°C) for no more than a total of 4 weeks, if needed.
- Store in the packaging provided to protect from light
until you are ready to prepare and use your dose.
- Do not use the autoinjector past the expiration date. The
expiration date is labeled EXP.
- Keep the autoinjector clean and away from spills.
This Instructions for Use has been approved by the U.S.
Food and Drug Administration.