Byetta PEN User manual

BYETTA®(exenatide) injection
PEN USER MANUAL
BYETTA®exenatide injection
250 mcg/mL, 1.2 mL
5 mcg
5 mcg PEN USER MANUAL
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.
Section 1 Read this section completely before you begin. Then, move on to Section 2–Getting Started.
WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN
PEN USER MANUAL
Read these instructions carefully BEFORE using your BYETTA Pen. For complete dosing and safety information,
also read the BYETTA Medication Guide that comes with the BYETTA Pen carton.
It is important that you use your pen correctly. Failure to follow these instructions completely may result in a wrong
dose, a broken pen or an infection.
These instructions do not take the place of talking with your healthcare provider about your medical
condition or your treatment. If you are having problems using your BYETTA Pen, call toll free
1-800-236-9933.
IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN
• Each BYETTA Pen contains enough medicine for injection two times each day for 30 days. You do not have to
measure any doses, the pen measures each dose for you.
• Do not transfer the medicine in the BYETTA Pen to a syringe or vial.
• Do not mix BYETTA and insulin in the same syringe or vial even if you take them at the same time.
• If any part of your pen appears broken or damaged, do not use the pen.
• This BYETTA Pen is not recommended for use by people who are blind or have vision problems without the help of a
person trained in the proper use of the pen.
• Follow the injection method explained to you by your healthcare provider.
• Follow Section 2 only to set up a new pen before rst use.
• Section 3 of this manual should be used for every injection.
ABOUT PEN NEEDLES
What kinds of needles can be used with my BYETTA Pen?
• Pen needles are not included with your pen. You may need a prescription to get them from your pharmacist.
• Use 29 (thin), 30, or 31 (thinner) gauge disposable pen needles with your BYETTA Pen. Ask your healthcare provider
which needle gauge and length is best for you.
Do I use a new needle for each injection?
• Yes. 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.
• Remove the needle from the pen immediately after you complete each injection. This will help prevent leakage of
BYETTA, keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
• Do not push the injection button on your pen unless a needle is attached to the pen.
13

BYETTA®(exenatide) injection
How do I throw away my needles?
Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of)
loose needles and syringes in your household trash. If you do not have a FDA-cleared sharps disposal container, you may
use a household container that is:
• Made of a heavy-duty plastic,
• Can be closed with a tight-tting, puncture-resistant lid, without sharps being able to 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.
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.
STORING YOUR BYETTA PEN
How do I store my BYETTA Pen?
• Prior to rst use, store your unused BYETTA Pen in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
• After rst use, your BYETTA Pen can be kept at a temperature cooler than 77°F (25°C).
• Do not freeze your BYETTA Pen. Do not use BYETTA if it has been frozen. BYETTA should be protected from light.
• When carrying the pen away from home, store the pen at a temperature between 36°F to 77°F (2°C to 25°C) and
keep dry.
• Do not store the pen with the needle attached. If the needle is left on the pen, BYETTA may leak from the pen and
air bubbles may form in the cartridge.
Keep your pen and needles out of the reach of children.
How long can I use a BYETTA Pen?
• You can use your BYETTA Pen for up to 30 days after setting up a new pen for rst use. After 30 days, throw away
the BYETTA Pen in a FDA-cleared sharps disposal container, even if it is not completely empty.
• Mark the date when you rst used your pen and the date 30 days later in the spaces below:
Date of First Use ________________________________ Date to Throw Away Pen _____________________
• BYETTA should not be used after the expiration date printed on the pen label.
How do I clean my BYETTA Pen?
• Wipe the outside of the pen with a clean, damp cloth.
• White particles may appear on the outside tip of the cartridge during normal use. You may remove them with an
alcohol wipe or alcohol swab.
See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free
1-800-236-9933 or visit www.BYETTA.com
Section 2 Read and follow the directions in this section only after you’ve read Section 1—What You
Need To Know About Your BYETTA Pen.
GETTING STARTED
Set up your new pen just before you use it the rst time. For routine use, do not repeat this one-time-only new pen
setup. If you do, you will run out of BYETTA before 30 days of use.
ready to pull dose knob out
ready to turn to dose position
ready to inject 5 mcg
dose knob pushed in and
ready to reset
14

BYETTA®(exenatide) injection
ONE-TIME-ONLY NEW PEN SETUP
STEP A Check the Pen
Note: Small air bubbles in the
cartridge are normal.
• Wash hands prior to use.
• Check pen label to make sure it is
your 5 mcg pen.
• Pull off the blue pen cap.
• Check BYETTA in the cartridge.
The liquid should be clear,
colorless, and free of particles.
If not, do not use.
STEP B Attach the Needle
• Remove paper tab from outer
needle shield.
• Push outer needle shield
containing the needle straight
onto the pen, then screw
needle on until secure.
• Pull off outer needle shield.
Do not throw away. • Pull off inner needle shield and throw away. A small drop
of liquid may appear. This is
normal.
STEP C Dial the Dose
• Check that the is in the
dose window. If not, turn
dose knob away from you
(clockwise) until it stops and
the is in the dose window.
• Pull dose knob out until it
stops and the is in the
dose window.
• Turn dose knob away from
you until it stops at .
Make sure that the 5 with the
line under it is in the center of
the dose window.
Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in
Section 4 of this user manual.
STEP D Prepare the Pen
• Point the needle of the pen up
and away from you.
PUSH & HOLD
• Use thumb to rmly push
injection button in until it
stops, then continue holding the
injection button in while slowly
counting to 5.
• If you do not see a stream or
several drops come from the
needle tip, repeat Steps C & D.
• Pen preparation is complete
when the is in the center
of the dose window and
you have seen a stream or
several drops come from the
needle tip.
Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.
15

BYETTA®(exenatide) injection
STEP E Complete New Pen Setup
• Turn dose knob away from
you until it stops and the
is in the dose window.
Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 7, in Section 4 of user manual.
Section 3 Now that you have done the one-time-only new pen setup, follow Section 3 for all of your injections.
ROUTINE USE
STEP 1 Check the Pen
Note: Small air bubbles will not
harm you or affect your dose.
• Wash hands prior to use.
• Check pen label to make sure it
is your 5 mcg pen.
• Pull off the blue pen cap.
• Check BYETTA in the cartridge.
• The liquid should be clear,
colorless, and free of particles.
If it is not, do not use.
STEP 2 Attach the Needle
• Remove paper tab from outer
needle shield.
• Push outer needle shield containing
the needle straight onto pen, then
screw needle on until secure.
• Pull off outer needle shield.
Do not throw away. • Pull off inner needle shield and throw away. A small
drop of liquid may appear.
This is normal.
STEP 3 Dial the Dose
• Check that the is in the
dose window. If not, turn
dose knob away from you
(clockwise) until it stops and
the is in the dose window.
• Pull dose knob out until
it stops and the is in the
dose window.
• Turn dose knob away from
you until it stops at .
Make sure that the 5 with the
line under it is in the center of
the dose window.
Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in
Section 4 of this user manual.
• For routine use, do not
repeat this one-time-only
new pen setup. If you do,
you will run out of BYETTA
before 30 days of use.
• You are now ready for your rst
dose of BYETTA.
• Go to Section 3, Step 3, for
instructions on how to inject
your rst routine dose.
16

BYETTA®(exenatide) injection
STEP 4 Inject the Dose
• Grip pen rmly.
• Insert needle into skin
using the under-the-skin
(subcutaneous) injection
method explained by your
healthcare provider.
PUSH & HOLD
• Use thumb to rmly push
injection button in until it
stops. Continue holding in the
injection button while slowly
counting to 5 to get a full dose.
• Remove needle from skin.
• Injection is complete when the
is in the center of the dose
window.
• The pen is now ready to reset.
Note: If you see several drops of BYETTA leaking from the needle after the injection, you may not have received a
complete dose. See Commonly Asked Questions, number 4, in Section 4 of this user manual.
STEP 5 Reset the Pen
• Turn dose knob away
from you until it stops
and the is in the dose
window.
Note: If you cannot turn the dose knob,
or if your pen leaks, your full dose has
not been delivered. See Commonly
Asked Questions, numbers 4 and 7, in
Section 4 of this user manual.
STEP 6 Remove and Dispose of the Needle
• Carefully put the outer needle
shield back over the needle.
• Remove the needle after
each injection.
• Unscrew the needle. • Throw away needles in a
FDA-cleared sharps disposal
container (See above “How do
I throw away my needles?”)
or as recommended by your
healthcare provider.
STEP 7 Store Pen for Next Dose
• Replace Blue Pen Cap on pen before storage.
• Store your BYETTA Pen at a temperature between 36°F to 77°F (2°C to 25°C). (See Storing Your BYETTA Pen in
Section 1 of this user manual for complete storage information.)
• When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1–7.
Section 4 COMMONLY ASKED QUESTIONS
1. Do I need to do the One-Time-Only New Pen Setup before every dose?
• No. The One-Time-Only New Pen Setup is done only once, just before each new pen is used for the rst time.
• The purpose of the setup is to make sure that your BYETTA Pen is ready to use for the next 30 days.
• If you repeat the One-Time-Only New Pen Setup before each routine dose, you will not have enough BYETTA
for 30 days. The small amount of BYETTA used in the new pen setup will not affect the 30-day supply of BYETTA.
2. Why are there air bubbles in the cartridge?
• A small air bubble is normal. It will not harm you or affect your dose.
• If the pen is stored with a needle attached, air bubbles may form in the cartridge. Do not store the pen with the needle attached.
3. What should I do if BYETTA does not come out of the needle tip after four tries during One-Time-Only
New Pen Setup?
• Carefully put the outer needle shield back over the needle. Remove the needle by unscrewing it. Throw away the
needle properly.
• Attach a new needle and repeat One-Time-Only New Pen Setup, Steps B–E, in Section 2 of this user manual. Once
you see several drops or a stream of liquid coming out of the tip of the needle, the setup is complete.
17

BYETTA®(exenatide) injection
4. Why do I see BYETTA leaking from my needle after I have nished my injection?
It is normal for a single drop to remain on the tip of your needle after your injection is complete. If you see more than one drop:
• You may not have received your full dose. Do not inject another dose. Talk with your healthcare provider about
what to do about a partial dose.
• To make sure that you get your full dose, when you take your injections, rmly push and hold the injection button
in and slowly count to 5 (see Section 3, Step 4: Inject the Dose).
5. How can I tell when the injection is complete?
The injection is complete when:
• You have rmly pushed the injection button in all the way until it stops
and
• You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin
and
• The is in the center of the dose window.
If you hear a click sound from your BYETTA Pen, ignore it. You must follow all the steps listed above to make sure
your injection is complete.
6. Where should I inject BYETTA?
Inject BYETTA into your abdomen, thigh, or upper
arm using the injection method explained to you by
your healthcare provider.
7. What if I cannot pull, turn, or push the dose knob?
Check the symbol in the dose window. Follow the steps
next to the matching symbol.
If is in the dose window:
• Pull the dose knob out until appears.
If is in the dose window and the dose knob will not turn:
• The cartridge in your BYETTA Pen may not have enough medicine to deliver a full dose. A small amount of
BYETTA will always stay in the cartridge. If the cartridge contains a small amount and the dose knob will not
turn, your pen does not have enough BYETTA and will not deliver any more doses. Get a new BYETTA Pen.
If and part of are in the dose window and the dose knob cannot be pushed in:
• The dose knob was not turned all the way. Continue turning the dose knob away from you until is in the center of
the dose window.
If part of and part of are in the dose window and the dose knob cannot be pushed in:
• The needle may be clogged, bent, or incorrectly attached.
• Attach a new needle. Make sure needle is on straight and screwed on all the way.
• Firmly push the injection button in all the way. BYETTA should come from needle tip.
If is in the dose window and the dose knob will not turn:
• The injection button was not pushed in all the way and a complete dose was not delivered. Talk with your healthcare
provider about what to do about a partial dose.
• Follow these steps to reset your pen for your next injection:
• Firmly push the injection button in all the way until it stops. Keep holding the injection button in and slowly count
to 5. Then release the injection button and turn the dose knob away from you until appears in the dose window.
• If you cannot turn the dose knob, the needle may be clogged. Replace the needle and repeat the step above.
• For your next dose, be sure to rmly push and hold the injection button in and slowly count to 5 before removing
needle from skin.
See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free
1-800-236-9933 or visit www.BYETTA.com
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
BYETTA® is a registered trademark of the AstraZeneca group of companies.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: December 2018 US-37816 3/20
BackFront
18

BYETTA®(exenatide) injection
PEN USER MANUAL
BYETTA®exenatide injection
250 mcg/mL, 2.4 mL
10 mcg
10 mcg PEN USER MANUAL
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.
Section 1 Read this section completely before you begin. Then, move on to Section 2–Getting Started.
WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN
PEN USER MANUAL
Read these instructions carefully BEFORE using your BYETTA Pen. For complete dosing and safety information,
also read the BYETTA Medication Guide that comes with the BYETTA Pen carton.
It is important that you use your pen correctly. Failure to follow these instructions completely may result in a wrong
dose, a broken pen or an infection.
These instructions do not take the place of talking with your healthcare provider about your medical
condition or your treatment. If you are having problems using your BYETTA Pen, call toll free
1-800-236-9933.
IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN
• Each BYETTA Pen contains enough medicine for injection two times each day for 30 days. You do not have to
measure any doses, the pen measures each dose for you.
• Do not transfer the medicine in the BYETTA Pen to a syringe or vial.
• Do not mix BYETTA and insulin in the same syringe or vial even if you take them at the same time.
• If any part of your pen appears broken or damaged, do not use the pen.
• This BYETTA Pen is not recommended for use by people who are blind or have vision problems without the help of a
person trained in the proper use of the pen.
• Follow the injection method explained to you by your healthcare provider.
• Follow Section 2 only to set up a new pen before rst use.
• Section 3 of this manual should be used for every injection.
ABOUT PEN NEEDLES
What kinds of needles can be used with my BYETTA Pen?
• Pen needles are not included with your pen. You may need a prescription to get them from your pharmacist.
• Use 29 (thin), 30, or 31 (thinner) gauge disposable pen needles with your BYETTA Pen. Ask your healthcare provider
which needle gauge and length is best for you.
Do I use a new needle for each injection?
• Yes. 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.
• Remove the needle from the pen immediately after you complete each injection. This will help prevent leakage of
BYETTA, keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
• Do not push the injection button on your pen unless a needle is attached to the pen.
19

BYETTA®(exenatide) injection
How do I throw away my needles?
Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of)
loose needles and syringes in your household trash. If you do not have a FDA-cleared sharps disposal container, you may
use a household container that is:
• Made of a heavy-duty plastic,
• Can be closed with a tight-tting, puncture-resistant lid, without sharps being able to 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.
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.
STORING YOUR BYETTA PEN
How do I store my BYETTA Pen?
• Prior to rst use, store your unused BYETTA Pen in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
• After rst use, your BYETTA Pen can be kept at a temperature cooler than 77°F (25°C).
• Do not freeze your BYETTA Pen. Do not use BYETTA if it has been frozen. BYETTA should be protected from light.
• When carrying the pen away from home, store the pen at a temperature between 36°F to 77°F (2°C to 25°C) and
keep dry.
• Do not store the pen with the needle attached. If the needle is left on the pen, BYETTA may leak from the pen and
air bubbles may form in the cartridge.
Keep your pen and needles out of the reach of children.
How long can I use a BYETTA Pen?
• You can use your BYETTA Pen for up to 30 days after setting up a new pen for rst use. After 30 days, throw away
the BYETTA Pen in a FDA-cleared sharps disposal container, even if it is not completely empty.
• Mark the date when you rst used your pen and the date 30 days later in the spaces below:
Date of First Use ________________________________ Date to Throw Away Pen _____________________
• BYETTA should not be used after the expiration date printed on the pen label.
How do I clean my BYETTA Pen?
• Wipe the outside of the pen with a clean, damp cloth.
• White particles may appear on the outside tip of the cartridge during normal use. You may remove them with an
alcohol wipe or alcohol swab.
See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free
1-800-236-9933 or visit www.BYETTA.com
Section 2 Read and follow the directions in this section only after you’ve read Section 1—What You
Need To Know About Your BYETTA Pen.
GETTING STARTED
Set up your new pen just before you use it the rst time. For routine use, do not repeat this one-time-only new pen
setup. If you do, you will run out of BYETTA before 30 days of use.
ready to pull dose knob out
ready to turn to dose position
ready to inject 10 mcg
dose knob pushed in and
ready to reset
20

BYETTA®(exenatide) injection
ONE-TIME-ONLY NEW PEN SETUP
STEP A Check the Pen
Note: Small air bubbles in the
cartridge are normal.
• Wash hands prior to use.
• Check pen label to make sure it is
your 10 mcg pen.
• Pull off the blue pen cap.
• Check BYETTA in the cartridge.
The liquid should be clear,
colorless, and free of particles.
If not, do not use.
STEP B Attach the Needle
• Remove paper tab from outer
needle shield.
• Push outer needle shield
containing the needle straight
onto the pen, then screw
needle on until secure.
• Pull off outer needle shield.
Do not throw away. • Pull off inner needle shield and throw away. A small drop
of liquid may appear. This is
normal.
STEP C Dial the Dose
• Check that the is in the
dose window. If not, turn
dose knob away from you
(clockwise) until it stops and
the is in the dose window.
• Pull dose knob out until it
stops and the is in the
dose window.
• Turn dose knob away from
you until it stops at .
Make sure that the 10 with
the line under it is in the
center of the dose window.
Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in
Section 4 of this user manual.
STEP D Prepare the Pen
• Point the needle of the pen up
and away from you.
PUSH & HOLD
• Use thumb to rmly push
injection button in until it
stops, then continue holding the
injection button in while slowly
counting to 5.
• If you do not see a stream or
several drops come from the
needle tip, repeat Steps C & D.
• Pen preparation is complete
when the is in the center
of the dose window and
you have seen a stream or
several drops come from the
needle tip.
Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.
21

BYETTA®(exenatide) injection
STEP E Complete New Pen Setup
• Turn dose knob away from
you until it stops and the
is in the dose window.
Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 7, in Section 4 of user manual.
Section 3 Now that you have done the one-time-only new pen setup, follow Section 3 for all of your injections.
ROUTINE USE
STEP 1 Check the Pen
Note: Small air bubbles will not
harm you or affect your dose.
• Wash hands prior to use.
• Check pen label to make sure it
is your 10 mcg pen.
• Pull off the blue pen cap.
• Check BYETTA in the cartridge.
• The liquid should be clear,
colorless, and free of particles.
If it is not, do not use.
STEP 2 Attach the Needle
• Remove paper tab from outer
needle shield.
• Push outer needle shield containing
the needle straight onto pen, then
screw needle on until secure.
• Pull off outer needle shield.
Do not throw away. • Pull off inner needle shield and throw away. A small drop
of liquid may appear. This is
normal.
STEP 3 Dial the Dose
• Check that the is in the
dose window. If not, turn
dose knob away from you
(clockwise) until it stops and
the is in the dose window.
• Pull dose knob out until
it stops and the is in the
dose window.
• Turn dose knob away from
you until it stops at .
Make sure that the 10 with
the line under it is in the
center of the dose window.
Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in
Section 4 of this user manual.
• For routine use, do not
repeat this one-time-only
new pen setup. If you do,
you will run out of BYETTA
before 30 days of use.
• You are now ready for your rst
dose of BYETTA.
• Go to Section 3, Step 3, for
instructions on how to inject
your rst routine dose.
22