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Read these instructions before you use the ClickJect Autoinjector
and each time you get a refill. There may be new information. Before you use the Autoinjector for the first time,
make sure your healthcare provider shows you the right way to use it.
Important:
• Keep the ClickJect Autoinjector in the refrigerator
until ready to use.
• Do not freeze.
INSTRUCTIONS FOR USE
ORENCIA® ClickJect
™
(abatacept) Injection
125 mg/mL, Single-Dose Autoinjector, For Subcutaneous Use Only
eyers Squibb Company
n, NJ 08543 USA
e
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For Position Only
N(01)1 03 XXXX XXXX XX C
A
F
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Fo
)1
Indication/Usage
Adult Rheumatoid Arthritis (RA):
ORENCIA® (abatacept) is a prescription medicine that reduces signs and
symptoms in adults 18 years or older with moderate to severe RA, including those who have not been helped
enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help
your ability to perform daily activities. In adults, ORENCIA may be used alone or with other RA treatments other
than tumor necrosis factor (TNF) antagonists.
Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults
with active psoriatic arthritis (PsA). In adults, ORENCIA may be used alone or with other PsA treatments.
Please read Important Safety Information on pages 16-18.
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Before You Begin
Before Use
Grip
Get to know the ClickJect Autoinjector
• The Autoinjector automatically delivers the medicine. The transparent tip locks over the
needle once the injection is complete and the Autoinjector is removed from the skin.
• Do not remove the orange needle cover until you are ready to inject.
Viewing Window
Activation Button (Blue)
Expiration Date
Needle Cover (Orange Cap)
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3
• Alcohol
swab
• Adhesive
bandage
• Cotton ball or gauze
• ClickJect
Autoinjector
• Sharps disposal
container
Gather supplies for your injection on a clean, flat surface
(only the ClickJect Autoinjector is included in the package):
Transparent Tip
After Use
Blue Indicator
Go to Step 1
3
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4
WAIT
Minutes
30
Let your ClickJect Autoinjector warm up.
Remove one Autoinjector from the refrigerator
and let it rest at room temperature for
30 minutes.
Do not remove the Autoinjector needle cover while
allowing it to reach room temperature.
Step 1: Prepare Your Autoinjector
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Liquid
Expiration Date
Examine the ClickJect Autoinjector:
• Check expiration date printed on the label.
Do not use if past the expiration date.
• Check the Autoinjector for damage.
Do not use if it is cracked or broken.
• Check the liquid through the viewing window.
It should be clear and colorless to pale yellow.
You may see a small air bubble. You do not need
to remove it. Do not inject if the liquid is cloudy,
discolored, or has particles in it.
Wash your hands well with soap and water.
Go to Step 2
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Outer area of
upper arms
Caregiver ONLY
Front of thighs
Abdomen,
avoid 2 inches
around navel
Injection Areas
Self-Injection
and Caregiver
Choose your injection site
in either the stomach (abdomen), front of
the thighs, or outer area of upper arm (only
if caregiver administered).
Rotate injection site.
• Each week you can use the same area of
your body, but use a different injection site
in that area.
• Do not inject into an area where the skin is
tender, bruised, red, scaly, or hard. Do not
give the injection in any areas with scars or
stretch marks.
• Record the date, time, and site where you inject.
Step 2: Prepare for Injection
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Gently clean injection site:
• Wipe the injection site with an alcohol swab and let it air dry.
• Do not touch the injection site again before giving the injection.
• Do not fan or blow on the clean area.
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Remove
Needle Cover
Pull orange needle cover
STRAIGHT off.
• DO NOT RECAP the Autoinjector.
• Throw away (discard) the needle cover in your
household trash.
• Do not use the Autoinjector if it is dropped
after the needle cover is removed.
Note: It is normal to see a drop of fluid
leaving the needle.
Go to Step 3
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8
90°
Window
Skin Pinch
Position the Autoinjector so you can see the viewing
window and it is at a 90º angle to the injection site. With
your other hand, gently pinch the cleaned skin.
Complete all steps to deliver your full dose of medicine:
WAIT
until blue
indicator
stops
moving
P
R
E
S
S
&
H
O
L
D
Seconds
15
PUSH
DOWN
on skin
Step 3: Inject Your Dose
8
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9
Press button, HOLD for 15 seconds AND watch window.
• You will hear a click as the injection begins.
• To deliver the full dose of medicine, hold the Autoinjector
in place for 15 seconds AND wait until the blue indicator
stops moving in window.
Remove the ClickJect Autoinjector from the injection site by
lifting it straight up. After you remove it from your skin, the transparent tip will
lock over the needle. Release skin pinch.
Push DOWN
on skin to unlock
the Autoinjector.
Go to Step 4
9
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Adhesive bandage
Cotton ball or gauze
Care of injection site:
• There may be a little bleeding at the injection site. You
can press a cotton ball or gauze over the injection site.
• Do not rub the injection site.
• If needed, you may cover the injection site with an
adhesive bandage.
Step 4: After the Injection
Disposing of used ClickJect Autoinjectors:
• Put your used ClickJect Autoinjector in an FDA-cleared Sharps disposal container right away after use.
Do not throw away (dispose of) loose needles and prefilled syringes in your household trash.
• If you do not have an FDA-cleared Sharps disposal container, you may use a household container that is:
º made of a heavy-duty plastic,
º can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
º upright and stable during use,
º leak resistant, and
º
properly labeled to warn of hazardous waste inside the container.
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Continued on next page
• 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 the FDA's website at:
http://www.fda.gov/safesharpsdisposal.
• 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 Frequently Asked Questions for additional disposal information.
If your injection is administered by a caregiver, this person must also handle
the Autoinjector carefully to prevent accidental needle stick injury and
possibly spreading infection.
Keep Autoinjector and the disposal container out of the reach of children.
How to store ORENCIA ClickJect Autoinjector
• Store ORENCIA in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep ORENCIA in the original package and out of the light.
• Do not freeze ORENCIA.
• Safely throw away medicine that is out of date or no longer needed.
Sharps disposal
container
Disposing of used ClickJect Autoinjectors:
• Put your used ClickJect Autoinjector in an FDA-cleared Sharps disposal container right away after use.
Do not throw away (dispose of) loose needles and prefilled syringes in your household trash.
• If you do not have an FDA-cleared Sharps disposal container, you may use a household container that is:
º made of a heavy-duty plastic,
º can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
º upright and stable during use,
º leak resistant, and
º
properly labeled to warn of hazardous waste inside the container.
11
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Frequently Asked Questions
Q. Why do I need to allow the Autoinjector to warm up at room temperature for 30 minutes prior
to injecting?
A. This step is primarily for your comfort. If the medicine is cold, the injection may take longer than
15 seconds. Never try to speed the warming process in any way, like using the microwave or placing
the Autoinjector in warm water.
Q. What if I accidentally remove the needle cover (orange cap) before I’m ready to use the Autoinjector?
A. If you remove the cover before you are ready to use the Autoinjector, be careful. Do not try to replace
it. Use the Autoinjector as soon as possible. While you prepare for the injection, carefully place the
Autoinjector on its side on a clean, flat surface. Be sure to keep the Autoinjector away from children.
Q. What if the Autoinjector appears to be broken or damaged?
A. Do not use the Autoinjector. Contact your healthcare provider or pharmacist for further instructions.
Q. What if the injection was not triggered?
A. Before the injection can be triggered, the device must be unlocked. To unlock, firmly push the
Autoinjector down on the skin without touching the button. Once the stop-point is felt, the device
is unlocked and can be triggered by pushing the button.
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Q. Why do I need to allow the Autoinjector to warm up at room temperature for 30 minutes prior
to injecting?
A. This step is primarily for your comfort. If the medicine is cold, the injection may take longer than
15 seconds. Never try to speed the warming process in any way, like using the microwave or placing
the Autoinjector in warm water.
Q. What if I accidentally remove the needle cover (orange cap) before I’m ready to use the Autoinjector?
A. If you remove the cover before you are ready to use the Autoinjector, be careful. Do not try to replace
it. Use the Autoinjector as soon as possible. While you prepare for the injection, carefully place the
Autoinjector on its side on a clean, flat surface. Be sure to keep the Autoinjector away from children.
Q. What if the Autoinjector appears to be broken or damaged?
A. Do not use the Autoinjector. Contact your healthcare provider or pharmacist for further instructions.
Q. What if the injection was not triggered?
A. Before the injection can be triggered, the device must be unlocked. To unlock, firmly push the
Autoinjector down on the skin without touching the button. Once the stop-point is felt, the device
is unlocked and can be triggered by pushing the button.
Q. I feel a little bit of burning and/or pain during injection. Is this normal?
A. When giving an injection, you may feel a prick from the needle. Sometimes, the medicine can cause slight
irritation near the injection site. If this occurs, the discomfort should be mild to moderate. If
you experience any side effects, including pain, swelling, or discoloration near the injection site,
contact your healthcare provider or pharmacist immediately. You are encouraged to report side effects
of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Q. How do I know I received my full dose?
A. Before lifting the Autoinjector from the injection site, check to ensure that the blue indicator
has stopped moving. Then, before disposing of the Autoinjector, check the bottom of the
transparent viewing window to make sure there is no liquid left inside. If the medicine has
not been completely injected, consult your healthcare provider or pharmacist.
Continued on next page
13
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Q. How should I dispose of a used Autoinjector?
A. Place used Autoinjector into an FDA-cleared Sharps disposal container right away after use.
• If you do not have one, you may use a household container that is:
• made of a heavy-duty plastic,
• can be closed with a tight-fitting, 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 Autoinjectors. For more information
about safe sharps disposal, and for specific information about sharps disposal in the state that you
live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
• Do not recycle your used Sharps disposal container.
Q. How should I keep my Autoinjector cool while traveling?
A. Your healthcare provider or pharmacist may be familiar with special carrying cases for injectable
medicines. Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Protect from light.
Frequently Asked Questions
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Q. How should I dispose of a used Autoinjector?
A. Place used Autoinjector into an FDA-cleared Sharps disposal container right away after use.
• If you do not have one, you may use a household container that is:
• made of a heavy-duty plastic,
• can be closed with a tight-fitting, 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 Autoinjectors. For more information
about safe sharps disposal, and for specific information about sharps disposal in the state that you
live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
• Do not recycle your used Sharps disposal container.
Q. How should I keep my Autoinjector cool while traveling?
A. Your healthcare provider or pharmacist may be familiar with special carrying cases for injectable
medicines. Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Protect from light.
Q. Can I take my Autoinjector on board an aircraft?
A. Generally, this is allowed. Be sure to pack your Autoinjector in your carry-on, and do not put it in your
checked luggage. You should carry it with you in your travel cooler at a temperature of 36°F to 46°F
(2°C to 8°C) until you are ready to use it. Airport security procedures and airline policies change from
time to time, so it’s best to check with airport authorities and the airline for any special rules. Prior to
flying, get a letter from your healthcare provider to explain that you are traveling with prescription
medicine that uses a device with a needle; if you are carrying a Sharps container in your carry-on
baggage, notify the screener at the airport.
Q. What if my Autoinjector does not stay cool for an extended period of time? Is it dangerous to use?
A. Contact 1-800-673-6242 for details.
If you have questions or concerns about your Autoinjector, please contact
a healthcare provider or call our toll-free help line at 1-800-673-6242.
Page 16
Important Safety Information for ORENCIA® (abatacept)
Please see additional Important Safety
Information on the next page.
16
Inform your healthcare provider of the following,
before you receive treatment with ORENCIA:
Infections: If you have any kind of infection,
even if it is small (such as an open cut or sore), an
infection that is in your whole body (such as the
flu), an infection that will not go away, or a history
of infections that keep coming back. ORENCIA
may make your immune system less able to fight
infections, so you may be more likely to get
infections or any infection you have may get worse.
Tuberculosis: If you have had tuberculosis (TB),
a positive skin test for TB, or if you recently have
been in close contact with someone who has
had TB. If you get any of the symptoms of TB (a
cough that does not go away, weight loss, fever,
night sweats), call your healthcare provider right
away. Before you start ORENCIA, your healthcare
provider may examine you for TB or perform
a skin test.
If you have or have had Viral Hepatitis. Before
you use ORENCIA, your healthcare provider may
examine you for hepatitis.
If you have a history of Chronic Obstructive
Pulmonary (lung) Disease (COPD).
If you are scheduled to have Surgery.
Allergies to the Ingredients of ORENCIA: The
ingredients of intravenous (IV) ORENCIA are:
abatacept, maltose, monobasic sodium phosphate,
and sodium chloride for administration. The
ingredients of subcutaneous (SC) ORENCIA are:
abatacept, sucrose, poloxamer 188, monobasic
sodium phosphate monohydrate, dibasic sodium
phosphate anhydrous, and water for injection.
Vaccinations: If you have recently received a
vaccination or are scheduled for any vaccination. If
you are receiving ORENCIA, and for 3 months after
you stop receiving ORENCIA, you should not take
live vaccines.
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Please see additional Important Safety
Information on the next page.
Diabetes: If you have diabetes and use a blood
glucose monitor to check your sugar levels.
The infusion of ORENCIA
®
(abatacept) contains
maltose, a sugar that can give falsely high blood
glucose readings with some monitors on the day
you receive your infusion. Your healthcare provider
may tell you to use a different way to monitor your
blood sugar levels. ORENCIA for SC injection does
not contain maltose; therefore, you do not need
to change the way you monitor your blood sugar if
you are taking ORENCIA subcutaneously.
Pregnancy: If you are pregnant, or plan to become
pregnant. It is not known if ORENCIA can harm
your unborn baby. If you took ORENCIA during
pregnancy, talk to your healthcare provider before
your baby receives any vaccines.
Breastfeeding: It is not known if ORENCIA passes
into your breastmilk. Talk to your healthcare
provider about the best way to feed your baby if
you use ORENCIA.
If you Take Any Other Kinds of Medicine,
including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
If you are Taking Other Biologic
Medicines such as: Enbrel
®
(etanercept),
Humira
®
(adalimumab), Remicade® (infliximab),
Kineret
®
(anakinra), Rituxan® (rituximab),
Simponi
®
(golimumab), Cimzia® (certolizumab pegol),
or Actemra
®
(tocilizumab). You may have a higher
chance of getting a serious infection if you take
ORENCIA with other biologic medicines.
Possible Side Effects of ORENCIA
ORENCIA can cause serious side
effects including:
• Serious infections. ORENCIA can make you more
likely to get infections or make the infection
that you have get worse. Some people have
died from these infections. Call your healthcare
provider immediately if you feel sick or get any
of the following signs of infection: fever; feel
very tired; cough; feel flu-like; or warm, red
or painful skin.
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Important Safety Information for ORENCIA® (abatacept) (cont.)
• Allergic reactions. Allergic reactions can
happen to people who use ORENCIA. Call your
healthcare provider or get emergency medical
help right away if you have any symptoms
of an allergic reaction, which may include
hives; swollen face, eyelids, lips, or tongue;
or trouble breathing.
• Hepatitis B infection. If you are a carrier of the
hepatitis B virus (a virus that affects the liver), the
virus can become active while you use ORENCIA.
Your healthcare provider may do a blood test
before you start treatment with ORENCIA.
• Vaccinations. You should not receive ORENCIA
with certain types of vaccines. ORENCIA may
cause some vaccinations to be less effective.
• Respiratory problems in people with COPD.
You may get certain respiratory problems
more often if you receive ORENCIA and have
COPD, including: worsened COPD, cough,
or trouble breathing.
• Cancer (malignancies). Certain kinds of cancer
have been reported in people receiving
ORENCIA. It is not known if ORENCIA increases
your chance of getting certain kinds of cancer.
Common side effects with ORENCIA are
headache, upper respiratory tract infection, sore
throat, and nausea. Other side effects in children
and adolescents may include diarrhea, cough,
fever, and abdominal pain.
These are not all the possible side effects of
ORENCIA.
Call your doctor for medical advice about side
effects. You may report side effects to FDA at
1-800- FDA-1088.
Click here for the Patient Information in the
Full Prescribing Information.
Page 19
Injection for Intravenous Use
Injection for Subcutaneous Use
If you have questions or concerns about
your ORENCIA® (abatacept) ClickJectTM Autoinjector,
please contact a healthcare provider familiar with
ORENCIA or call our toll-free help line at
1-800-ORENCIA (1-800-673-6242).
Click here for the Patient Information in the Full Prescribing Information.
© 2017 Bristol-Myers Squibb Company
ORENCIA is a registered trademark and ClickJect is a trademark of
Bristol-Myers Squibb Company. All other trademarks are property
of their respective owners.
427US1701798-05-01 Aug/17
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