Bimzelx 2 mL Autoinjector Instructions for use

INSTRUCTIONS
FOR USE
BIMZELX® (bim zel’ ex)
(bimekizumab-bkzx)
INJECTION, FOR
SUBCUTANEOUS USE
320 mg/2 mL
single-dose
autoinjector
Indication: BIMZELX® is a prescription medicine used to
treat adults with moderate-to-severe plaque psoriasis
who may benefit from taking injections or pills (systemic
therapy) or treatment using ultraviolet light alone or with pills
(phototherapy), adults with active psoriatic arthritis, adults with
active non-radiographic axial spondyloarthritis with objective
signs of inflammation, adults with active ankylosing spondylitis,
and adults with moderate-to-severe hidradenitis suppurativa.
Important Safety Information: Suicidal thoughts and behavior
have happened in some people treated with BIMZELX. Get
medical help right away or call the National Suicide and
Crisis Lifeline at 988 if you, your caregiver, or your family
member notice any of these symptoms.
Please see accompanying full Prescribing
Information and Medication Guide.
This Instructions for Use
contains information on
how to inject BIMZELX.
Read this Instructions
for Use before using the
BIMZELX autoinjector
and each time you get
a refill. There may be
new information. This
information does not take
the place of talking to your
healthcare provider about
your medical condition or
treatment.
Each BIMZELX autoinjector
is for one-time (singledose) use only.
2
IMPORTANT INFORMATION YOU NEED TO
KNOW BEFORE INJECTING BIMZELX:
• Your healthcare provider should show you or a
caregiver how to prepare and inject BIMZELX
before using the autoinjector for the first time.
Do not inject yourself or someone else until you
have been shown how to inject BIMZELX the
right way. Call your healthcare provider if you
have any questions.
• These instructions are for 1 injection only.
• The BIMZELX autoinjector has a needle safety
feature that will be activated to cover the
needle after the injection is finished. The needle
safety feature will help to prevent needle stick
injuries to anyone who handles the autoinjector
after injection.
• Do not share or reuse your BIMZELX
autoinjector as you may give or get an infection.
• Do not remove the needle cap until just before
you give the injection.
• If you have vision or hearing problems,
do not use the BIMZELX autoinjector without
help from a caregiver.
How should I store BIMZELX autoinjector?
• Store the BIMZELX autoinjector in the refrigerator
between 36°F to 46°F (2°C to 8°C).
• BIMZELX autoinjectors may be stored at room
temperature up to 77°F (25°C) in the original
carton for up to 30 days. Do not place BIMZELX
autoinjectors back in the refrigerator after they
have been stored at room temperature.
• Write the date removed from the refrigerator
in the space provided on the carton and throw
away if it has been kept at room temperature
and not used within 30 days.
• Keep BIMZELX in the original carton until ready
for use to protect from light.
• Do not freeze BIMZELX.
• Do not shake BIMZELX.
• Do not use the BIMZELX autoinjector past the
expiration date printed on the carton.
Keep BIMZELX autoinjectors and all medicines
out of the reach of children.
3
BIMZELX®
AUTOINJECTOR PARTS
(SEE FIGURE A):
Figure A
Cap
Needle guard
Viewing window
Handle
4
BIMZELX
SUPPLIESAUTOINJECTOR
NEEDED PARTS
(SEE FIGURE A):
FOR EACH BIMZELX
INJECTION
Figure A.
Needle Guard
Cap
Viewing Window
Needle Guard
1 BIMZELX autoinjector
For each BIMZELX
injection, you will n
For each BIMZELX injection, you will
BIMZELX
autoinjector
Not provided in1the
BIMZELX
1
autoinjector carton:
1 BIMZELX autoinjector
Not provided in the BIMZELX
autoinjector
carton:
1
Needle Guard
H
....................................
.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..
Not provided in the 1BIMZELX
autoinjector
carton:
alcohol
swab
1 Alcohol
swab
For each BIMZELX injection, you will need:
Alcohol
Swab
.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..
....................................
....................................
.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..
Alcohol
Swab
....................................
.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..
1 Alcohol swab
1 BIMZELX
autoinjector
1 Clean
cotton ball
1
Not provided in the BIMZELX autoinjector carton:
....................................
.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..
Alcohol
Swab
....................................
.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..
1 Clean
cotton
1 clean
cotton
ball ball
1 Puncture-resistant sharps
disposal container.
1 Alcohol swab
Ca
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sharpspr
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cotton ball at the end of this or
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5
SETTING UP FOR YOUR
BIMZELX® INJECTION
STEP 1
Take the BIMZELX autoinjector carton out
of the refrigerator. Do not use the BIMZELX
autoinjector(s) if the carton seal is broken.
Throw it away and get a new one.
• Keep the BIMZELX autoinjector in its original
carton for 30 to 45 minutes to warm to
room temperature. This will help to reduce
discomfort when injecting.
■
■
■
Do not microwave the autoinjector,
run hot water over it, or leave it in
direct sunlight.
Do not shake the autoinjector.
Do not take the cap off the autoinjector
until you are ready to inject.
STEP 2
Find a clean, flat,
and well-lit work
surface, like a table.
6
STEP 3
Gather the supplies needed for your injection.
STEP 4
Wash your hands well with soap and
water and dry with a clean towel.
7
SETTING UP FOR YOUR
BIMZELX® INJECTION
(CONT’D)
STEP 5
Inspect the BIMZELX autoinjector (see Figure B):
B)
• Remove the BIMZELX autoinjector from the
carton.
• Make sure the name BIMZELX appears on
the label.
Check the expiration date printed
on the label.
Check the medicine through the viewing
window. The medicine inside should be
clear to slightly pearly, and colorless to
pale brownish-yellow. You may see air
bubble(s) in the liquid. This is normal.
• Do not use the BIMZELX autoinjector,
throw it away, and get a new one if:
the expiration date printed on the label
has passed;
the medicine is cloudy, discolored, or
has particles; or
it looks damaged or has been dropped.
■
■
■
■
■
Figure B
Viewing window
Expiry date
8
CHOOSE AND PREPARE
YOUR INJECTION SITE
STEP 6
Choose and clean your injection site.
• The sites you may choose for your
injection are:
Your stomach area (abdomen) or
your thigh (see Figure C).
The back of your arm (see Figure D).
BIMZELX may be injected into the back
of your arm by a healthcare provider or
caregiver only.
■
■
Figure C
Abdomen or thigh
Figure D
Back of arm
• Do not inject into areas where the skin is
tender, bruised, red, hard, thick, scaly, or
affected by psoriasis, or within 2 inches of
the belly button (navel).
• You should change (rotate) your injection
site with each injection. Do not use the
same injection site 2 times in a row.
STEP 7
Prepare your skin.
• Clean the injection site with an alcohol swab.
Let the area dry completely. Do not touch
the cleaned area again before injecting.
9
INJECTING BIMZELX
STEP 8
Remove the BIMZELX autoinjector cap.
• Hold the BIMZELX autoinjector firmly with
one hand around the handle. Pull the cap
straight off (away from) the autoinjector
with the other hand (see Figure E).
Although you cannot see the needle
tip, it is now uncovered.
Put the cap into an FDA-cleared sharps
disposal container right away. You will
not need the cap again.
Do not touch the needle guard or put
the cap back on, as this could activate
the autoinjector and cause you to
stick yourself.
■
■
Figure E
STEP 9
Hold the BIMZELX autoinjector at a 90-degree
angle to the cleaned injection site (see Figure F).
F)
Figure F
90°
10
STEP 10
Place the BIMZELX autoinjector flat against your skin
and then firmly press the BIMZELX autoinjector down
against your skin. You will hear a “click” sound. Your
injection begins when the 1st “click” is heard (see
Figure G).
G)
Figure G
• Do not lift the
autoinjector away
from the skin.
First click
Keep holding the BIMZELX
autoinjector in place and
pressed firmly against your
skin. It will take about
20 seconds to receive
your full dose.
HOLD
Figure H
15s
Second
click
HOLD
Figure I
Slowly count to 5
1 ... 2 ... 3 ... 4 ... 5
• You will hear a 2nd “click”
in about 20 seconds after
you hear the first click.
• The second click tells you
the injection is almost
complete. You should see
the yellow color indicator
filling the viewing window
(see Figure H).
• After the 2nd click,
continue to hold down the
BIMZELX autoinjector for
an additional 5 seconds
(slowly count to 5). This
will ensure you receive
your full dose (see Figure I).
• Important: When you remove the autoinjector,
if the viewing window has not turned yellow,
you may not have received a full dose. Call
your healthcare provider right away.
11
STEP 11
Remove the BIMZELX autoinjector by carefully
pulling the BIMZELX autoinjector straight up from
your skin. The needle guard will automatically
cover the needle. Do not try to touch the needle.
• Press a clean cotton ball over the injection
site for a few seconds. Do not rub the
injection site. You may see slight bleeding
or a drop of liquid. This is normal. If needed,
you may cover the injection site with a small
adhesive bandage.
STEP 12
Dispose of (throw away) the used BIMZELX
autoinjector (see Figure J).
• Put the used BIMZELX autoinjector
in an FDA-cleared sharps disposal
container right away after use. Do not
throw away (dispose of) the BIMZELX
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 a heavy-duty plastic,
closed with a tight-fitting, punctureresistant 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.
■
■
■
■
■
12
INJECTING BIMZELX
(CONT’D)
• 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 needles and
syringes. For more information about
safe sharps disposal, and for specific
information about sharps disposal in
your state, go to the FDA website at:
http://www.fda.gov/safesharpsdisposal.
• Do not recycle your used sharps
disposal container.
Figure J
You can sign up to receive sharps containers
for BIMZELX autoinjector disposal at no
additional cost by going to www.BIMZELX.com
or by calling 1-844-599-2273.
Manufactured by:
UCB, Inc., 1950 Lake Park Drive, Smyrna, GA 30080
US License No. 1736
This Instructions for Use has been approved by the U.S. Food and
Drug Administration.
Issued: 10/2024
13
Indication: BIMZELX® is a prescription medicine used to treat adults
with moderate-to-severe plaque psoriasis who may benefit from taking
injections or pills (systemic therapy) or treatment using ultraviolet light
alone or with pills (phototherapy), adults with active psoriatic arthritis,
adults with active non-radiographic axial spondyloarthritis with objective
signs of inflammation, adults with active ankylosing spondylitis, and
adults with moderate-to-severe hidradenitis suppurativa.
Important Safety Information: Suicidal thoughts and behavior have
happened in some people treated with BIMZELX. Get medical help right
away or call the National Suicide and Crisis Lifeline at 988 if you, your
caregiver, or your family member notice any of these symptoms.
BIMZELX affects the immune system. It may increase your risk of infections,
which can be serious. Do not use BIMZELX if you have any symptoms of
infection without talking to your doctor. If you have any symptoms of
infection after starting BIMZELX, call your doctor right away.
Inspired by patients.
Driven by science.
BIMZELX® is made by UCB, a global biopharmaceutical
company. UCB is passionate about helping patients
and their families with chronic severe diseases.
BIMZELX® is a registered trademark of the UCB Group of
Companies.
14
©2024 UCB, Inc., Smyrna, GA 30080. All rights reserved.
US-BK-2401528
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