Coherus BioSciences UDENYCA User manual

Instructions for Use
UDENYCA™ (yoo-den-i-kah)
(pegfilgrastim-cbqv)
Injection
Single-Dose Prefilled Syringe
Guide to Parts
Before use
Figure 1
Important: The needle is covered by a needle cap before use
After use
Figure 2
Important
Read the Patient Information for important information you need to know about
UDENYCA before using these Instructions for Use.
Storing the UDENYCA prefilled syringe
•Store UDENYCA prefilled syringes in the
refrigerator between 36°F to 46° F (2°C to 8°C).
•Keep the UDENYCA prefilled syringe in the
original carton to protect from light.
•Do not freeze UDENYCA.
oIf UDENYCA is accidentally frozen, allow
the prefilled syringe to thaw in the
refrigerator before injecting.
oThrow away (dispose of) any UDENYCA
prefilled syringes that have been frozen
more than 1 time.
•Throw away (dispose of) any UDENYCA prefilled
syringes that have been left out at room
temperature for more than 48 hours.
•Keep the UDENYCA prefilled syringe out of the
reach of children.
Needle Safety Guard
Activated
Label
Needle Cap
Inspection Window
Needle
Plunger
Plunger Head
Finger Grips
Syringe
Body
Needle Safety Guard
Unactivated

Using the prefilled syringe
•
It is important that you do not try to give the
injection unless you or your caregiver has
received training from your healthcare
provider.
•Make sure that the name UDENYCA appears
on the carton and prefilled syringe label.
•Check the carton and prefilled syringe label to
make sure the dose strength is 6 mg/0.6 mL.
•You should not inject a dose of UDENYCA to
children weighing less than 45 kg from a
UDENYCA prefilled syringe. A dose less than
0.6 mL (6 mg) cannot be accurately measured
using the UDENYCA prefilled syringe.
•Do not use a prefilled syringe after the
expiration date on the label.
•Do not shake the prefilled syringe
•Do not remove the needle cap from the
prefilled syringe until you are ready to inject.
•Do not use the prefilled syringe if the carton is
open or damaged.
•Do not use a prefilled syringe if it has been
dropped on a hard surface. The prefilled
syringe may be broken even if you cannot see
the break. Use a new prefilled syringe.
•Do not attempt to activate the needle safety
guard prior to injection
Call your healthcare provider if you have any
questions.

Prepare the injection
1 - Remove carton from refrigerator and check expiration date
1A: Remove the carton from the refrigerator and
check the expiration date printed on the carton.
(See Figure 3)
Do not use if the expiration date has passed.
Figure 3
1B: Open the carton and remove the sealed
syringe tray. (See Figure 4)
Figure 4
2 - Allow UDENYCA to reach room temperature and gather supplies
2A: Place the sealed syringe tray on a flat, clean
work surface and allow it to sit at room
temperature for at least 30 minutes.
(See Figure 5)
Do not attempt to warm up the syringe in any
other way, such as a microwave, hot water, or
direct sunlight.
Figure 5
2B: Gather the following supplies:
(See Figure 6)
•alcohol wipe
•cotton ball or gauze
•1 adhesive bandage
•sharps disposal container
Figure 6

3 - Wash your hands and remove syringe from tray
3A: Wash your hands well with soap and warm
water. (See Figure 7)
Figure 7
3B: Open the tray by peeling away the cover.
Remove the prefilled syringe from the tray by
grasping the middle of the syringe body and
carefully pulling it out of the tray. (See Figure 8)
For Safety reasons:
•Do not grab the plunger, plunger head.
•Do not grab the needle cap.
Figure 8
4 - Inspect the syringe and medicine
Check the medicine through the Inspection
Window. The medicine should be clear and
colorless. It is normal to see 1 or more air
bubbles in the syringe. Removal of the air is not
needed. (See Figure 9)
Do not use the prefilled syringe if:
•the medicine appears discolored or cloudy.
•the medicine contains lumps, flakes, or
particles.
•it appears used or damaged.
•if the needle cap is missing or not securely
attached.
•the expiration date printed on the label has
passed.
In all cases, use a new prefilled syringe and call your
healthcare provider.
Figure 9

Select and clean injection site
5 - Select and clean the injection site
5A: Select the injection site. The recommended
injection sites for a subcutaneous injection are
the: (See Figure 10)
•Abdomen (except for a two-inch area
surrounding the navel)
•Thighs
•Back of upper arms (only if someone else is
giving you the injection)
•Upper outer area of the buttocks (only if
someone else is giving you the injection)
Do not inject into moles, scars, birthmarks, or
areas where the skin is tender, bruised, red, or
hard.
If you want to use the same injection site, make
sure it is not the same spot on the injection site
you used for a previous injection.
Figure 10
5B: Clean the injection site with an alcohol wipe.
(See Figure 11)
Do not touch this area again before injection.
Figure 11
Inject the dose
6 - Remove needle cap
Remove the needle cap by pulling it straight off.
(See Figure 12)
•Do not remove the needle cap from the
prefilled syringe until you are ready to inject.
•Do not twist or bend the needle cap.
•Do not hold the prefilled syringe by the
plunger rod
•Do not put the needle cap back onto the
syringe. Dispose of (throw away) the needle
cap in your household trash
•Do not use the prefilled syringe if it has
been dropped with the needle cap removed.
Figure 12
7 – Position fingers
Grasp the body of the syringe like a dart (just
under the finger grips) with your thumb and index
fingers. (See Figure 13)
•Do not touch the plunger or grasp the
syringe above the finger grips.
Figure 13
Back of
upper arm
Abdomen
Upper
outer
buttock
Thigh

8 – Pinch the skin and insert the needle
8A: Use your free hand to gently pinch the
cleaned injection site to create a firm surface.
(See Figure 14)
Figure 14
8B: Hold the pinch. Insert the needle into the skin
at a 45 to 90-degree angle. (See Figure 15)
•Do not touch the plunger head while
inserting the needle into the skin.
•Do not touch the cleaned area of the skin
Figure 15
8C: After fully inserting the needle, release the
pinched skin and use your free hand to stabilize
the bottom of the syringe.
Then move your other hand into injection
position with your thumb on the plunger head.
(See Figure 16)
Figure 16
9 – Push plunger head down to deliver dose
9A: Using slow and constant pressure, push the
plunger head down until it reaches the bottom.
This will help to ensure that you receive the full
dose. (See Figure 17)
Figure 17
9B: While the needle is still inserted, slowly move
your thumb back, allowing the plunger to rise.
This will release the needle safety guard to
safely cover the needle. Then remove the
syringe from the injection site. (See Figure 18)
Important: When you remove the syringe, if it
looks like the medicine is still in the syringe, this
means you have not received a full dose. Call
your healthcare provider right away.
•If you see drops of blood at the injection site,
treat by pressing a cotton ball or gauze to
the site as needed.
Figure 18

Dispose
10 – Dispose of used prefilled syringes
Put the used prefilled syringe into an FDA-
cleared sharps disposal container right away
after use. Do not throw away the syringe in the
household trash. (See Figure 19)
Figure 19
•If you do not have a FDA-cleared sharps disposal container, you may use a household
container that is:
omade of a heavy-duty plastic
ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to
come out
oupright and stable during use
oleak-resistant
oproperly 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 the FDA's website at: http://www.fda.gov/safesharpsdisposal.
•Do not reuse the prefilled syringe.
•Do not recycle prefilled syringes or sharps disposal container or throw them into household
trash.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 11/2018

UDENYCA™ (pegfilgrastim-cbqv)
Manufactured by: Coherus BioSciences, Inc., Redwood City, California 94065-1442
U.S. License No. 2023
© 2018 Coherus BioSciences Inc. All rights reserved.
For more information go to www.UDENYCA.com, or call 1-800-4UDENYCA (1-800-483-3692)
PMD-0005, Rev. 01