Single-Dose Prefilled Syringe
What is UDENYCA?
UDENYCA is a man-made form of granulocyte
colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body.
It stimulates the growth of neutrophils, a type of white blood cell important
in the body's fight against infection.
Do not take UDENYCA if you have had a serious
allergic reaction to pegfilgrastim or filgrastim products.
Before you receive UDENYCA, tell your healthcare
provider about all of your medical conditions, including if you:
- have a sickle cell disorder.
- have kidney problems.
- are pregnant or plan to become pregnant. It is not known
if UDENYCA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
if UDENYCA passes into your breast milk.
Tell your healthcare provider about all of the
medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
How will I receive UDENYCA?
- UDENYCA is given as an injection under your skin
(subcutaneous injection) by a healthcare provider. If your healthcare provider
decides that the subcutaneous injections can be given at home by you or your
caregiver, follow the detailed “Instructions for Use” that comes with your
UDENYCA for information on how to prepare and inject a dose of UDENYCA.
- You and your caregiver will be shown how to prepare and
inject UDENYCA before you use it.
- You should not inject a dose of UDENYCA to children
weighing less than 45kg from a UDENYCA prefilled syringe. A dose less than 0.6
mL (6mg) cannot be accurately measured using the UDENYCA prefilled syringe.
- If you are receiving UDENYCA because you are also
receiving chemotherapy, the last dose of UDENYCA should be injected at least 14
days before and 24 hours after your dose of chemotherapy.
- If you miss a dose of UDENYCA, talk to your healthcare
provider about when you should give your next dose.
What are possible side effects of UDENYCA?
UDENYCA may cause serious side effects, including:
- Spleen rupture. Your spleen may become enlarged
and can rupture. A ruptured spleen can cause death. Call your healthcare
provider right away if you have pain in the left upper stomach area or your
- A serious lung problem called Acute Respiratory
Distress Syndrome (ARDS). Call your healthcare provider or get emergency
care right away if you have shortness of breath with or without a fever,
trouble breathing, or a fast rate of breathing.
- Serious allergic reactions. UDENYCA can cause
serious allergic reactions. These reactions can cause a rash over your whole
body, shortness of breath, wheezing, dizziness, swelling around your mouth or
eyes, fast heart rate, and sweating. If you have any of these symptoms, stop
using UDENYCA and call your healthcare provider or get emergency medical help
- Sickle cell crises. You may have a serious sickle
cell crisis if you have a sickle cell disorder and receive UDENYCA. Serious
sickle cell crises have happened in people with sickle cell disorders receiving
pegfilgrastim that has sometimes led to death. Call your healthcare provider
right away if you have symptoms of sickle cell crisis such as pain or
- Kidney injury (glomerulonephritis). UDENYCA can
cause kidney injury. Call your healthcare provider right away if you develop
any of the following symptoms:
- swelling of your face or ankles
- blood in your urine or dark colored urine
- you urinate less than usual
- Increased white blood cell count (leukocytosis).
Your healthcare provider will check your blood during treatment with UDENYCA.
- Capillary Leak Syndrome. UDENYCA can cause fluid
to leak from blood vessels into your body's tissues. This condition is called
“Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms
that may become life-threatening. Get emergency medical help right away if you
develop any of the following symptoms:
- swelling or puffiness and are urinating less than usual
- trouble breathing o swelling of your stomach-area
(abdomen) and feeling of fullness
- dizziness or feeling faint o a general feeling of
- Inflammation of the aorta (aortitis). Inflammation
of the aorta (the large blood vessel that transports blood from the heart to
the body) has been reported in patients who received pegfilgrastim. Symptoms
may include fever, abdominal pain, feeling tired, and back pain. Call your
healthcare provider if you experience these symptoms.
The most common side effects of UDENYCA are pain
in the bones, arms, and legs.
These are not all the possible side effects of UDENYCA.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store UDENYCA?
- Store UDENYCA in the refrigerator between 36°F to 46°F
(2°C to 8°C).
- Do not freeze. If UDENYCA is accidentally frozen,
allow the prefilled syringe to thaw in the refrigerator before injecting.
- Do not use a UDENYCA prefilled syringe that has
been frozen more than 1 time. Use a new UDENYCA prefilled syringe.
- Throw away (dispose of) any UDENYCA that has been left at
room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours or frozen
more than 1 time.
- Keep the prefilled syringe in the original carton to
protect from light.
- Do not shake the prefilled syringe.
- Take UDENYCA out of the refrigerator 30 minutes before
use and allow it to reach room temperature before preparing an injection.
Keep the UDENYCA prefilled syringe out of the reach of
General information about the safe and effective use
Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use UDENYCA for a
condition for which it was not prescribed. Do not give UDENYCA to other people,
even if they have the same symptoms that you have. It may harm them. You can
ask your pharmacist or healthcare provider for information about UDENYCA that
is written for health professionals.
What are the ingredients in UDENYCA?
Active ingredient: pegfilgrastim-cbqv
Inactive ingredients: acetate, polysorbate 20,
sodium, and sorbitol in Water for Injection.
Instructions for Use
(pegfilgrastim-cbqv) Injection Single-Dose Prefilled Syringe
Guide to Parts
Important: The needle is covered by
a needle cap before use
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.
- If UDENYCA is accidentally
frozen, allow the prefilled syringe to thaw in the refrigerator before
- Throw 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.
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
- Do not use a prefilled syringe
after the expiration date on the label.
- Do not shake the prefilled
- 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
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.
1B: Open the carton and remove
the sealed syringe tray. (See Figure 4)
2 -Allow UDENYCA to reach room temperature and gather
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.
2B: Gather the following
supplies: (See Figure 6)
- alcohol wipe
- cotton ball or gauze
- 1 adhesive bandage
- sharps disposal container
3 -Wash your hands and remove syringe from tray
3A: Wash your hands well with soap and warm water. (See
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
- Do not grab the needle cap.
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
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
- Back of upper arms (only if someone else is giving you
- 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.
5B: Clean the injection site
with an alcohol wipe. (See Figure 11)
Do not touch this area again
Inject the dose
6 -Remove needle cap
Remove the needle cap by pulling it straight off. (See
- 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
- 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.
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.
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
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
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)
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)
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
10 - Dispose of used
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)
- If you do not have a
FDA-cleared sharps disposal container, you may use a household container that
- 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
- 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 the FDA's website at: http://www.fda.gov/safesharpsdisposal.
- Do not reuse the prefilled
- 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.