(pegfilgrastim-bmez) injection Single-dose prefilled syringe
What is ZIEXTENZO?
ZIEXTENZO 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 bodyÃ¢â¬™s fight against infection.
Do not take ZIEXTENZO if you have had a serious
allergic reaction to pegfilgrastim products or filgrastim products.
Before you receive ZIEXTENZO, tell your healthcare
provider about all of your medical conditions, including if you:
- have a sickle cell disorder.
- have kidney problems.
- are allergic to latex. The needle cap on the prefilled
syringe contains dry natural rubber (made from latex). You should not inject
ZIEXTENZO using the prefilled syringe if you have latex allergies.
- are pregnant or plan to become pregnant. It is not known
if ZIEXTENZO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
if ZIEXTENZO 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 ZIEXTENZO?
- ZIEXTENZO 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
yourcaregiver, follow the detailed “Instructions for Use” that comes with your
ZIEXTENZO for information on howto prepare and inject a dose of ZIEXTENZO.
- You and your caregiver will be shown how to prepare and
inject ZIEXTENZO before you use it.
- You should not inject a dose of ZIEXTENZO to children
weighing less than 45 kg from a ZIEXTENZO prefilled syringe. A dose less than
0.6 mL (6 mg) cannot be accurately measured using the ZIEXTENZO prefilled
- If you are receiving ZIEXTENZO because you are also
receiving chemotherapy, the last dose of ZIEXTENZO should be injected at least
14 days before and 24 hours after your dose of chemotherapy.
- If you miss a dose of ZIEXTENZO, talk to your healthcare
provider about when you should give your next dose.
What are possible side effects of ZIEXTENZO?
ZIEXTENZO 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
help right away if you have shortness of breath with or without a fever,
trouble breathing, or a fast rate of breathing.
- Serious allergic reactions. ZIEXTENZO 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 ZIEXTENZO and call your healthcare provider or get emergency medical help
- Sickle cell crises. You may have a serious sickle
cell crisis, which could lead to death, if you have a sickle cell disorder and
receive ZIEXTENZO. Call your healthcare provider right away if you have
symptoms of sickle cell crisis such as pain or difficulty breathing.
- Kidney injury (glomerulonephritis). ZIEXTENZO 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 ZIEXTENZO.
- Capillary Leak Syndrome. ZIEXTENZO can cause fluid
to leak from blood vessels into your bodyÃ¢â¬™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
- swelling of your stomach area (abdomen) and feeling of
- dizziness or feeling faint
- a general feeling of tiredness
- Inflammation of the aorta (aortitis). Inflammation
of the aorta (the large blood vessel which 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 ZIEXTENZO are pain in the
bones, arms, and legs.
These are not all the possible side effects of ZIEXTENZO.
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 ZIEXTENZO?
- Store ZIEXTENZO in the refrigerator between 36°F to 46°F
(2°C to 8°C).
- Take ZIEXTENZO out of the refrigerator for at least 15 to
30 minutes before use and allow it to reach room temperature before preparing
- Avoid freezing. If ZIEXTENZO is accidently frozen, allow
the prefilled syringe to thaw in the refrigerator before injecting.
- Do not use a ZIEXTENZO prefilled syringe that has been
frozen more than 1 time. Use a new ZIEXTENZO prefilled syringe.
- Keep the prefilled syringe in the original carton to
protect from light or physical damage.
- Do not shake the prefilled syringe.
- Throw away (dispose of) any ZIEXTENZO that has been left
at room temperature, 68°F to 77°F (20°C to 25°C), for more than 72 hours.
Keep the ZIEXTENZO prefilled syringe out of the reach
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 ZIEXTENZO for a
condition for which it was not prescribed. Do not give ZIEXTENZO 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
ZIEXTENZO that is written for health professionals.
What are the ingredients in ZIEXTENZO?
Active ingredient: pegfilgrastim-bmez
Inactive ingredients: acetic acid, polysorbate 20,
sorbitol, and Water for Injection. Sodium hydroxide may be added as necessary
to adjust pH.
Instructions for Use
Single-dose prefilled syringe
Guide to Parts
Figure A: Before use. The ZIEXTENZO prefilled syringe
with needle guard not activated
Important: The needle is
covered by the needle cap before use.
Figure B: After Use. The ZIEXTENZO prefilled syringe
with needle guard activated.
Read the Patient Information that comes with ZIEXTENZO
for important information you need to know about ZIEXTENZO before using these
Instructions for Use.
Storing the ZIEXTENZO
- Store ZIEXTENZO in a refrigerator
between 36°F to 46°F (2°C to 8°C).
- Store ZIEXTENZO prefilled
syringe in its outer carton to protect it from light or physical damage.
- Take ZIEXTENZO out of the
refrigerator at least 15 to 30 minutes before use to allow it to reach room
temperature before preparing the injection.
- Avoid freezing. If ZIEXTENZO is
accidentally frozen, thaw in the refrigerator before injecting.
- Do not use a ZIEXTENZO prefilled
syringe that has been frozen more than 1 time. Use a new ZIEXTENZO prefilled
- Throw away (dispose of) any
ZIEXTENZO that has been left at room temperature 68°F to 77°F (20°C to 25°C)
for more than 72 hours. See “14. Disposing of used prefilled syringes”.
Keep ZIEXTENZO and all
medicines out of the reach of children.
- It is important that you do
not try to give the injection unless you or yourcaregiver have received
training from your healthcare provider.
- The needle cap on the prefilled
syringe contains natural rubber (made from latex). Tell your healthcare provider
if you are allergic to latex. Do not handle the prefilled syringe if you are
allergic to latex.
- Make sure that the name
ZIEXTENZO 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
ZIEXTENZO to children weighing less than 45 kg from a ZIEXTENZO prefilled
syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the
ZIEXTENZO prefilled syringe.
- Do not use a ZIEXTENZO
prefilled syringe after the expiration date on the label.
- Do not open the outer carton
until you are ready to use the ZIEXTENZO prefilled syringe. Do not use
the ZIEXTENZO prefilled syringe if the seal of the tray is broken, as it may
not be safe for you to use.
- 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 shake the ZIEXTENZO
- Be careful not to touch the
needle guard wings before use. Touching them may cause the needle guard to be
activated too early.
- Do not try to activate the
needle safety guard before the injection.
- Do not remove the needle cap
until just before you give the injection.
- Do not reuse a ZIEXTENZO prefilled
syringe. Throw away (dispose of) used prefilled syringes right away after use
in a sharps disposal container. See “14. Disposing of used prefilled syringes”.
Call your healthcare provider
if you have any questions.
Prepare the injection.
1. Find a clean, flat, well-lit
2. Remove the carton from the
refrigerator and check the expiration date printed on the carton.
3. Remove the tray containing a
ZIEXTENZO prefilled syringe from the carton and place it unopened on your clean
work surface for at least 15 to 30 minutes, so that it can reach room
- Do not use the prefilled syringe
if the carton is damaged.
- Do not try to warm the prefilled
syringe by using a heat source such as hot water or a microwave.
- Do not leave the prefilled
syringe in direct sunlight.
- Do not shake the prefilled
4. Wash your hands well with
soap and water.
Gather the following
supplies for the injection (See Figure C):
- 1 alcohol wipe
- 1 cotton ball or gauze pad
- 1 sharps disposal container
- 1 adhesive bandage
5. Open the tray by peeling
away the cover. Remove the ZIEXTENZO prefilled syringe from the tray by
grabbing the transparent safety guard (See Figure D).
For safety reasons:
- Do not grab the plunger rod.
- Do not grab the gray needle cap.
Check to be sure that the
plastic clear needle guard is located over the barrel of the glass syringe. If
the clear needle guard is covering the needle cap, as shown in Figure B above,
the needle guard has been activated. Do not try to use this prefilled
syringe. Throw away (dispose of) this prefilled syringe. See “14. Disposing
of used prefilled syringes”. Start over with a new prefilled syringe.
Inspect the prefilled syringe
and medicine (See Figure E).
6. Make sure that the medicine
in the prefilled syringe is clear and colorless to slightly yellowish. You may
see small air bubbles in the liquid. This is normal. Do not use the
prefilled syringe if:
- the medicine looks discolored
- the medicine contains lumps,
flakes, or particles
- it appears used or damaged
- 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.
Select and clean the
You can use (See Figure F and Figure
- the front of your thighs
- stomach-area (abdomen), except
for a 2 inch area right around the navel (belly button)
- upper outer area of the
buttocks (only if someone else is giving you the injection
- outer area of upper arm (only if someone else is giving
you the injection)
Choose a different site each
time you give yourself an injection. Do not inject again in the
exact same spot. Do not inject into areas where the skin is tender,
bruised, red, scaly or hard. Avoid areas with scars or stretch marks.
7. Clean the injection site with an alcohol wipe. Let the
skin dry. Do not touch the cleaned area again before injecting.
Prepare the ZIEXTENZO
prefilled syringe for use
8. Hold the prefilled syringe
by the syringe barrel. Carefully pull the needle cap straight off to remove it
from the ZIEXTENZO prefilled syringe (See Figure H).
- Do not twist or bend the gray
- Do not hold the prefilled
syringe by the plunger rod.
Throw away the needle cap in
your household trash. Do not put the needle cap back onto the prefilled
syringe. You may see a drop of liquid at the end of the needle. This is normal.
9. With your other hand, gently
pinch the skin at the injection site to create a firm surface. Insert the
needle into the skin at an angle of 45 to 90 degrees, as shown (See Figure I).
Push the needle all the way in to ensure that the medicine can be fully
10. Hold the ZIEXTENZO
prefilled syringe as shown (See Figure J). Slowly press down the plunger head
as far as it will go until the plunger head is completely between the needle
Important: Keep the skin pinched while injecting.
11. Keep the plunger fully
pressed down while you carefully pull the needle straight out from the
injection site and off your skin (See Figure K).
12. Slowly release the plunger
and allow the syringe needle guard to automatically cover the exposed needle (See
13. There may be a small amount
of blood at the injection site. You can press a cotton ball or gauze pad onto
the injection site. Do not rub the injection site. Apply an adhesive bandage if
14. Disposing of used prefilled syringes
Put the used prefilled syringes
in an FDA-cleared sharps disposal container right away after use (See Figure M).
Do not throw away the syringe in the household trash.
- If you do not have an
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 FDAÃ¢â¬™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.
Important: Keep the sharps disposal container out
of the reach of children.
This Instructions for Use has been approved by the U.S.
Food and Drug Administration.