PATIENT INFORMATION
Fulphila™
(FULL-fil-ah)
(pegfilgrastim-jmdb) Injection Single-Dose Prefilled Syringe
What is Fulphila?
Fulphila 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 Fulphila if you have had a serious
allergic reaction to pegfilgrastim or filgrastim products.
Before you receive Fulphila, 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 Fulphila will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
if pegfilgrastim 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 Fulphila?
- Fulphila 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
Fulphila for information on how to prepare and inject a dose of Fulphila.
- You and your caregiver will be shown how to prepare and
inject Fulphila before you use it.
- You should not inject a dose of Fulphila to children
weighing less than 45 kg from a Fulphila prefilled syringe. A dose less than
0.6 mL (6 mg) cannot be accurately measured using the Fulphila prefilled
syringe.
- If you are receiving Fulphila because you are also
receiving chemotherapy, the last dose of Fulphila should be injected at least
14 days before and 24 hours after your dose of chemotherapy.
- If you miss a dose of Fulphila, talk to your healthcare
provider about when you should give your next dose.
What are possible side effects of Fulphila?
Fulphila 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
left shoulder.
- 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. Fulphila 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 Fulphila and call your healthcare provider or get emergency medical help
right away.
- Sickle cell crises. You may have a serious sickle
cell crisis if you have a sickle cell disorder and receive Fulphila. Serious sickle
cell crises have happened in people with sickle cell disorders receiving
Fulphila that has sometimes led to death. Call your healthcare provider right
away if you have symptoms of sickle cell crisis such as pain or difficulty
breathing.
- Kidney injury (glomerulonephritis). Fulphila 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 Fulphila.
- Capillary Leak Syndrome. Fulphila 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
- swelling of your stomach-area (abdomen) and feeling of
fullness
- dizziness or feeling faint
- a general feeling of tiredness
The most common side effects of Fulphila are pain in the
bones, arms, and legs.
These are not all the possible side effects of Fulphila.
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 Fulphila?
- Store Fulphila in the refrigerator between 36°F to 46°F
(2°C to 8°C).
- Do not freeze. If Fulphila is accidently frozen,
allow the prefilled syringe to thaw in the refrigerator before injecting.
- Do not use a Fulphila prefilled syringe that has
been frozen more than 1 time. Use a new Fulphila prefilled syringe.
- Throw away (dispose of) any Fulphila that has been left
at room temperature, 68°F to 77°F (20°C to 25°C) for more than 72 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 Fulphila out of the refrigerator 30 minutes before
use and allow it to reach room temperature before preparing an injection.
Keep the Fulphila prefilled syringe out of the reach
of children.
General information about the safe and effective use
of Fulphila.
Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use Fulphila for a
condition for which it was not prescribed. Do not give Fulphila 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
Fulphila that is written for health professionals.
What are the ingredients in Fulphila?
Active ingredient: pegfilgrastim-jmdb
Inactive ingredients: acetate, D-sorbitol,
polysorbate 20, and sodium in Water for Injection.
This Patient Information has been approved by the U.S.
Food and Drug Administration.
Instructions for Use
FULPHILA™
(FULL-fil-ah)
(pegfilgrastim-jmdb) injection, for subcutaneous use
Single-Dose Prefilled Syringe
Guide to Parts
Important Information
Read the Patient Information for important information
you need to know about Fulphila before using these Instructions for Use.
Storing the Fulphila prefilled syringe
- Store Fulphila in the refrigerator between 36°F to 46°F
(2°C to 8°C).
- Do not freeze. If Fulphila is accidentally frozen,
allow the prefilled syringe to thaw in the refrigerator before injecting.
- Do not use a Fulphila prefilled syringe that has
been frozen more than 1 time. Use a new Fulphila prefilled syringe.
- Throw away (dispose of) any Fulphila that has been left
at room temperature, 68°F to 77°F (20°C to 25°C) for more than 72 hours or
frozen more than 1 time. See Step 4: Disposing of used prefilled
syringes.
- Keep the prefilled syringe in the original carton to
protect from light.
- For questions about storage, contact your healthcare
provider or pharmacist.
- Keep the Fulphila prefilled syringe out of the reach of
children.
Before you use a Fulphila prefilled syringe, read this
important information:
- It is important that you do not try to give yourself
the injection unless you have received training from your healthcare provider.
- The prefilled syringe has a needle safety guard that will
be activated to cover the needle after the injection is given. The needle guard
will help prevent needlestick injuries to anyone who handles the prefilled
syringe after the injection has been given.
- Make sure that the name Fulphila appears on the carton
and prefilled syringe label.
- Fulphila is given as an injection into the tissue just
under the skin (subcutaneous injection).
- You should not inject a dose of Fulphila to children
weighing less than 45 kg from a Fulphila prefilled syringe. A dose less than
0.6 mL (6 mg) cannot be accurately measured using the Fulphila prefilled
syringe.
- Do not use a prefilled syringe after the
expiration date on the label.
- Do not shake the prefilled syringe.
- Do not use the prefilled syringe if the carton is
open or damaged.
- Do not remove the gray needle cap from the
prefilled syringe until you are ready to inject.
- Do not use the prefilled syringe if it has been
dropped on a hard surface. The syringe may be broken even if you cannot see the
break. Use a new prefilled syringe.
- Do not attempt to activate the prefilled syringe
prior to injection.
- Do not attempt to remove the needle safety guard
from the prefilled syringe.
- Do not attempt to remove the label from the
prefilled syringe barrel before injecting your dose of Fulphila.
Call your healthcare provider if you have any questions.
Step 1: Gather supplies
A -Find a clean, well-lit and flat work surface, such as
a table.
B -Take the prefilled syringe carton out of the
refrigerator and place it on your clean work surface. Allow it to reach room
temperature for 30 minutes before giving an injection.
C Remove the prefilled syringe tray from the carton.
D - Wash your hands thoroughly with soap and water.
E - Gather the supplies for the injection:
- 1 alcohol wipe
- 1 cotton ball or gauze pad
- 1 adhesive bandage
- an FDA-cleared sharps disposal container
Step 2: Prepare for injection
F - Open the tray by peeling away the cover. Grab the
needle safety guard to remove the prefilled syringe from the tray.
For safety reasons:
- Do not grab the plunger rod.
- Do not grasp the gray needle cap.
G - Inspect the medicine and prefilled syringe.
Make sure the medicine in the prefilled syringe is
clear and colorless.
Do not use the prefilled syringe if:
- The medicine is cloudy or discolored, or contains flakes
or particles.
- The prefilled syringe has been dropped.
- Any part appears cracked or broken.
- The gray 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.
H - Prepare and clean the injection site.
There are 4 injection sites that you can use:
- thigh
- 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), and
- the outer area of the upper arm (only if someone else is
giving you the injection).
Clean the injection site with an alcohol wipe. Let the
skin dry.
- Do not touch this area again before injecting.
- Do not inject into areas where the skin is tender,
bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
- 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.
I - Hold the prefilled syringe by the needle safety
guard. When ready, carefully pull the gray needle cap straight off and away
from the body.
- Do not twist or bend the gray needle cap.
- Do not hold the prefilled syringe by the plunger
rod.
- Do not put the gray needle cap back onto the
prefilled syringe. Dispose of (throw away) the gray needle cap in your
household trash.
Step 3: Inject the dose
J - Pinch the cleaned injection site to create a firm
surface.
! Keep skin pinched while injecting.
K - Hold the pinch. Insert the needle into the skin
between 45 to 90 degrees.
- Do not touch the cleaned area of the skin
L - Using slow and constant pressure, push the plunger
rod until it reaches the bottom.
! The plunger must be pushed fully in order to inject
the full dose.
M - Once the entire dose has been injected, the needle
safety guard will be triggered. You can do either of the following:
- Release the plunger until the entire needle is covered
and then remove the needle from the injection site.
or
- Gently remove the needle from the injection site and
release the plunger until the entire needle is covered by the needle safety
guard.
After releasing the plunger, the needle safety guard will
safely cover the injection needle.
- Once the needle has been removed from the injection site,
dispose of the syringe and needle in your sharps disposal container right away.
See “Step 4: Disposing of used prefilled syringes”.
- If the needle safety guard is not activated or only
partially activated, discard the product (without replacing the needle cap). See
“Step 4: Disposing of used prefilled syringes”.
- If your injection is given by another person, they
should also be careful when removing the needle from your skin in order to
prevent accidental needlestick injury and possible infections.
- When you remove the syringe, if it looks like the
medicine is still in the syringe barrel, this means you have not received the
full dose. Call your healthcare provider right away.
N -Examine the injection site. If there is blood, press a
cotton ball or gauze pad on the injection site. Do not rub the injection site.
Apply an adhesive bandage if needed.
Step 4: Disposing of used prefilled syringes
- Put the used prefilled syringe in an FDA-cleared sharps
disposal container right away after use. 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 is:
- made of 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
- 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.
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Important: Keep the sharps disposal container out
of the reach of children.
- Do not reuse the prefilled syringe.
- Do not recycle prefilled syringes or throw them
into household waste.
This Instructions for Use has been approved by the U.S.
Food and Drug Administration.