Welcome to the

If you haven’t already been prescribed
Neulasta or the On-body Injector
for Neulasta, talk to your doctor
about whether it is right for you.
Welcome to the
1-844-MYNEULASTA
(1-844-696-3852)
Neulasta® is a prescription medicine used to help reduce the chance of infection due to
a low white blood cell count, in people with certain types of cancer (non-myeloid), who
receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.
If the On-body Injector for Neulasta was placed on the back of your arm, a caregiver
must be available to monitor the On-body Injector for Neulasta.
Please see Important Safety Information on pages 10-11.
About your
cancer care
Being told you have cancer can feel overwhelming—you’ll have lots of new information to
understand, appointments to keep, and decisions to make. Your healthcare team is there
to help support and guide you throughout your journey, and to help you get the treatment
option that is right for you.
Chemotherapy, or “chemo,” is one of those treatment options—it is given to help stop or slow
down the growth of cancer, which is caused when cells in your body grow out of control.1,2
Decreased
white
blood cells
Increased
risk of
infection
Strong chemotherapy may
weaken your immune system.5
The strong chemotherapy your doctor
prescribed may reduce the number of white
blood cells in your body.3 White blood cells
are a key part of your immune system—your
body’s natural defenses against infection.
As your white blood cell count goes down,
your risk of infection goes up.4
Important Safety Information
Do not take Neulasta® if you have had a serious allergic reaction
to Neulasta® (pegfilgrastim) or NEUPOGEN® (filgrastim).
Please see additional Important Safety Information on pages 10-11.
2
Why your doctor has prescribed
Neulasta (pegfilgrastim)
®
Neulasta is a prescription medication
used to help reduce the risk of infection
(initially marked by fever) in patients
with some tumors receiving strong
chemotherapy that decreases the number
of infection-fighting white blood cells.5
Neulasta is similar to a protein made
by your body and is sometimes called
a white blood cell booster because it
causes your body to make more white
blood cells. This helps increase your
natural defenses against infection.6,7
Increased white blood cells
Neulasta increases
white blood cell
counts.7
Neulasta is given once for each cycle
of chemotherapy.
Neulasta should only be administered on the
day your healthcare provider has determined
and should not be delivered until approximately
24 hours after receiving chemotherapy.
Important Safety Information
Tell your healthcare provider if you:
• Have sickle cell trait or sickle cell disease
• Have had severe skin reactions to acrylic adhesives
• Are allergic to latex
• Have problems with your kidneys
• Have any other medical problems
• Are pregnant or plan to become pregnant. It is not
known if Neulasta® may harm your unborn baby
• Are breastfeeding or plan to breastfeed.
It is not known if Neulasta® passes into your
breast milk
Tell your healthcare provider about all the
medicines you take, including prescription
and over-the-counter medicines, vitamins,
and herbal supplements.
Please see additional Important Safety
Information on pages 10-11.
3
Getting to know
the Neulasta (pegfilgrastim) Onpro™ kit
®
The Neulasta® OnproTM kit includes the On-body Injector for
Neulasta, which your healthcare provider activates by filling it
with your Neulasta dose. Your Healthcare provider then applies
the On-body Injector to your skin, either on the back of the arm
or abdomen. It is applied on the same day you have chemotherapy,
and you leave the doctor’s office wearing the On-body Injector.
The On-body Injector has been designed to deliver your
Neulasta approximately 27 hours after your healthcare provider
has applied it on your skin.
Important Information
While the On-body Injector for Neulasta is in place you should avoid:
•
• Bumping the On-body
• Using hot tubs, whirlpools,
Traveling, driving or
operating heavy machinery
Injector for Neulasta or
or saunas, and direct
during hour 26 through
knocking it off your body.
sunlight. These may
hour 29 after the On-body • Getting body lotion, creams,
affect Neulasta.
Injector for Neulasta
• Peeling off or disturbing
oils, and skin cleansing
is applied.
products near the On-body
the On-body Injector
• Sleeping on the On-body
Injector for Neulasta.
for Neulasta adhesive
These products may loosen
before you receive your
Injector for Neulasta or
the adhesive that holds
full dose of Neulasta.
applying pressure on the
the On-body Injector for
On-body Injector for
Neulasta onto your body.
Neulasta. The On-body
Injector for Neulasta may
Please see pages 8-9 for additional important
not work properly.
information about the On-body Injector.
4
Understanding the On-body Injector for Neulasta (pegfilgrastim)
8,9
®
For full information about the On-body Injector, please see Patient Instructions for Use.
Flashing green
On-body Injector is working properly
Solid green (or turned off)
Medication delivery should be complete. Check to see if fill
indicator reads “empty” and there is no noticeably wet adhesive
Flashing red
On-body Injector error—call your healthcare provider immediately
Status light
Adhesive pad
Audio
Fill indicator
On-body Injector
will beep before
and after dose
delivery.
The black line should be
at FULL until the On-body
Injector starts delivering
your dose of Neulasta.
Cannula window
The black line should
be at EMPTY when
your Neulasta delivery
is complete.
Allows you to view the
cannula (a short, soft tube)
that your Neulasta passes
through during the
45-minute dose delivery.
Actual size.
Please see Important Safety Information for Neulasta on pages 10-11.
5
At the doctor’s office:
The day that the On-body Injector
for Neulasta (pegfilgrastim) is applied
8,9
®
On the day of your chemotherapy, your healthcare provider will
prepare an area of skin and apply the On-body Injector.
Abdomen
Back of
upper arm
What happens immediately after the On-body Injector is applied?
Once the On-body Injector is placed on your skin, it will beep and the yellow light will
flash. A short needle will insert the cannula, which is designed to allow Neulasta to be
delivered under your skin 27 hours later. The needle is designed to go back into the
On-body Injector, but the cannula will remain in place until the On-body Injector is removed.
For the next 27 hours, the green light will flash every 5 seconds. This means the
On-body Injector is working properly.
Important Information
Keep the On-body Injector for Neulasta at least 4 inches away from electrical
equipment such as cell phones, cordless telephones, microwaves and other common appliances.
If the On-body Injector for Neulasta is too close to electrical equipment,
it may not work correctly and can lead to a missed or incomplete dose of Neulasta.
Please see pages 8-9 for additional important information about the On-body Injector.
Please see Important Safety Information for Neulasta on pages 10-11.
6
At home or other setting:
The day of Neulasta (pegfilgrastim) delivery
®
8
On the day of Neulasta delivery, you will be responsible for the
following (as described in detail in the Patient Instructions for Use):
It is important that you thoroughly review the Patient Instructions For Use. These instructions
cover everything you need to know about the On-body Injector. The information in this brochure
does not replace the Patient Instructions For Use. Please contact your healthcare provider if you
have any questions.
Check the status light occasionally. It should be flashing green
for about 27 hours.
FULL
EMPTY
FULL
EMPTY
, check the status light. If the light
If you hear beeping
is flashing RED, call your healthcare provider immediately.
Monitor the dose delivery. Remember:
• A caregiver should be with you the first time that you receive
Neulasta with the On-body Injector for Neulasta
• If the On-body Injector for Neulasta was placed on the back
of your arm, always have a caregiver available to monitor
the On-body Injector for Neulasta
Remove the On-body Injector.
FULL
EMPTY
Confirm the dose delivery.
Dispose of the On-body Injector according to local laws and regulations
to avoid accidental needle stick. To participate in Amgen’s voluntary
disposal program, call 1-844-MYNEULASTA (1-844-696-3852) or
click here to enroll.
7
What is the most important information I need
to know about receiving Neulasta (pegfilgrastim)
with the On-body Injector for Neulasta?
®
7
•
See the Instructions for Use for the
On-body Injector for Neulasta for
detailed information about the
On-body Injector for Neulasta and
important information about your
dose delivery that has been written
by your healthcare provider.
–Know the time that delivery of your
dose of Neulasta is expected to start.
–Avoid traveling, driving, or operating
heavy machinery during hour 26 through
hour 29 after the On-body Injector for
Neulasta is applied. Avoid activities and
places that may interfere with monitoring
during the 45-minute period that
Neulasta is expected to be delivered
by the On-body Injector for Neulasta,
and for 1 hour after delivery.
•
A caregiver should be with you the first
time that you receive Neulasta with the
On-body Injector for Neulasta.
•
If you have an allergic reaction during
the delivery of Neulasta, remove the
On-body Injector for Neulasta by
grabbing the edge of the adhesive pad
and peeling off the On-body Injector
for Neulasta. Get emergency medical
help right away.
•
You should only receive a dose of
Neulasta on the day your healthcare
provider tells you.
•
You should not receive your dose
of Neulasta any sooner than 24 hours
after you finish receiving your
chemotherapy. The On-body Injector for
Neulasta is programmed to deliver your
dose about 27 hours after your healthcare
provider places the On-body Injector for
Neulasta on your skin.
Continued on page 9.
8
What is the most important information I need to know about receiving
Neulasta (pegfilgrastim) with the On-body Injector for Neulasta?7 continued
®
•
Do not expose the On-body Injector
for Neulasta to the following because
the On-body Injector for Neulasta may
be damaged and you could be injured:
–MRI
–CT scan
–X-ray
–Ultrasound
–Oxygen-rich environments, such
as hyperbaric chambers
•
Avoid airport X-ray scans. Request a
manual pat down instead. Use care during
a manual pat down to help prevent the
On-body Injector for Neulasta from being
accidentally removed.
•
Keep the On-body Injector for Neulasta
at least 4 inches away from electrical
equipment such as cell phones, cordless
telephones, microwaves and other
common appliances. If the On-body
Injector for Neulasta is too close to electrical
equipment, it may not work correctly
and can lead to a missed or incomplete
dose of Neulasta.
•
The On-body Injector is for adult
patients only.
•
Call your healthcare provider right
away if the:
–On-body Injector for Neulasta comes off
before or during a dose delivery.
Do not re-apply it.
–On-body Injector for Neulasta is leaking.
–Adhesive on your On-body Injector
for Neulasta becomes noticeably
wet (saturated) with fluid, or there is
dripping. This may mean that Neulasta
is leaking out of your On-body
Injector for Neulasta. If this happens
you may only receive some of your
dose of Neulasta, or you may not
receive a dose at all.
–On-body Injector for Neulasta status
light is flashing red.
Please review the Patient Instructions for Use for complete instructions and information about the
On-body Injector. Discuss any questions you have with your healthcare provider. The information
in this guide is intended as a summary. It is not intended to replace any instructions from your
healthcare provider or the Instructions For Use which came packaged with the On-body Injector
for Neulasta. If you haven’t already been prescribed Neulasta or the On-body Injector for
Neulasta, talk to your doctor about whether it is right for you.
9
Please see Important Safety Information on pages 10–11.
Important Safety Information
7
Who should not take Neulasta®?
Do not take Neulasta® if you have had a serious allergic reaction to Neulasta®
(pegfilgrastim) or NEUPOGEN® (filgrastim).
What should I tell my health care provider before taking Neulasta®? Tell your
healthcare provider if you:
• Have sickle cell trait or sickle cell disease
• Have had severe skin reactions to acrylic adhesives
• Are allergic to latex
• Have problems with your kidneys
• Have any other medical problems
• Are pregnant or plan to become pregnant. It is not known if Neulasta® may
harm your unborn baby
• Are breastfeeding or plan to breastfeed. It is not known if Neulasta® passes
into your breast milk
Tell your healthcare provider about all the medicines you take, including prescription
and over-the-counter medicines, vitamins, and herbal supplements.
What are possible serious side effects of Neulasta®?
• Spleen Rupture. Your spleen may become enlarged and can rupture while
taking Neulasta®. A ruptured spleen can cause death. Call your doctor right
away if you have pain in the left upper stomach area or left shoulder tip area.
This pain could mean your spleen is enlarged or ruptured.
•
A serious lung problem called Acute
Respiratory Distress Syndrome (ARDS).
Call your healthcare provider or get
emergency medical help right away
if you get any of these symptoms
of ARDS: fever, shortness of breath,
trouble breathing, or a fast rate
of breathing.
Continued on page 11.
10
Important Safety Information continued
7
•
•
•
•
•
Serious Allergic Reactions. Get emergency
may become life-threatening. Get emergency
medical help right away if you get any
medical help right away if you develop any
of these symptoms of a serious allergic
of the following symptoms:
reaction with Neulasta®: shortness of breath,
– swelling or puffiness and are urinating
wheezing, dizziness, swelling around the
less often
mouth or eyes, fast pulse, sweating, and hives.
– trouble breathing
Sickle Cell Crises. Severe sickle cell crises,
– swelling of your stomach-area (abdomen)
and sometimes death, can happen in people
and feeling of fullness
with sickle cell trait or disease who receive
– dizziness or feeling faint
filgrastim, a medicine similar to Neulasta®.
– a general feeling of tiredness
Kidney injury (glomerulonephritis). Kidney
The most common side effect of Neulasta® is
injury has been seen in patients who
pain in the bones and in your arms and legs.
received Neulasta®. You should notify your
Tell your healthcare provider if you have any
healthcare provider right away if you
side effect that bothers you or that does not go
experience puffiness in your face or ankles,
away. These are not all the possible side effects
blood in your urine or brown colored urine
of Neulasta®. Call your doctor for medical advice
or you notice you urinate less than usual.
about side effects. You may report negative
Increased white blood cell count
side effects FDA at 1-800-FDA-1088.
(leukocytosis). Your doctor will check your
For more information about Neulasta®, talk with
blood during treatment with Neulasta®.
your healthcare provider or pharmacist; go to
Capillary Leak Syndrome. Neulasta® can
www.neulasta.com, or call 1-844-696-3852
cause fluid to leak from blood vessels into
(1-844-MYNEULASTA).
your body’s tissues. This condition is called
For more information, please see the full
“Capillary Leak Syndrome” (CLS). CLS can
Prescribing Information for Neulasta.
quickly cause you to have symptoms that
References: 1. Chemotherapy: What it is, how it helps. American Cancer Society. www.cancer.org/acs/groups/cid/documents/webcontent
/003321-pdf.pdf. Accessed June 4, 2014. 2. What is cancer? American Cancer Society. www.cancer.org/cancer/cancerbasics/what-is-cancer. Accessed
June 4, 2014. 3. Wujcik D. Infection. In: Yarbro CH, Frogge MH, Goodman M, eds. Cancer Symptom Management. Sudbury, MA: Jones and Bartlett
Publishers, Inc; 2004:252-267. 4. Caring for the patient with cancer at home: A guide for patients and families. American Cancer Society.
www.cancer.org/acs/groups/cid/documents/webcontent/002818-pdf.pdf. Accessed June 4, 2014. 5. Neulasta® (pegfilgrastim) Important Safety
Information. Thousand Oaks, CA: Amgen. 6. Neulasta® (pegfilgrastim) Prescribing Information. Thousand Oaks, CA: Amgen. 7. Neulasta® (pegfilgrastim)
Patient Prescribing Information. Thousand Oaks, CA: Amgen. 8. On-Body Injector for Neulasta® (pegfilgrastim) Patient Instructions For Use.
Thousand Oaks, CA: Amgen. 9. Neulasta® (pegfilgrastim) Delivery Kit Healthcare Provider Instructions For Use. Thousand Oaks, CA: Amgen.
11
11
Please see the completed
Instructions for Use with your
Dose Delivery Information.
The Neulasta® Onpro kit
TM
includes a single dose of Neulasta and a single-use On-body Injector
•
Applied the same day as chemotherapy is administered6
•
Designed to automatically administer Neulasta
the next day (approximately 27 hours after application)9
Visit www.neulasta.com to learn more about the
Neulasta® Onpro kit or call 1-844-MYNEULASTA (1-844-696-3852).
TM
Do not take Neulasta if you have had an allergic reaction to Neulasta
(pegfilgrastim) or to NEUPOGEN® (filgrastim).
Please see Important Safety Information on pages 10-11.
Please see the Neulasta full Prescribing Information, including the
On-body Injector for Neulasta Patient Instructions For Use.
© 2015 Amgen Inc.
All rights reserved. USA-003-120650