Instruction Guide
SimponiOne®
Safe
Returns
Simple, Safe Disposal.
®
SELECTED IMPORTANT SAFETY INFORMATION
SIMPONI® (golimumab) can lower your ability to fight
infections. Serious and sometimes fatal events may occur.
There have been reports of serious infections including
tuberculosis (TB) and infections caused by bacteria, fungi,
or viruses that have spread throughout the body. Other
possible serious side effects may include lymphoma, skin
cancer, a rare and fatal cancer called hepatosplenic T-cell
lymphoma, other cancers, hepatitis B, heart failure, nervous
system problems, lupus-like syndrome, or allergic reactions.
To learn more about these and other serious risks, please
read the Important Safety Information on pages 7-8 and the
Medication Guide, and talk with your doctor.
Welcome to SimponiOne® Safe Returns®
SIMPONI® (golimumab) is the first and only
once-monthly self-injectable biologic treatment
with just one injection each month for adults with:
moderate to severe rheumatoid arthritis (RA),
with the medicine methotrexate
active psoriatic arthritis, alone or with
the medicine methotrexate
active ankylosing spondylitis
Methotrexate is used as directed.
Once you and your doctor are comfortable with the
self-injection process, you will inject SIMPONI® under
the skin, just once a month.
SELECTED IMPORTANT SAFETY INFORMATION
SIMPONI (golimumab) can lower your ability to fight
infections. Serious and sometimes fatal events may occur.
There have been reports of serious infections including
tuberculosis (TB) and infections caused by bacteria, fungi,
or viruses that have spread throughout the body. Other
possible serious side effects may include lymphoma,
skin cancer, a rare and fatal cancer called hepatosplenic
T-cell lymphoma, other cancers, hepatitis B, heart failure,
nervous system problems, lupus-like syndrome, or allergic
reactions. To learn more about these and other risks,
please read the Important Safety Information on pages 7-8,
and the Medication Guide, and talk with your doctor.
®
2
Once-a-year return service for your
once-monthly treatment with SIMPONI®
SimponiOne® Safe Returns® combines a simple and
safe way to dispose of your used SIMPONI® injection
device immediately after each once-monthly treatment,
with the convenience of a once-a-year return service —
at no additional cost to you.
Simple:
Safe Returns® gives you everything you need to properly
dispose of your used SIMPONI® injection devices for a full
year before mailing them back. Just follow the step-by-step
instructions provided in this guide.
Safe:
Placing your used SmartJect® autoinjector or used syringe
into the specially-designed Safe Returns® disposal container,
tightening the lid securely, and storing it out of the reach of
children and pets, helps keep everyone safe.
Convenient:
The Safe Returns® container can hold 12 used SmartJect®
autoinjectors, so you can return it for disposal just once a
year — reducing the shipping materials you have to receive,
paperwork you have to do, and trips to the post office you
have to make, compared to the once-monthly Safe Returns®
service. And because the Safe Returns® disposal container
holds even more used syringes, you can return it for disposal
even less frequently.
Getting Started
3
Using your Safe Returns® disposal container
Inside each Safe Returns® box is a white plastic disposal
container. Carefully remove the container without damaging
or discarding any materials that may be inside the blue
shipping box. After removing the contents, the blue shipping
box can be safely discarded.
The Safe Returns® disposal container can safely hold a full
year of used SIMPONI® injection devices.
Here’s how to use it:
S
tore the sealed Safe Returns® disposal container
somewhere that is safe, but within easy reach — a bedroom
closet, for example. Always be sure to keep your container
safely away from children and pets.
I mmediately after each monthly
SIMPONI® treatment, unscrew the
container’s cap and place the used
injection device into the container,
with the injection end pointed away
from you.
Safe Returns® disposal container
SELECTED IMPORTANT SAFETY INFORMATION
SIMPONI® (golimumab) can lower your ability to fight
infections. Serious and sometimes fatal events may occur.
There have been reports of serious infections including
tuberculosis (TB) and infections caused by bacteria, fungi, or
viruses that have spread throughout the body. Other possible
serious side effects may include lymphoma, skin cancer, a
rare and fatal cancer called hepatosplenic T-cell lymphoma,
other cancers, hepatitis B, heart failure, nervous system
problems, lupus-like syndrome, or allergic reactions. To
learn more about these and other serious risks, please
read the Important Safety Information on pages 7-8 and the
Medication Guide, and talk with your doctor.
D
o not place anything other than
your used SIMPONI® autoinjectors
or used syringes into the disposal
container.
C
lose the container by screwing the cap on firmly.
Be sure that it is tight and secure.
D
O NOT FILL PAST THE LINE ON THE FRONT LABEL OF
THE CONTAINER. The Safe Returns® container is designed
to hold 12 used autoinjector devices. It can hold even more
used syringes, so it can be returned less frequently.
Ordering a New Disposal Container
4
The Safe Returns® Replacement Pack
When your container is full, after your 12th injection, contact
SimponiOne® Support and we’ll send you a Safe Returns®
Replacement Pack with a new disposal container, along with
everything you need to properly and easily dispose of your
filled container, at no cost to you.
C
all SimponiOne® Support at:
877-MY SIMPONI (877-697-4676),
Monday – Friday, 8:00 AM – 8:00 PM ET
O
r order your replacement pack here
D
C
If you need to return a filled Safe Returns® disposal
container, but don’t need a new one, call SimponiOne®
Support or visit us online, and we’ll send you a
postage-paid mail-back box.
A
Each Safe Returns® Replacement Pack contains:
B
F
ostage-paid mail-back box with inner brown box liner
P
Safe Returns® disposal container
Plastic bag
Tie for sealing the plastic bag (taped to underside
of box lid)
E Two strips of tape for sealing the inner brown liner
and mail-back box
F Waste Tracking Document (located inside documents
pouch on side of mail-back box)
Appearance may vary slightly
A
B
C
D
SELECTED IMPORTANT SAFETY INFORMATION
E
SIMPONI® (golimumab) can lower your ability to fight
infections. Serious and sometimes fatal events may occur.
There have been reports of serious infections including
tuberculosis (TB) and infections caused by bacteria, fungi, or
viruses that have spread throughout the body. Other possible
serious side effects may include lymphoma, skin cancer, a rare
and fatal cancer called hepatosplenic T-cell lymphoma, other
cancers, hepatitis B, heart failure, nervous system problems,
lupus-like syndrome, or allergic reactions. To learn more about
these and other serious risks, please
read the Important Safety Information
on pages 7-8 and the Medication
Guide, and talk with your doctor.
Returning a Container for Disposal
5
Packing your filled container in the
postage-paid mail-back box
S
ecure the container’s screw top and place the sealed
container into the plastic bag. Securely seal the bag using
the tie located on the underside of the mail-back box lid.
P
lace the sealed plastic bag with container into the inner
brown box liner inside the white postage-paid mail-back box.
DO NOT SEPARATE THE TWO BOXES.
F old flaps on inner brown box liner and secure using one
strip of tape provided. If needed, use additional packaging
tape to seal the flaps.
C
lose and seal the top lid of the white mail-back box
using the remaining strip of tape. If needed, use additional
packaging tape to seal the lid.
C
omplete the return address section on label on top of the box.
Completing the mail-back form
T ake out the 4-part Waste Tracking Document from the
plastic pouch on the side of the mail-back box. Don’t damage
the pouch — the completed forms must be reinserted.
C
onfirm the pre-printed information in Section 1 and make
changes as needed.
When packaged correctly, the Safe Returns® mail-back box
will meet all U.S. Postal Service regulations for mailing to a
disposal site through the U.S. Mail.
SELECTED IMPORTANT SAFETY INFORMATION
SIMPONI® (golimumab) can lower your ability to fight
infections. Serious and sometimes fatal events may occur.
There have been reports of serious infections including
tuberculosis (TB) and infections caused by bacteria, fungi, or
viruses that have spread throughout the body. Other possible
serious side effects may include lymphoma, skin cancer, a
rare and fatal cancer called hepatosplenic T-cell lymphoma,
other cancers, hepatitis B, heart failure, nervous system
problems, lupus-like syndrome, or allergic reactions. To
learn more about these and other serious risks, please
read the Important Safety Information on pages 7-8 and the
Medication Guide, and talk with your doctor.
Important: you must print your name, sign, and date where
it indicates Generator (Mailer) Certification in Section 2.
K
eep the last copy of the document for your records.
(NJ residents keep the first copy only.) Then put the three
remaining copies back into the pouch and close it.
Returning the postage-paid mail-back box for disposal
M
ail the properly sealed Safe Returns® box at a U.S. Post
Office, or anywhere the U.S. Postal Service arranges pickups.
You may also give it to your mail carrier for pickup.
W
hen your mail-back box is received by the disposal
facility (Stericycle), you will be mailed a copy of the waste
generator document, confirming
that it has been destroyed.
Important Things to Consider
Q. What has changed with SimponiOne® Safe Returns®?
A. W
e made Safe Returns® simple, safe, and convenient,
with a larger disposal container that can hold 12 used
SmartJect® autoinjectors, so you can return it for disposal
just once a year. And because the disposal container
holds even more used syringes, it can be returned for
disposal even less frequently. When the container is full,
in about a year, let us know, and we’ll send you a new
container along with a postage-paid mail-back box to
return the filled container. This will reduce the shipping
materials you have to receive, paperwork you have to do,
and trips to the post office you have to make, compared
to the once-monthly Safe Returns® service.
Q. W
hen my Safe Returns® container is filled, how do
I get a new one?
A. W
hen your disposal container is filled, simply request a
Safe Returns® Replacement Pack.
C
all SimponiOne® Support at: 877-MY SIMPONI
(877-697-4676), Monday – Friday, 8:00 AM – 8:00 PM ET
Or order online here
We will send you the Safe Returns® Replacement Pack
with a new disposal container, along with everything
you need to properly and easily dispose of your filled
container, including a postage-paid mail-back box.
Q. A
fter ordering, when can I expect to receive my
replacement pack in the mail?
A. Y our Safe Returns® Replacement Pack should arrive in the
mail within 5-10 business days after you have placed your
order by phone or online.
Q. W
hat if I damage or misplace my disposal
container or mail-back box?
A. D
o not use the Safe Returns® disposal container or
mail-back box if they are damaged. If you damage or
misplace your container or packing materials and need a
replacement, call SimponiOne® Support at 877-MY SIMPONI
(877-697-4676), Monday – Friday, 8:00 AM – 8:00 PM ET,
or visit here.
Q. H
ow will I know if my filled container was received
and disposed of properly?
A. Y ou will receive a copy of the waste tracking document
from the disposal facility (Stericycle), notifying you that
your filled container was disposed of properly.
6
Q. Will you continue to automatically mail me
Safe Returns® containers?
A. N
o, containers will not be sent to you automatically.
When you need a new Safe Returns® Replacement Pack,
you must request one by calling SimponiOne® Support
at 877-MY SIMPONI (877-697-4676), Monday – Friday,
8:00 AM – 8:00 PM ET, or visit here.
Q. If I have a once-monthly Safe Returns® pack with
grey-colored tube, can I still return it for disposal?
A. Y es, if you have a once-monthly Safe Returns® pack, you can
use it to return your used SIMPONI® injection device. If you
are continuing with Safe Returns®, you do not need to reenroll in the service to receive an initial disposal container.
Q. W
hat if I need to return a filled container but don’t
require a new one?
A. C
all SimponiOne® Support at 877-MY SIMPONI
(877-697-4676), Monday – Friday, 8:00 AM – 8:00 PM ET,
or visit here, and we’ll send you a postage-paid
mail-back box. Follow the instructions for returning your
filled container for disposal.
Q. Why is it important to complete and return the
waste tracking document?
A. S
tate and federal laws require a completed waste tracking
document for the disposal of all used injection devices.
Please confirm the pre-printed information in Section 1;
print your name, sign, and date Section 2; then place the
completed form inside the documents pouch on the side of
the mail-back box.
SELECTED IMPORTANT SAFETY INFORMATION
SIMPONI® (golimumab) can lower your ability to fight
infections. Serious and sometimes fatal events may occur.
There have been reports of serious infections including
tuberculosis (TB) and infections caused by bacteria, fungi, or
viruses that have spread throughout the body. Other possible
serious side effects may include lymphoma, skin cancer, a rare
and fatal cancer called hepatosplenic T-cell lymphoma, other
cancers, hepatitis B, heart failure, nervous system problems,
lupus-like syndrome, or allergic reactions. To learn more about
these and other serious risks, please
read the Important Safety Information
on pages 7-8 and the Medication
Guide, and talk with your doctor.
Important Safety Information
SERIOUS INFECTIONS
SIMPONI® (golimumab) is a prescription medicine. SIMPONI®
can lower your ability to fight infections. There are reports of
serious infections caused by bacteria, fungi, or viruses that
have spread throughout the body, including tuberculosis (TB)
and histoplasmosis. Some of these infections have been fatal.
Your doctor will test you for TB before starting SIMPONI®
and will monitor you for signs of TB during treatment. Tell
your doctor if you have been in close contact with people
with TB. Tell your doctor if you have been in a region (such
as the Ohio and Mississippi River Valleys and the Southwest)
where certain fungal infections like histoplasmosis or
coccidioidomycosis are common.
You should not start SIMPONI® if you have any kind of
infection. Tell your doctor if you are prone to or have a history
of infections or have diabetes, HIV or a weak immune system.
You should also tell your doctor if you are currently being
treated for an infection or if you have or develop any signs of
an infection such as:
fever, sweat, or chills
muscle aches
cough
shortness of breath
blood in phlegm
weight loss
warm, red, or painful skin
or sores on your body
diarrhea or stomach pain
b urning when you urinate
or urinate more than normal
feel very tired
CANCER
Unusual cancers have been reported in children and
teenage patients taking TNF-blocker medicines. For children
and adults taking TNF blockers, including SIMPONI®, the
chances for getting lymphoma or other cancers may increase.
Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma,
has occurred mostly in teenage or young adult males with
Crohn’s disease or ulcerative colitis who were taking other TNF
blockers with azathioprine or 6-mercaptopurine. You should tell
your doctor if you have had or develop lymphoma or
other cancers.
Some people treated with SIMPONI® have developed certain
kinds of skin cancer. If any changes in the appearance of
your skin or growths on your skin occur during or after your
treatment with SIMPONI®, tell your doctor.
7
USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including
ORENCIA (abatacept), KINERET (anakinra), ACTEMRA
(tocilizumab), RITUXAN (rituximab), or another TNF blocker, or
if you are scheduled to or recently received a vaccine. People
taking SIMPONI® should not receive live vaccines or treatment
with a weakened bacteria (such as BCG for bladder cancer).
HEPATITIS B INFECTION
Reactivation of hepatitis B virus has been reported in patients
who are carriers of this virus and are taking TNF-blocker
medicines, such as SIMPONI®. Some of these cases have
been fatal. Your doctor should do blood tests before and after
you start treatment with SIMPONI®. Tell your doctor if you
know or think you may be a carrier of hepatitis B virus or if you
experience signs of hepatitis B infection, such as:
feel very tired
dark urine
skin or eyes look yellow
little or no appetite
vomiting
muscle aches
c lay-colored
bowel movements
fevers
chills
stomach discomfort
skin rash
HEART FAILURE
Heart failure can occur or get worse in people who use
TNF blockers, including SIMPONI®. If you develop new
or worsening heart failure with SIMPONI®, you may need
treatment in a hospital, and it may result in death. Your doctor
will closely monitor you if you have heart failure. Tell your doctor
right away if you get new or worsening symptoms of heart
failure like shortness of breath, swelling of your lower legs or
feet, or sudden weight gain.
NERVOUS SYSTEM PROBLEMS
Rarely, people using TNF blockers, including SIMPONI®, can
have nervous system problems such as multiple sclerosis or
Guillain-Barré syndrome. Tell your doctor right away if you have
symptoms like vision changes, weakness in your arms or legs,
or numbness or tingling in any part of
your body.
Important Safety Information
continued on page 8.
Important Safety Information (cont’d)
IMMUNE SYSTEM PROBLEMS
Rarely, people using TNF blockers have developed lupus-like
symptoms. Tell your doctor if you have any symptoms such as a
rash on your cheeks or other parts of the body, sensitivity to the
sun, new joint or muscle pain, becoming very tired, chest pain
or shortness of breath, swelling of the feet, ankles, and/or legs.
ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker
medicines, including SIMPONI®. Tell your doctor if you have any
symptoms of an allergic reaction while taking SIMPONI® such
as hives, swollen face, breathing trouble, or chest pain. Some
reactions can be serious and life-threatening.
LIVER PROBLEMS
Serious liver problems can happen in people using TNF
blockers, including SIMPONI®. Contact your doctor
immediately if you develop symptoms such as feeling very tired,
skin or eyes look yellow, poor appetite or vomiting, or pain on
the right side of your stomach.
Common side effects of SIMPONI® include: upper respiratory
tract infection, reaction at site of injection, and viral infections.
BLOOD PROBLEMS
Low blood counts have been seen with people using TNF
blockers, including SIMPONI®. If this occurs, your body may
not make enough blood cells to help fight infections or help
stop bleeding. Your doctor will check your blood counts before
and during treatment. Tell your doctor if you have signs such as
fever, bruising, bleeding easily, or paleness.
OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you are allergic to rubber or latex. The needle
cover contains dry natural rubber.
Tell your doctor if you are pregnant, planning to become
pregnant or are breastfeeding or have a baby and were using
SIMPONI® during pregnancy. Tell your baby’s doctor before
your baby receives any vaccine because of an increased risk
of infection for up to 6 months after birth.
PSORIASIS
New or worse psoriasis symptoms may occur. Tell your doctor if
you develop red scaly patches or raised bumps that are filled
with pus.
Please read the Medication Guide for SIMPONI® and discuss
any questions you have with your doctor.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
042501-151027
8
Important Things to Remember
Y ou must request a Safe Returns® Replacement Pack,
including a new disposal container and mail-back box,
when your container is filled. Call SimponiOne® Support
at 877-MY SIMPONI (877-697-4676), Monday – Friday,
8:00 AM – 8:00 PM ET, or visit here.
D
o not put anything in your Safe Returns® postage-paid
mail-back box other than one disposal container filled with
used injection devices, following the instructions in this guide.
D
o not overfill the container.
It is important that you complete Section 2 of the waste
tracking document to ensure your container is properly
received and disposed of. Please print your name, sign,
and date the form.
I f you need to change your mailing information, or if you
damage or misplace your disposal container or packing
materials and need replacements, or to learn more about
SimponiOne® Support Services, call 877-MY SIMPONI
(877-697-4676) or visit Simponi.com/Support.
T he total residual fluid is limited to 50 ml.
T otal weight of the container is limited to 6 pounds.
J anssen Biotech, Inc., the maker of SIMPONI® (golimumab)
is not liable for anything shipped via Safe Returns®.
9
REGULATORY NOTICE TO CONSUMER REGARDING
MAILING OF PACK:
All individuals must be aware that they are responsible
for preparing the pack for mailing in accordance with the
directions provided. No other materials may be placed
in the pack for mailing. All original packaging materials
provided must be utilized. Improper packaging or mailing
of any other materials is in violation of Federal Postal
Service Regulations and could be subject to action up to
and including full prosecution of the laws of the Federal
U.S. Postal Service. Should you have any questions or have
any problems with the pack call SimponiOne® Support at
877-MY-SIMPONI (877-697-4676).
SELECTED IMPORTANT SAFETY INFORMATION
SIMPONI® (golimumab) can lower your ability to fight
infections. Serious and sometimes fatal events may occur.
There have been reports of serious infections including
tuberculosis (TB) and infections caused by bacteria, fungi, or
viruses that have spread throughout the body. Other possible
serious side effects may include lymphoma, skin cancer, a
rare and fatal cancer called hepatosplenic T-cell lymphoma,
other cancers, hepatitis B, heart failure, nervous system
problems, lupus-like syndrome, or allergic reactions.
To learn more about these and other serious risks, please
read the Important Safety Information on pages 7-8 and the
Medication Guide, and talk with your doctor.
To learn about other tools and services
from SimponiOne® Support, visit
Simponi.com/Support
or call 877-MY SIMPONI (877-697-4676)
© Janssen Biotech, Inc. 2016
02/16
004337-151118
Just one injection, once a month.