I M P O R T A N T
C A f *
*T Ç
O
r
ENCIA
/
rx
only
( a b a t a c e p t ) '
The information below does not take the place of talking with your healthcare professional. Only your healthcare professional
knows the specifics of your condition and how ORENCIA may fit into your overall therapy. Talk to your healthcare professional if
you have any questions about ORENCIA (pronounced oh-REN-see-ah).
RHEUMATOID ARTHRITIS (RA)
RA is a disease of the immune system which
causes joint pain and damage, and impacts
the ability to perform daily activities.
ABOUT ORENCIA
ORENCIA (abatacept) is a prescription medicine
that reduces signs and symptoms in:
• adults
with
moderate
to
severe
RA,
including those who have not been helped
enough
by
other
medicines
lor
RA.
ORENCIA may prevent further damage to
your bones and joints and may help your
ability to perform daily activities.
In RA, ORENCIA can reduce pain and joint
inflammation, but
it can
also
make your
immune system less able to fight infection.
ORF.NCIA can make you more likely to get
infections or make any infection worse. It is
important to tell your doctor if you think you
have any infections.
BEFORE YOU START ORENCIA
Tell your healthcare professional about all
your medical conditions, including if you:
• Have an infection that won't go away or are
prone to infections. If you have an infection
when taking ORENCIA, you may have a
higher
chance
for
getting
serious
side
effects.
• Have had tuberculosis (TB) or have been in
contact with someone who has it. 'fell your
healthcare professional right away if you get
a dry cough that does not go away, weight
loss, fever, or night sweats.
• I lave or have had viral hepatitis. Before you
use ORENCIA, your doctor may examine
you for hepatitis.
• Have
a
history
of
chronic
obstructive
pulmonary (lung) disease (CORD).
• Are scheduled to have surgery.
• Are allergic to any of the ingredients in
ORENCIA
such
as:
abatacept,
maltose,
monobasic sodium phosphate, or sodium
chloride for administration.
• Recently
received
a
vaccination
or
are
scheduled for any vaccination. If you are
receiving ORENCIA, you should not take
live vaccines.
• Have diabetes and
use
a
blood
glucose
monitor. You may get falsely high blood
glucose readings with certain types of blood
glucose monitors I he day you receive an
infusion of ORENCIA.
• Are pregnant or planning to become pregnant.
It is not known if ORENCIA (abatacept) can
harm
your
unborn
baby.
Bristol-Myers
Squibb Company has a registry tor pregnant
women exposed to ORENCIA. The purpose
of this registry is to check the health of the
pregnant mother and her child. Patients are
encouraged to call the registry themselves or
ask their doctors to contact the registry tor
them by calling 1-877-311-8972.
• Are breast-feeding. You will need to decide
to either breast-feed or receive treatment
with ORENCIA, but not both.
Tell
your
healthcare
professional
about
all
the
medicines
you
take,
including
prescription and non-prescription medicines,
vitamins, and herbal supplements.
Especially tell your doctor if you take other
biologic medicines to treat RA such as:
• Enbrel (etanercept)
• 1
lumira® (adalimumab)
• Remicade (infliximab)
• Kineret1
(anakinra)
• Rituxan* (rituximab)
You may have a higher chance of getting a
serious infection if you take ORENCIA with
other biologic medicines for your RA.
Know the medicines you take. Keep a list of
your medicines and show it to your doctor
and
pharmacist
when
you
get
a
new
prescription.
IMPORTANT INFORMATION ABOUT POSSIBLE
SIDE EFFECTS WITH ORENCIA
ORENCIA
can
cause
serious
side
effects
including:
• Serious
infections.
Patients
receiving
ORENCIA have a higher chance of gelling
infections including pneumonia, and other
infections caused by viruses,
bacteria, or
fungi. Call your doctor right away if you feel
sick or get any of the following symptoms of
infection, which may be early signs of a
serious infection:
•
a fever
• feel very tired
• have a cough
• have flu-like symptoms
• warm, red, or painful skin
• Allergic
reactions.
Allergic reactions
can
happen on the day of treatment or the day
after receiving ORENCIA. Tell your doctor or
get emergency medical help right away if
you have hives, swollen face, eyelids, lips,
tongue, throat, or trouble breathing.
• Cancer
(malignancies).
Certain
kinds
of
cancer
have
been
reported
in
patients
receiving ORENCIA (abatacept).
It is not
known if ORENCIA increases your chance of
getting certain kinds of cancer.
• Vaccinations.
You
should
not
receive
ORENCIA with certain types of vaccines (live
vaccines). ORENCIA may also cause some
vaccinations to be less effective. Talk with
your doctor about your vaccination plans.
• Respiratory
problem s
in
patients
with
Chronic
O bstructive
Pulm onary
Disease
(COPD).
You may get certain respiratory
problems
more
often
if
you
receive
ORENCIA and have COPD, including:
• worsened COPD
• pneumonia
• cough
• trouble breathing
Com m on side effects of ORENCIA include:
•
headache
• upper respiratory tract infection
• sore throat
• nausea
Tell your doctor if you have any side effect
that bothers you or that does not go away.
These are not all the possible side effects of
ORENCIA. For more information, ask your
doctor or pharmacist.
Call your doctor for medical advice about side
effects. You may report side effects to FDA at
1-800-FDA-1088.
HOW WILL I RECEIVE ORENCIA?
• You will be given ORENCIA by a healthcare
provider through a needle placed in a vein
(IV or intravenous infusion) in your arm. It
takes about 30 minutes to give you the full
dose of medicine.
GENERAL INFORMATION ABOUT ORENCIA
Medicines
arc
sometimes
prescribed
for
conditions that are not mentioned in patient
information leaflets. L)o not use ORENCIA for
a condition for which it was not prescribed.
You
can
ask
your
pharmacist
or
doctor
for
information
about
ORENCIA
that
is
written for health professionals. For more
information, go to www.ORENCIA.com or
the company internet site at www.BMS.com
or call 1-80Û-ORENCIA toll-free.
Bristol-Myers Squibb
<£>2008
Bristol Myers Squibb Company
ORENCIA is a registered trademark of Bristol Myers Squibb Company.
Enbrel, Humira, Remicade, Kineret and Rituxan are trademarks of their respective companies.
Based on 1186240Л4 04/08
B5- BOO01C -O'! -08- R A
Printed in USA
427US08CBS00702
April/08
