CONSUMER BRIEF SUMMARY
CONSULT PACKAGE INSERT FOR FULL
PRESCRIBING INFORMATION
HUMIRA®
(HU-MARE-AH) (adalimumab)
Read the Medication Guide that comes with HUMIRA before you start taking it and each
time you get a refill. There may be new information. This brief summary does not take the
place of talking with your doctor about your medical condition or treatment with HUMIRA.
Patient Information
W h a t is th e m o s t im p o rta n t
in fo rm a tio n I s h o u ld k n o w a b o u t
HUM IRA?
__________________________
HUMIRA is a medicine that affects your
immune system. HUMIRA can lower the
ability of the immune system to fight
infections.
Serious infections have
happened in patients taking HUMIRA.
These infections include tuberculosis
(TB) and infections caused by viruses,
fungi or bacteria that have spread
throughout the body. Some patients
have died from these infections.
• Your doctor should test you for TB before
starting HUMIRA.
• Your doctor should monitor you closely
for signs and symptoms of TB during
treatment with HUMIRA.
Before starting HUMIRA, tell your
doctor if you:
• think you have an infection. You should
not start taking HUMIRA if you have any
kind of infection.
• are being treated for an infection
• have signs of an infection, such as a
fever, cough, or flu-like symptoms
• have any open cuts or sores on your
body
• get a lot of infections or have infections
that keep coming back
• have diabetes
• have TB, or have been in close contact
with someone with TB
• were born in, lived in, or traveled to
countries where there is more risk for
getting TB. Ask your doctor if you are not
sure.
• live or have lived in certain parts of
the country (such as the Ohio and
Mississippi River valleys) where there is
an increased risk for getting certain kinds
of fungal infections (histoplasmosis,
coccidioidomycosis, or blastomycosis).
If you do not know if you have lived
in an area where histoplasmosis,
coccidioidomycosis, or blastomycosis is
common, ask your doctor.
• have or have had hepatitis B
• use the medicine Kineret (anakinra). You
may have a higher chance for serious
infections and a low white blood cell
count when taking HUMIRA with Kineret.
• are scheduled to have major surgery
After starting HUMIRA, call your doctor
right away
if you have an infection, or any
sign of an infection, including:
• a fever
®
feel very tired
• a cough
• flu-like symptoms
• warm, red, or painful skin
• open cuts or sores on your body
HUMIRA can make you more likely to get
infections or make any infection that you may
have worse.
Certain types of Cancer.
• There have been cases of unusual cancers
in children and teenage patients using
TNF-blocking agents.
6 For children and adults taking TNF-blocker
medicines, including HUMIRA, the chances
of getting lymphoma or other cancers may
increase.
• Some patients receiving HUMIRA have
developed types of cancer called non-
melanoma skin cancer (basal cell cancer
and squamous cell cancer of the skin),
which are generally not life-threatening
if treated. Tell your doctor if you have a
bump or open sore that doesn’t heal.
s Patients with RA, especially more serious
RA, may have a higher chance for getting
a kind of cancer called lymphoma.
See the section “What are the possible
side effects of HUMIRA?” below for
more information.
W h a t is HUM IRA?
HUMIRA is a medicine called a Tumor
Necrosis Factor (TNF) blocker. HUMIRA is
used in adults or children (as indicated) to:
• Reduce the signs and symptoms of:
° moderate to severe rheumatoid
arthritis (RA)
in adults. HUMIRA can be
used alone or with methotrexate or with
certain other medicines. HUMIRA may
prevent further damage to your bones
and joints and may help your ability to
perform daily activities.
• moderate to severe polyarticular
juvenile idiopathic arthritis (JIA)
in children 4 years of age and older.
HUMIRA can be used alone or with
methotrexate or with certain other
medicines.
8 psoriatic arthritis (PsA).
HUMIRA
can be used alone or with certain other
medicines. HUMIRA may prevent further
damage to your bones and joints and
may help your ability to perform daily
activities.
• ankylosing spondylitis (AS)
• moderate to severe Crohn’s disease
(CD)
in adults who have not responded
well to other treatments.
• Treat moderate to severe chronic
(lasting a long time) plaque
psoriasis (Ps)
in adults who have
the condition in many areas of their
body and who may benefit from taking
injections or pills (systemic therapy)
or phototherapy (treatment using
ultraviolet light alone or with pills).
People with these diseases have too much
of a protein called tumor necrosis factor
(TNF) in the affected areas of the body.
HUMIRA can block the bad effects of TNF
in those affected areas, but it can also
lower the ability of the immune system to
fight infections. See
“What is the most
important information I should know
about HUMIRA?”
and
“What are the
possible side effects of HUMIRA?”
W h a t s h o u ld I te ll m y d o c to r
b e fo re ta k in g HUM IRA?
___________
Before starting HUMIRA, tell your
doctor about all of your health
conditions, including if you:
• have an infection. See “What is the most
important information I should know
about HUMIRA?”
• have any numbness or tingling or have a
disease that affects your nervous system
such as multiple sclerosis or Guillain-
Barre syndrome.
• have heart failure or other heart
conditions. If you have heart failure, it
may get worse while you are taking
HUMIRA.
• have recently received or are scheduled
to receive a vaccine. Patients receiving
HUMIRA should not receive live vaccines.
Except for live vaccines, patients may still
receive vaccines while on HUMIRA. It is
recommended that children with juvenile
idiopathic arthritis be brought up to date
with all immunizations prior to starting
HUMIRA.
• are allergic to rubber or latex. The needle
cover on the prefilled syringe contains
dry natural rubber. Tell your doctor if you
have any allergies to rubber or latex.
• are allergic to HUMIRA or to any of
its ingredients. See the end of the
Medication Guide for a list of ingredients
in HUMIRA.
Tell your doctor if you are pregnant,
planning to become pregnant, or
breastfeeding.
HUMIRA should only be
used during a pregnancy if needed. Women
who are breastfeeding should talk to their
doctor about whether or not to use HUMIRA.
