Pregnancy Registry: Abbott Laboratories
has a registry for pregnant women who take
HUMIRA. The purpose of this registry is to
check the health of the pregnant mother
and her child. Talk to your doctor if you are
pregnant and contact the registry at
1-877-311-8972.
Tell your doctor about all the medicines
you take, including prescription and
non-prescription medicines, vitamins
and herbal supplements. Especially,
tell your doctor if you take Kineret
(anakinra). You may have a higher chance
for serious infections and a low white blood
cell count when taking HUMIRA with Kineret.
Also, tell your doctor if you are taking
other medicines that suppress the immune
system.
Know the medicines you take. Keep a
list of your medicines with you to show
your doctor and pharmacist each time
you get a new medicine.
How should I take HUMIRA?
See the section, “ How do I prepare and
give an injection of HUMIRA?” at the end
of the Medication Guide that comes with
HUMIRA for complete instructions for use.
• HUMIRA is given by an injection under
the skin. Your doctor will tell you how
often to take an injection of HUMIRA. This
is based on your condition to be treated.
Do not inject HUMIRA more often than
prescribed.
• Make sure you have been shown
how to inject HUMIRA before you do
it yourself. You can call your doctor or
1-800-4HUMIRA (448-6472) if you have
any questions about giving yourself an
injection. Someone you know can also
help you with your injection.
• If you take more HUMIRA than you were
told to take, call your doctor.
• Do not miss any doses of HUMIRA. If you
forget to take HUMIRA, inject a dose as
soon as you remember. Then, take your
next dose at your regular scheduled
time. This will put you back on schedule.
To help you remember when to take
HUMIRA, you can mark your calendar
ahead of time with the stickers provided
in the back of the Medication Guide.
What are the possible side
effects of HUMIRA?
HUMIRA can cause serious side effects,
including:
may be treated with medicine for TB before
you begin treatment with HUMIRA and during
treatment with HUMIRA. Even if your TB
test is negative your doctor should carefully
monitor you for TB infections while you are
taking HUMIRA. Patients who had a negative
TB skin test before receiving HUMIRA have
developed active TB. Tell your doctor if you
have any of the following symptoms while
taking or after taking HUMIRA:
• cough that does not go away
• low grade fever
• weight loss
• loss of body fat and muscle (wasting)
• Allergic reactions. Signs of a serious
allergic reaction include a skin rash, a
swollen face, or trouble breathing.
• Hepatitis B virus reactivation in
patients who carry the virus in their
blood. In some cases patients have died
as a result of hepatitis B virus being
reactivated. Your doctor should monitor
you carefully during treatment with
HUMIRA if you carry the hepatitis B virus
in your blood. Tell your doctor if you have
any of the following symptoms:
• feel unwell
• poor appetite
• tiredness (fatigue)
• fever, skin rash, or joint pain
• Nervous system problems. Signs and
symptoms of a nervous system problem
include: numbness or tingling, problems
with your vision, weakness in your arms or
legs, and dizziness.
• Blood problems. Your body may not
make enough of the blood cells that help
fight infections or help to stop bleeding.
Symptoms include a fever that does not go
away, bruising or bleeding very easily, or
looking very pale.
• New heart failure or worsening of heart
failure you already have. Symptoms
include shortness of breath or swelling of
your ankles or feet or sudden weight gain.
• Immune reactions including a lupus-
like syndrome. Symptoms include chest
discomfort or pain that does not go away,
shortness of breath, joint pain, or a rash
on your cheeks or arms that gets worse
in the sun. Symptoms may go away when
you stop HUMIRA.
• Psoriasis. Some people using HUMIRA
had new psoriasis or worsening of
psoriasis they already had. Tell your doctor
if you develop red scaly patches or raised
bumps that are filled with pus. Your doctor
may decide to stop your treatment with
• Injection site reactions such as
redness, rash, swelling, itching, or
bruising. These symptoms usually will go
away within a few days. If you have pain,
redness or swelling around the injection
site that doesn't go away within a few
days or gets worse, call your doctor right
away.
• Upper respiratory infections (including
sinus infections)
• Headaches
• Rash
• Nausea
These are not all the possible side effects
with HUMIRA. Tell your doctor if you have
any side effect that bothers you or that does
not go away. Ask your doctor or pharmacist
for more information.
General information about HUMIRA
Medicines are sometimes prescribed
for purposes other than those listed in a
Medication Guide. Do not use HUMIRA for
a condition for which it was not prescribed.
Do not give HUMIRA to other people, even if
they have the same condition. It may harm
them.
This brief summary summarizes the most
important information about HUMIRA.
If you would like more information, talk
with your doctor. You can ask your doctor
or pharmacist for information about
HUMIRA that was written for healthcare
professionals.
Call your doctor for medical advice about
side effects. You may report side effects to
FDA at 1-800-FDA-1088.
For more information go to www.HUMIRA.
com or you can enroll in a patient support
program by calling 1-800-4HUMIRA
(448-6472).
Rev. July, 2010
Ref: 03-A329-R21
U.S. Govt. Lic. No. 0043
Abbott Laboratories
North Chicago, IL 60064, U.S.A.
64C-419212 MASTER
64Y-437308
Abbott
See “What is the most important
information I should know about
HUMIRA?”
• Serious infections.
Your doctor will examine you for TB and
perform a test to see if you have TB. If your
doctor feels that you are at risk for TB, you
HUMIRA.
Call your doctor or get medical care right
away if you develop any of the above
symptoms. Your treatment with HUMIRA
may be stopped.
Common side effects with HUMIRA
include:
