Important Safety Information1
What is the most important information I should know
about HUMIRA?
•
Serious infections.
HUMIRA can lower your ability 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, and monitor you closely for
signs and symptoms of TB during treatment with HUMIRA.
•
Certain types of Cancer.
There have been cases of unusual cancers in
children and teenagers using TNF-blocker medicines. For children and
adults taking TNF-blocker medicines, including HUMIRA, the chance of
getting lymphoma or other cancers may increase. Some patients have
developed non-melanoma skin cancer; tell your doctor if you have a
bump or open sore that doesn't heal.
Tell your doctor about all of your health conditions,
including if you:
✓ Think you have an infection. Don't start HUMIRA if you have any kind
of infection.
✓ Are being treated for infection, or have signs of an infection, such as
fever, cough, or flu-like symptoms
✓ Have any open cuts or sores
✓ 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, or were
born in, lived in, or traveled where there is more risk for getting TB
✓ Live or have lived in an area (such as the Ohio and Mississippi River
valleys) where there is an increased risk for getting certain kinds of
fungal infections, such as histoplasmosis.
✓ Have or have had hepatitis B
✓ Take other medicines, especially Kineret (anakinra). Some medicines
that suppress the immune system may increase your risk of serious
infections.
✓ Are scheduled for major surgery
✓ Have numbness or tingling or a nervous system disease, such as
multiple sclerosis or Guillain-Barre syndrome.
✓ Have heart failure or other heart conditions
✓ Have recently received or are scheduled to receive a vaccine. Patients
receiving HUMIRA should not receive live vaccines.
✓ Are allergic to rubber, latex, or any ingredients of HUMIRA
✓ Are pregnant, planning to become pregnant, or breastfeeding
Call your doctor right away if you have an infection or any sign of
an infection while on HUMIRA.
HUMIRA can cause other serious side effects, including:
• Allergic reactions.
• Hepatitis B virus reactivation in patients that carry the virus in
their blood.
• Nervous system problems.
• Blood problems.
• New heart failure or worsening of heart failure you already have.
• Immune reactions including a lupus-like syndrome.
• New psoriasis or worsening of psoriasis you already have.
Common side effects of HUMIRA include
injection site reactions
(redness, rash, swelling, itching, or bruising), upper respiratory infections,
headaches, rash, and nausea.
These are not all of the possible side effects with HUMIRA.
For more information, talk to your health care provider.
Reference: 1. HUMIRA injection [package insert]. North Chicago, IL;
Abbott Laboratories.
Please see additional Patient Information
on the following pages.
Talk to your
dermatologist about
HUMIRA
a d a lim u m a b
An example of
75% skin clearance.
For illustrative purposes only.
Your results may vary.
In one clinical trial for m oderate to severe
chronic plaque psoriasis patients, 7 out of
10 adults taking HUMIRA saw 75% skin
clearance and 6 out of 10 patients had
clear or alm ost clear skin at 16 weeks.
©2010 Abbott Laboratories I Abbott Park, IL 60064 I 64Y-437308 I September 2010 I Printed in the U.S.A.
