Important Safety Information About HUMIRA® (adalimumab)1
What is the most important information I should know about HUMIRA?
You should discuss the potential benefits and risks of HUMIRA with your doctor.
HUMIRA is a TNF blocker medicine that can lower the ability of your immune system
to fight infections. You should not start taking HUMIRA if you have any kind of
infection unless your doctor says it is okay.
- Serious infections have happened in people taking HUMIRA. These serious
infections include tuberculosis (TB) and infections caused by viruses, fungi, or
bacteria that have spread throughout the body. Some people have died from these
infections. Your doctor should test you for TB before starting HUMIRA,
and check you closely for signs and symptoms of TB during treatment with HUMIRA.
If your doctor feels you are at risk, you may be treated with medicine for TB.
- Cancer. For children and adults taking TNF blockers, including
HUMIRA, the chance of getting lymphoma or other cancers may increase. There have
been cases of unusual cancers in children, teenagers, and young adults using TNF
blockers. Some people have developed a rare type of cancer called hepatosplenic
T-cell lymphoma. This type of cancer often results in death. If using TNF blockers
including HUMIRA, your chance of getting two types of skin cancer (basal cell and
squamous cell) may increase. These types are generally not life-threatening if treated;
tell your doctor if you have a bump or open sore that doesn’t heal.
What should I tell my doctor BEFORE starting HUMIRA?
Tell your doctor about all of your health conditions, including
if you:
- Have an infection, are being treated for infection, or have symptoms of an infection
- Get a lot of infections or 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, coccidioidomycosis, or blastomycosis
- Have or have had hepatitis B
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- Are scheduled for major surgery
- Have or have had cancer
- Have numbness or tingling or a nervous system disease such as multiple sclerosis
or Guillain-Barré syndrome
- Have or had heart failure
- Have recently received or are scheduled to receive a vaccine. HUMIRA patients may
receive vaccines, except for live vaccines
- Are allergic to rubber, latex, or any HUMIRA ingredients
- Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
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Also tell your doctor about all the medicines you take. You should
not take HUMIRA with ORENCIA® (abatacept), KINERET®
(anakinra), REMICADE® (infliximab), ENBREL® (etanercept),
CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab).
Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN®
(azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).
What should I watch for AFTER starting HUMIRA?
HUMIRA can cause serious side effects, including:
- Serious infections. These include TB and infections caused by viruses,
fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight
loss, or loss of body fat and muscle.
- Hepatitis B infection in carriers of the virus. Symptoms include
muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little
or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort,
and skin rash.
- Allergic reactions. Symptoms of a serious allergic reaction include
hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
- Nervous system problems. Signs and symptoms include numbness or
tingling, problems with your vision, weakness in your arms or legs, and dizziness.
- Blood problems. Symptoms include a fever that does not go away,
bruising or bleeding very easily, or looking very pale.
- Heart failure (new or worsening). Symptoms include shortness of
breath, swelling of your ankles or feet, and 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 rash on your cheeks or arms that gets worse in the sun.
- Liver problems. Symptoms include feeling very tired, skin or eyes
that look yellow, poor appetite or vomiting, and pain on the right side of your
stomach (abdomen).
- Psoriasis (new or worsening). Symptoms include red scaly patches
or raised bumps that are filled with pus.
Call your doctor or get medical care right away if you develop any of the above
symptoms.
Common side effects of HUMIRA include injection site reactions
(redness, rash, swelling, itching, or bruising), upper respiratory infections
(sinus infections), headaches, rash, and nausea.
These are not all of the possible side effects with HUMIRA. Tell your doctor if
you have any side effect that bothers you or that does not go away.
Remember, tell your doctor right away if you have an infection or symptoms of an
infection, including:
- Fever, sweats, or chills
- Muscle aches
- Cough
- Shortness of breath
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- Blood in phlegm
- Weight loss
- Warm, red, or painful skin or sores on your body
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- Diarrhea or stomach pain
- Burning when you urinate
- Urinating more often than normal
- Feeling very tired
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HUMIRA is given by injection under the skin.
This is the most important information to know about HUMIRA. For more information,
talk to your health care provider.
Uses
HUMIRA is a prescription medicine used to:
- Reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA
can be used alone, 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, with methotrexate,
or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. 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) in adults.
- Moderate to severe Crohn's disease (CD) and to achieve and maintain
clinical remission in adults who have not responded well to conventional treatments.
HUMIRA is also for these adults who have lost response to or are unable to tolerate
infliximab.
- Treat moderate to severe chronic plaque psoriasis (Ps) in adults
who are ready for systemic therapy or phototherapy, and are under the care of a
doctor who will decide if other systemic therapies are less appropriate.
Please see the
full Prescribing Information, including the
Medication Guide, for HUMIRA and discuss it 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.
If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW)
for assistance.
Legal Notices/Privacy Policy. Copyright 2010, Abbott Laboratories, Abbott Park,
Illinois, U.S.A. If you have any questions about Abbott's HUMIRAMentor.com
website that have not been answered
click here. This website and the information contained herein is intended
for use by US residents only, is provided for informational purposes only and is
not intended to replace a discussion with a healthcare provider. All decisions regarding
patient care must be made with a healthcare provider and consider the unique characteristics
of each patient.
If you have questions about HUMIRA, please visit www.HUMIRA.com or call 1.800.4.HUMIRA.
Reference: 1. HUMIRA Injection [package insert]. North Chicago,
IL: Abbott Laboratories.
64X-772180