Important Safety Information About HUMIRA® (adalimumab)
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.
- 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. If your doctor feels
you are at risk, you may be treated with medicine for TB.
- 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.
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 signs of an infection
- Get a lot of infections or have infections that keep coming back
- Have any open cuts or sores on your body
- 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
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- Have or have had hepatitis B
- Are scheduled for major surgery
- Have numbness or tingling or have a disease that affects your nervous system such
as multiple sclerosis or Guillain-Barré 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 or latex, or any ingredients of HUMIRA
- Are pregnant, planning to become pregnant, or breastfeeding
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Also tell your doctor about all the medicines you take, especially Kineret (anakinra).
Some medicines that suppress the immune system may increase your risk of serious
infections.
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 cough, low-grade fever, weight
loss, or loss of body fat and muscle.
- Allergic reactions. Signs of a serious allergic reaction include skin rash,
a swollen face, or trouble breathing.
- Hepatitis B virus reactivation in patients that carry the virus in their blood.
Symptoms include feeling unwell, poor appetite, tiredness, fever, rash, or joint
pain.
- 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.
- 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 rash
on your cheeks or arms that gets worse in the sun.
- 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, call your doctor right away if you have an infection or any signs
of an infection, including:
- A fever
- Feeling very tired
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- A cough
- Flu-like symptoms
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- Warm, red, or painful skin
- Open cuts or sores on your body
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This is the most important information to know about HUMIRA. For more information,
talk to your health care provider.
Information You Should Know About HUMIRA® (adalimumab)
HUMIRA is a medicine called a tumor necrosis factor (TNF) blocker. HUMIRA
is taken by injection and is available by prescription only.
HUMIRA is used 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.
- 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) 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 (lasting a
long time) plaque psoriasis (Ps) in adults who are under the ongoing care
of a physician, 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). When considering HUMIRA, your physician
will determine if other systemic therapies are medically less appropriate.