Adalimumab-bwwd is a prescription medicine used:
- To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab-bwwd can be used alone,
with methotrexate, or with certain other medicines.
- Moderate to severe polyarticular juvenile idiopathic
arthritis (JIA) in children
2 years and older. Adalimumab-bwwd can be used alone, or with
methotrexate.
- Psoriatic arthritis (PsA) in adults.
Adalimumab-bwwd can be used alone or with certain other medicines.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe hidradenitis suppurativa (HS) in
adults.
- To treat moderate to severe Crohn’s disease (CD) in adults and
children 6 years of age and older.
- To treat moderate to severe ulcerative colitis (UC) in adults. Limitations of Use: The effectiveness of adalimumab products has not
been established in patients who have lost response to or were intolerant
to TNF blockers.
- To 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).
- To treat non-infectious intermediate (middle part of the eye),
posterior (back of the eye), and panuveitis (all parts of
the eye) in adults.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
Adalimumab-bwwd?
You should discuss the potential benefits and risks of
Adalimumab-bwwd with your doctor. Adalimumab-bwwd is a tumor
necrosis factor (TNF) blocker medicine that can lower the ability of
your immune system to fight infections. You should not start taking
Adalimumab-bwwd if you have any kind of infection unless your doctor
says it is okay.
Serious infections have happened in people taking adalimumab
products. 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 Adalimumab-bwwd, and
check you closely for signs and symptoms of TB during treatment with Adalimumab-bwwd,
even if your TB test was negative. If your doctor feels you are at risk for
TB, you may be treated with medicine for TB before you begin treatment with
Adalimumab-bwwd and during treatment with Adalimumab-bwwd.
Cancer. For children and adults taking TNF blockers, including Adalimumab-bwwd,
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 you use TNF
blockers, including Adalimumab-bwwd, your chance of getting 2 types of skin
cancer (basal cell and squamous cell) may increase. These types of cancer
are generally not life-threatening if treated; tell your doctor if you have
a bump or open sore that does not heal.
What should I tell my doctor BEFORE starting Adalimumab-bwwd?
Tell your doctor about all of your medical 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 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). These infections may happen
or become more severe if you use Adalimumab-bwwd. Ask your doctor if
you do not know if you have lived in an area where these infections
are common.
- Have or have had hepatitis B.
- 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.
Adalimumab-bwwd patients may receive vaccines, except for live
vaccines. Children should be brought up to date on all vaccines
before starting Adalimumab-bwwd.
- Are allergic to Adalimumab-bwwd or any of its ingredients.
-
Are pregnant, planning to become pregnant, breastfeeding, or
planning to breastfeed.
-
Have a baby and were using Adalimumab-bwwd during your pregnancy.
Tell your baby’s doctor before your baby receives any vaccines.
Also tell your doctor about all the medicines you take. You should
not take Adalimumab-bwwd 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® (6-mercaptopurine, 6-MP).
What should I watch for after starting Adalimumab-bwwd?
Adalimumab-bwwd 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 (decreased blood cells that help fight infections
or stop bleeding). 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). These problems can lead to liver failure and
death.
- 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 Adalimumab-bwwd include injection site
reactions (pain, redness, rash, swelling, itching, or bruising),
upper respiratory infections (sinus infections), headaches, and
rash. These are not all of the possible side effects with
Adalimumab-bwwd. 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
- Blood in phlegm
- Warm, red, or painful skin or sores on your body
- Diarrhea or stomach pain
- Burning when you urinate
- Urinating more often than normal
- Feeling very tired
- Weight loss
Adalimumab-bwwd is given by injection under the skin.
This is not all of the important information to know about
Adalimumab-bwwd. For more information, talk to your health care
provider.
Please read the accompanying Medication Guide for Adalimumab-bwwd,
including the information about serious infections and cancers, and
discuss it with your doctor. The Instructions for Use and Physician
Prescribing Information are also available.
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.