ABRILADA™ What is the most important information I should know about ABRILADA?

(adalimumab-afzb)

What is the most important information I should know about ABRILADA?

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 healthcare provider should test you for TB before starting ABRILADA.
•
Your healthcare provider should check you closely for signs and symptoms of TB during treatment with ABRILADA.

You should not start taking ABRILADA if you have any kind of infection unless your healthcare provider says it is okay.
Before starting ABRILADA, tell your healthcare provider if you:

•
think you have an infection or have symptoms of infection such as:
o
fever, sweats, or chills
o
muscle aches
o
cough
o
shortness of breath
o
blood in phlegm
o
warm, red, or painful skin or sores on your body
o
diarrhea or stomach pain
o
burning when you urinate or urinate more often than normal
o
feel very tired
o
weight loss
•
are being treated for an infection.
•
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.
•
were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
•
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 ABRILADA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
•
have or have had hepatitis B.
•
use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP).
•
are scheduled to have major surgery

After starting ABRILADA, call your healthcare provider right away if you have an infection, or any sign of an infection.
ABRILADA can make you more likely to get infections or make any infection that you may have worse.
Cancer

•
For children and adults taking tumor necrosis factor (TNF) blockers, including ABRILADA, the chances of getting cancer may increase.
•
There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers.
•
People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
•
If you use TNF blockers including ABRILADA your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal.
•
Some people receiving TNF blockers including ABRILADA developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6-MP).

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What is the most important information I should know about ABRILADA?

What is the most important information I should know about ABRILADA?

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 healthcare provider should test you for TB before starting ABRILADA.
•
Your healthcare provider should check you closely for signs and symptoms of TB during treatment with ABRILADA.

You should not start taking ABRILADA if you have any kind of infection unless your healthcare provider says it is okay.
Before starting ABRILADA, tell your healthcare provider if you:

•
think you have an infection or have symptoms of infection such as:
o
fever, sweats, or chills
o
muscle aches
o
cough
o
shortness of breath
o
blood in phlegm
o
warm, red, or painful skin or sores on your body
o
diarrhea or stomach pain
o
burning when you urinate or urinate more often than normal
o
feel very tired
o
weight loss
•
are being treated for an infection.
•
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.
•
were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
•
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 ABRILADA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
•
have or have had hepatitis B.
•
use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP).
•
are scheduled to have major surgery

After starting ABRILADA, call your healthcare provider right away if you have an infection, or any sign of an infection.
ABRILADA can make you more likely to get infections or make any infection that you may have worse.
Cancer

•
For children and adults taking tumor necrosis factor (TNF) blockers, including ABRILADA, the chances of getting cancer may increase.
•
There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers.
•
People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
•
If you use TNF blockers including ABRILADA your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal.
•
Some people receiving TNF blockers including ABRILADA developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6-MP).
Prescribing Information
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Health Professional Information

What is the most important information I should know about ABRILADA?

What is the most important information I should know about ABRILADA?

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 healthcare provider should test you for TB before starting ABRILADA.
•
Your healthcare provider should check you closely for signs and symptoms of TB during treatment with ABRILADA.

You should not start taking ABRILADA if you have any kind of infection unless your healthcare provider says it is okay.
Before starting ABRILADA, tell your healthcare provider if you:

•
think you have an infection or have symptoms of infection such as:
o
fever, sweats, or chills
o
muscle aches
o
cough
o
shortness of breath
o
blood in phlegm
o
warm, red, or painful skin or sores on your body
o
diarrhea or stomach pain
o
burning when you urinate or urinate more often than normal
o
feel very tired
o
weight loss
•
are being treated for an infection.
•
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.
•
were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
•
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 ABRILADA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
•
have or have had hepatitis B.
•
use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP).
•
are scheduled to have major surgery

After starting ABRILADA, call your healthcare provider right away if you have an infection, or any sign of an infection.
ABRILADA can make you more likely to get infections or make any infection that you may have worse.
Cancer

•
For children and adults taking tumor necrosis factor (TNF) blockers, including ABRILADA, the chances of getting cancer may increase.
•
There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers.
•
People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
•
If you use TNF blockers including ABRILADA your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal.
•
Some people receiving TNF blockers including ABRILADA developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6-MP).

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