RIABNI® (rituximab-arrx) is a prescription medicine used to treat:
RIABNI® is not indicated for treatment of children.
Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide.
RIABNI® is a biosimilar of the biologic medicine Rituxan® (rituximab).
RIABNI® is made by Amgen, a world leader in biologic MEDICINES WITH MORE THAN 40 YEARS of experience
RIABNI® is a medicine that targets specific B cells that may play a role in rheumatoid arthritis. B cells are part of the immune system.
B cells have a protein called CD20 on their surface
RIABNI® attaches to the CD20 marker on the B cell. Overactive B cells are believed to play a role in the symptoms and joint damage of RA
RIABNI® kills B cells throughout the body
RIABNI® can also harm healthy cells in your body.
FDA = Food and Drug Administration.
What is the most important information I should know about RIABNI®?
RIABNI® can cause serious side effects that can lead to death, including:
Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of RIABNI®:
Severe Skin and Mouth Reactions: Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RIABNI®:
Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes during treatment with RIABNI®.
Tell your healthcare provider right away if you have new or worsening symptoms or if anyone close to you notices these symptoms:
have or have had any severe infections including:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take or have taken:
If you are not sure if your medicine is one listed above, ask your healthcare provider.
What are the possible side effects of RIABNI®?
See “What is the most important information I should know about RIABNI®?”
Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
TLS can happen within 12 to 24 hours after an infusion of RIABNI®. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS.
Serious Infections: Serious infections can happen during and after treatment with RIABNI®, and can lead to death. RIABNI® can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with RIABNI® include bacterial, fungal, and viral infections. After receiving RIABNI®, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. People with serious infections should not receive RIABNI®. Tell your healthcare provider right away if you have any symptoms of infection:
Your healthcare provider will stop treatment with RIABNI® if you have severe, serious, or life-threatening side effects.
In adults with GPA or MPA the most common side effects of RIABNI® also include:
Other side effects with RIABNI® include:
These are not all of the possible side effects with RIABNI®. For more information, ask your doctor for medical advice about side effects. 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. You may also report side effects to Amgen at 1-800-772-6436.
RIABNI® is not indicated for treatment of children.
Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide.
RIABNI® is a registered trademark of Amgen, Inc.
What is the most important information I should know about RIABNI?
RIABNI can cause serious side effects that can lead to death, including:
Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of RIABNI:
Severe Skin and Mouth Reactions: Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RIABNI:
Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes during treatment with RIABNI.
Tell your healthcare provider right away if you have new or worsening symptoms or if anyone close to you notices these symptoms:
have or have had any severe infections including:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your. healthcare provider if you take or have taken:
If you are not sure if your medicine is one listed above, ask your healthcare provider.
What are the possible side effects of RIABNI?
See “What is the most important information I should know about RIABNI?”
Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
TLS can happen within 12 to 24 hours after an infusion of RIABNI. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS.
Serious Infections: Serious infections can happen during and after treatment with RIABNI, and can lead to death. RIABNI can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with RIABNI include bacterial, fungal, and viral infections. After receiving RIABNI, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. People with serious infections should not receive RIABNI. Tell your healthcare provider right away if you have any symptoms of infection:
Your healthcare provider will stop treatment with RIABNI if you have severe, serious, or life-threatening side effects.
In adults with GPA or MPA the most common side effects of RIABNI also include:
Other side effects with RIABNI include:
These are not all of the possible side effects with RIABNI. For more information, ask your doctor for medical advice about side effects. 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. You may also report side effects to Amgen at 1-800-772-6436.
RIABNI® is not indicated for treatment of children.
Please see full Prescribing Information , including BOXED WARNINGS and Medication Guide.
Rituxan® is a registered trademark of Biogen.
RIABNI is a trademark of Amgen, Inc.