ELREXFIO What are the possible side effects of ELREXFIO?

(elranatamab-bcmm)

What are the possible side effects of ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
See “What is the most important information I should know about ELREXFIO?”
•
Infections. Upper respiratory tract infections and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.
o
Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with ELREXFIO.
o
Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including:
▪
fever of 100.4 °F (38 °C) or higher
▪
chills
▪
cough
▪
shortness of breath
▪
chest pain
▪
sore throat
▪
pain during urination
▪
feeling weak or generally unwell
•
Decreased white blood cell counts. Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. Fever can happen with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.
•
Liver problems. ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:
o
tiredness
o
loss of appetite
o
pain in your right upper stomach-area (abdomen)
o
dark urine
o
yellowing of your skin or the white part of your eyes

Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.

The most common side effects of ELREXFIO include:

•
tiredness
•
injection site reaction, such as redness, itching, pain, bruising, rash, swelling, tenderness
•
diarrhea
•
muscle and bone pain
•
decreased appetite
•
rash
•
cough
•
nausea
•
fever

The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.


These are not all of the possible side effects of ELREXFIO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Find ELREXFIO medical information:

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What are the possible side effects of ELREXFIO?

What are the possible side effects of ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
See “What is the most important information I should know about ELREXFIO?”
•
Infections. Upper respiratory tract infections and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.
o
Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with ELREXFIO.
o
Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including:
▪
fever of 100.4 °F (38 °C) or higher
▪
chills
▪
cough
▪
shortness of breath
▪
chest pain
▪
sore throat
▪
pain during urination
▪
feeling weak or generally unwell
•
Decreased white blood cell counts. Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. Fever can happen with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.
•
Liver problems. ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:
o
tiredness
o
loss of appetite
o
pain in your right upper stomach-area (abdomen)
o
dark urine
o
yellowing of your skin or the white part of your eyes

Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.

The most common side effects of ELREXFIO include:

•
tiredness
•
injection site reaction, such as redness, itching, pain, bruising, rash, swelling, tenderness
•
diarrhea
•
muscle and bone pain
•
decreased appetite
•
rash
•
cough
•
nausea
•
fever

The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.


These are not all of the possible side effects of ELREXFIO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Prescribing Information
Download Prescribing Information

Health Professional Information

What are the possible side effects of ELREXFIO?

What are the possible side effects of ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
See “What is the most important information I should know about ELREXFIO?”
•
Infections. Upper respiratory tract infections and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.
o
Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with ELREXFIO.
o
Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including:
▪
fever of 100.4 °F (38 °C) or higher
▪
chills
▪
cough
▪
shortness of breath
▪
chest pain
▪
sore throat
▪
pain during urination
▪
feeling weak or generally unwell
•
Decreased white blood cell counts. Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. Fever can happen with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.
•
Liver problems. ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:
o
tiredness
o
loss of appetite
o
pain in your right upper stomach-area (abdomen)
o
dark urine
o
yellowing of your skin or the white part of your eyes

Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.

The most common side effects of ELREXFIO include:

•
tiredness
•
injection site reaction, such as redness, itching, pain, bruising, rash, swelling, tenderness
•
diarrhea
•
muscle and bone pain
•
decreased appetite
•
rash
•
cough
•
nausea
•
fever

The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.


These are not all of the possible side effects of ELREXFIO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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