INFLECTRA® What should I avoid while receiving INFLECTRA?

(infliximab-dyyb)

What should I avoid while receiving INFLECTRA?

Tell your doctor about all the medicines you take

What are the possible side effects of INFLECTRA?
INFLECTRA can cause serious side effects, including:
See "What is the most important information I should know about INFLECTRA?".
Serious Infections

•
Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as INFLECTRA. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as skin). Some patients die from these infections. If you get an infection while receiving treatment with INFLECTRA your doctor will treat your infection and may need to stop your INFLECTRA treatment.
•
Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving INFLECTRA:
o
a fever
o
feel very tired
o
have a cough
o
have flu-like symptoms
o
warm, red, or painful skin
•
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with INFLECTRA and during treatment with INFLECTRA.
•
Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving INFLECTRA. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
•
If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with INFLECTRA. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with INFLECTRA and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
o
feel unwell
o
poor appetite
o
tiredness (fatigue)
o
fever, skin rash, or joint pain

Heart Failure
If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving INFLECTRA. Your congestive heart failure may get worse while you are receiving INFLECTRA. Be sure to tell your doctor of any new or worse symptoms including:

•
shortness of breath
•
swelling of ankles or feet
•
sudden weight gain

Treatment with INFLECTRA may need to be stopped if you get new or worse congestive heart failure.
Other Heart Problems
Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of infliximab products. Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you have any of these symptoms.
Liver Injury
Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:

•
jaundice (skin and eyes turning yellow)
•
dark brown-colored urine
•
pain on the right side of your stomach area (right-sided abdominal pain)
•
fever
•
extreme tiredness (severe fatigue)

Blood Problems
In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:

•
have a fever that does not go away
•
bruise or bleed very easily
•
look very pale

Nervous System Disorders
Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:

•
changes in your vision
•
numbness or tingling in any part of your body
•
seizures
•
weakness in your arms or legs

Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
Allergic Reactions
Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your INFLECTRA treatment or shortly afterward. Your doctor may need to stop or pause your treatment with INFLECTRA and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:

•
hives (red, raised, itchy patches of skin)
•
difficulty breathing
•
chest pain
•
high or low blood pressure
•
fever
•
chills

Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred within 3 to 12 days after receiving treatment with infliximab products. Tell your doctor right away if you have any of these signs of delayed allergic reaction to INFLECTRA:

•
fever
•
rash
•
headache
•
sore throat
•
muscle or joint pain
•
swelling of the face and hands
•
difficulty swallowing

Lupus-like Syndrome
Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with INFLECTRA.

•
chest discomfort or pain that does not go away
•
shortness of breath
•
joint pain
•
rash on the cheeks or arms that gets worse in the sun

Psoriasis
Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with INFLECTRA.
The most common side effects of infliximab products include:

•
respiratory infections, such as sinus infections and sore throat
•
headache
•
coughing
•
stomach pain

Infusion reactions can happen up to 2 hours after your infusion of INFLECTRA. Symptoms of infusion reactions may include:

•
fever
•
chills
•
chest pain
•
low blood pressure or high blood pressure
•
shortness of breath
•
rash
•
itching

Children with Crohn's disease showed some differences in side effects of treatment compared with adults with Crohn's disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who received infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.
Tell your doctor about any side effect that bothers you or does not go away.
These are not all of the side effects with INFLECTRA. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Find INFLECTRA® medical information:

Find INFLECTRA® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

INFLECTRA® Quick Finder

Medication Guide

Health Professional Information

What should I avoid while receiving INFLECTRA?

What should I avoid while receiving INFLECTRA?

Tell your doctor about all the medicines you take

What are the possible side effects of INFLECTRA?
INFLECTRA can cause serious side effects, including:
See "What is the most important information I should know about INFLECTRA?".
Serious Infections

•
Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as INFLECTRA. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as skin). Some patients die from these infections. If you get an infection while receiving treatment with INFLECTRA your doctor will treat your infection and may need to stop your INFLECTRA treatment.
•
Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving INFLECTRA:
o
a fever
o
feel very tired
o
have a cough
o
have flu-like symptoms
o
warm, red, or painful skin
•
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with INFLECTRA and during treatment with INFLECTRA.
•
Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving INFLECTRA. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
•
If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with INFLECTRA. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with INFLECTRA and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
o
feel unwell
o
poor appetite
o
tiredness (fatigue)
o
fever, skin rash, or joint pain

Heart Failure
If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving INFLECTRA. Your congestive heart failure may get worse while you are receiving INFLECTRA. Be sure to tell your doctor of any new or worse symptoms including:

•
shortness of breath
•
swelling of ankles or feet
•
sudden weight gain

Treatment with INFLECTRA may need to be stopped if you get new or worse congestive heart failure.
Other Heart Problems
Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of infliximab products. Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you have any of these symptoms.
Liver Injury
Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:

•
jaundice (skin and eyes turning yellow)
•
dark brown-colored urine
•
pain on the right side of your stomach area (right-sided abdominal pain)
•
fever
•
extreme tiredness (severe fatigue)

Blood Problems
In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:

•
have a fever that does not go away
•
bruise or bleed very easily
•
look very pale

Nervous System Disorders
Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:

•
changes in your vision
•
numbness or tingling in any part of your body
•
seizures
•
weakness in your arms or legs

Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
Allergic Reactions
Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your INFLECTRA treatment or shortly afterward. Your doctor may need to stop or pause your treatment with INFLECTRA and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:

•
hives (red, raised, itchy patches of skin)
•
difficulty breathing
•
chest pain
•
high or low blood pressure
•
fever
•
chills

Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred within 3 to 12 days after receiving treatment with infliximab products. Tell your doctor right away if you have any of these signs of delayed allergic reaction to INFLECTRA:

•
fever
•
rash
•
headache
•
sore throat
•
muscle or joint pain
•
swelling of the face and hands
•
difficulty swallowing

Lupus-like Syndrome
Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with INFLECTRA.

•
chest discomfort or pain that does not go away
•
shortness of breath
•
joint pain
•
rash on the cheeks or arms that gets worse in the sun

Psoriasis
Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with INFLECTRA.
The most common side effects of infliximab products include:

•
respiratory infections, such as sinus infections and sore throat
•
headache
•
coughing
•
stomach pain

Infusion reactions can happen up to 2 hours after your infusion of INFLECTRA. Symptoms of infusion reactions may include:

•
fever
•
chills
•
chest pain
•
low blood pressure or high blood pressure
•
shortness of breath
•
rash
•
itching

Children with Crohn's disease showed some differences in side effects of treatment compared with adults with Crohn's disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who received infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.
Tell your doctor about any side effect that bothers you or does not go away.
These are not all of the side effects with INFLECTRA. Ask your doctor or pharmacist for more information.
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 should I avoid while receiving INFLECTRA?

What should I avoid while receiving INFLECTRA?

Tell your doctor about all the medicines you take

What are the possible side effects of INFLECTRA?
INFLECTRA can cause serious side effects, including:
See "What is the most important information I should know about INFLECTRA?".
Serious Infections

•
Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as INFLECTRA. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as skin). Some patients die from these infections. If you get an infection while receiving treatment with INFLECTRA your doctor will treat your infection and may need to stop your INFLECTRA treatment.
•
Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving INFLECTRA:
o
a fever
o
feel very tired
o
have a cough
o
have flu-like symptoms
o
warm, red, or painful skin
•
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with INFLECTRA and during treatment with INFLECTRA.
•
Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving INFLECTRA. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
•
If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with INFLECTRA. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with INFLECTRA and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
o
feel unwell
o
poor appetite
o
tiredness (fatigue)
o
fever, skin rash, or joint pain

Heart Failure
If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving INFLECTRA. Your congestive heart failure may get worse while you are receiving INFLECTRA. Be sure to tell your doctor of any new or worse symptoms including:

•
shortness of breath
•
swelling of ankles or feet
•
sudden weight gain

Treatment with INFLECTRA may need to be stopped if you get new or worse congestive heart failure.
Other Heart Problems
Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of infliximab products. Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you have any of these symptoms.
Liver Injury
Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:

•
jaundice (skin and eyes turning yellow)
•
dark brown-colored urine
•
pain on the right side of your stomach area (right-sided abdominal pain)
•
fever
•
extreme tiredness (severe fatigue)

Blood Problems
In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:

•
have a fever that does not go away
•
bruise or bleed very easily
•
look very pale

Nervous System Disorders
Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:

•
changes in your vision
•
numbness or tingling in any part of your body
•
seizures
•
weakness in your arms or legs

Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
Allergic Reactions
Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your INFLECTRA treatment or shortly afterward. Your doctor may need to stop or pause your treatment with INFLECTRA and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:

•
hives (red, raised, itchy patches of skin)
•
difficulty breathing
•
chest pain
•
high or low blood pressure
•
fever
•
chills

Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred within 3 to 12 days after receiving treatment with infliximab products. Tell your doctor right away if you have any of these signs of delayed allergic reaction to INFLECTRA:

•
fever
•
rash
•
headache
•
sore throat
•
muscle or joint pain
•
swelling of the face and hands
•
difficulty swallowing

Lupus-like Syndrome
Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with INFLECTRA.

•
chest discomfort or pain that does not go away
•
shortness of breath
•
joint pain
•
rash on the cheeks or arms that gets worse in the sun

Psoriasis
Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with INFLECTRA.
The most common side effects of infliximab products include:

•
respiratory infections, such as sinus infections and sore throat
•
headache
•
coughing
•
stomach pain

Infusion reactions can happen up to 2 hours after your infusion of INFLECTRA. Symptoms of infusion reactions may include:

•
fever
•
chills
•
chest pain
•
low blood pressure or high blood pressure
•
shortness of breath
•
rash
•
itching

Children with Crohn's disease showed some differences in side effects of treatment compared with adults with Crohn's disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who received infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.
Tell your doctor about any side effect that bothers you or does not go away.
These are not all of the side effects with INFLECTRA. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information.9AM-5PM ET Monday to Friday; excluding holidays.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.