What are the possible side effects of RENFLEXIS?
RENFLEXIS can cause serious side effects, including:
Serious infections
• Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as RENFLEXIS. 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 RENFLEXIS your doctor will treat your infection and may need to stop your RENFLEXIS treatment.
• Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving RENFLEXIS:
a fever
feel very tired
have a cough
have flu-like symptoms
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 RENFLEXIS and during treatment with RENFLEXIS.
• Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving RENFLEXIS. 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 RENFLEXIS. 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 RENFLEXIS and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
feel unwell
poor appetite
tiredness (fatigue)
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 RENFLEXIS. Your congestive heart failure may get worse while you are receiving RENFLEXIS. 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 RENFLEXIS 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 RENFLEXIS treatment or shortly afterward. Your doctor may need to stop or pause your treatment with RENFLEXIS 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 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 RENFLEXIS:
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 RENFLEXIS.
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 using 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 RENFLEXIS.
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 RENFLEXIS. 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 who received infliximab 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 took 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 RENFLEXIS. 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.
See the section "What is the most important information I should know about RENFLEXIS?" above for more information.