SUMMARY  

• Here are passages from the REMICADE MEDICATION GUIDE, which may be helpful to address your question.
• Please review the full REMICADE MEDICATION GUIDE for more information on “Important information I should know about REMICADE” section.

What are the possible side effects of REMICADE?

REMICADE can cause serious side effects, including:

• Serious Infections
  • Some patients, especially those 65 years and older have had serious infections while receiving REMICADE. These serious infections include tuberculosis (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 REMICADE, your doctor will treat your infection and may need to stop your REMICADE treatment.¹
  • Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving REMICADE¹:
    • 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 REMICADE and during treatment with REMICADE.
  • Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving REMICADE. Patients who had a negative TB skin test before receiving REMICADE 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 REMICADE. 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 REMICADE and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms¹:
    • 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 REMICADE. Your congestive heart failure may get worse while you are receiving REMICADE. Be sure to tell your doctor of any new or worse symptoms including¹:
    • Shortness of breath
    • Swelling of ankles or feet
    • Sudden weight gain
  • Treatment with REMICADE may need to be stopped if you get new or worse congestive heart failure.¹
• 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 REMICADE. 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.¹
• Liver Injury. Some patients receiving REMICADE have developed serious liver problems. Tell your doctor if you have¹:
  • 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 REMICADE, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you¹:
  • Have a fever that does not go away
  • Bruise or bleed very easily
  • Look very pale
• Nervous System Disorders
  • Some patients receiving REMICADE have developed problems with their nervous system. Tell your doctor if you have¹:
    • 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 REMICADE. 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.¹
• Allergic Reactions
  • Some patients have had allergic reactions to REMICADE. Some of these reactions were severe.  These reactions can happen while you are getting your REMICADE treatment or shortly afterward. Your doctor may need to stop or pause your treatment with REMICADE and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include¹:
    • Hives (red, raised, itchy patches of skin)
    • Difficulty breathing
    • Chest pain
    • High or low blood pressure
    • Fever
    • Chills
  • Some patients treated with REMICADE have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with REMICADE. Tell your doctor right away if you have any of these signs of delayed allergic reaction to REMICADE¹:
    • 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 REMICADE.¹
  • 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 REMICADE 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 REMICADE.¹

Common side effects of REMICADE

• The most common side effects of REMICADE include¹:
  • 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 REMICADE. Symptoms of infusion reactions may include¹:
  • Fever
  • Chills
  • Chest pain
  • Low blood pressure or high blood pressure
  • Shortness of breath
  • Rash
  • Itching
• Children who received REMICADE in studies for Crohn’s disease showed some differences in side effects compared with adults who received REMICADE for 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 REMICADE for ulcerative colitis in clinical studies, more children had infections as compared with adults.¹

Tell your doctor about any side effect that bothers you or does not go away. These are not all of the side effects with REMICADE. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to Food and Drug Administration (FDA) at 1-800-FDA-1088.¹

ADDITIONAL INFORMATION

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest using it in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the MEDICATION GUIDE for REMICADE.¹