REMICADE® (Infliximab)

REMICADE®

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Important Safety Information

REMICADE® (infliximab) is a prescription infusion medication used to treat several medical conditions — including Crohn’s disease and ulcerative colitis in pediatric and adult patients. It also treats rheumatoid and psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

It is possible for REMICADE® to lower your immune system’s ability to fight infections — especially in patients who are 65 years of age or older and have had serious infections caused by viruses, tuberculosis, or histoplasmosis. It is also possible for pediatric patients to develop unusual cancers while undergoing therapy with REMICADE®. The risk is higher in teenage or young adult males with Crohn’s disease or ulcerative colitis.

What is the most important information I should know about REMICADE®?

Talk to your doctor about your medical history to determine whether you need additional monitoring during treatment. There are certain medical conditions that may make it dangerous to undergo treatment with REMICADE®, including:

  • Tuberculosis (TB)
  • Diabetes
  • Immune system issues
  • Infections that keep coming back
  • Cancer
  • Heart failure
  • Hepatitis B
  • Nervous system disorders

In addition, some medications may not react well when combined with REMICADE®. Tell your doctor about all drugs you’re currently taking, regardless of whether they’re prescription, over-the-counter, vitamins, or herbal supplements. Specific medications that may require additional attention include Kineret (anakinra), ORENCIA® (abatacept), or ACTEMRA® (tocilizumab), as well as biologics. Patients who are undergoing treatment with REMICADE® should not receive live vaccines. Tell your doctor if you have any vaccines scheduled.

REMICADE® could also increase the risk of blood infections, lymphoma, skin, or cervical cancer. Tell your doctor if you see any changes or growths on your skin, or are experiencing poor appetite, flu-like symptoms, or painful or opens sores.

Side Effects of REMICADE®

As with any prescription medication, REMICADE® carries the risk of side effects. The most common ones include:

  • Headaches
  • Skin rash
  • Coughing
  • Stomach pain
  • Sore throat
  • Sinus infections

In rare cases, some patients may experience life-threatening side effects. Seek emergency medical care immediately if you experience any of the following symptoms:

  • Chest discomfort or pain
  • Shortness of breath
  • Lightheadedness
  • Irregular heartbeat
  • Dizziness
  • Joint pain
  • Nausea
  • Vomiting
  • Arm pain
  • Stomach pain
  • A fever that doesn’t go away
  • Severe paleness
  • Bruising
  • Unusual bleeding
  • Jaundice (yellow skin and eyes)
  • Dark brown urine
  • Right-sided abdominal pain
  • Severe tiredness
  • Numbness or tingling
  • Blurry vision
  • Slurred speech
  • Sudden confusion
  • Trouble understanding
  • A sudden, severe headache
  • Trouble seeing in one or both eyes
  • Loss of balance or coordination
  • Seizures

These symptoms could be an indication of infections, reactivation of Hepatitis B, heart failure, liver injury, blood or nervous system disorders, stroke, or allergic reactions. Talk to your doctor if you’ve had issues with these types of conditions in the past.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

REMICADE® is used to treat Crohn’s disease and ulcerative colitis in pediatric and adult patients, as well as rheumatoid and psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Infusion therapy is administered for at least two hours, with dosage varying depending on the condition being treated, as well as the age and weight of the patient.

Please refer to the full prescribing information.