Indication and Safety Information for REMICADE

REMICADE has been used to treat more than one million patients worldwide for conditions like plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease in adults, pediatric Crohn’s disease, ulcerative colitis, and ankylosing spondylitis. The safety profile of REMICADE has been evaluated through medical trials conducted over the past 16 years.

Indications

• Plaque Psoriasis
  REMICADE is approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if REMICADE is appropriate considering other available therapies.
• Rheumatoid Arthritis
  REMICADE, used in combination with methotrexate, can reduce signs and symptoms, help stop further joint damage, and improve physical function in many patients with moderate to severe RA.
• Psoriatic Arthritis
  REMICADE can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in many patients with psoriatic arthritis.
  
• Adult Crohn's Disease
  REMICADE is for patients with moderate to severe Crohn’s who haven't responded well to other therapies.
• Pediatric Crohn's Disease
  REMICADE is for children (ages 6-17) with moderate to severe Crohn's disease who haven't responded well to other therapies.
• Ulcerative Colitis
  REMICADE can reduce the signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in patients with moderate to severe UC who haven't responded well to other therapies.
• Ankylosing Spondylitis
  REMICADE is for patients with active ankylosing spondylitis.

IMPORTANT SAFETY INFORMATION

There are reports of serious infections, including tuberculosis (TB), sepsis, and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a TB test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if, you have lived in a region where histoplasmosis or coccidioidomycosis is common.

Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Children and young adults who have been treated for Crohn’s disease with REMICADE have developed a rare type of lymphoma that often results in death. These patients also were receiving drugs known as azathioprine or 6-mercaptopurine. If you take REMICADE or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers or if you have a lung disease called chronic obstructive pulmonary disease (COPD).

Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of your ankles or feet, or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as feeling unwell, poor appetite, tiredness, fever, skin rash, and/or joint pain.

There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Tell your doctor if you have liver problems and contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue. 

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, visual disturbances, or seizures while taking REMICADE.

Allergic reactions, some severe, have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Tell your doctor if you have experienced a severe allergic reaction.  The most common side effects of REMICADE are: respiratory infections (such as sinus infections and sore throat), headache, rash, coughing, and stomach pain.

Medication Guide

• Please read the Medication Guide for REMICADE and discuss with your doctor.
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