Expert: DANIL HAMMOUDI.MD - 10/9/2006

Question
My daughter-in-law has had almost 20 operations due to ulcitive colitis and now they think she has crohn's. She has been to the Clevland Clinic and they can not operate until a year has gone past.  They are going to try Remacaid as a last resort because they don't think she will make a year. What is the track record for this drug.  Thank you.

Answer
DOES SHE HAS CROHN OR ULCERATIVE COLITIS NOT BOTH?
IF SHE IS IN FLARE NO SURGERY IS INDICATED.
Before she starts treatment with Remicade, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Treatment with Remicade may increase your risk of developing certain types of cancer or autoimmune disorders (such as a lupus-like syndrome). Talk with your doctor about your individual risk.
  •    Remicade can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
  •    Serious and sometimes fatal infections may occur during treatment with Remicade. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, easy bruising or bleeding, pale skin, or unusual weakness.
  •    Do not receive a "live" vaccine while you are being treated with Remicade, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
•     You should not use this medication if you have heart failure, or if you are also being treated with anakinra (Kineret).
  •    Before using Remicade, tell your doctor if you have:
  ·    an active or recent infection;
  ·    a history of tuberculosis;
  ·    congestive heart failure; or
  ·    if you are also using medicines that can make your immune system weak (such as steroids, chemotherapy, or radiation treatment).
  •    Before using Remicade, tell your doctor if you have:
  ·    kidney disease;
  ·    multiple sclerosis;
  ·    epilepsy or other seizure disorder;
  ·    liver disease;
  ·    cancer; or
  ·    an autoimmune disorder such as lupus.
  •    If you have any of these conditions, you may not be able to use Remicade, or you may need a dosage adjustment or special tests during treatment.
  •    Treatment with Remicade may increase your risk of developing certain types of cancer or autoimmune disorders (such as a lupus-like syndrome). Talk with your doctor about your individual risk.
  •    Remicade is in the FDA pregnancy category B. This means that it is unlikely to be harmful to an unborn baby. Do not use Remicade without first talking to your doctor if you are pregnant or could become pregnant during treatment.
  •    It is not known whether Remicade passes into breast milk.

What are the possible side effects of Remicade?
  •    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
  •    Serious and sometimes fatal infections may occur during treatment with Remicade. Contact her doctor right away if you have signs of infection such as:
  ·    fever, chills, sore throat, flu symptoms;
  ·    easy bruising or bleeding, pale skin, unusual weakness;
  •    
  ·    feeling short of breath, even with mild exertion;
  ·    swelling of your ankles or feet;
  ·    problems with vision;
  ·    chest pain, joint pain, redness or discoloration of your face;
  ·    numbness or tingling;
  ·    weak feeling in your arms or legs; or
  ·    nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
  •    Other less serious side effects are more likely to occur, such as:
  ·    stuffy nose, sinus pain; or
  ·    mild stomach pain.
  •    

thanks