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SIMPONI(TM) (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Date:4/24/2009

ch as:

  • fever, sweat, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more than normal
  • feel very tired

Tell your doctor about all the medications you take or if you are scheduled to or recently received a vaccine.

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blocker medicines, such as SIMPONI(TM). Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONI(TM). 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:

  • feel very tired
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • muscle aches
  • dark urine
  • clay-colored bowel movements
  • fevers
  • chills
  • stomach discomfort
  • skin rash

If you take SIMPONI(TM) or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.

Heart failure can occur or get worse in people who use TNF blockers like SIMPONI(TM). Your doctor will monitor you closely if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.

Rarely, people using TNF blo
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SOURCE Centocor Ortho Biotech Inc.
Copyright©2009 PR Newswire.
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