Golimumab (Simponi) side effects: risk of serious fungal infections

Centocor Ortho Biotech and FDA reminded prescribers of the risk of serious fungal infections associated with TNF-α blockers, this includes the newer Simponi (golimumab).

Simponi is a recently approved human monoclonal antibody for the treatment of rheumatic diseases. Its indications include:

  • Moderately to severely active Rheumatoid Arthritis (RA) in adults, in combination with methotrexate.
  • Active Psoriatic Arthritis (PsA) in adults, alone or in combination with methotrexate.
  • Active Ankylosing Spondylitis in adults (AS).

According to the FDA, histoplasmosis and other invasive fungal infections are not consistently recognized in patients under other TNF-α blockers such as Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This has resulted in delays in appropriate antifungal treatment, which in some cases has lead to death. The agency also added  a Boxed Warning to this group of medications,  alerting about an increased risk of  lymphoma.

Also, the UK’s National Institute for Health and Clinical Excellence (NICE) issued in February 2009 an update of the rheumatoid arthritis clinical guidelines.


MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Simponi (golimumab)

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