Safety

Long-term SYLVANT® Safety Evaluation

Long-term safety evaluation for SYLVANT®
 
 

The long-term safety of SYLVANT® (siltuximab) was evaluated in a study of patients treated for a median of 5.1 years (range: 3.4-7.2 years)

  • The most common adverse reactions (>20%) reported by subjects receiving SYLVANT® in this study were upper respiratory tract infection, diarrhea, pain in extremities, arthralgia, and fatigue1
  • In the study, no patient was removed from therapy for any reason1

STUDY DESIGN: LONG-TERM SAFETY EVALUATION1

  • The safety of long-term administration was studied in patients with MCD enrolled in the initial dose-finding study of SYLVANT® who were benefiting from chronic SYLVANT® therapy (N=19)
  • SYLVANT® was administered at a dose of 11 mg/kg every 3 to 6 weeks

Concurrent Active Severe Infections

  • Do not administer to patients with severe infections until the infection resolves. SYLVANT® may mask signs and symptoms of acute inflammation including suppression of fever and of acute phase reactants such as C-reactive protein (CRP). Monitor patients closely for infections. Institute prompt anti-infective therapy and do not administer further SYLVANT® until the infection resolves.

Vaccinations

  • Do not administer live vaccines to patients receiving SYLVANT® because interleukin-6 (IL-6) inhibition may interfere with the normal immune response to new antigens.

 

References

  1. SYLVANT® [package insert]. Horsham, PA: Janssen Biotech, Inc.