SYLVANT® is well tolerated.
In idiopathic Multicentric Castleman Disease (iMCD) studies, the most common adverse reactions occurring >20% of patients treated with SYLVANT® were:1
The most serious adverse reactions associated with SYLVANT® in clinical trials were anaphylactic reactions.
In clinical trials, 5.1% of patients treated with SYLVANT® had an infusion related reaction or hypersensitivity reactions (0.8% of patients had a severe reaction).
In long-term treatment of iMCD with SYLVANT® (at the recommend dose of 11 mg/kg every 3 weeks ), 6.3% of patients had an infusion related/hypersensitivity reaction (1.3% had severe reactions).
SYLVANT® clinical trials provide safety data on 87 MCD patients treated at the recommended dose of 11 mg/kg every 3 weeks. Identified adverse reactions are listed in Table 7.
Table 7: Adverse reactions in SYLVANT® treated patients in MCD clinical studies1
1. SYLVANT® EU Summary of Product Characteristics (2019).