Tolerability

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

• Infections (including upper-respiratory tract infection)
• Pruritus
• Rash
• Athralgia
• Diarrhoea
  

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