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Tolerability & safety

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).

Adverse event profile

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

Table 7: Adverse reactions in SYLVANT® treated patients in MCD clinical studies

References
1. SYLVANT® Summary of Product Characteristics (2019)