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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

  • Pruritus

    Pruritus

  • Rash

    Rash

  • Infections (including upper-respiratory tract infection)

    Infections
    (including upper-respiratory tract infection)

  • Athralgia

    Athralgia

  • Diarrhoea

    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 7.1

Table 7: Adverse reactions in SYLVANT® treated patients in MCD clinical studies1

VERY COMMON
(≥1/10)		 COMMON
(≥1/100 to <1/10)
Infections and infestations Upper respiratory tract infection, urinary tract infection, nasopharyngitis –
Blood and lymphatic system disorders Neutropenia, thrombocytopenia –
Immune system disorders – Anaphylactic reaction
Metabolism and nutrition disorders Hypertriglyceridaemia, hyperuicaemia Hypercholesterolaemia
Nervous system disorders Dizziness, headache –
Respiratory, thoracic and
mediastinal disorders		 Oropharyngeal pain –
Vascular disorders Hypertension –
Gastrointestinal disorders Nausea, abdominal pain, vomiting,
constipation, diarrhoea, gastroesophageal
reflux disease, mouth ulceration		 –
Skin and subcutaneous tissue disorders Rash, pruritus, eczema –
Musculoskeletal and connective
tissue disorders		 Arthralgia, pain in extremity –
Renal and urinary disorders Renal impairment –
General disorders and administration site conditions Localised oedema –
Investigations Weight increased –

 

References

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

EUSA Sylvant © 2021 EUSA Pharma      Date of prep: November 2021    GL-SIL-2100105

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