Sylvant® is the official global commercial brand name, and Sawenke is its Chinese brand name. It is a chimeric monoclonal antibody targeting interleukin-6 (IL-6). It specifically binds to human IL-6, blocks IL-6-mediated signal transduction, inhibits abnormal lymphocyte proliferation and inflammatory cascade reactions related to multicentric Castleman’s disease.
Main Indications
Treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV)-negative and human herpesvirus-8 (HHV-8)-negative.
Clinical Research
A multinational, randomized, double-blind, placebo-controlled Phase II pivotal clinical trial confirmed that siltuximab achieved a significantly higher durable tumor and symptomatic response rate compared with placebo in HIV-negative and HHV-8-negative MCD patients. Long-term extension studies verified sustained therapeutic benefits and a manageable safety profile during prolonged treatment.
Common Side Effects
Severe risks: Severe hypersensitivity and infusion-related reactions, increased risk of serious infections.
Common mild adverse reactions: Pruritus, rash, upper respiratory tract infection, fatigue, diarrhea, nausea, peripheral edema, arthralgia, elevated blood uric acid levels.
Approval Status in China
Original drug Sylvant® (Siltuximab for Injection, Chinese brand name: Sawenke®) was officially approved for marketing in China in 2021, with the specification of 100mg per vial. It is a prescription orphan drug for rare disease treatment.
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