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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Limitation of Use
SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.
There is currently no drug history available for this drug.
SYLVANT (siltuximab) is a human-mouse chimeric monoclonal antibody that binds human interleukin-6 (IL-6). SYLVANT is produced by Chinese hamster ovary cells.
SYLVANT is supplied as a sterile, white, preservative free, lyophilized powder in single-use vials.
Each SYLVANT 100 mg single-use vial contains 100 mg siltuximab, 3.7 mg L-histidine (from L-histidine and L-histidine monohydrochloride monohydrate), 0.8 mg polysorbate 80, and 169 mg sucrose.
Each SYLVANT 400 mg single-use vial contains 400 mg siltuximab, 14.9 mg L-histidine (from L-histidine and L-histidine monohydrochloride monohydrate), 3.2 mg polysorbate 80, and 677 mg sucrose.
Following reconstitution with Sterile Water for Injection, USP (per section 2.2), the resulting pH is approximately 5.2. The resulting solution contains 20 mg/mL siltuximab to be administered by intravenous infusion following dilution [see Dosage and Administration (2)].