Generic Name and Formulations:
Siltuximab 100mg, 400mg; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Janssen Biotech, Inc.
Indications for SYLVANT:
Multicentric Castleman’s disease (MCD) in adults who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Limitation of use: not studied in patients with MCD who are HIV positive or HHV-8 positive.
Give by IV infusion over 1 hour. 11mg/kg every 3 weeks until treatment failure.
Concurrent active severe infections: do not give siltuximab until resolved. May mask signs/symptoms of acute inflammation, fever, and acute phase reactants (eg, CRP); monitor closely. Have resuscitative equipment and personnel available. Discontinue if severe infusion-related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes occur; do not restart. Stop infusion if mild-to-moderate infusion reactions occur; if resolves, may restart at lower infusion rate and consider using antihistamines, acetaminophen, corticosteroids. GI perforation. Perform blood tests prior to each dose for the first 12 months and every 3 dosing cycles thereafter. Consider delaying treatment if hematology criteria not met (see full labeling). Women of childbearing potential should use contraception during and for 3 months after treatment. Pregnancy (Cat.C); avoid. Nursing mothers: not recommended.
Concomitant live vaccines: not recommended. May antagonize CYP450 substrates; monitor drugs with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); adjust dose as needed. Decreased effectiveness with concomitant CYP3A4 substrates (eg, oral contraceptives, lovastatin, atorvastatin); caution.
Pruritus, increased weight, rash, hyperuricemia, upper respiratory tract infection, edema; hypersensitivity reactions.