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.
Limitations 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: avoid 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 signs of anaphylaxis occur. Stop infusion if mild-to-moderate infusion reactions occur; if resolves, may restart at lower infusion rate and consider using antihistamines, acetaminophen, corticosteroids. Increased risk for 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.