Sylvant

— THERAPEUTIC CATEGORIES —
  • White blood cell disorders

Sylvant Generic Name & Formulations

General Description

Siltuximab 100mg, 400mg; lyophilized pwd for IV infusion after reconstitution; preservative-free.

Pharmacological Class

Interleukin-6 antagonist.

How Supplied

Single-use vial—1

Manufacturer

Sylvant Indications

Indications

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.

Sylvant Dosage and Administration

Adult

Give by IV infusion over 1 hour. 11mg/kg every 3 weeks until treatment failure.

Children

Not established.

Sylvant Contraindications

Not Applicable

Sylvant Boxed Warnings

Not Applicable

Sylvant Warnings/Precautions

Warnings/Precautions

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). Advise females of reproductive potential to use effective contraception during and for 3 months after the last dose. Pregnancy. Nursing mothers: not recommended (during and for 3 months after the last dose).

Sylvant Pharmacokinetics

See Literature

Sylvant Interactions

Interactions

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.

Sylvant Adverse Reactions

Adverse Reactions

Pruritus, increased weight, rash, hyperuricemia, upper respiratory tract infection, edema; hypersensitivity reactions.

Sylvant Clinical Trials

See Literature

Sylvant Note

Not Applicable

Sylvant Patient Counseling

See Literature