• Treatment of multicentric Castleman's disease (MCD) patients who are negative for HIV and human herpesvirus-8 (HHV-8).

Contraindicated in:

• Hypersensitivity
• Severe infections
• OB: Pregnancy (↑ risk of infection in infants)
• Lactation: Lactation.

Use Cautiously in:

• End stage renal disease or severe hepatic impairment
• Pedi: Safety and effectiveness not established in children
• Geri: Older adults may be more sensitive to drug effects.

CV: edema, hypotension.

Derm: pruritus, rash, dry skin, eczema, psoriasis, skin hyperpigmentation.

F and E: dehydration.

GI: abdominal pain/distention, diarrhea, ↓ appetite, GI PERFORATION, constipation, oropharyngeal pain.

GU: renal impairment.

Hemat: thrombocytopenia.

Metab: hyperuricemia, weight gain, ↑ lipids.

MS: musculoskeletal pain.

Neuro: fatigue, headache.

Misc: ↑ risk of infection, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), infusion reactions.

Drug-Drug:

• May ↓ immune response to live vaccines (avoid administration)
• May restore function of CYP450 enzyme and ↑ metabolism of CYP450 substrates (including CYP3A4) especially those with narrow therapeutic indices, including atorvastatin, cyclosporine, hormonal contraceptives, lovastatin, theophylline and warfarin; careful monitoring is recommended during and for several wk after treatment with siltuximab.

• Lyophilized powder for injection : 100 mg/vial; 400 mg/vial;

• IV (Adults): 11 mg/kg every 3 wks.

Sylvant

• Binds to interleukin-6 (IL-6) preventing binding to IL-6 receptors. MCD is associated with overproduction of IL-6.

• Decreased tumor load and manifestations of MCD including infections, fevers, weight loss, fatigue and night sweats.

Therapeutic Classification:

Pharmacologic Classification: interleukin antagonists

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Used up in the binding process.

Half-life: 20.6 days (range 14.2–29.7 days).

(blood levels)

• Explain purpose of siltuximab to patient. Advise patient to read Patient Information prior to starting therapy and before each infusion in case of changes.
• Advise patient to notify health care professional at risk for GI perforation (have or have had any stomach or bowel (intestine) problems, such as diverticulitis or ulcers) or if pain in stomach area occurs.
• Advise patient to notify health care professional if signs and symptoms of infection or allergic reactions (difficulty breathing, chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash) occur.
• Advise patient to avoid receiving live vaccines during therapy.
• Advise patient to consult health care professional before taking other Rx or OTC medications, vitamins, or herbal products
• Rep: Caution females of reproductive potential to use effective contraception and to avoid breastfeeding during and for at least 3 mo following therapy.

sil-TUX-i-mab

NDC Code^*

• 57894- Janssen Biotech, Inc.
  • 57894-420- SYLVANT
    • 57894-420-01- 1 VIAL, SINGLE-USE in 1 CARTON (57894-420-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• 57894- Janssen Biotech, Inc.
  • 57894-421- SYLVANT
    • 57894-421-01- 1 VIAL, SINGLE-USE in 1 CARTON (57894-421-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• 73090- EUSA Pharma (UK) Ltd
  • 73090-420- Sylvant
    • 73090-420-01- 1 VIAL, SINGLE-DOSE in 1 BOX (73090-420-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• 73090- EUSA Pharma (UK) Ltd
  • 73090-421- Sylvant
    • 73090-421-01- 1 VIAL, SINGLE-DOSE in 1 BOX (73090-421-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE