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SYLVANT® 100 mg and 400mg powder for concentrate for solution for infusion PRESCRIBING INFORMATION

ACTIVE INGREDIENT:Siltuximab, 100 mg or 400 mg siltuximab powder

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): Treatment of adults with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus 8 (HHV 8) negative.

DOSAGE & ADMINISTRATION: Adults & Elderly: recommended 11 mg/kg siltuximab intravenous infusion over 1 hour every 3 weeks until treatment failure. Perform haematology tests before each dose for first 12 months, then every third cycle; consider delaying treatment if absolute neutrophil count/platelet count reduced or haemoglobin increased (refer to SmPC for levels). Withhold treatment if severe infection or any severe non haematological toxicity until recovery. Consider discontinuation if more than 2 dose delays due to treatment-related toxicities during first 48 weeks. Children: No data. Renal & Hepatic impairment: No studies.

CONTRAINDICATIONS: Severe hypersensitivity to active substance or any excipient.

SPECIAL WARNINGS & PRECAUTIONS: Concurrent active serious infections: treat prior to administering SYLVANT. Total IgG, IgA, or IgM levels below normal in 4 to 11% of patients in clinical study. Two cases of reactivated hepatitis B reported when concomitant high dose dexamethasone, and bortezomib, melphalan and prednisone in multiple myeloma. Monitor for serious infections as SYLVANT may mask signs/symptoms of acute inflammation. Vaccinations: do not administer live, attenuated vaccines concurrently or within 4 weeks prior to SYLVANT. Hyperlipidaemia observed. Infusion reactions: reduce infusion rate if mild/moderate; consider use of antihistamines, acetaminophen, and corticosteroids. Discontinue if severe infusion related hypersensitivity reactions occur. Malignancy: potential risk. Gastrointestinal perforation: caution when increased risk of perforation/evaluate if symptoms present. Hepatic impairment: monitor patients.

SIDE EFFECTS: Very common: upper respiratory tract infection, nasopharyngitis, neutropenia, thrombocytopenia, hypertriglyceridaemia, hypertension, abdominal pain, maculopapular rash, pruritus, renal impairment, localised oedema, weight increased.

Common: Anaphylactic reaction.

Refer to SmPC for other side effects.

PREGNANCY: not recommended. Women of childbearing potential must use effective contraception during and up to 3 months after treatment.

LACTATION: No data.

INTERACTIONS: Concomitant use of CYP450 substrates with a narrow therapeutic index: monitor the effect (e.g., warfarin) or concentration (e.g., cyclosporine or theophylline). Caution with CYP3A4 substrates.

LEGAL CATEGORY: POM.

PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS:
SYLVANT 100 mg powder for concentrate for solution for infusion, 1 vial per pack, EU/1/14/928/001: £415.
SYLVANT 400 mg powder for concentrate for solution for infusion, 1 vial per pack, EU/1/14/928/002: £1,661.

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG UK

Prescribing information last revised: June 2014
PIVER06/2014

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse reactions related to this medicinal product. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.