SYLVANT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL [SIN14762P]

Product Info

SYLVANT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

[SIN14762P]

4.1 Therapeutic indications

SYLVANT is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

4.2 Posology and method of administration

This medicinal product should be administered by qualified healthcare professionals and under appropriate medical supervision.

Posology

The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.

Treatment criteria
Haematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every third dosing cycle thereafter. Before administering the infusion, the prescriber should consider delaying treatment, if the treatment criteria outlined in Table 1 are not met. Dose reduction is not recommended.

The SYLVANT therapy should be withheld if the patient has a severe infection or any severe non-haematological toxicity and can be restarted at the same dose after recovery.

If the patient develops a severe infusion related reaction, anaphylaxis, severe allergic reaction, or cytokine release syndrome related to the infusion, further administration of SYLVANT should be discontinued. Discontinuing the medicinal product should be considered if there are more than 2 dose delays due to toxicities related to the treatment during the first 48 weeks.

Special populations

Elderly patients
No major age-related differences in pharmacokinetics (PK) or in safety profile were observed in clinical studies. No dose adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal and/or hepatic impairment
No formal studies have been conducted to investigate the PK of siltuximab in patients with renal or hepatic impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of siltuximab in children aged 17 years and younger have not been established.
No data are available.

Method of administration

Siltuximab must be administered as an intravenous infusion.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.