Sylvant

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. 6 mmol/L) a SYLVANT may increase haemoglobin levels in MCD patients 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. 2). 4). 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. 6.

Summary of the safety profile Infections (including upper respiratory tract infections), pruritus, rash, arthralgia, and diarrhoea were the most common adverse reactions , occurring in > 20% of siltuximab-treated patients in Castleman’s disease (CD) clinical studies.

The most serious adverse reaction associated with the use of siltuximab was anaphylactic reaction. Data from all patients treated with siltuximab monotherapy (n = 370) form the overall basis of the safety evaluation. 1). 6 Tabulated list of adverse reactions Table 2 lists adverse reactions observed in MCD patients treated with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks.

Within the system organ class, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 8%) of patients treated with siltuximab monotherapy. 3% for severe reactions). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 7 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Traceability In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Concurrent active serious infections Infections, including localised infections, should be treated prior to administration of SYLVANT.

8). 3% of patients in the clinical study. Decreases in total IgG, IgA, or IgM levels below normal were observed in the range of 4 to 11% patients in the MCD trial (Study 1). 4 All clinical studies with SYLVANT excluded patients with clinically significant infections, including those known to be hepatitis B surface antigen positive.

Two cases of reactivated hepatitis B have been reported when SYLVANT was administered concomitantly with high dose dexamethasone, and bortezomib, melphalan and prednisone in multiple myeloma patients. SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute-phase reactants, such as C-reactive protein (CRP).

Therefore, prescribers should diligently monitor patients receiving treatment in order to detect serious infections. Vaccinations Live, attentuated vaccines should not be given concurrently or within 4 weeks before initiating SYLVANT as clinical safety has not been established.

8). Patients should be managed according to current clinical guidelines for management of hyperlipidaemia. Infusion related reactions and hypersensitivity During intravenous infusion of SYLVANT, mild to moderate infusion reactions may improve following slowing of or stopping the infusion.

Upon resolution of the reaction, reinitiating the infusion at a lower infusion rate and therapeutic administration of antihistamines, acetaminophen, and corticosteroids may be considered. For patients who do not tolerate the infusion following these interventions, SYLVANT should be discontinued.

, anaphylaxis). The management of severe infusion reactions should be dictated by the signs and symptoms of the reaction. 8). Malignancy Immunomodulatory medicinal products may increase the risk of malignancy. On the basis of limited experience with siltuximab the present data do not suggest any increased risk of malignancy.

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