Multicentric Castleman's disease (MCD)

Active Ingredient: Siltuximab

Indication for Siltuximab

Population group: only adults (18 years old or older)

Siltuximab 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.

For this indication, competent medicine agencies globally authorize below treatments:

11 mg/kg once every 3 weeks

Route of admnistration

Intravenous

Defined daily dose

11 - 11 mg per kg of body weight

Dosage regimen

From 11 To 11 mg per kg of body weight once every 21 day(s)

Detailed description

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 siltuximab 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 the following table are not met. Dose reduction is not recommended.

Treatment criteria:

Laboratory parameterRequirements before first siltuximab administrationRetreatment criteria
Absolute neutrophil count≥1.0 × 109/L≥1.0 × 109/L
Platelet count≥75 × 109/L≥50 × 109/L
Haemoglobina<170 g/L (10.6 mmol/L)<170 g/L (10.6 mmol/L)

a Siltuximab may increase haemoglobin levels in MCD patients.

The siltuximab 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 siltuximab 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.

Dosage considerations

Siltuximab must be administered as an intravenous infusion given over 1 hour.

Active ingredient

Siltuximab

Siltuximab is a monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6. Siltuximab prevents the binding of human IL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of the hexameric signaling complex with gp130 on the cell surface.

Read more about Siltuximab

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