Active Ingredient: Siltuximab
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:
Intravenous
11 - 11 mg per kg of body weight
From 11 To 11 mg per kg of body weight once every 21 day(s)
The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.
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 parameter | Requirements before first siltuximab administration | Retreatment 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.
Siltuximab must be administered as an intravenous infusion given over 1 hour.
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