[90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with Follicular Lymphoma

Subtype:

Follicular Lymphoma (FL)

License:

EMA

Class:

CD20 MAb

Newly Diagnosed

SmPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000547/WC500049469.pdf

1. Approved Labelling

[90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with Follicular Lymphoma (FL).

2. Treatment Regimen

Zevalin must only be received, handled and administered by qualified personnel and must be prepared in accordance with both radiation safety and pharmaceutical quality requirements.

Zevalin must be used following pre-treatment with rituximab. Please refer to the Summary of Product Characteristics of rituximab for detailed guidance on its use.

The treatment regimen consists of two intravenous administration of rituximab and one administration of Zevalin solution in the following order:

  • Day 1: intravenous infusion of 250 mg/m2 rituximab
  • Day 7, 8 or 9:
    • Intravenous infusion of 250mg/m2 rituximab shortly (within 4 hours) before administration of Zevalin solution
    • 10-minute intravenous infusion of Zevalin solution

Repeated use: Data on the re-treatment of patients with Zevalin are not available.

The recommended radioactivity dose of Zevalin solution is:

  • Treatment of rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL):
    • Patients with ≥ 150,000 platelets/mm3: 15 MBq/kg body weight
    • Patients with 100,000-150,000 platelets/mm3: 11 MBq/kg
  • The maximum dose must not exceed 1200 MBq

Repeated use: Data on the re-treatment of patients with [90Y]-radiolabelled Zevalin are not available.

Consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.

  • Patients with ≥ 150,000 platelets/mm3: 15 MBq/kg up to a maximum of 1200 MBq
  • For patients with less than 150,000 platelets per mm3 see section 4.4

Repeated use: Data on the re-treatment of patients with [90Y]-radiolabelled Zevalin are not available.

Method of administration:

The [90Y]-radiolabelled Zevalin solution must be prepared according to section 12. Before administration to the patient, the percent radio incorporation of the prepared [90Y]-radiolabelled Zevalin must be checked according to the procedure outlined n section 12. If the average radiochemical purity is less than 95%, the preparation must not be administered.

The prepared solution must be given as a slow intravenous infusion over 10 minutes. The infusion must not be administered as an intravenous bolus.

Zevalin may be infused directly by stopping the flow from an infusion bag and administering it directly into the line. A 0.2 or 0.22-micron low protein binding filter must be on line between the patient and the infusion port. The line must be flushed with at least 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection after the infusion of Zevalin.

3. AE/Warnings

Please see section 4.4 of the SmPC.

 

 

 

 

 

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