Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with Follicular Lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

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/002799/WC500171594.pdf

1. Approved Labelling

Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with Follicular Lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

2. Treatment Regimen

For patients with Follicular lymphoma (FL), the recommended dose of Gazyvaro in combination with bendamustine is shown in Table 1.

Table 1: Dose of Gazyvaro to be administered during 6 treatment cycles each of 28 days duration, followed by Gazyvaro maintenance for patients with FL

Cycle Day of treatment Dose of Gazyvaro
Cycle 1 Day 1 1,000 mg
Day 8 1,000 mg
Day 15 1,000 mg
Cycles 2-6 Day 1 1,000 mg
Maintenance Every two months for two years or until disease progression (whichever occurs first) 1,000 mg
Induction (in combination with bendamustine)
Cycle 1

The recommended dose of Gazyvaro in combination with bendamustine is 1,000 mg administered on Day 1, Day 8 and Day 15 of the first 28 day treatment cycle.

Cycles 2-6

The recommended dose of Gazyvaro in combination with bendamustine is 1,000 mg administered on Day 1 of each 28 day treatment cycle.

 

Patients who respond to induction treatment (i.e. the initial 6 treatment cycles) with Gazyvaro in combination with bendamustine or have stable disease should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for two years or until disease progression (whichever occurs first).

 

Six treatment cycles, each of 28 day duration, followed by maintenance once every two months for two years or until disease progression (whichever occurs first).

 

If a planned dose of Gazyvaro is missed, it should be administered as soon as possible; do not wait until the next planned dose. During induction, the planned treatment interval for Gazyvaro should be maintained between doses. During maintenance, maintain the original dosing schedule for subsequent doses. 

 

3. AE/Warnings

Please see section 4.4 of the SmPC.

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