Rituxan Hycela is indicated for the treatment of adult patients with previously untreated Follicular Lymphoma (FL) in combination with first line chemotherapy and in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy

INN:

Subtype:

Follicular Lymphoma (FL)

License:

FDA

Class:

CD20 monoclonal antibody

Newly Diagnosed

PIhttps://www.gene.com/download/pdf/rituxan_hycela_prescribing.pdf 

1. Approved Labelling 

Rituxan Hycela is indicated for the treatment of adult patients with previously untreated Follicular Lymphoma (FL) in combination with first line chemotherapy and in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.

2. Treatment Regimen 

All patients must receive at least one full dose of a rituximab product by intravenous infusion before starting treatment with Rituxan Hycela. 

The recommended dose is Rituxan Hycela  1,400 mg/23,400 Units (1,400 mg rituximab and 23,400 Units hyaluronidase human) subcutaneously at a fixed dose irrespective of patient’s body surface area according to the following schedules:

Previously Untreated FL

Administer on Day 1 of Cycles 2–8 of chemotherapy (every 21 days), for up to 7 cycles following a full dose of a rituximab product by intravenous infusion on Day 1 of Cycle 1 of chemotherapy (i.e., up to 8 cycles in total).

In patients with complete or partial response, initiate Rituxan Hycela maintenance treatment 8 weeks following completion of Rituxan Hycela in combination with chemotherapy. Administer Rituxan Hycela as a single-agent every 8 weeks for 12 doses.

3. AE/Warnings

Please see section 5 of the PI.

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