Rituxan Hycela is indicated for the treatment of adult patients with Non-progressing (including stable disease), Follicular Lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy

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 Non-progressing (including stable disease), Follicular Lymphoma (FL) as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

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:

Non-progressing, Follicular Lymphoma after first line CVP chemotherapy

Following completion of 6–8 cycles of CVP chemotherapy and a full dose of a rituximab product by intravenous infusion at week 1, administer once weekly for 3 weeks (i.e., 4 weeks in total) at 6 month intervals to a maximum of 16 doses

3. AE/Warnings

Please see section 5 of the PI.

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