Rituxan Hycela is indicated for the treatment of adult patients with previously untreated Diffuse Large B-cell Lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens

INN:

Subtype:

Diffuse Large B-Cell Lymphoma (DLBCL)

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 Diffuse Large B-cell Lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

2. Treatment Regimen 

All patients must receive at least one full dose of a rituximab product by intravenous infusion in combination with CHOP chemotherapy before starting treatment with Rituxan Hycela. Premedicate before each dose.

The recommended dose for DLBCL is Rituxan Hycela 1,400 mg/23,400 Units (1,400 mg rituximab and 23,400 Units hyaluronidase human) at a fixed dose irrespective of patient’s body surface area in combination with CHOP chemotherapy.

Administer Rituxan Hycela 1,400 mg/23,400 Units on Day 1 of Cycles 2–8 of CHOP chemotherapy for up to 7 cycles following a full dose of a rituximab product by intravenous infusion at Day 1, Cycle 1 of CHOP chemotherapy (i.e., up to 6–8 cycles in total).

3. AE/Warnings

Please see section 5 of the PI.

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