Rituxan Hycela is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CLL

INN:

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

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, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated Chronic Lymphocytic Leukemia (CLL).

2. Treatment Regimen 

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

The recommended dose for CLL is Rituxan Hycela 1,600 mg/26,800 Units (1,600 mg rituximab and 26,800 Units hyaluronidase human) in combination with FC chemotherapy, at a fixed dose, irrespective of patient’s body surface area.

Administer Rituxan Hycela 1,600 mg/26,800 Units on Day 1 of Cycles 2–6 (every 28 days) for a total of 5 cycles following a full intravenous dose at Day 1, Cycle 1 (i.e., 6 cycles in total).

3. AE/Warnings

Please see section 5 of the PI.

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