Drug intelligence / Profile preview

rituximab and hyaluronidase human

Development stage
Approved
Lead developer
Roche
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

Rituximab + rHuPH20 (brand names Rituxan Hycela and MabThera SC) is a subcutaneous fixed-dose co-formulation of the CD20-directed cytolytic monoclonal antibody rituximab and recombinant human hyaluronidase (rHuPH20). Developed by Roche (including its subsidiary Genentech) in collaboration with Halozyme Therapeutics, this formulation utilizes Halozyme's Enhanze drug delivery technology. Recombinant human hyaluronidase temporarily degrades hyaluronan in the subcutaneous extracellular matrix, increasing tissue permeability and enabling the subcutaneous injection of large volumes of rituximab (1400 mg or 1600 mg) in just 5 to 7 minutes, compared to several hours for intravenous infusion. Rituximab + rHuPH20 is approved for the treatment of adult patients with CD20-positive B-cell malignancies, including previously untreated and relapsed/refractory follicular lymphoma (FL), previously untreated diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). It is administered only after patients have tolerated at least one full dose of intravenous rituximab.

Brand names
Rituxan HycelaMabThera SC
Other names
rituximab and hyaluronidaserituximab/hyaluronidase humanrituximab/hyaluronidaserituximab plus hyaluronidaserituximab + rHuPH20subcutaneous rituximab
02

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