RITUXAN HYCELA
RITUXAN HYCELA is a combination of rituximab and hyaluronidase human indicated for the treatment of adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. Depending on the specific malignancy, the drug is used as a single agent, as maintenance therapy, or in combination with various chemotherapy regimens. Treatment must only be initiated after a patient has received at least one full dose of a rituximab product via intravenous infusion. This medication is intended for the treatment of malignancies and is not indicated for non-malignant conditions.
How RITUXAN HYCELA Works
Rituximab is a monoclonal antibody that targets the CD20 antigen on the surface of pre-B and mature B-lymphocytes, leading to B-cell lysis through complement-dependent and antibody-dependent cell-mediated cytotoxicity. Hyaluronidase human is an endoglycosidase that increases the permeability of subcutaneous tissue by temporarily depolymerizing hyaluronan in the extracellular matrix. This process increases the absorption rate of rituximab into the systemic circulation. The effects of hyaluronidase are local and reversible, with tissue permeability typically restored within 24 to 48 hours.
Details
- Status
- Prescription
- First Approved
- 2017-06-22
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
RITUXAN HYCELA Approval History
What RITUXAN HYCELA Treats
3 indicationsRITUXAN HYCELA is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Follicular Lymphoma
- Diffuse Large B-cell Lymphoma
- Chronic Lymphocytic Leukemia
RITUXAN HYCELA Boxed Warning
SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Severe mucocutaneous reactions, some with fatal outcomes ( 5.1 ). Hepatitis B virus reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.2 ). Progressive multifocal leuko...
WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Severe mucocutaneous reactions, some with fatal outcomes ( 5.1 ). Hepatitis B virus reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.2 ). Progressive multifocal leukoencephalopathy resulting in death ( 5.3 ). Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA [see Warnings and Precautions (5.1) ]. Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab-containing products, including RITUXAN HYCELA, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN HYCELA. Discontinue RITUXAN HYCELA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.2) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ].
RITUXAN HYCELA Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
RITUXAN HYCELA Competitors
Pro10 other drugs also target CD20. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD20). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RITUXAN HYCELA FDA Label Details
ProIndications & Usage
FDA Label (PDF)RITUXAN HYCELA is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult patients with: Follicular Lymphoma (FL) Relapsed or refractory, follicular lymphoma as a single agent Previously untreated follicular lymphoma 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 Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophos...
WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. S...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.