Prescription medicine
Hyaluronidase and rituximab Brand names: Rituxan; first approved as Rituxan Hycela
Hyaluronidase and rituximab (Rituxan) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the hyaluronidase and rituximab FDA label on DailyMed (effective December 15, 2025, Genentech, Inc.); the BLA 761064 record on Drugs@FDA; every hyaluronidase and rituximab label on DailyMed.
Highlights of the record
FDA label of December 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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) ]. […]
Used for
From the label: indications and usageRITUXAN 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) ( 1.1 ) 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
Forms and strengths
- 120 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- June 22, 2017 Rituxan Hycela, Genentech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is hyaluronidase and rituximab used for?
From the label: indications and usageRITUXAN 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) ( 1.1 ) 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 cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy Diffuse Large B-cell Lymphoma […]
Conditions named in the indications of hyaluronidase and rituximab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD20-directed Cytolytic Antibody and Endoglycosidase.
Source: FDA drug label (Rituxan Hycela), Genentech, Inc., effective December 15, 2025 (SPL set 3e5b7e82-f018-4eaf-ae78-d6145a906b20), via openFDA; the full label on DailyMed
What does the patient leaflet for hyaluronidase and rituximab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about RITUXAN HYCELA?RITUXAN HYCELA can cause serious side effects that can lead to death, including: Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RITUXAN HYCELA: painful sores or ulcers on your skin, lips or in your mouth blisters peeling skin rash pustules Hepatitis B virus (HBV) reactivation. Before you receive RITUXAN HYCELA, your doctor will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving RITUXAN HYCELA could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure, and death. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RITUXAN HYCELA. Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes during treatment with RITUXAN HYCELA. Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive RITUXAN HYCELA. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any new or worsening symptoms or if anyone close to you notices these symptoms: confusion dizziness or loss of balance difficulty walking or talking decreased strength or weakness on one side of your body vision problems, such as blurred vision or loss of vision Serious allergic reactions and other severe reactions. […]
Source: FDA drug label (Rituxan Hycela), Genentech, Inc., effective December 15, 2025 (SPL set 3e5b7e82-f018-4eaf-ae78-d6145a906b20), via openFDA; the full label on DailyMed
Is there a generic for hyaluronidase and rituximab (Rituxan)?
No generic hyaluronidase and rituximab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the hyaluronidase and rituximab label say about other medicines?
The hyaluronidase and rituximab label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Premedicate patients with an antihistamine and acetaminophen prior to each administration of RITUXAN HYCELA [see Dosage and Administration (2.5) ]. |
| Cisplatin | drug interactions | Renal toxicity when used in combination with cisplatin. |
Source: FDA drug label (Rituxan Hycela), Genentech, Inc., effective December 15, 2025 (SPL set 3e5b7e82-f018-4eaf-ae78-d6145a906b20), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as hyaluronidase and rituximab?
6 other medicines are given the same way (subcutaneous) and in the same FDA class as hyaluronidase and rituximab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Elranatamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Epcoritamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Mosunetuzumab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Talquetamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Teclistamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Isatuximab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other cd20-directed cytolytic antibodys
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other