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RIABNI (RITUXIMAB-ARRX)
RIABNI (generic name: RITUXIMAB-ARRX) is a CD20-directed Cytolytic Antibody [EPC] drug developed by AMGEN INC. It is currently FDA-approved.
RIABNI is a B-lymphocyte antigen CD20 binding agent used as a treatment for various conditions, including Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, and Diffuse Large B-Cell Lymphoma. It is administered in combination with other treatments, such as HDMP, rituximab, and venetoclax, as part of clinical trials to evaluate its efficacy in these conditions.
At a glance
| Generic name | RITUXIMAB-ARRX |
|---|---|
| Sponsor | AMGEN INC |
| Drug class | CD20-directed Cytolytic Antibody [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RIABNI infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RIABNI infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, 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 RIABNI. Discontinue RIABNI and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ] .
Common side effects
- Infusion-related reactions
- Lymphopenia
- Infection
- Fever
- Chills
- Asthenia
- Neutropenia
- Nausea
- Vomiting
- Pruritus
- Rash
- Urticaria
Serious adverse events
- Sepsis
- Grade 3-4 infusion-related reactions
- Grade 3-4 cytopenias
- Serious infections (Grade 3-4)
- Viral infections
- Bacterial infections
- Fungal infections
Key clinical trials
- Ibrutinib vs Ibrutinib + Rituximab (i vs iR) in Patients With Relapsed (CLL) (Phase 2)
- A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 (Phase 3)
- Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Ly (Phase 2)
- A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulin (Phase 2)
- Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma (Phase 3)
- Phase I/II, Open-Label Study of R-ICE (Rituximab-Ifosfamide-Carboplatin-Etoposide) With Lenalidomide (R2-ICE) in Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (Phase 1)
- A Phase I Study of Glofitamab With Alternating R-CHOP/R-DHAP in Previously Untreated Mantle Cell Lymphoma (Phase 1)
- A Phase I Study of MLN8237 in Combination With Bortezomib and Rituximab in Relapsed and Refractory Mantle Cell and Low Grade Non-Hodgkin Lymphoma (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- RIABNI CI brief — competitive landscape report
- RIABNI updates RSS · CI watch RSS
- AMGEN INC portfolio CI
Frequently asked questions about RIABNI
What is RIABNI?
RIABNI (RITUXIMAB-ARRX) is a CD20-directed Cytolytic Antibody [EPC] drug developed by AMGEN INC.
Who makes RIABNI?
RIABNI is developed and marketed by AMGEN INC (see full AMGEN INC pipeline at /company/amgen).
What is the generic name of RIABNI?
RITUXIMAB-ARRX is the generic (nonproprietary) name of RIABNI.
What drug class is RIABNI in?
RIABNI belongs to the CD20-directed Cytolytic Antibody [EPC] class. See all CD20-directed Cytolytic Antibody [EPC] drugs at /class/cd20-directed-cytolytic-antibody-epc.
What development phase is RIABNI in?
RIABNI is FDA-approved (marketed).
What are the side effects of RIABNI?
Common side effects of RIABNI include Infusion-related reactions, Lymphopenia, Infection, Fever, Chills, Asthenia. Serious adverse events: Sepsis, Grade 3-4 infusion-related reactions, Grade 3-4 cytopenias, Serious infections (Grade 3-4).
Related
- Drug class: All CD20-directed Cytolytic Antibody [EPC] drugs
- Manufacturer: AMGEN INC — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing