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Riabni

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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  • Product Details

    Description

    Riabni (rituximab-arrx) is a biosimilar to Rituxan (rituximab), a chimeric monoclonal antibody that targets the CD20 antigen found on the surface of pre-B and mature B lymphocytes. Riabni is indicated for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA) in combination with methotrexate, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). As a biosimilar, Riabni has been shown to be highly similar in safety, purity, and potency to the reference product, with no clinically meaningful differences.

    Fact Table

    Formula

    C6416H9874N1686O1987S44

    License

    US FDA (2020)

    Bioavailability

    100% (IV only)

    Legal status

    Rx-only

    Chemical Name

    Rituximab-arrx

    Elimination half-life

    18–22 days

    Dosage (Strength)

    100 mg/10 mL and 500 mg/50 mL single-dose vials

    Pregnancy

    May cause fetal harm; use only if benefits justify risks

    Brands

    Riabni (biosimilar to Rituxan)

    Protein binding

    Not applicable (monoclonal antibody)

    PubChem CID

    Not available (biologic)

    MedlinePlus

    a601240

    ChEBI

    Not available

    ATC code

    L01XC02

    DrugBank

    DB00073

    KEGG

    D08631

    Routes of administration

    Intravenous

    Directions

    Riabni is administered by intravenous (IV) infusion. Dosage and frequency vary by indication:

    For NHL and CLL: Administered in combination with chemotherapy regimens per treatment cycle schedules.

    For RA: 1000 mg IV on days 1 and 15, in combination with methotrexate, repeated every 24 weeks or based on disease activity.

    For GPA/MPA: Administered as 375 mg/m² IV once weekly for 4 weeks, or as per updated treatment protocols.

    Premedication with antihistamines and antipyretics is recommended prior to each infusion to reduce the risk of infusion-related reactions. Infusions should be administered under medical supervision with facilities available for managing anaphylaxis.

    Ingredients

    Active Ingredient: Rituximab-arrx

    Inactive Ingredients: Polysorbate 80, sodium chloride, sodium citrate, citric acid monohydrate, water for injection. The solution is preservative-free and requires dilution before IV infusion.

    Contraindications

    Riabni is contraindicated in patients with:

    Known severe hypersensitivity (e.g., anaphylaxis) to rituximab or any of the excipients

    Active, severe infections, including severe hepatitis B virus (HBV) infection

    Cautions

    Serious infusion reactions, including fatal reactions, have been reported. Monitor patients closely during and after infusion, especially the first dose. Reactivation of HBV can occur and may lead to fulminant hepatitis; screen all patients for HBV before initiation. Progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain infection, has been reported. Use with caution in patients with preexisting cardiovascular or pulmonary conditions. Immunizations should be completed prior to starting therapy when possible.

    Side Effects

    Common side effects include:

    Infusion-related reactions

    Fever

    Chills

    Fatigue

    Headache

    Nausea

    Infections (e.g., upper respiratory tract infections, bronchitis)

    Serious adverse effects may include:

    Severe infusion reactions

    Tumor lysis syndrome

    Hepatitis B reactivation

    Progressive multifocal leukoencephalopathy

    Severe mucocutaneous reactions

    Cytopenias

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 13951

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