FDA approved Riabni (rituximab-arrx) for Non-Hodgkin Lymphoma, CLL, RA, GPA/MPA, and Pemphigus VulgarisFDA approved Riabni for Five Serious Conditions Including Some Cancers

Riabni is a CD20-directed cytolytic antibody. The label does not provide further mechanistic detail.

Riabni is indicated for adult patients with: - Non-Hodgkin lymphoma (NHL): relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL as a single agent; previously untreated follicular, CD20-positive B-cell NHL in combination with first-line chemotherapy and, in patients achieving complete or partial response to a rituximab product with chemotherapy, as single-agent maintenance; non-progressing (including stable disease), low-grade, CD20-positive B-cell NHL as a single agent after first-line CVP chemotherapy; previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based regimens. - Chronic lymphocytic leukemia (CLL): previously untreated and previously treated CD20-positive CLL, in combination with fludarabine and cyclophosphamide (FC). - Rheumatoid arthritis (RA): moderately to severely active RA in adults with inadequate response to one or more TNF antagonist therapies, in combination with methotrexate. - Granulomatosis with polyangiitis (GPA, Wegener's granulomatosis) and microscopic polyangiitis (MPA): in combination with glucocorticoids. - Pemphigus vulgaris (PV): moderate to severe PV in adults.

Administer only as an intravenous infusion; do not administer as an intravenous push or bolus. Riabni should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions, which can be fatal. Premedicate before each infusion. - NHL: 375 mg/m2. - CLL: 375 mg/m2 in cycle 1 and 500 mg/m2 in cycles 2 to 6, with FC, every 28 days. - As a component of the Zevalin (ibritumomab tiuxetan) therapeutic regimen: 250 mg/m2. - RA: two 1,000 mg intravenous infusions separated by 2 weeks (one course) every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. Methylprednisolone 100 mg intravenously or equivalent glucocorticoid is recommended 30 minutes before each infusion. - GPA and MPA induction: 375 mg/m2 once weekly for 4 weeks with glucocorticoids. Follow-up dose for patients achieving disease control: two 500 mg intravenous infusions separated by two weeks, then 500 mg intravenously every 6 months thereafter based on clinical evaluation. - PV: two 1,000 mg intravenous infusions separated by 2 weeks with a tapering course of glucocorticoids, then 500 mg intravenously at Month 12 and every 6 months thereafter or based on clinical evaluation. Dose upon relapse is 1,000 mg intravenously, with consideration to resume or increase glucocorticoid dose based on clinical evaluation. Subsequent infusions may be no sooner than 16 weeks after the previous infusion. Methylprednisolone 100 mg intravenously or equivalent is recommended 30 minutes before each infusion.

Trial data not available in label.

Screen all patients for hepatitis B virus (HBV) infection by measuring HBsAg and anti-HBc before initiating treatment. Obtain complete blood counts including platelets prior to treatment. Severe infusion-related reactions can be fatal. The label text provided does not include a full contraindications section.

Riabni provides a CD20-directed cytolytic antibody option across B-cell malignancies and select autoimmune and inflammatory conditions, used as monotherapy or in combination with chemotherapy, methotrexate, or glucocorticoids depending on indication. It is