Rituximab

RITUXAN

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What it isCD20-directed monoclonal antibody depleting B cells; B-cell malignancies, rheumatoid arthritis, and ANCA vasculitis.

Why this oneIt remains a backbone of B-cell lymphoma therapy while also treating antibody-mediated autoimmune disease.

What limits it⚑ Hepatitis B reactivation can be fatal, so screen before treatment; infusion reactions, PML, and hypogammaglobulinemia also matter.

FDA label

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BOXED WARNING Fatal infusion-related reactions (~80% with first infusion); severe mucocutaneous reactions (some fatal); hepatitis B virus reactivation (fulminant hepatitis, hepatic failure, death); progressive multifocal leukoencephalopathy (PML), including fatal PML.

FDA dosing	Population	Start	Target
Non-Hodgkin's lymphoma (CD20+ B-cell)	Adult	375 mg/m² IV	weekly ×4–8 or on day 1 of each chemo cycle (per regimen)
Mature B-cell NHL / mature B-cell acute leukemia (with chemotherapy)	Peds ≥6 mo	375 mg/m² IV	6 infusions with LMB chemotherapy
Chronic lymphocytic leukemia (CD20+, with fludarabine/cyclophosphamide)	Adult	375 mg/m² IV cycle 1	500 mg/m² IV cycles 2–6 (every 28 days)
Rheumatoid arthritis (with methotrexate)	Adult	1,000 mg IV ×2 separated by 2 weeks	repeat every 24 weeks (no sooner than every 16 weeks)
Granulomatosis with polyangiitis / microscopic polyangiitis (with glucocorticoids)	Adult	375 mg/m² IV weekly ×4 (induction)	follow-up two 500 mg IV 2 weeks apart, then 500 mg every 6 months
Granulomatosis with polyangiitis / microscopic polyangiitis (with glucocorticoids)	Peds ≥2 yr	375 mg/m² IV weekly ×4 (induction)	follow-up two 250 mg/m² IV 2 weeks apart, then 250 mg/m² every 6 months
Pemphigus vulgaris (moderate to severe)	Adult	1,000 mg IV ×2 separated by 2 weeks (with tapering glucocorticoids)	500 mg IV at Month 12 and every 6 months thereafter

Renal Undefined

Hepatic Undefined

Dose and frequency are indication-specific (see indications).

Instructions

Give as IV infusion only — do not give as IV push or bolus; administered by a healthcare professional with support to manage severe infusion reactions
Premedicate with acetaminophen and an antihistamine before each infusion (add methylprednisolone 100 mg IV or equivalent for RA, GPA/MPA, and PV)
Screen all patients for HBV (HBsAg and anti-HBc) and obtain CBC with platelets before starting; monitor during and after therapy
PCP and herpesvirus prophylaxis for CLL (and PCP prophylaxis for GPA/MPA); avoid live virus vaccines
Females of reproductive potential: use effective contraception during and for 12 months after the last dose

Cautions

Infusion-related reactions (can be fatal)
Severe mucocutaneous reactions (some fatal)
Hepatitis B virus reactivation
Progressive multifocal leukoencephalopathy (PML)
Tumor lysis syndrome
Serious bacterial, fungal, and new/reactivated viral infections
Cardiovascular reactions (arrhythmia, MI, cardiogenic shock)
Renal toxicity
Bowel obstruction and perforation
Avoid live virus vaccines
Embryo-fetal toxicity

Adverse reactions

infusion-related reactions
fever
lymphopenia
chills
infection
asthenia
neutropenia (CLL)
upper respiratory tract infection (RA)
nausea/diarrhea/headache/muscle spasms (GPA/MPA)

Pregnancy Can cause fetal harm — B-cell lymphocytopenia in infants exposed in utero (human data). Advise of risk; effective contraception for 12 months after the last dose.

Lactation Limited data; low levels reported in human milk. Advise not to breastfeed during treatment and for 6 months after the last dose.

⚠ BOXED WARNINGS