1. Chronic Lymphocytic Leukemia (CLL): Treatment of CD20-positive CLL in adults in combination with fludarabine and cyclophosphamide. 2. Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA): Treatment in adults and pediatric patients ?2 years of age in combination with glucocorticoids. 3. Non-Hodgkin Lymphoma (NHL): Treatment of relapsed or refractory low-grade or follicular B-cell NHL, previously untreated follicular B-cell NHL, nonprogressing low-grade B-cell NHL, and previously untreated diffuse large B-cell lymphoma. 4. Pemphigus Vulgaris: Treatment of moderate to severe pemphigus vulgaris in adults. 5. Rheumatoid Arthritis (RA): In combination with methotrexate for moderately to severely active RA in adults with inadequate response to TNF antagonists.

Anticancer- Monoclonal antibodies

1. Onset: B-cell depletion occurs within 2 weeks in patients with rheumatoid arthritis and within 3 weeks in patients with non-Hodgkin lymphoma. 2. Distribution: Volume of distribution (Vd) ~3.1 L in adults with RA or GPA/MPA. 3. Half-life elimination: Median terminal half-life: 32 days (CLL), 22 days (NHL), 18 days (RA). 4. Excretion: Clearance ranges from 0.24 to 0.335 L/day depending on clinical condition.

There are no contraindications listed in the manufacturer's US labeling.

Crosses the placenta; may cause B-cell lymphocytopenia in infants <6 months. Contraception recommended during therapy and for 12 months after last dose. Discontinue once pregnancy is confirmed unless disease is life- or organ-threatening.

Detected in breast milk. Manufacturer recommends avoiding breastfeeding during treatment and for 6 months after last dose. Expert consensus considers it compatible with breastfeeding due to minimal gastrointestinal absorption.

Common (>10%): Infusion-related reactions (12–77%), fever (5–56%), infection (19–63%), fatigue (13–39%), headache, nausea, cytopenias (anemia, neutropenia, lymphocytopenia). Boxed warnings: Fatal infusion reactions, severe mucocutaneous reactions, HBV reactivation, PML.

Route: IV administration only; do not administer as IV push or bolus. Premedication: Recommended with acetaminophen and an antihistamine; methylprednisolone is often required 30 minutes prior for specific indications like RA or vasculitis. Infusion Rate: Initial infusion starts at 50 mg/hour, increasing by 50 mg/hour every 30 minutes to a maximum of 400 mg/hour. Preparation: Dilute to a final concentration of 1 to 4 mg/mL with NS or D5W

GPA/MPA (?2 years): Induction therapy typically uses 375 mg/m2 once weekly for 4 doses. Mature B-cell NHL/ALL: 375 mg/m2 administered in combination with chemotherapy protocols. Other uses (Off-label): Dosing for conditions like autoimmune hemolytic anemia or systemic lupus erythematosus is often 375 mg/m2 weekly.

No adjustment needed; not significantly removed by dialysis.

No adjustment needed for hepatic impairment, including Child-Pugh A–C.

1. Intact vials: 2–8°C; protect from light; do not freeze or shake. 2. Diluted solution: Stability varies by product; generally 2–8°C for 24 h, then room temperature for 24 h; some biosimilars allow longer refrigerated stability per manufacturer.