Rituximab Injection
Rituximab Injection (Rituxan) is an intravenous antibody medicine used to treat certain blood cancers (non-Hodgkin's lymphoma and chronic lymphocytic leukemia) and certain immune-related conditions (rheumatoid arthritis, GPA, MPA and pemphigus vulgaris).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Rituximab (Rituxan) is an IV antibody that destroys B cells, a type of white blood cell; used since 1997 and available as biosimilars, it is a cornerstone of non-Hodgkin's lymphoma and chronic lymphocytic leukemia treatment and also treats rheumatoid arthritis, GPA and MPA (forms of blood vessel inflammation) and the blistering skin disease pemphigus vulgaris. Most people handle it well, though the first infusion often brings fever, chills, itching or rash, and infections come more easily. Its boxed warning covers fatal infusion reactions, severe skin and mouth reactions, hepatitis B flare-ups (hence screening first) and PML, a rare brain infection, so report blisters, yellowing skin or new confusion promptly.
Clinical pearls
- Expect an antihistamine and acetaminophen before each infusion; the first infusion starts slowly, so plan for a long visit.
- Get any non-live vaccines at least 4 weeks before starting, and avoid live vaccines before and during treatment.
- Use effective contraception during treatment and for 12 months after the last dose, and avoid breastfeeding for 6 months after.
- In lymphoma, little or no urine after the first infusion can signal rapid tumor breakdown harming the kidneys; report it quickly.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Rituxan has a boxed warning, the strongest kind, for four serious risks.
- Infusion reactions: These can be fatal, usually within 24 hours. About 80% of fatal reactions happened with the first infusion. You are watched closely, and the infusion is stopped for severe reactions.
- Severe skin and mouth reactions: Some have been fatal.
- Hepatitis B reactivation: A past hepatitis B infection can flare up and cause liver failure or death. You are tested before treatment and monitored during and after it.
- PML: A rare, often fatal brain infection. Report new neurologic symptoms right away.
Patient information guide A plain-language walkthrough of Rituximab Injection, written from its FDA label.
What Rituximab Injection is used for
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Rituximab Injection (Rituxan) is used for several cancers and immune conditions:
- Non-Hodgkin's lymphoma in adults, including relapsed or refractory low-grade or follicular B-cell NHL, previously untreated follicular NHL, and previously untreated diffuse large B-cell NHL
- Previously untreated advanced mature B-cell lymphomas and B-cell acute leukemia in children 6 months and older, with chemotherapy
- Chronic lymphocytic leukemia in adults, with fludarabine and cyclophosphamide
- Moderately to severely active rheumatoid arthritis in adults, with methotrexate, after inadequate response to TNF blockers
- GPA and MPA in adults and children 2 years and older, with glucocorticoids
- Moderate to severe pemphigus vulgaris in adults
How Rituximab Injection works
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Rituximab is a monoclonal antibody that binds to CD20, a protein on the surface of B cells. Once attached, it triggers the destruction of those cells. B cells are involved in certain blood cancers and are also believed to contribute to inflammation in rheumatoid arthritis.
Rituximab Injection dosage
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Rituxan is given only by IV infusion in a medical setting. It is never given as a push or bolus.
- The schedule depends on your condition and other treatments.
- Medicines to reduce infusion reactions are given first.
- The first infusion starts slowly and is sped up as tolerated.
- Food does not apply, since it is given by IV. Ask your care team what to do if you miss an appointment.
Dosing details from the FDA-approved label
From the Rituximab Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adult and pediatric B-cell NHL
- 375 mg/m2 as an intravenous infusion
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL: once weekly for 4 or 8 doses
- Retreatment: once weekly for 4 doses
- Previously untreated follicular: Day 1 of each cycle of chemotherapy for up to 8 doses, then maintenance as a single agent every 8 weeks for 12 doses in patients with complete or
- Maximum: 16 doses (non-progressing, low-grade, CD20-positive B-cell NHL after first-line CVP)
- Pediatric patients aged 6 months and older with mature B-cell NHL/B-AL receive six infusions in combination with LMB chemotherapy
- Chronic lymphocytic leukemia (CLL)
- 375 mg/m2 the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2–6 (every 28 days)
- In combination with FC
- Component of Zevalin Therapeutic Regimen for NHL
- 250 mg/m2 in accordance with the Zevalin package insert
- Rheumatoid arthritis (RA)
- Two-1,000 mg intravenous infusions separated by 2 weeks
- Subsequent courses every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks
- Given with methotrexate; methylprednisolone 100 mg intravenous or equivalent glucocorticoid 30 minutes prior to each infusion is recommended
- Adult patients with active GPA and MPA (induction)
- 375 mg/m2 intravenous infusion once weekly for 4 weeks
- In combination with glucocorticoids: methylprednisolone 1,000 mg intravenously per day for 1 to 3 days followed by oral prednisone, beginning within 14 days prior to or with initiation of RITUXAN
- Adult patients with GPA and MPA (follow up after disease control)
- Two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation
- In combination with glucocorticoids
- Pediatric patients with GPA and MPA (induction)
- 375 mg/m2 once weekly for 4 weeks
- In combination with glucocorticoids
- Pediatric patients with GPA and MPA (follow up after disease control)
- Two 250 mg/m2 intravenous infusions separated by two weeks, followed by a 250 mg/m2 intravenous infusion every 6 months thereafter based on clinical evaluation
- In combination with glucocorticoids
- Pemphigus vulgaris (PV)
- Two-1,000 mg intravenous infusions separated by 2 weeks, then a 500 mg intravenous infusion at Month 12 and every 6 months thereafter or based on clinical evaluation
- Upon relapse: 1,000 mg intravenous infusion
- With a tapering course of glucocorticoids; subsequent infusions no sooner than 16 weeks after the previous infusion
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administer only as an intravenous infusion ( 2.1 ). Do not administer as an intravenous push or bolus ( 2.1 ). RITUXAN should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur. ( 2.1 ). The dose for adult and pediatric B-cell NHL is 375 mg/m 2 ( 2.2 ). The dose for CLL is 375 mg/m 2 in the first cycle and 500 mg/m 2 in cycles 2–6, in combination with FC, administered every 28 days ( 2.3 ). The dose as a component of Zevalin ® (ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m 2 ( 2.4 ). The dose for RA in combination with methotrexate is 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 intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion ( 2.5 ). The induction dose for adult patients with active GPA and MPA in combination with glucocorticoids is 375 mg/m 2 once weekly for 4 weeks. The follow up dose for adult patients with GPA and MPA who have achieved disease control with induction treatment, in combination with glucocorticoids is two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation ( 2.6 ). The induction dose for pediatric patients with GPA and MPA in combination with glucocorticoids is 375 mg/m 2 once weekly for 4 weeks. The follow up dose for pediatric patients with GPA and MPA who have achieved disease control with induction treatment, in combination with glucocorticoids is two 250 mg/m 2 intravenous infusions separated by two weeks, followed by a 250 mg/m 2 intravenous infusion every 6 months thereafter based on clinical evaluation ( 2.6 ). The dose for PV is two-1,000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids, then a 500 mg intravenous infusion at Month 12 and every 6 months thereafter or based on clinical evaluation. Dose upon relapse is a 1,000 mg intravenous infusion with considerations to resume or increase the glucocorticoid dose based on clinical evaluation. Subsequent infusions may be no sooner than 16 weeks after the previous infusion ( 2.7 ).
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Rituximab Injection side effects
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Common side effects include:
Common side effects
- Infusion-related reactions (fever, chills, itching, rash, nausea)
- Fever and chills
- Infections, including colds and urinary tract infections
- Weakness or tiredness (asthenia)
- Low white blood cell counts (lymphopenia, neutropenia)
- Headache
- Nausea and diarrhea
- Muscle spasms
When to get medical help
- Get help right away for trouble breathing, wheezing, swelling of the face or throat, dizziness, chest pain or fast or irregular heartbeat during or after an infusion.
- Tell your care team about blistering, peeling skin, or sores in the mouth or on the skin.
- Report yellowing of the skin or eyes, dark urine, or severe tiredness, which can signal hepatitis B reactivation.
- Report new confusion, vision changes, trouble walking, or weakness, which can signal PML (a rare brain infection).
- Call for fever, chills or other signs of infection.
- Report severe belly pain or repeated vomiting.
- Report little or no urine, or swelling, especially soon after the first infusion in lymphoma.
Seek help promptly for breathing trouble, severe skin reactions, signs of infection, liver symptoms, or new neurologic symptoms.
Rituximab Injection warnings and precautions
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The biggest risks are the boxed warnings: fatal infusion reactions, severe skin and mouth reactions, hepatitis B reactivation, and PML.
- Tumor lysis syndrome and kidney problems, mainly in lymphoma
- Serious infections, including fatal ones
- Heart rhythm problems and heart attack
- Bowel obstruction or perforation
- Harm to an unborn baby
Rituximab Injection interactions
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No formal interaction studies were done, but note:
- Cisplatin: linked to kidney toxicity with Rituxan.
- Live vaccines: not recommended, since safety has not been studied.
- Other biologics or DMARDs (besides methotrexate): watch closely for infection.
Interactions listed in the FDA-approved label
From the Rituximab Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Fludarabine or cyclophosphamide (patients with CLL): RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide.
- Methotrexate or cyclophosphamide (patients with RA): Concomitant administration did not alter the pharmacokinetics of rituximab.
- Cisplatin: Renal toxicity when used in combination with cisplatin. See Warnings and Precautions (5.8).
Read the label’s full interactions text
7 DRUG INTERACTIONS Formal drug interaction studies have not been performed with RITUXAN. In patients with CLL, RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical trials of patients with RA, concomitant administration of methotrexate or cyclophosphamide did not alter the pharmacokinetics of rituximab. Renal toxicity when used in combination with cisplatin ( 5.8 ).
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Rituximab Injection
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- Get tested for hepatitis B before starting.
- Tell your doctor about active infections, heart or lung problems.
- Pregnancy: use effective contraception during treatment and for 12 months after the last dose.
- Do not breastfeed during treatment and for 6 months after.
- Update vaccines before starting if possible.
- Older adults had more heart and lung reactions in lymphoma studies.
What Rituximab Injection does in the body
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Rituxan depletes B cells in the blood and tissues. In lymphoma studies, B cells began to recover at about 6 months and returned to normal by about 12 months. In rheumatoid arthritis, most patients had near-complete B-cell depletion within 2 weeks, and some immunoglobulin (antibody) levels dropped.
How your body processes Rituximab Injection
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Rituximab stays in the body a long time. In lymphoma, the typical half-life was about 22 days, and it was detectable in the blood 3 to 6 months after treatment. In CLL the half-life was about 32 days, and in rheumatoid arthritis about 18 days. Clearance rises with larger body size.
How to store Rituximab Injection
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Store RITUXAN vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Rituximab Injection
53 supplements and herbal products have documented interactions with Rituximab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 52
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Rituximab Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Rituximab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Rituxan for?
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How will I get it?
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What side effects should I expect?
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When should I call my doctor?
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Why do I need a hepatitis B test first?
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Is it safe in pregnancy or breastfeeding?
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Is Rituximab Injection available over the counter?
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When was Rituximab Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Rituximab Injection on HelloPharmacist
Rituximab Injection forms and strengths (how it comes)
Rituximab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Rituximab Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Rituxan is used for non-Hodgkin's lymphoma and chronic lymphocytic leukemia.
- Rituxan is used for rheumatoid arthritis with methotrexate after TNF blocker failure.
- Rituxan is used for GPA and MPA with glucocorticoids.
- Rituxan is used for moderate to severe pemphigus vulgaris in adults.
- Rituxan is given only as an intravenous infusion, never as an IV push or bolus.
- Rituxan should be given by a healthcare professional who can manage severe infusion reactions.
- Rituxan infusions are preceded by premedication such as an antihistamine and acetaminophen.
- Rituxan infusions may be slowed or paused if a reaction occurs.
Rituximab Injection on the U.S. market: products, makers and brands
How Rituximab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Rituximab Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1997. Brand names on the directory include Rituxan, Truxima, Ruxience and 1 more; the rest are generics.
How widely Rituximab Injection is used (Medicaid data)
A general measure of how commonly Rituximab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Rituximab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Rituximab Injection prescribed? Of the 1,601 medications we measure, Rituximab Injection ranks #743 by Medicaid prescriptions — more than 54% of them.
Utilization by Rituximab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
50 ML rituximab-pvvr 10 MG/ML Injection Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2273520
50 ML rituximab 10 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1657867
50 ML rituximab-abbs 10 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2105834
10 ML rituximab-pvvr 10 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2273512
50 ML rituximab-arrx 10 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2472335
10 ML rituximab-abbs 10 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2105826
10 ML rituximab 10 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1657862
10 ML rituximab-arrx 10 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2472327
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Rituximab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 8 of 11 listed Rituximab Injection NDCs with Medicaid activity.
Compare Rituximab Injection products
A representative set of FDA-listed product records for Rituximab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 10 mg/mL | Intravenous | Genentech, Inc. × 2 listings | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Rituximab Injection NDCs →
Rituximab Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Rituximab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Rituximab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Rituximab Injection FDA approval history
How Rituximab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Rituximab Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Rituximab recalls since July 2021.
✅No Rituximab recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 121191 1 dose form · 8 strengths
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Dose form (SCDF) Injection RxCUI 1657861In current FDA listingsClinical drug / strength (SCD) 10 ML rituximab 10 MG/MLRxCUI 165786210 ML rituximab-abbs 10 MG/MLRxCUI 210582610 ML rituximab-arrx 10 MG/MLRxCUI 247232710 ML rituximab-pvvr 10 MG/MLRxCUI 227351250 ML rituximab 10 MG/MLRxCUI 165786750 ML rituximab-abbs 10 MG/MLRxCUI 210583450 ML rituximab-arrx 10 MG/MLRxCUI 247233550 ML rituximab-pvvr 10 MG/MLRxCUI 2273520
Look up RxCUI 121191 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Rituximab Injection supply and shortage status
Whether Rituximab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Rituximab Injection brand names
Rituximab Injection is sold under 4 brand names in the FDA directory — Rituxan, Truxima, Ruxience, Riabni. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Rituximab Injection: manufacturers and labelers
One company lists Rituximab Injection products with the FDA. By number of product records, the largest are Genentech, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Rituximab Injection drug class (RxNorm)
Rituximab Injection belongs to the CD20-directed Cytolytic Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Rituximab Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →